HLD and Sterilization: Current Issues and New Technologies William A. Rutala, PhD, MPH Director, 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, USA Disclosure: 3M

HLD and Sterilization: Current Issues and New Technologies Sterilization  Cleaning, 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 Pathogens  MERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola

CDC Guideline for Disinfection and Sterilization Rutala, Weber, HICPAC. November

Disinfection and Sterilization in Healthcare Facilities WA Rutala, DJ Weber, and HICPAC, l Overview Last Centers for Disease Control and Prevention guideline in 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 Sterilization  Cleaning, 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 Pathogens  MERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola

Disinfection and Sterilization WA Rutala, DJ Weber, and HICPAC, 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, Cleaning of the object Organic and inorganic load present Type and level of microbial contamination Concentration of and exposure time to disinfectant/sterilant Nature of the object Temperature and relative humidity

Cleaning l Items must be cleaned using water with detergents or enzymatic cleaners before processing. l Cleaning reduces the bioburden and removes foreign material (organic residue and inorganic salts) that interferes with the sterilization process. l 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 l 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 l Manual

Bioburden on Surgical Devices Non-lumen Surgical Instruments Carry a Low Microbial Load (<100 CFU, 85%) l Bioburden on instruments used in surgery (Nystrom, J Hosp Infect 1981) 62% contaminated with < % contaminated with < % contaminated with <10 3 l Bioburden on surgical instruments (Rutala, Am J Infect Control 1997) 72% contained < % contained <10 2 l Bioburden on surgical instruments (50) submitted to CP (Rutala, AJIC 2014) 58% contained <10 20% contained < % contained <5x10 2 6% contained <10 3

Washer/Disinfector Rutala WA et al. Infect Control Hosp Epidemiol 2014;35: Five Chambers Pre-wash: water/enzymatic is circulated over the load for 1 min Wash: detergent wash solution (150 o F) 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 (180 o F) 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/Disinfector Removal/Inactivation of Inoculum (Exposed) on Instruments Rutala et al. Infect Control Hosp Epidemiol : WD Conditions OrganismInoculum Log Reduction Positives RoutineMRSA2.6x10 7 Complete 0/8 RoutineVRE2.6x10 7 Complete 0/8 Routine P aeruginosa 2.1x10 7 Complete 0/8 Routine M terrae 1.4x /8 RoutineGS spores5.3x /14 No Enz/DetVRE2.5x10 7 Complete 0/10 No Enz/DetGS spores8.3x /10

Washer/disinfectors are very effective (>7 log 10 reduction) in removing/inactivating microorganisms from instruments

Cleaning Indicators for Washer Disinfector l Monitor the automated washer and instrument cleaning chemistry functionality; AAMI recommends weekly (preferably daily) l Washer indicators have been used in Europe and Canada and some US hospitals l Indicator includes proteins, lipids, and polysaccharides to mimic common challenging test soils l Washer indicators are chemical indicators imprinted with a dried test soil formula and a dye

How Clean Is Clean? l AAMI and FDA trying to gain consensus l Reached consensus on maximum levels of top three common markers after a device is cleaned Less than 6.4 µg/cm 2 for protein Less than 12 µg/cm 2 for total organic compound Less than 2.2 µg/cm 2 for hemoglobin l Research needs to be performed to determine how healthcare facilities should verify cleanliness (real-time tests and meaningful analytical endpoints) l Manufacturers’ ensure the HCF can clean the device (time, resources, device design)

Methods in Sterilization

Sterilization of “Critical Objects” Steam sterilization-1970s Ethylene oxide-1970s Hydrogen peroxide gas plasma-1993 Vaporized hydrogen peroxide-2011

Emerging Technologies

Ozone and Hydrogen Peroxide l Sterizone VP4, 510(k) FDA clearance,TSO 3 Canada l Sterilizer has a 4.4ft 3 chamber l Advantages/Disadvantages-not yet known

Nitrogen Dioxide (Noxilizer, MD 2004; seeking industrial claim; 2016 HC) l NO 2 has unique properties including a low boiling point (21 o C) and a high vapor pressure, which facilitate effective dispersion of NO 2 gas at low concentration l Log-linear inactivation at 3.5mg/L NO 2 gas concentration and 75% RH using G. stearothermophilus spores l Toxicity-OSHA PEL for NO 2 is 5ppm l Compatible with most polymers used in medical devices

New LTST Technology l Supercritical CO 2 l Peracetic acid vapor l Gaseous chlorine dioxide

Immediate-Use Steam Sterilization AAMI, AORN, APIC, IAHCSMM l “Flash” originally defined as sterilization of an unwrapped medical instrument subjected to an abbreviated exposure time and then used after cycle completion without storage (contrast to “terminal sterilization”) l “Flash sterilization” antiquated term l IUSS has the same critical reprocessing steps (cleaning, decontaminating and transporting sterilized items) l Surveyors want IUSS <5% of cycles (preferably 1-2%)

Immediate-Use Steam Sterilization AAMI, AORN, APIC, IAHCSMM l “Immediate use” is broadly defined as the shortest possible time between a sterilized items removal from the sterilizer and its aseptic transfer to the sterile field. l Because of the potential for serious infections, implanted surgical devices should not be sterilized by immediate-use method unless a documented emergency situation when no option is available

Biological Indicators Select BIs that contain spores of Bacillus atrophaeus Rationale: BIs are the only sterilization process monitoring device 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 :423

Super Rapid Readout Biological Indicators Commercially 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/Procedure 2010, US DHHS Top 10 Outpatient Surg/Proc-53M l Lens and cataract procedures-7M l Endoscopy of large intestine-5.7M l Endoscopy of small intestine-3.4M l Therapeutic injections-1.4M l Coronary artery exam-1M l Knee arthroscopy-~1M l Hernia repair-~1M l Tonsillectomy/adenoidectomy-750K l Cystoscopy-750K Top 10 Inpatient Surg/Proc-46M l Coronary artery exam-1M l C-section 1.3M l Cardiac cath-1.1M l Endoscopy of small intestine-1M l Diagnostic ultrasound-~900K l CAT scans-740K l Realign broken bone-672K l Balloon angioplasty of coronary- 661K l Coronary artery stent-661K

HLD and Sterilization: Current Issues and New Technologies Sterilization  Cleaning, 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 Pathogens  MERS-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), 20 o C Germicide 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)* ppm Accelerated 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

Resert TM HLD l High Level Disinfectant - Chemosterilant l 2% hydrogen peroxide, in formulation pH stabilizers Chelating agents Corrosion inhibitors l Efficacy (claims need verification) Sporicidal, virucidal, bactericidal, tuberculocidal, fungicidal l HLD: 8 mins at 20 o C l Odorless, non-staining, ready-to-use l No special shipping or venting requirements l Manual or automated applications l 12-month shelf life, 21 days reuse l 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 l New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate probes Laryngoscopes

Reprocessing Semicritical Items l New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate probes Laryngoscopes

“Superbug” Outbreaks l Cedars-Sinai Medical Center, UCLA Ronald Reagan Medical Center, University of Pittsburgh Medical Center, Virginia Mason Medical Center, tertiary care facility in NE Illinois l ABC, CBS, NBC, CNN, New York Times, LA Times l Congress asked the FDA why “didn’t move more quickly and aggressively to ensure patient safety” l Professional organizations (ASGE, AGA) and FDA investigating

GI ENDOSCOPES l Widely used diagnostic and therapeutic procedure (~20 million GI procedures annually in the US) l GI endoscope contamination during use ( in/10 5 out) l Semicritical items require high-level disinfection minimally l Inappropriate cleaning and disinfection has lead to cross- transmission l 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 Endoscopy Kovaleva et al. Clin Microbiol Rev : ScopeOutbreaksMicro (primary)Pts Contaminated Pts InfectedCause (primary) Upper GI19 Pa, H. pylori, Salmonella 16956Cleaning/Dis- infection (C/D) Sigmoid/Colon oscopy 5 Salmonella, HCV 146Cleaning/Dis- infection ERCP23Pa15289C/D, water bottle, AER Bronchoscopy51Pa, Mtb, Mycobacteria 77898C/D, AER, water Totals Based 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 l Epstein et al. JAMA 2014;312: (NE IL) l Wendorf et al. ICHE 2015 (Seattle) l 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: CHALLENGES NDM-Producing E. coli Associated ERCP MMWR 2014;62:1051; Epstein et al. JAMA 2014;312: 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 Outbreaks Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press l Margin of safety with endoscope reprocessing minimal or non-existent for two reasons: l Microbial load  GI endoscopes contain  Cleaning results in 2-6 log 10 reduction  High-level disinfection results in 4-6 log 10 reduction  Results in a total 6-12 log 10 reduction of microbes  Level of contamination after processing: 4 log 10 (maximum contamination, minimal cleaning/HLD) l Complexity of endoscope

Reason for Endoscope-Related Outbreaks Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press l Margin of safety with endoscope reprocessing minimal or non-existent l Microbial load  GI endoscopes contain  Cleaning results in 2-6 log 10 reduction  High-level disinfection results in 4-6 log 10 reduction  Results in a total 6-12 log 10 reduction of microbes  Level of contamination after processing: 4log 10 (maximum contamination, minimal cleaning/HLD) l Complexity of endoscope l 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 Outbreaks Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press l Margin of safety with endoscope reprocessing minimal or non-existent for two reasons: l Microbial load  GI endoscopes contain  Cleaning results in 2-6 log 10 reduction  High-level disinfection results in 4-6 log 10 reduction  Results in a total 6-12 log 10 reduction of microbes  Level of contamination after processing: 4log 10 (maximum contamination, minimal cleaning/HLD l Complexity of endoscope

ENDOSCOPE REPROCESSING: CHALLENGES Complex [elevator channel]-10 9 bacteria Surgical instruments-<10 2 bacteria

ENDOSCOPE REPROCESSING

FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES l Heat labile l Long, narrow lumens l Right angle bends l Rough or pitted surfaces l Springs and valves l Damaged channels may impede microbial exposure to HLD l Heavily contaminated with pathogens, l Cleaning (4-6 log 10 reduction) and HLD (4-6 log 10 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: l Ethylene oxide sterilization after high level disinfection with periodic microbiologic surveillance l Double high-level disinfection with periodic microbiologic surveillance l High-level disinfection with scope quarantine until negative culture l Liquid chemical sterilant processing system using peracetic acid (rinsed with extensively treated potable water) with periodic microbiologic surveillance l High-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 MethodAdvantagesDisadvantages 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 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 MethodAdvantagesDisadvantages 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 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 MethodAdvantagesDisadvantages 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 MethodAdvantagesDisadvantages 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) Validation Alfa et al. Am J Infect Control 2013;41:245 l Validated as a monitoring tool for assessing cleaning because it detects organic residuals l 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 l ATP <200 RLU benchmark for clean, equates to <4 log 10 CFUs/cm 2 or 10 6 CFUs per endoscope l Thus, an endoscope assessed as clean using ATP could still have a significant microbial load (e.g., 10 6 )

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 :

Potential Future Methods to Prevent GI- Endoscope Related Outbreaks Rutala WA, Weber WA. Infect Control Hosp Epidemiol 2015, In press l Steam sterilizable GI endoscopes l New low temperature sterilization methods proving SAL achieved (or optimizing current LTST) l Disposable sterile GI endoscopes l Improved GI endoscope design (to reduce or eliminate challenges listed above) l 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 l New Developments in Reprocessing Endoscopes Cystoscopes, ureteroscopes, hysteroscopes Prostate probes Laryngoscopes

Reprocessing Channeled Endoscopes Cystoscopes, Ureteroscopes, Hysteroscopes

Reprocessing Channeled Endoscopes Rutala, Gergen, Bringhurst, Weber Exposure Method VRE Contamination Before HLD (glutaraldehyde) VRE Contamination After HLD Passive HLD (immersed, not perfused) 3.6x x x x x x10 7 Active HLD (perfused HLD into channel with syringe) 8.4x x x CFU 0 l Pathogens must have exposure to HLD for inactivation l Immerse channeled flexible scope into HLD will not inactivate channel pathogens l Completely immerse the endoscope in HLD and ensure all channels are perfused l Air pressure in channel stronger than fluid pressure at fluid-air interface

Prostate Biopsy Probe l Evaluated effectiveness of HLD when assembled (needle biopsy holder in probe) and unassembled. l Inoculated ( P.aeruginosa ): internal lumen/outside surface of needle biopsy holder; internal lumen of probe with and without needle biopsy holder in place l Conclusion: HLD achieved when unassembled but not when assembled

Disinfection of Prostate Probe Rutala, Gergen, Weber. ICHE. 2007;28:916 Needle guide must be removed from the probe for disinfection

Disinfection of Prostate Probe Rutala, Gergen, Weber. ICHE; 2007;28:916

Do Not Reuse Single Use Devices l Federal judge convicted a urologist who reused needle guides meant for single use during prostate procedures (Sept 2014) l Third party reprocessor OK l Criminal prosecution (based on conspiracy to commit adulteration)

Reprocessing of Rigid Laryngoscopes JHI 2008, 68:101; ICHE 2007, 28:504; AJIC 2007, 35: 536 l Limited guidelines for reprocessing laryngoscope’s blades and handles l Many hospitals consider blade as semicritical (HLD) and handle as noncritical (LLD) l Blades linked to HAIs; handles not directly linked to HAIs but contamination with blood/OPIM suggest its potential and blade and handle function together l 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 l 55/64 (86%) of the handles deemed “ready for patient use” positive for S. aureus, enterococci, Klebsiella, Acinetobacter Anesth Analg 2009;109:479 l 30/40 (75%) samples from handles positive (CONS, Bacillus, Streptococcus, S. aureus, Enterococcus) after cleaning AANA J 1997;65:241 l 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 Blades The Joint Commission, FAQ, October 24, 2011 l 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 Sterilization  Cleaning, 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 Pathogens  MERS-CoV, HPV, C. difficile, Prions, Enterovirus 68, Ebola

Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants Prions Bacterial spores (C. difficile) Mycobacteria Small, non-enveloped viruses (HPV, polio, EV-D68) Fungal spores Gram-negative bacilli (Acinetobacter) Vegetative fungi and algae Large, 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 Prions Bacterial spores (C. difficile) Mycobacteria Small, non-enveloped viruses (HPV, polio, EV-D68) Fungal spores Gram-negative bacilli (Acinetobacter) Vegetative fungi and algae Large, 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 registered products; most chlorine-based, some HP/PA-based, PA with silver

SHEA Prion Guideline Rutala, Weber. Infect Control Hosp Epidemiol 2010;31:107

Management of Neurosurgical Instruments and Patients Exposed to CJD l Conventional sterilization/disinfection inadequate for prions. Need special prion reprocessing (critical/semi device contaminated with high risk tissue from high-risk patient) l 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. l Thomas et al. J Clin Neurosci 2013;20:1207. Reviews prevention strategies l McDonnell et al. J Hosp Infect. 2013;85:268. Investigates the combination of cleaning, disinfection and/or sterilization on prions l 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 Sterilization  Cleaning, 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 Pathogens  MERS-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).

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