HLD and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director,...

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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