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HLD and Sterilization:Current Issues and New Technologies
William A. Rutala, PhD, MPHDirector, Hospital Epidemiology, Occupational Health and Safety at UNC Health Care; Research Professor of
Medicine and Director, Statewide Program for Infection Control and Epidemiology at University of
North Carolina School of Medicine at Chapel Hill, USADisclosure: 3M
HLD and Sterilization:Current Issues and New Technologies
SterilizationCleaning, washer disinfector, emerging technologies,
biological indicators, outpatient surgeries/procedures High-Level Disinfection
Endoscope-related infections, new HLD, channeled scopes, laryngoscopes, reuse of single-use items
D/S and Emerging PathogensMERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola
www.disinfectionandsterilization.org
CDC Guideline for Disinfection and SterilizationRutala, Weber, HICPAC. November 2008. www.cdc.gov
Disinfection and Sterilization in Healthcare FacilitiesWA Rutala, DJ Weber, and HICPAC, www.cdc.gov
Overview Last Centers for Disease Control and Prevention guideline
in 1985 158 pages (>82 pages preamble, 34 pages
recommendations, glossary of terms, tables/figures, >1000 references)
Evidence-based guideline Cleared by HICPAC February 2003; delayed by FDA Published in November 2008
HLD and Sterilization:Current Issues and New Technologies
SterilizationCleaning, washer disinfector, emerging technologies,
biological indicators, outpatient surgeries/procedures High-Level Disinfection
Endoscope-related infections, new HLD, channeled scopes, laryngoscopes, reuse of single-use items
D/S and Emerging PathogensMERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola
Disinfection and SterilizationWA Rutala, DJ Weber, and HICPAC, www.cdc.gov
EH Spaulding believed that how an object will be disinfected depended on the object’s intended use.
CRITICAL - objects which enter normally sterile tissue or the vascular system or through which blood flows should be sterile.
SEMICRITICAL - objects that touch mucous membranes or skin that is not intact require a disinfection process (high-level disinfection [HLD]) that kills all microorganisms but high numbers of bacterial spores.
NONCRITICAL -objects that touch only intact skin require low-level disinfection (or non-germicidal detergent).
Efficacy of Disinfection/Sterilization Influencing Factors
WA Rutala, DJ Weber, and HICPAC, www.cdc.gov
Cleaning of the objectOrganic and inorganic load presentType and level of microbial contaminationConcentration of and exposure time to disinfectant/sterilantNature of the objectTemperature and relative humidity
Cleaning Items must be cleaned using water with detergents or
enzymatic cleaners before processing. Cleaning reduces the bioburden and removes foreign
material (organic residue and inorganic salts) that interferes with the sterilization process.
Cleaning and decontamination should be done as soon as possible after the items have been used as soiled materials become dried onto the instruments.
Cleaning Mechanical cleaning machines-automated equipment may
increase productivity, improve cleaning effectiveness, and decrease worker exposure Utensil washer-sanitizer Ultrasonic cleaner Washer sterilizer Dishwasher Washer disinfector
Manual
Bioburden on Surgical DevicesNon-lumen Surgical Instruments Carry a Low Microbial Load (<100 CFU, 85%)
Bioburden on instruments used in surgery (Nystrom, J Hosp Infect 1981) 62% contaminated with <101
82% contaminated with <102
91% contaminated with <103
Bioburden on surgical instruments (Rutala, Am J Infect Control 1997) 72% contained <101
86% contained <102
Bioburden on surgical instruments (50) submitted to CP (Rutala, AJIC 2014) 58% contained <10 20% contained < 102
16% contained <5x102
6% contained <103
Washer/DisinfectorRutala WA et al. Infect Control Hosp Epidemiol 2014;35:883-885
• Five Chambers Pre-wash: water/enzymatic is circulated over the load for 1 min Wash: detergent wash solution (150oF) is sprayed over load for 4 min Ultrasonic cleaning: basket is lowered into ultrasonic cleaning tank
with detergent for 4 min Thermal and lubricant rinse: hot water (180oF) is sprayed over load
for 1 min; instrument milk lubricant is added to the water and is sprayed over the load
Drying: blower starts for 4 min and temperature in drying chamber 180F
Washer/DisinfectorRemoval/Inactivation of Inoculum (Exposed) on Instruments
Rutala et al. Infect Control Hosp Epidemiol 2014. 35:883-885.
WD Conditions Organism Inoculum Log Reduction Positives
Routine MRSA 2.6x107 Complete 0/8
Routine VRE 2.6x107 Complete 0/8
Routine P aeruginosa 2.1x107 Complete 0/8
Routine M terrae 1.4x108 7.8 2/8
Routine GS spores 5.3x106 4.8 11/14
No Enz/Det VRE 2.5x107 Complete 0/10
No Enz/Det GS spores 8.3x106 5.5 8/10
Washer/disinfectors are very effective (>7 log10 reduction) in removing/inactivating
microorganisms from instruments
Cleaning Indicators for Washer Disinfector Monitor the automated washer and
instrument cleaning chemistry functionality; AAMI recommends weekly (preferably daily)
Washer indicators have been used in Europe and Canada and some US hospitals
Indicator includes proteins, lipids, and polysaccharides to mimic common challenging test soils
Washer indicators are chemical indicators imprinted with a dried test soil formula and a dye
How Clean Is Clean? AAMI and FDA trying to gain consensus Reached consensus on maximum levels of top three common markers
after a device is cleaned Less than 6.4 µg/cm2 for protein Less than 12 µg/cm2 for total organic compound Less than 2.2 µg/cm2 for hemoglobin
Research needs to be performed to determine how healthcare facilities should verify cleanliness (real-time tests and meaningful analytical endpoints)
Manufacturers’ ensure the HCF can clean the device (time, resources, device design)
Methods in Sterilization
Sterilization of “Critical Objects”
Steam sterilization-1970sEthylene oxide-1970s
Hydrogen peroxide gas plasma-1993Vaporized hydrogen peroxide-2011
Emerging Technologies
Ozone and Hydrogen Peroxide
Sterizone VP4, 510(k) FDA clearance,TSO3 Canada Sterilizer has a 4.4ft3 chamber Advantages/Disadvantages-not yet known
Nitrogen Dioxide(Noxilizer, MD 2004; seeking industrial claim; 2016 HC)
NO2 has unique properties including a low boiling point (21oC) and a high vapor pressure, which facilitate effective dispersion of NO2 gas at low concentration
Log-linear inactivation at 3.5mg/L NO2 gas concentration and 75% RH using G. stearothermophilus spores
Toxicity-OSHA PEL for NO2 is 5ppm Compatible with most polymers used in medical devices
New LTST Technology Supercritical CO2
Peracetic acid vapor Gaseous chlorine dioxide
Biological Indicators • Select BIs that contain spores of
Bacillus atrophaeus
• Rationale: BIs are the onlysterilization process monitoringdevice that provides a direct measure of the lethality of the process
Bacillus atrophaeus
Rapid Readout BIs for Steam Now Require a 1-3h Readout Compared to 24-48h
Rutala, Jones, Weber ICHE 1996. 17:423
Super Rapid Readout Biological IndicatorsCommercially available
1491 BI (blue cap)• Monitors 270°F and 275°F gravity –displacement steam sterilization cycles• 30 minute result (from 1hour)
1492V BI (brown cap)• Monitors 270°F and 275°F dynamic-air-removal (pre-vacuum) steam sterilization cycles• 1 hour result (from 3 hours)
Routine Load Release/Routine Sterilizer Efficacy Monitoring Ethylene Oxide Sterilizers
BI Process Challenge Device• BI placed in PCD representative of
packs being sterilized• AAMI routine test pack or commercially
available, FDA cleared BI PCD• Placement: Full load in center• Frequency: in each load• Attest™ 1298 Test Pack contains Attest
1294™ Rapid Readout BI for EO with 4 hour final result
ANSI/AAMI ST41:2008( R)2012, Section 10
US Outpatient Surgery/Procedures Pass
Inpatient Surgery/Procedure
Outpatient vs Inpatient Surgery/Procedure2010, US DHHS
Top 10 Outpatient Surg/Proc-53M Lens and cataract procedures-7M Endoscopy of large intestine-5.7M Endoscopy of small intestine-3.4M Therapeutic injections-1.4M Coronary artery exam-1M Knee arthroscopy-~1M Hernia repair-~1M Tonsillectomy/adenoidectomy-750K Cystoscopy-750K
Top 10 Inpatient Surg/Proc-46M Coronary artery exam-1M C-section 1.3M Cardiac cath-1.1M Endoscopy of small intestine-1M Diagnostic ultrasound-~900K CAT scans-740K Realign broken bone-672K Balloon angioplasty of coronary-661K Coronary artery stent-661K
HLD and Sterilization:Current Issues and New Technologies
SterilizationCleaning, washer disinfector, emerging technologies,
biological indicators, outpatient surgeries/procedures High-Level Disinfection
Endoscope-related infections, new HLD, channeled scopes, laryngoscopes, reuse of single-use items
D/S and Emerging PathogensMERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola
DISINFECTION AND STERILIZATION
• EH Spaulding believed that how an object will be disinfected depended on the object’s intended use CRITICAL - objects which enter normally sterile tissue or the
vascular system or through which blood flows should be sterile SEMICRITICAL - objects that touch mucous membranes or skin
that is not intact require a disinfection process (high-level disinfection[HLD]) that kills all microorganisms except for high numbers of bacterial spores
NONCRITICAL - objects that touch only intact skin require low-level disinfection
High-Level Disinfection of “Semicritical Objects”
Exposure Time > 8m-45m (US), 20oCGermicide Concentration_____Glutaraldehyde > 2.0%Ortho-phthalaldehyde 0.55%Hydrogen peroxide* 7.5%Hydrogen peroxide and peracetic acid* 1.0%/0.08%Hydrogen peroxide and peracetic acid* 7.5%/0.23%Hypochlorite (free chlorine)* 650-675 ppmAccelerated hydrogen peroxide 2.0%Peracetic acid 0.2%Glut and isopropanol 3.4%/26%Glut and phenol/phenate** 1.21%/1.93%___*May cause cosmetic and functional damage; **efficacy not verified
ResertTM HLD High Level Disinfectant - Chemosterilant 2% hydrogen peroxide, in formulation
pH stabilizers Chelating agents Corrosion inhibitors
Efficacy (claims need verification) Sporicidal, virucidal, bactericidal, tuberculocidal, fungicidal
HLD: 8 mins at 20oC Odorless, non-staining, ready-to-use No special shipping or venting requirements Manual or automated applications 12-month shelf life, 21 days reuse Material compatibility/organic material resistance (Fe, Cu)?
*The Accelerated Hydrogen Peroxide technology and logo are the property of Virox Technologies, Inc. Modified from G MacDonald. AJIC 2006;34:571
Reprocessing Semicritical Items
New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate probes Laryngoscopes
Reprocessing Semicritical Items
New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate probes Laryngoscopes
“Superbug” Outbreaks
Cedars-Sinai Medical Center, UCLA Ronald Reagan Medical Center, University of Pittsburgh Medical Center, Virginia Mason Medical Center, tertiary care facility in NE Illinois
ABC, CBS, NBC, CNN, New York Times, LA Times Congress asked the FDA why “didn’t move more quickly and
aggressively to ensure patient safety” Professional organizations (ASGE, AGA) and FDA
investigating
GI ENDOSCOPES Widely used diagnostic and therapeutic procedure (~20 million GI
procedures annually in the US) GI endoscope contamination during use (107-10 in/105 out) Semicritical items require high-level disinfection minimally Inappropriate cleaning and disinfection has lead to cross-transmission In the inanimate environment, although the incidence remains very
low, endoscopes represent a significant risk of disease transmission. In fact, more outbreaks of infection associated with endoscopes than any reusable medical device in healthcare.
Transmission of Infection by EndoscopyKovaleva et al. Clin Microbiol Rev 2013. 26:231-254
Scope Outbreaks Micro (primary) Pts Contaminated
Pts Infected Cause (primary)
Upper GI 19 Pa, H. pylori, Salmonella
169 56 Cleaning/Dis-infection (C/D)
Sigmoid/Colonoscopy
5 Salmonella, HCV 14 6 Cleaning/Dis-infection
ERCP 23 Pa 152 89 C/D, water bottle, AER
Bronchoscopy 51 Pa, Mtb,Mycobacteria
778 98 C/D, AER, water
Totals 98 1113 249Based on outbreak data, if eliminated deficiencies associated with cleaning, disinfection, AER , contaminated water and drying would eliminate about 85% of the outbreaks.
Nosocomial Infections via GI Endoscopes• Infections traced to deficient practices
Inadequate cleaning (clean all channels) Inappropriate/ineffective disinfection (time exposure, perfuse
channels, test concentration, ineffective disinfectant, inappropriate disinfectant)
Failure to follow recommended disinfection practices (tapwater rinse)
Flaws and complexity in design of endoscopes or AERs
Recent Outbreaks When Manufacturer’s Instructions and Professional Guidelines Followed
Epstein et al. JAMA 2014;312:1447-1455 (NE IL) Wendorf et al. ICHE 2015 (Seattle) At least four other CRE outbreaks related to ERCP
UCLA Ronald Reagan Medical Center Cedar Sinai Medical Center Univ of Pittsburgh Medical Center Wisconsin medical facility
ENDOSCOPE REPROCESSING: CHALLENGESNDM-Producing E. coli Associated ERCP
MMWR 2014;62:1051; Epstein et al. JAMA 2014;312:1447-1455
NDM-producing E.coli recovered from elevator channel (elevator channel orients catheters, guide wires and accessories into the endoscope visual field; crevices difficult to access with cleaning brush and may impede effective reprocessing or killing CRE)
Reason for Endoscope-Related OutbreaksRutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Margin of safety with endoscope reprocessing minimal or non-existent for two reasons:
Microbial load GI endoscopes contain 107-10
Cleaning results in 2-6 log10 reduction
High-level disinfection results in 4-6 log10 reduction
Results in a total 6-12 log10 reduction of microbes
Level of contamination after processing: 4 log10 (maximum contamination, minimal cleaning/HLD)
Complexity of endoscope
Reason for Endoscope-Related OutbreaksRutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Margin of safety with endoscope reprocessing minimal or non-existent Microbial load
GI endoscopes contain 107-10
Cleaning results in 2-6 log10 reduction
High-level disinfection results in 4-6 log10 reduction
Results in a total 6-12 log10 reduction of microbes
Level of contamination after processing: 4log10 (maximum contamination, minimal cleaning/HLD)
Complexity of endoscope Biofilms-unclear if contribute to failure of endoscope reprocessing
BIOFILMS(Multi-layered bacteria plus exopolysaccharides that cement cell to surface; develop in wet environments; if reprocessing performed promptly after use and endoscope dry the
opportunity for biofilm formation is minimal)
Reason for Endoscope-Related OutbreaksRutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Margin of safety with endoscope reprocessing minimal or non-existent for two reasons:
Microbial load GI endoscopes contain 107-10
Cleaning results in 2-6 log10 reduction
High-level disinfection results in 4-6 log10 reduction
Results in a total 6-12 log10 reduction of microbes
Level of contamination after processing: 4log10 (maximum contamination, minimal cleaning/HLD
Complexity of endoscope
ENDOSCOPE REPROCESSING: CHALLENGES
Complex [elevator channel]-109 bacteria Surgical instruments-<102 bacteria
ENDOSCOPE REPROCESSING
FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES
Heat labile Long, narrow lumens Right angle bends Rough or pitted surfaces Springs and valves Damaged channels may impede
microbial exposure to HLD Heavily contaminated with
pathogens, 107-10
Cleaning (4-6 log10 reduction) and HLD (4-6 log10 reduction) essential for patient safe instrument
What Should We Do Now?
Current Enhanced Methods for Reprocessing Duodenoscopes
Hospitals performing ERCPs should do one of the following (priority ranked); doing nothing is not an option:Ethylene oxide sterilization after high level disinfection with periodic microbiologic surveillanceDouble high-level disinfection with periodic microbiologic surveillanceHigh-level disinfection with scope quarantine until negative cultureLiquid chemical sterilant processing system using peracetic acid (rinsed with extensively treated potable water) with periodic microbiologic surveillanceHigh-level disinfection with periodic microbiologic surveillance
Summary of Advantages and Disadvantages of HLD and Sterilization Enhancements for Reprocessing Duodenoscopes
Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Method Advantages Disadvantages
HLD with ETO
• Major endoscope manufacturer offers ETO as sterilization option
• Ideally, should be used after standard high-level disinfection
• Some data demonstrate reduced infection risk with HLD followed by ETO
• Single-dose cartridge and negative- pressure chamber minimizes the potential for gas leak and ETO exposure
• Simple to operate and monitor• Compatible with most medical materials
• Requires aeration time to remove ETO residue
• Only 20% of US hospitals have ETO on-site
• Lengthy cycle/aeration time• No microbicidal efficacy data
proving SAL 10-6 achieved• Studies question microbicidal
activity in presence of organic matter/salt
• ETO is toxic, a carcinogen, flammable
• May damage endoscope
Summary of Advantages and Disadvantages of HLD and Sterilization Enhancements for Reprocessing Duodenoscopes
Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Method Advantages Disadvantages
HLD, Microbiologic surveillance
• HLD inactivate MDR organisms including CREs
• Microbiologic surveillance offered as supplement by CDC
• Based on recent ERCP outbreaks, infection risk related to device complexity and microbial load
• No data demonstrating reduced infection risk
• Sensitivity of microbiologic surveillance unknown
• 48-72 hours before culture results known
• No consensus regarding sampling scheme, 100% or 10% of scopes per week/per month?
• No cutoff to define effective disinfection (0 GNR?)
Summary of Advantages and Disadvantages of HLD and Sterilization Enhancements for Reprocessing Duodenoscopes
Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Method Advantages Disadvantages
HLD only (not listed as an enhanced method for reprocessing endoscope)
• HLD inactivate MDR organisms including CREs
• Current standard of care• Wide availability
• Based on recent ERCP outbreaks, infection risk related to device complexity and microbial load
• No enhancement to reduce infection risk associated with ERCP scopes
• Some HLD (e.g., aldehydes) may cross-link proteins
Summary of Advantages and Disadvantages of HLD and Sterilization Enhancements for Reprocessing Duodenoscopes
Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Method Advantages Disadvantages
HLD, ATP (not listed as an enhanced method for reprocessing endoscope)
• HLD inactivate MDR organisms including CREs
• Real-time monitoring tool• Simple to conduct• Detects organic residue
• Based on recent ERCP outbreaks, infection risk related to device complexity and microbial load
• No data demonstrating reduced infection risk
• Does not detect microbial contamination
• ATP not validated as risk factor for patient-to-patient transmission
• Unknown cut-off level to assure safety
Adenosine Triphosphate (ATP) ValidationAlfa et al. Am J Infect Control 2013;41:245
Validated as a monitoring tool for assessing cleaning because it detects organic residuals
ATP is not a good indicator of microbial contamination and has not been validated as a method to assess the risk of patient-to-patient transmission
ATP <200 RLU benchmark for clean, equates to <4 log10 CFUs/cm2 or 106 CFUs per endoscope
Thus, an endoscope assessed as clean using ATP could still have a significant microbial load (e.g., 106)
To protect the public health we must shift endoscope reprocessing from HLD
to sterilization. FDA should mandate that GI endoscopes used in healthcare
facilities be sterile by 2018.
GI Endoscopes: Shift from Disinfection to Sterilization
Rutala, Weber. JAMA 2014. 312:1405-1406
Potential Future Methods to Prevent GI-Endoscope Related Outbreaks
Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press
Steam sterilizable GI endoscopes New low temperature sterilization methods proving SAL 10-6
achieved (or optimizing current LTST) Disposable sterile GI endoscopes Improved GI endoscope design (to reduce or eliminate
challenges listed above) Use of non-endoscope methods to diagnosis or treat disease
(e.g., capsule endoscopy, blood tests to detect GI cancer, stool DNA test)
Reprocessing Semicritical Items
New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate probes Laryngoscopes
Reprocessing Channeled EndoscopesCystoscopes, Ureteroscopes, Hysteroscopes
Reprocessing Channeled EndoscopesRutala, Gergen, Bringhurst, Weber. 2015
Exposure Method
VRE Contamination Before HLD (glutaraldehyde)
VRE Contamination After HLD
Passive HLD(immersed, not perfused)
3.6x108
2.0x108
1.1x108
7.5x108
1.0x108
6.8x107
Active HLD (perfused HLD into channel with syringe)
8.4x107
1.5x108
2.8x108
1 CFU00
Pathogens must have exposure to HLD for inactivation
Immerse channeled flexible scope into HLD will not inactivate channel pathogens
Completely immerse the endoscope in HLD and ensure all channels are perfused
Air pressure in channel stronger than fluid pressure at fluid-air interface
Prostate Biopsy Probe Evaluated effectiveness of HLD when assembled (needle
biopsy holder in probe) and unassembled. Inoculated (106-107 P.aeruginosa): internal lumen/outside
surface of needle biopsy holder; internal lumen of probe with and without needle biopsy holder in place
Conclusion: HLD achieved when unassembled but not when assembled
Disinfection of Prostate ProbeRutala, Gergen, Weber. ICHE. 2007;28:916
Needle guide must be removed from the probe for disinfection
Disinfection of Prostate ProbeRutala, Gergen, Weber. ICHE; 2007;28:916
Do Not Reuse Single Use Devices Federal judge convicted a
urologist who reused needle guides meant for single use during prostate procedures (Sept 2014)
Third party reprocessor OK Criminal prosecution
(based on conspiracy to commit adulteration)
Reprocessing of Rigid LaryngoscopesJHI 2008, 68:101; ICHE 2007, 28:504; AJIC 2007, 35: 536
Limited guidelines for reprocessing laryngoscope’s blades and handles
Many hospitals consider blade as semicritical (HLD) and handle as noncritical (LLD)
Blades linked to HAIs; handles not directly linked to HAIs but contamination with blood/OPIM suggest its potential and blade and handle function together
Ideally, clean then HLD/sterilize blades and handles (UNCHC-blades wrapped in a tray-Sterrad; handle wrapped in tray [without batteries]-steam); the blades and handles placed together in a Ziploc bag. Blades and handles checked for function prior to packaging.
Contamination of Laryngoscope Handles
J Hosp Infect 2010;74:123 55/64 (86%) of the handles deemed “ready for patient use” positive for
S. aureus, enterococci, Klebsiella, Acinetobacter
Anesth Analg 2009;109:479 30/40 (75%) samples from handles positive (CONS, Bacillus,
Streptococcus, S. aureus, Enterococcus) after cleaning
AANA J 1997;65:241 26/65 (40%) of the handles and 13/65 (20%) of the blades were positive
for occult blood. These blades and handles were identified as ready for patient use.
Laryngoscopes BladesThe Joint Commission, FAQ, October 24, 2011
How should we process and store laryngoscope blades? Processed via sterilization or HLD Packaged in some way Stored in a way that prevents recontamination. Examples
of compliant storage include, but are not limited to, a peel pack post steam sterilization (long-term) or wrapping in a sterile towel (short term)
Should not place unwrapped blades in an anesthesia drawer
HLD and Sterilization:Current Issues and New Technologies
SterilizationCleaning, washer disinfector, emerging technologies,
biological indicators, outpatient surgeries/procedures High-Level Disinfection
Endoscope-related infections, new HLD, channeled scopes, laryngoscopes, reuse of single-use items
D/S and Emerging PathogensMERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola
Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants
PrionsBacterial spores (C. difficile)
MycobacteriaSmall, non-enveloped viruses (HPV, polio, EV-D68)
Fungal sporesGram-negative bacilli (Acinetobacter)
Vegetative fungi and algaeLarge, non-enveloped viruses
Gram-positive bacteria (MRSA, VRE)Enveloped viruses (Ebola, MERS-CoV)
Most Resistant
Most Susceptible
LLD-kill microbes in “green”; HLD kill microbes in “blue”
Norovirus, C. difficile spores, MERS-CoV, Enterovirus D68, Ebola, MDR organisms such carbapenemase-
producing Enterobacteriaceae (CRE)
•In general, emerging pathogens are susceptible to currently available
disinfectants. However, some pathogens need additional information (e.g., prions,
C. difficile spores).
Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants
PrionsBacterial spores (C. difficile)
MycobacteriaSmall, non-enveloped viruses (HPV, polio, EV-D68)
Fungal sporesGram-negative bacilli (Acinetobacter)
Vegetative fungi and algaeLarge, non-enveloped viruses
Gram-positive bacteria (MRSA, VRE)Enveloped viruses (Ebola, MERS-CoV)
Most Resistant
Most Susceptible
C. Difficile Spores EPA-Registered Products
• List K: EPA’s Registered Antimicrobials Products Effective Against C. difficile spores, April 2014
• http://www.epa.gov/oppad001/list_k_clostridium.pdf• 34 registered products; most chlorine-based, some
HP/PA-based, PA with silver
SHEA Prion GuidelineRutala, Weber. Infect Control Hosp Epidemiol 2010;31:107
Management of Neurosurgical Instruments and Patients Exposed to CJD
Conventional sterilization/disinfection inadequate for prions. Need special prion reprocessing (critical/semi device contaminated with high risk tissue from high-risk patient)
Belay et al. ICHE 2014;34:1272. Decontamination options combine chemical and SS-1) immerse in 1N NaOH and heat in gravity at ≥121C for 30m in appropriate container; 2) immerse in 1N NaOH or NaOCl 20,000ppm 1h then transfer into water and autoclave at ≥121C for 1h; 3) immerse in 1N NaOH or NaOCl 20,000ppm 1h, rinse with water, transfer to pan and autoclave at 121C (gravity) or 134C (porous) for 1 hour. Clean and sterilize by conventional means.
Thomas et al. J Clin Neurosci 2013;20:1207. Reviews prevention strategies McDonnell et al. J Hosp Infect. 2013;85:268. Investigates the combination of cleaning,
disinfection and/or sterilization on prions Rutala, Weber. ICHE 2010;31:107. SHEA Guideline-134C for 18m in prevacuum or
NaOH/autoclave (such as CDC option 2)
HLD and Sterilization:Current Issues and New Technologies
SterilizationCleaning, washer disinfector, emerging technologies,
biological indicators, outpatient surgeries/procedures High-Level Disinfection
Endoscope-related infections, new HLD, channeled scopes, laryngoscopes, reuse of single-use items
D/S and Emerging PathogensMERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola
High-Level Disinfection and Sterilization: Current Issues and New Technologies
• New D/S technologies (new disinfectants, BIs, washer disinfectors) and practices (e.g., perfused channel scopes with HLD) could reduce risk of infection.
• Endoscope represent a nosocomial hazard. Endoscopes have narrow margin of safety due to complexity and microbial load. Urgent need to develop methods to reduce GI-endoscope-related outbreaks (e.g., new/optimized LTST, steam sterilizable GI scopes, improved scope design, etc).
• Do not reuse single-use devices• In general, emerging pathogens are susceptible to currently available
disinfectants. However, some pathogens need additional information (e.g., prions, C. difficile spores).
THANK YOU!www.disinfectionandsterilization.org