49
Endoscope Technology and Clinical Advancements Erin Kyle, DNP, RN, CNOR, NEA-BC
Endoscope Technology and Clinical Advancements
Erin Kyle DNP RN CNOR NEA-BC
Challenges call for innovation ndashand innovation leads to progress
Philipp Bozzini (1773-1809)
Bozzinirsquos Lichleiter
Endoscopy the beginning
Classic Challenges in Endoscopy
bull Visualization
bull Illumination
bull Optics
Modern Challenges in Endoscopy
is_190807_artificial_intelligence_ai_heart_rate_800x450jpg (234times160) (medscapestaticcom) hqdefaultjpg (480times360) (ytimgcom) This Photo by Unknown Author is licensed under CC BY
Artificial Intelligence Navigation Infection Prevention
Gastrointestinal Endoscopy
Digestive Endoscopy Volume 32 Issue 4 Pages 512-522 First published 08 July 2019 DOI (101111den13481)
Urology
bull Narrow band imaging (NBI)bull 2005
bull Light from 2 wavelengths blue (415 nm) and green (540 nm)
bull Bladder cancer diagnosis
bull Autofluorescence
bull Optical coherence
Narrow Band Imaging - an overview | ScienceDirect Topics
Narrow Band Imaging - an overview | ScienceDirect Topics
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Challenges call for innovation ndashand innovation leads to progress
Philipp Bozzini (1773-1809)
Bozzinirsquos Lichleiter
Endoscopy the beginning
Classic Challenges in Endoscopy
bull Visualization
bull Illumination
bull Optics
Modern Challenges in Endoscopy
is_190807_artificial_intelligence_ai_heart_rate_800x450jpg (234times160) (medscapestaticcom) hqdefaultjpg (480times360) (ytimgcom) This Photo by Unknown Author is licensed under CC BY
Artificial Intelligence Navigation Infection Prevention
Gastrointestinal Endoscopy
Digestive Endoscopy Volume 32 Issue 4 Pages 512-522 First published 08 July 2019 DOI (101111den13481)
Urology
bull Narrow band imaging (NBI)bull 2005
bull Light from 2 wavelengths blue (415 nm) and green (540 nm)
bull Bladder cancer diagnosis
bull Autofluorescence
bull Optical coherence
Narrow Band Imaging - an overview | ScienceDirect Topics
Narrow Band Imaging - an overview | ScienceDirect Topics
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Philipp Bozzini (1773-1809)
Bozzinirsquos Lichleiter
Endoscopy the beginning
Classic Challenges in Endoscopy
bull Visualization
bull Illumination
bull Optics
Modern Challenges in Endoscopy
is_190807_artificial_intelligence_ai_heart_rate_800x450jpg (234times160) (medscapestaticcom) hqdefaultjpg (480times360) (ytimgcom) This Photo by Unknown Author is licensed under CC BY
Artificial Intelligence Navigation Infection Prevention
Gastrointestinal Endoscopy
Digestive Endoscopy Volume 32 Issue 4 Pages 512-522 First published 08 July 2019 DOI (101111den13481)
Urology
bull Narrow band imaging (NBI)bull 2005
bull Light from 2 wavelengths blue (415 nm) and green (540 nm)
bull Bladder cancer diagnosis
bull Autofluorescence
bull Optical coherence
Narrow Band Imaging - an overview | ScienceDirect Topics
Narrow Band Imaging - an overview | ScienceDirect Topics
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Classic Challenges in Endoscopy
bull Visualization
bull Illumination
bull Optics
Modern Challenges in Endoscopy
is_190807_artificial_intelligence_ai_heart_rate_800x450jpg (234times160) (medscapestaticcom) hqdefaultjpg (480times360) (ytimgcom) This Photo by Unknown Author is licensed under CC BY
Artificial Intelligence Navigation Infection Prevention
Gastrointestinal Endoscopy
Digestive Endoscopy Volume 32 Issue 4 Pages 512-522 First published 08 July 2019 DOI (101111den13481)
Urology
bull Narrow band imaging (NBI)bull 2005
bull Light from 2 wavelengths blue (415 nm) and green (540 nm)
bull Bladder cancer diagnosis
bull Autofluorescence
bull Optical coherence
Narrow Band Imaging - an overview | ScienceDirect Topics
Narrow Band Imaging - an overview | ScienceDirect Topics
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Modern Challenges in Endoscopy
is_190807_artificial_intelligence_ai_heart_rate_800x450jpg (234times160) (medscapestaticcom) hqdefaultjpg (480times360) (ytimgcom) This Photo by Unknown Author is licensed under CC BY
Artificial Intelligence Navigation Infection Prevention
Gastrointestinal Endoscopy
Digestive Endoscopy Volume 32 Issue 4 Pages 512-522 First published 08 July 2019 DOI (101111den13481)
Urology
bull Narrow band imaging (NBI)bull 2005
bull Light from 2 wavelengths blue (415 nm) and green (540 nm)
bull Bladder cancer diagnosis
bull Autofluorescence
bull Optical coherence
Narrow Band Imaging - an overview | ScienceDirect Topics
Narrow Band Imaging - an overview | ScienceDirect Topics
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Gastrointestinal Endoscopy
Digestive Endoscopy Volume 32 Issue 4 Pages 512-522 First published 08 July 2019 DOI (101111den13481)
Urology
bull Narrow band imaging (NBI)bull 2005
bull Light from 2 wavelengths blue (415 nm) and green (540 nm)
bull Bladder cancer diagnosis
bull Autofluorescence
bull Optical coherence
Narrow Band Imaging - an overview | ScienceDirect Topics
Narrow Band Imaging - an overview | ScienceDirect Topics
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Urology
bull Narrow band imaging (NBI)bull 2005
bull Light from 2 wavelengths blue (415 nm) and green (540 nm)
bull Bladder cancer diagnosis
bull Autofluorescence
bull Optical coherence
Narrow Band Imaging - an overview | ScienceDirect Topics
Narrow Band Imaging - an overview | ScienceDirect Topics
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Pulmonology
bull Flexible bronchoscope commercialized - 1968
bull From the eyepiece to a video screen ndash 1987
bull First therapeutic use of bronchoscope ndash 1980 ndashNdYAG Laser
bull Autofluorescence bronchoscopy
bull EBUS ndash early 2000rsquos ndash ultrasound transducer at the tip
bull 2018 - Electromagnetic navigation-based technology
bull 2019 - Robotic-assisted endoluminal bronchoscopy for minimally invasive lung procedures Shape-sensing technology
EndobronchialUltrasound-imgjpg (765times536) (pulmonarypracticeassociatescom)
Intuitive | Robotic-Assisted Bronchoscopy | Ion Resources
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Navigation in Pulmonology
From Implications of Shape-Sensing Robotic Bronchoscopy in a Lung Cancer Practice httpsyoutubeCUyjBatRLfAt=424
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Key Takeaways
bull The challenges that we have faced in visualization illumination and optics for diagnosis and treatment of disease has resulted in profound innovation over the past 200 years of endoscopy
bull The challenges that we face today are leading to even more innovation in more advanced applications such as navigation and minimally invasive procedures
bull Innovations in infection prevention are foundational for patient safety in endoscopy
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Infection Prevention in Endoscopy
Because of recent outbreaks associated with multi-drug resistant organisms among patients who have undergone endoscopic procedures best practices and technology advancements in the area of infection prevention will be the focus of the remainder of todayrsquos presentation and part 2 of this series next week
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
References
bull Jeong BC (2018) Recent Technological Advances in Cystoscopy for the Detection of Bladder Cancer In Bladder Cancer Academic Press
bull PN Chhajed K Shibuya H Hoshino M Chiyo K Yasufuku K Hiroshima T Fujisawa (2005) A comparison of video and autofluorescence bronchoscopy in patients at high risk of lung cancer European Respiratory Journal 25 951-955
bull Gulati S Patel M Emmanuel A Haji A Hayee B and Neumann H (2020) The future of endoscopy Advances in endoscopic image innovations Digestive Endoscopy 32 512-522
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
AmbuCompany HistoryPioneering Single Use Endoscopy
Jens Kemp
Vice President of MarketingAmbu
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Ambu a Danish company was founded in 1937 by German Engineer HolgarHesse Ambu is historically known for inventing the self-inflating manual resuscitator
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Today Ambu is a rapidly growing Global Medtech Company
Supplies medical devices for hospitals and ambulances and specialty clinics
Global RampD amp manufacturing including USA
4000 employees worldwide almost 1000 in the US
Revenue 201920 USD 583m 26 growth
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Ambu has a long legacy of developing breakthrough innovations In 2009 Ambu launched the worlds first single use endoscope
2004AuraOnce
1958Ambu Manikin
1956Ambuventilation bag
1976BlueSensor
2013aScope 3 and aView
1991SPUR
2009aScope 1
2011KingVision
1996Concentric needle
2018aScope4
2019aScopeENT
Pioneer single use endoscopy
Launch the worldrsquos first
single use endoscope
2011aScope 2
2020aScope 4 Cysto
2020aScope Duodeno
2020aView2 Advance Monitor Platform
Successfully
enter ENT and
Urology Enter GI
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
In 2006 we asked ourselves How amp where was Ambu going to develop in the future and how do we move to more technology intensive products
Trend towards low cost image sensors Gold Standard Diff Airways still reusable
Single use electronics + Ambursquos expertise and manufacturing platform for single use
MD (plastics) + Markets that have not changed to single use
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
aScope 1 was launched in 2009 to address availability issues in the OR ER amp ICU for gold standard in difficult airway management
13 of airway deaths were associated with difficult tracheal intubation
ICU was the setting for less than 20 of events but counted for almost half the deaths
More than 60 of ICU events resulted in death or brain damage compared to 14 in anesthesia
Immediate access to a fiberscope for airway inspection or difficult airway management was a recurrent problem
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Today Ambu is the market leader in single use endoscopy with a clear ambition to be the most innovative single use endoscope company
Global pioneer and leader of single-use
endoscopy
Largest manufacturer of SU scopes gt1M scopes
last year
Market leading RampD and innovation within single use
endoscopy300+ RampD FTEs
One of the fastest growing companies in
MedTech
~400000 Ambu single use endoscopes used per year in US
3000 US hospitals using Ambusingle use endoscopes More than 95 of the top 500 US hospitals using Ambu Single Use bronchoscopes
Endoscopy field team of 300+ including close to 100 clinical specialists providing training and education for our customers
ALL major GPOs have Ambusingle use endoscopes on contract
Pulmonology ENT Urology GI
Ambu US today
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
At the core of Ambu is a unique RampD enginehellip
Modularization Rapid product introduction
Refining diagnostic assessments to
improve outcomes and workflows
EnhancedVisualization
Enabling next generation diagnostics
eg Ultra HD ultrasound
Facilitating integration of diagnostic and
therapeutic tools
Artificial Intelligence
WorkflowCompatibility
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
~4x more products launches than in the previous three years
201718 201819
GI
201920 202122
GI
202021
GI
GI
202223
8new
products
4new
products3
new products
2new
products0new
products
product launches new scopes and monitors
8new
products
hellipWhich allows us to scale our innovation output considerably 20 product launches planned for the next three years
ENT
Urology
Pulm
Pulm
Urology
ENT
Pulm
Urology
ENT
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Rapid growth in the past 10 years and strong market drivers
1440
96
200
364
560618
1085
1300-1400
1314 19201213 1415 1516 18191617 1718 2021
Infection control
Convenience
amp flexibility
RegulationsEconomics
Technology amp
Innovation
Single use
endoscopy
market
expected to
grow to $24bn
in 2024
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Multiple companies are now developing single use endoscopy and more a coming
1314 19201415 1516 18191617 1718 2021
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Thank you
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Flexible Endoscope Processing
Erin Kyle DNP RN CNOR NEA-BC
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Endoscope Processing Rooms or Areas
bull One or two-room design
bull Physically separated from patient care areas
bull Unidirectional workflow
bull Keep doors closed
bull HVAC design parameters
bull Safe work environment
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Precleaning at the Point of Use
Use
As soon as possible
after removal from the patient
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Transporting As soon as possible after the procedure
bull Leak proof
bull Puncture resistant
bull Large enough to contain all contents
Closed container or closed transport cart
Labeled with biohazard legend
bull Delayed processing procedures
Endoscope IFU for timeframeThis Photo by Unknown Author is licensed under CC BY-SA-NC
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Leak Testing
As described in the IFU
Before manual cleaning
Leak test failure
bull Remove from service for repair or replacement
Positive-leak-test-result-Air-bubbles-emitting-from-the-surface-of-the-bronchoscopepng (720times486) (researchgatenet)
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Manual Cleaning
As soon as possible after leak testing
In accordance with the IFU
bull Endoscope
bull Cleaning solution
Submerge
Exterior surfaces ndash clean amp soft lint-free cloth or sponge
Channels and distal end ndash clean brush
Actuate while cleaning
Elevator mechanism ndash raise and lower while brushing28_endoscope-cleaningjpg (900times600) (outpatientsurgerynet)
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Inspecting the Endoscope
bull Use illumination and magnification for inspection
bull Inspect internal channels using a camera or borescope
bull cleanlinessbull missing partsbull clarity of lensesbull integrity of seals and gasketsbull physical or chemical damagebull moisturebull function
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
High-Level Disinfection (HLD) Liquid Chemical Sterilization (LCS)
bull Automated systems preferred over manual processing
bull Follow IFU for endoscope and automated endoscope reprocessor(AER)
bull Verify securement of connectors
bull AERs have cleaning HLD rinse and dry cycles
bull Depends on the model
bull Dry the endoscope surfaces and lumens with pressure-regulated instrument air
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Packaging and Sterilization
bull If endoscope IFU allows package and sterilize the endoscope
bull Sterilization is preferred over HLD
gss67f-lowtemp-sterilization-1140-740jpg (1140times740) (getingecom)
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Storingbull Drying cabinet is preferred
bull If drying cabinet not available closed cabinet with HEPA-filtered air with positive pressure
bull Cabinet should be clean
bull Valves open and removed parts detached but with the endoscope
bull Visual identification of ready-to-use endoscope
bull Interdisciplinary team to determine storage time (ldquohang timerdquo)
drycabinet_filterjpg (464times329) (olympusamericacom)
scss8136dredp-dss3316_stainless-steel-suredry-16-scope-drying-cabinet-with-dri-scope-aid-electronic-lock-doors-
openjpg (1820times1820) (universalmedicalinccom)
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Maintaining Records
Include in records related to flexible endoscope procedures
date amp time of processing
patient identifier
procedure
identity of the practitioner
performing the procedure
identity of the endoscope amp
disposable endoscope
accessories used during the procedure
Records of endoscope processing that are traceable to the procedure and patient
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Initial and ongoing education and competency assessment
bull Controlling processing environment
bull Manufacturerrsquos IFU for the endoscope processing supplies equipment and accessories
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
Certification
Performance audits
sterile_processing-overview-imagepng (224times194) (halyardhealthcom)
Endoscope Processing Personnel Education
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
bull Controlling processing environment
bull Leak testing
bull Manual cleaning
bull Inspecting (eg lighted magnification and use of borescope)
bull HLD processes
bull LCS (liquid chemical sterilization) processes
bull Packaging and sterilization
bull Storage
bull Records and traceability
bull Quality assurance measures
bull Loaned endoscopes accessories and equipment
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Quality Management
bull Interdisciplinary team
bull Water quality
bull Preventative maintenance
bull Endoscopes
bull Automated endoscope repressors (AERs)
bull Other equipment (eg drying cabinets)
bull Performance audits
bull Evaluate need for microbiologic surveillance cultures
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
References amp Resourcesbull Guideline for cleaning and care of surgical instruments In Guidelines for Perioperative Practice Denver CO AORN
Inc 2021
bull Guideline for sterilization packaging systems In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for high level disinfection In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for sterilization In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull Guideline for flexible endoscope processing In Guidelines for Perioperative Practice Denver CO AORN Inc 2021
bull ANSIAAMI ST582013 Chemical Sterilization and High-Level Disinfection in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2013
bull ANSIAAMI ST902017 Processing of Health Care ProductsmdashQuality Management Systems for Processing in Health Care Facilities Arlington VA Association for the Advancement of Medical Instrumentation 2017
bull ANSIAAMI ST912015 Flexible and semi-rigid endoscope processing in health care facilities Arlington VA Association for the Advancement of Medical Instrumentation 2015
bull AAMI TIR342014(R) 2017 Water for the reprocessing of medical devices Arlington VA Association for the Advancement of Medical Instrumentation 2014
bull Rutala WA Weber DJ the Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008 Atlanta GA Centers for Disease Control and Prevention 2008
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Evolution of Reprocessing
Christian EscobarDirector of Marketing VisualizationAmbu
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Flexible Endoscopy Endoscope Reprocessing
bull Over the past 50 years flexible endoscopy has become a valuable clinical instrument in nearly every health care specialty
bull Reusable flexible endoscopes and the effort to ensure they are made ready for patient use ndash reprocessing ndash have evolved in an interlocking cadence of progress
bull Often the two critically connected components ndash endoscopes and reprocessing ndashevolved at different disconnected paces ndash creating challenges
bull Recently the evolution of reusable endoscopes has challenged the sustainability of cost-effective and time efficient reprocessing
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Correlating Evolutions A history and overview Endoscope Technology and Complex Reprocessing
Rigid Flexible Fiberoptic Flexible VideoModel and MFG
variation and expansion
Flexible Interventional Scopes (EBUS
Duodenoscopes)
Soap Detergent
Formaldehyde Glutaraldehyde OPA Peracetic Acid EtO Gas Plasma
Soaking RinsingLeak
TestingChannel
Scrubbing
Point-of-Care
cleaningAir Drying
Part Port Removals
Damage Repairs
Transport and
Storage
FDA CDCSocietal
GuidelinesHICPAC
Multi-Society Guidelines
Manufactures Instructions for
Use
Joint Commission
Inpatient Outpatient
Surgery Center Variations
Superbug Updates
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Why is there still risk regarding endoscopes and reprocessing
bull The complexity of the entire picture requires consistent adherence to processes and verifications across a wide-array of stakeholders in a high-pressure environment
bull Increases in patient-throughput and point of care locations not always met with capital or labor investment to support ndash leading to time crunches and pressurized scenarios
bull Equipment maintenance ndash ensuring no minor or major damage that could influence efficacy
bull Endoscopes and associated procedures continue to evolve in complexity
bull Superbug and other complex organic challenges
Endoscope Design
Cleaning Process Quality
Disinfection + Sterilization
Guidelines and Training
What about the perfect execution on reprocessing
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
2
Complexity Even in Ideal Performance of ReprocessingSystematic Reviews of Contamination and Infection Risk
Duodenoscopes1-2
Bronchoscopes3
Sources (1) Larsen et al 2020 Rate and impact of duodenoscope contamination A systematic review and meta-analysis EClinicalMedicine 25100451 (2) Barakat
et al 2020 Cost utility analysis comparing duodenoscope reprocessingsterilization novel duodenoscopes with disposable endcaps and fully disposable
duodenoscopes GIE 916 (3) Mouritsen et al 2020 A systematic review and cost effectiveness analysis of reusable vs single-use bronchoscopes Anaesthesia
75529-40
152
Patients with an infection attributable to
bronchoscopes
1 in 3828
153
Duodenoscopes contaminated after
reprocessing
1 in 7
Patients with an infection attributable to
duodenoscopes
1 in 50
Contamination Rate
Patient Infection Rate
Contamination Rate
Patient Infection Rate
Bronchoscopes contaminated after
reprocessing
1 in 7
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
The Reprocessing Sustainability Challenge Increasing patient throughput and point of care sites for endoscopy
bull Hospitals would like to increase endoscopy patient throughput
bull Reprocessing limitations will require more process and investment to meet demand ndashadding to cost complexity and attention
bull Ultimately - How to expand endoscopy use and point-of-care sites without adding to the process creating bottlenecks and pressure on stakeholders
One way to meet the growing demand for endoscopy while addressing the reprocessing
challengehellip
Adding single-use flexible endoscopyAre there ways to increase capacity
while simplifying process
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Single-Use Flexible Endoscopy Solution
No reprocessing required
Simplify point-of-care compliance without adding to the burden of staff and SPD
bull Solves design and process complexity challenges all together
bull Improves workflow efficiency for clinicians ndash simple plug-and-play use
bull Endoscopes are ready when needed at point of care
bull Eliminates all costs associated reusable scope inventory reprocessing repair loaners leak testing transport storage
bull Eliminates the risk associated with Superbug and aggressive organisms
bull Alleviates training demands with simple compliance approach
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
AmbuInnovating for Life
Endoscopy Solutions forPulmonology Critical Care OR
Gastroenterology
Otolaryngology
Urology
Anesthesia
Emergency Medicine
Thank you
Questions
Thank you
Questions
