1. Disinfection and Sterilization: What’s New William A. Rutala, PhD, MPH Director, Hospital Epidemiology, Occupational Health and Safety, UNC Health Care; Research Professor of Medicine and Director, Statewide Program for Infection Control and Epidemiology, University of North Carolina School of Medicine, Chapel Hill, NC

2. DISCLOSURES Consultation and Honoraria ASP (Advanced Sterilization Products), Clorox Honoraria 3M Grants CDC, CMS

3. Learning Objective Describe two current issues or new technologies used in disinfection/sterilization of: Critical devices Semicritical devices Noncritical devices/surfaces

4. 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

5. Disinfection and Sterilization: What’s New Current Issues and New Technologies Sterilization of critical items  Biological indicators, cleaning indicators, washer disinfectors High-level disinfection for semi-critical items  Endoscope reprocessing issues, new high-level disinfectants Low-level disinfection of non-critical items  New low-level disinfectants, curtain decontamination, green products, contact time, iPads, touchscreens, selecting a disinfectant D/S and Emerging Pathogens  MERS, HPV, C. difficile, Prions

6. www.disinfectionandsterilization.org

7. Disinfection and Sterilization: What’s New Current Issues and New Technologies Sterilization of critical items  Biological indicators, cleaning indicators, washer disinfectors High-level disinfection for semi-critical items  Endoscope reprocessing issues, new high-level disinfectants Low-level disinfection of non-critical items  New low-level disinfectants, curtain decontamination, green products, contact time, iPads, touchscreens, selecting a disinfectant D/S and Emerging Pathogens  MERS, HPV, C. difficile, Prions

8. Rapid Readout BIs for Steam Now Require a 1-3h Readout Compared to 24-48h

9. Attest™ 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 1 hour) 1492V BI (brown cap) Monitors 270°F and 275°F dynamic-air-removal (pre-vacuum) steam sterilization cycles 1 hour result (from 3 hours)

11. Washer/Disinfector Rutala WA, Gergen MF, Weber DJ, ICHE. July 2014 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

13. Washer/Disinfector Removal/Inactivation of Inoculum (Exposed) on Instruments Rutala et al. Infect Control Hosp Epidemiol. July 2014. 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 1.4x10 8 7.8 2/8 RoutineGS spores5.3x10 6 4.811/14 No Enz/DetVRE2.5x10 7 Complete 0/10 No Enz/DetGS spores8.3x10 6 5.5 8/10

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

15. 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.

16. 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

17. Disinfection and Sterilization: What’s New Current Issues and New Technologies Sterilization of critical items  Biological indicators, cleaning indicators, washer disinfectors High-level disinfection for semi-critical items  Endoscope reprocessing issues, new high-level disinfectants Low-level disinfection of non-critical items  New low-level disinfectants, curtain decontamination, green products, contact time, iPads, selecting a disinfectant D/S and Emerging Pathogens  MERS, HPV, C. difficile, Prions

18. 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

19. 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)* 650-675 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

20. 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

21. ENDOSCOPE REPROCESSING

22. ENDOSCOPES Widely used diagnostic and therapeutic procedure (11-22 million GI procedures annually in the US) GI endoscope contamination during use (10 9 in/10 5 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

23. Transmission of Infection by Endoscopy Kovaleva et al. Clin Microbiol Rev 2013. 26:231-254 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 Totals981113249 Based on outbreak data, if eliminated deficiencies associated with cleaning, disinfection, AER, contaminated water and drying would eliminate about 85% of the outbreaks.

24. 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

25. FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES l Require low temperature disinfection l Long narrow lumens l Right angle turns l Blind lumens l May be heavily contaminated with pathogens (9-10 logs inside) l Cleaning (4-6 log 10 reduction) and HLD (4-6 log 10 reduction) essential for patient safe instrument

26. MULTISOCIETY GUIDELINE ON REPROCESSING GI ENDOSCOPES, 2011 Petersen et al. ICHE. 2011;32:527

27. ENDOSCOPE REPROCESSING Multi-Society Guideline on Endoscope Reprocessing, 2011 PRECLEAN- point-of-use (bedside) remove debris by wiping exterior and aspiration of detergent through air/water and biopsy channels; leak testing CLEAN- mechanically cleaned with water and enzymatic cleaner HLD/STERILIZE- immerse scope and perfuse HLD/sterilant through all channels for exposure time (>2% glut at 20m at 20 o C). If AER used, review model-specific reprocessing protocols from both the endoscope and AER manufacturer RINSE- scope and channels rinsed with sterile water, filtered water, or tap water. Flush channels with alcohol and dry DRY-use forced air to dry insertion tube and channels STORE- hang in vertical position to facilitate drying; stored in a manner to protect from contamination

28. Endoscope Reprocessing Methods Ofstead, Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

29. Performed all 12 steps with only 1.4% of endoscopes using manual versus 75.4% of those processed using AER

30. Automated Endoscope Reprocessors (AER) l Manual cleaning of endoscopes is prone to error. AERs can enhance efficiency and reliability of HLD by replacing some manual reprocessing steps l AER Advantages: automate and standardize reprocessing steps, reduce personnel exposure to chemicals, filtered tap water l AER Disadvantages: failure of AERs linked to outbreaks, does not eliminate precleaning (until now-EvoTech) BMC Infect Dis 2010;10:200 l Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors; used wrong set-up or connector MMWR 1999;48:557 l Must ensure exposure of internal surfaces with HLD/sterilant

31. Automated Endoscope Reprocessors with Cleaning Claim (requires procedure room pre-cleaning) Advantage Plus Endoscope Reprocessing System Evo-Tech (eliminates soil and microbes equivalent to optimal manual cleaning. BMC ID 2010;10:200)

32. ENDOSCOPE REPROCESSING: CHALLENGES NDM-Producing E. coli Associated ERCP MMWR 2014;62:1051 NDM-producing E.coli recovered from elevator channel

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

34. ENDOSCOPE REPROCESSING: CHALLENGES NDM-Producing E. coli Associated ERCP MMWR 2014;62:1051 March-July 2013, 9 patients with cultures for New Delhi Metallo-ß- Lactamase producing E. coli associated with ERCP History of undergoing ERCP strongly associated with cases NDM-producing E.coli recovered from elevator channel No lapses in endoscope reprocessing identified Hospital changed from automated HLD to ETO sterilization Due to either failure of personnel to complete required process every time or intrinsic problems with these scopes (not altered reprocessing)

35. ENDOSCOPE REPROCESSING: CHALLENGES NDM-Producing E. coli Associated ERCP MMWR 2014;62:1051 Recommendations Education/adherence monitoring  Certification/competency testing of reprocessing staff Enforcement of best practices-preventive maintenance schedule Improved definition of the scope of the issue and contributing factors Development of innovative approaches to improve and assess the process  Systematic assessment of the ability of AERs/technicians to clean/disinfect scopes  Disinfection evaluation testing that relates to risk of pathogen transmission Perform periodic microbiologic surveillance of duodenoscopes (e.g., weekly, monthly) to assess whether bacteria have survived the reprocessing procedure.

36. TRANSMISSION OF INFECTION Gastrointestinal endoscopy >150 infections transmitted Salmonella sp. and P. aeruginosa Clinical spectrum ranged from colonization to death Bronchoscopy ~100 infections transmitted M. tuberculosis, atypical Mycobacteria, P. aeruginosa Endemic transmission may go unrecognized (e.g., inadequate surveillance, low frequency, asymptomatic infections) Kovaleva et al. Clin Microbiol Rev 2013. 26:231-254

37. FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES l Require low temperature disinfection l Long narrow lumens l Right angle turns l Blind lumens l May be heavily contaminated with pathogens (9-10 logs inside) l Cleaning (4-6 log 10 reduction) and HLD (4-6 log 10 reduction) essential for patient safe instrument

38. GI Endoscopes HLD-Narrow Margin of Safety Narrow margin of safety associated with high-level disinfection of semicritical items Instrument contaminated with 9 logs or 1,000,000,000 microorganisms Cleaning eliminates ~5 logs (or 100,000 fold reduction) High-level disinfection process inactivates ~ 5 logs of microbes (100,000 fold) Likely exposed to previous patient’s pathogens if reprocessing protocol is not followed precisely Encourage manufacturers to develop sterilization technology for endoscopes

39. Margin of Safety HLD of Colonoscopes vs Sterilization of Surgical Devices

40. Audit Manual Cleaning of Endoscopes Establishing Benchmarks Alfa et al. Am J Infect Control 2012;40:860. Rapid Use Scope Test detects organic residuals: protein (<6.4µg/cm 2 ); hemoglobin (<2.2.µg/cm 2 ); and carbohydrate (<1.2µg/cm 2 ) Alfa et al. Am J Infect Control 2013;41:245-248. If 10 6 per scope]) were achieved. Alfa et al. Am J Infect Control 2014;42:e1-e5. 200 RLU adequate for ATP.

41. Audit Manual Cleaning of Endoscopes Issues for consideration What is the clinical importance of 10 6 /scope] bioburden: that is, has it been related epidemiologically or clinically to decrease or increase risk of infection? ATP may be related to markers (e.g., protein) but markers may have no relationship to microbes/disease and providing patient safe instrument. Ideally, validation of benchmarks should include correlation with patients’ clinical outcome. The CDC has suggested that sampling be done when there are epidemiological data that demonstrate risk (e.g., endotoxin testing and microbial testing of water used in dialysis correlated to increased risk of pyrogenic reactions in patient).

42. ATP and Microbial Contamination Rutala, Gergen, Weber. Unpublished 2014 PathogenMicrobial LoadATP C. difficile 10 6 <100 Acinetobacter baumannii ~10 4 <100 MRSA~10 4 <100 ATP no correlation to microbes

43. The Joint Commission Greater emphasis on infection prevention by The Joint Commission Sometimes do not use evidence-based guidelines for citations 5-7 day endoscope reprocessing-RFI, challenged, revoked Contact times for disinfectants Transporting clean scope-RFI, challenged, revoked Storage of processed scopes

44. Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2011 Unresolved Issues Interval of storage after which endoscopes should be reprocessed before use  Data suggest that contamination during storage for intervals of 7- 14 days is negligible, unassociated with duration, occurs on exterior of instruments and involves only common skin organisms  Data are insufficient to proffer a maximal outer duration for use of appropriately cleaned, reprocessed, dried and stored endoscopes  Without full data reprocessing within this interval may be advisable for certain situations (endoscope entry to otherwise sterile regions such as biliary tree, pancreas)

45. Endoscopes Reprocessed If Unused 5 Days AORN, 2010 InvestigatorShelf LifeContamination RateRecommendation Osborne, Endoscopy 2007 18.8h median 15.5% CONS, Micrococcus, Bacillus Environmental /process contamination Rejchrt, Gastro Endosc 2004 5 days3.0% (4/135), skin bacteria (CONS, diphteroids) Reprocessing before use not necessary Vergis, Endoscopy 2007 7 days8.6% (6/70), all CONSReprocessing not necessary for at least 7d Riley, GI Nursing, 2002 24,168h 50% (5/10), <3 CFU CONS, S. aureus, P. aeurginosa, Micrococcus Left for up to 1 week Provided all channels thoroughly reprocessed and dried, reuse within 10-14 appears safe. Data are insufficient to offer maximum duration for use.

46. Fecal Transplants for Refractory C. difficile Infection Criteria for eligibility -failed standard therapy, no contraindication to colonoscopy, confirmed C. difficile toxin positive, etc Self-identified donor-donor will respond to eligibility questions: no GI cancer, no metabolic disease, no prior use of illicit drugs, etc Donor Testing-Stool- C. difficile toxin, O&P, bacterial pathogen panel ( Salmonella, Shigella, Giardia, norovirus, etc). Serum-RPR, HIV-1, HIV-2, HCV Ab, CMV viral load, HAV IgM and IgG, HBsAg, liver tests, etc Stool preparation-fresh sample into 1 liter sterile bottle, 500ml saline added, vigorously shaking to liquefy, solid pieces removed with sterile gauze so sample is liquid, liquid stool drawn up into 7 sterile 50ml syringes, injected into terminal ileum, cecum, ascending colon, traverse colon, descending colon, sigmoid colon. Colonoscope reprocessed by HLD.

47. Disinfection and Sterilization: What’s New Current Issues and New Technologies Sterilization of critical items  Biological indicators, cleaning indicators, washer disinfectors High-level disinfection for semi-critical items  Endoscope reprocessing issues, new high-level disinfectants Low-level disinfection of non-critical items  New low-level disinfectants, curtain decontamination, green products, contact time, iPads, touchscreens, selecting a disinfectant D/S and Emerging Pathogens  MERS, HPV, C. difficile, Prions

48. LOW-LEVEL DISINFECTION FOR NONCRITICAL EQUIPMENT AND SURFACES Exposure time > 1 min Germicide Use Concentration Ethyl or isopropyl alcohol70-90% Chlorine100ppm (1:500 dilution) Phenolic UD Iodophor UD Quaternary ammonium UD Improved hydrogen peroxide (HP) 0.5%, 1.4% ____________________________________________________ UD=Manufacturer’s recommended use dilution

49. BACTERICIDAL ACTIVITY OF DISINFECTANTS (log 10 reduction) WITH A CONTACT TIME OF 1m WITH/WITHOUT FCS. Rutala et al. ICHE. 2012;33:1159 OrganismIHP-0.5%0.5% HPIHP Cleaner-Dis 1.4% 1.4% HP3.0% HPQUAT MRSA>6.6<4.0>6.5<4.0 5.5 VRE>6.3<3.6>6.1<3.6 4.6 MDR- Ab >6.8<4.3>6.7<4.3 >6.8 MRSA, FCS>6.7NT>6.7NT<4.2 VRE, FCS>6.3NT>6.3NT<3.8 MDR- Ab, FCS >6.6NT>6.6NT<4.1>6.6 Improved hydrogen peroxide is significantly superior to standard HP at same concentration and superior or similar to the QUAT tested

50. Hospital Privacy Curtains (pre- and post-intervention study; sampled curtain, sprayed “grab area” 3x from 6-8” with 1.4% IHP and allowed 2 minute contact; sampled curtain)

51. Decontamination of Curtains with Activated HP (1.4%) Rutala, Gergen, Weber. Am J Infect Control. 2014;42:426-428 CP for:Before Disinfection CFU/5 Rodacs (#Path) After Disinfection CFU/5 Rodacs (#Path) % Reduction MRSA330 (10 MRSA)21*(0 MRSA)93.6% MRSA186 (24 VRE)4* (0 VRE)97.9% MRSA108 (10 VRE)2* (0 VRE)98.2% VRE 75 (4 VRE)0 (0 VRE)100% VRE68 (2 MRSA)2* (0 MRSA)97.1% VRE98 (40 VRE)1* (0 VRE)99.0% MRSA618 (341 MRSA)1* (0 MRSA)99.8% MRSA55 (1 VRE)0 (0 MRSA)100% MRSA, VRE320 (0 MRSA, 0 VRE)1* (0 MRSA, 0 VRE)99.7% MRSA288 (0 MRSA)1* (0 MRSA)99.7% Mean2146/10=215 (432/10=44)33*/10=3 (0)98.5% * All isolates after disinfection were Bacillus sp; now treat CP patient curtains at discharge with IHP

52. Thoroughness of Environmental Cleaning Carling et al. ECCMID, Milan, Italy, May 2011 Mean = 32% >110,000 Objects

53. MONITORING THE EFFECTIVENESS OF CLEANING Cooper et al. AJIC 2007;35:338 Visual assessment-not a reliable indicator of surface cleanliness ATP bioluminescence-measures organic debris (each unit has own reading scale, <250-500 RLU) Microbiological methods-<2.5CFUs/cm 2 -pass; can be costly and pathogen specific Fluorescent marker-transparent, easily cleaned, environmentally stable marking solution that fluoresces when exposed to an ultraviolet light (applied by IP unbeknown to EVS, after EVS cleaning, markings are reassessed)

54. ALL “TOUCHABLE” (HAND CONTACT) SURFACES SHOULD BE WIPED WITH DISINFECTANT “ High touch” objects only recently defined (no significant differences in microbial contamination of different surfaces) and “high risk” objects not epidemiologically defined.

55. Donskey CJ. Am J Infect Control 2013;41:S12

56. Environmental Disinfection Interventions Donskey CJ. Am J Infect Control 2013;41:S12 Cleaning product substitutions Improvements in the effectiveness of cleaning and disinfection practices Education Audit and feedback Addition of housekeeping personnel or specialized cleaning staff Automated technologies Conclusion: Improvements in environmental disinfection may prevent transmission of pathogens and reduce HAIs

57. TECHNOLOGIES TO IMPROVE DISINFECTION OF ENVIRONMENTAL SURFACES New surface disinfectants Improved hydrogen peroxide Electrochemically activated saline solution “No touch” terminal disinfection UV light: UV-C or pulsed xenon Hydrogen peroxide systems: Vapor or aerosol Portable devices: UV, steam “Self disinfecting” surfaces Heavy metal surface coatings: Silver, copper Sharklet pattern Germicide impregnated surfaces: Triclosan Light-activated antimicrobial coating

58. Touchscreen Cleaning Follow the manufacturer’s recommendations QUATS are not recommended by some manufacturer Prepare the cleaning solution according to the manufacturer’s instructions (e.g., alcohol, glutaraldehyde, mild soap, phenolic) Wet a clean, soft cloth with the selected cleaning solution Remove excess liquid from the cloth and squeeze damp Wipe exposed surfaces (do not allow liquid to enter interior) Remove any soap residue by gently wiping with clean cloth

59. Disinfection iPads Howell et al. J Hosp Infect. 2014 l To limit liability manufacturers warn against all cleaning products l Apple recommends soft, slightly damp, lint-free cloth (AJIC 2013. 41:1136) l Contaminated iPads with MRSA, VRE and C. difficile l Wipes (alcohol/Quat; chlorine dioxide; CHG/alcohol [catheter hubs, injection ports]) most effective for MRSA/VRE. All wipes less effective for C. difficile. l No damage and residual effect with 2% CHG plus 70% alcohol after 480 cleanings.

60. CONTACT TIMES FOR SURFACE DISINFECTION

61. Most Prevalent Pathogens Causing Healthcare-Associated Infections Rutala, Weber. Infect Control Hosp Epidemiol. July 2014 l Staphylococcus aureus (15.6%) l E coli (11.5%) l Coagulase-negative Staphylococcus (CoNS) (11.4%) l Klebsiella (8.0%) l Pseudomonas aeruginosa (7.5%) l Enterococcus faecalis (6.8%) l Candida albicans (5.3%) l Enterobacter spp. (4.7%) l Other Candida spp. (4.2%) l Enterococcus faecium (4.1%) l Enterococcus s pp. (3.0%) l Proteus spp. (2.5%) l Serratia spp. (2.1%) l Acinetobacter baumannii (1.8%) Modify Disinfectant Used l C. difficile spores-over the past decade, incidence of C. difficile increasing and now most common in some hospitals l Norovirus

62. Kill Claims for Most Prevalent Pathogens Each disinfectant requires a specific time it must remain in contact with the microbe to achieve disinfection. This is known as the kill time or contact time Some disinfectants may have a kill time for bacteria of 1m, which means bacteria in label disinfected in 1m Other low-level disinfectants, often concentrated formulas require dilution, are registered by the EPA with contact time of 10m Such a long contact time is not practical

63. CONTACT TIMES FOR SURFACE DISINFECTION Follow the EPA-registered contact times, ideally Some products have achievable contact times for bacteria/viruses (30 seconds-2 minutes) Other products have non-achievable contact times If use a product with non-achievable contact time Use >1 minute based on CDC guideline and scientific literature Prepare a risk assessment http://www.unc.edu/depts/spice/dis/SurfDisRiskAssess2011.pdf http://www.unc.edu/depts/spice/dis/SurfDisRiskAssess2011.pdf

64. How About “Green” Products? Today, the definition of green is unregulated It can mean: Sustainable resources/plant-based ingredients Free of petrochemicals Biodegradable No animal testing Minimal carbon footprint Traded fairly It can, but does not always mean “safer”

65. Efficacy of “Green” Products to Inactivate MDR Pathogens Rutala, Gergen, Weber. Unpublished results. 2013 No measurable activity against A. baumannii, A. xyloxidans, Burkholderia cenocepacia, K. pneumoniae, MRSA and P. aeruginosa, VRE, Stenotrophomonas maltophilia

66. Transfer of C. difficile Spores by Nonsporicidal Wipes Cadnum et al. ICHE 2013;34:441-2 Detergent/nondisinfectant-nonsporicidal wipes transfer or spread microbes/spores to adjacent surfaces; disinfectants inactivate microbes

67. Key Considerations for Selecting the Ideal Disinfectant for Your Facility Rutala, Weber. Infect Control Hosp Epidemiol. July 2014. ConsiderationQuestion to AskScore (1-10) Kill ClaimsDoes the product kill the most prevalent healthcare pathogens Kill Times and Wet- Contact Times How quickly does the product kill the prevalent healthcare pathogens. Ideally, contact time greater than or equal to the kill claim. SafetyDoes the product have an acceptable toxicity rating, flammability rating Ease-of-UseOdor acceptable, shelf-life, in convenient forms (wipes, spray), water soluble, works in organic matter, one-step (cleans/disinfects) Other factorsSupplier offer comprehensive training/education, 24-7 customer support, overall cost acceptable (product capabilities, cost per compliant use, help standardize disinfectants in facility) Note: Consider the 5 components shown, give each product a score (1 is worst and 10 is best) in each of the 5 categories, and select the product with the highest score as the optimal choice (maximum score is 50).

68. Disinfection and Sterilization: What’s New Current Issues and New Technologies Sterilization of critical items  Biological indicators, cleaning indicators, washer disinfectors High-level disinfection for semi-critical items  Endoscope reprocessing issues, new high-level disinfectants Low-level disinfection of non-critical items  New low-level disinfectants, curtain decontamination, green products, contact time, iPads, selecting a disinfectant D/S and Emerging Pathogens  MERS, HPV, C. difficile, Prions

69. Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants Prions (CJD) Bacterial spores (C. difficile) Protozoal oocysts Helminth eggs Mycobacteria Small, non-enveloped viruses (norovirus) Protozoal cysts Fungal spores Gram-negative bacilli (Acinetobacter) Vegetative fungi and algae Large, non-enveloped viruses’ Gram-positive bacteria (MRSA, VRE) Enveloped viruses (coronavirus) Most Resistant Most Susceptible

70. Middle East Respiratory Syndrome-Coronavirus MERS-CoV

71. MERS-CoV Middle East Respiratory Syndrome History and Epidemiology First reported in Saudi Arabia in 2012. Etiologic agent is a coronavirus (MERS-CoV) Nearly all cases in or near Arabian Peninsula Transmission via close contact 536 cases and 145 deaths (27%); most from Saudi Arabia (450 cases and 118 deaths) Two non-linked, imported cases in US (MMWR; May 14, 2014) Symptoms Fever, cough, shortness of breath

72. Inactivation of Coronavirus by Disinfectants/Antiseptics and Survival on Surfaces Sattar, Springthorpe, Karim, Loro. Epidemiol Infect 1989;102:493 3 log 10 reduction in 1m by 2% glut, 70% alcohol, 1% PI, phenolic, and 5,000 ppm chlorine Hulkower, Casanova, Rutala, Weber, Sobsey. Am J Infect Control 2011;39:401 2 log 10 reduction in 1m by phenolic (use-dilution), OPA, 70% ethanol, 62% ethanol, 71% ethanol Casanova, Rutala, Weber, Sobsey. Infect Control Hosp Epidemiol. 2010;31:560 2-3 log 10 reduction in 4-24h on gloves, gowns, N95, scrub fabric; 1 log 10 reduction at 2h Casanova, Jeon, Rutala, Weber, Sobsey Appl Env Micro. 2010;76:2712 4-5 logs persisted for 3 days at 50% RH and 28 days at 20% RH Disinfectants and antiseptics (e.g., ethanol) effective in 1m; survives on PPE (hours) and surfaces (days)

73. Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants Prions (CJD) Bacterial spores (C. difficile) Protozoal oocysts Helminth eggs Mycobacteria Small, non-enveloped viruses (papillomavirus, polio) Protozoal cysts Fungal spores Gram-negative bacilli (Acinetobacter) Vegetative fungi and algae Large, non-enveloped viruses’ Gram-positive bacteria (MRSA, VRE) Enveloped viruses (coronavirus) Most Resistant Most Susceptible

74. ENDOSCOPE REPROCESSING: CHALLENGES Susceptibility of Human Papillomavirus J Meyers et al. J Antimicrob Chemother, Epub Feb 2014 l Most common STD l Disinfectants (to include HLD) no effect on HPV l Finding inconsistent with other small, non-enveloped viruses such as polio and parvovirus l Further investigation warranted: test methods unclear; glycine; organic matter; comparison virus l Use HLD consistent with FDA- cleared instructions (no alterations)

75. Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants Prions (CJD) Bacterial spores (C. difficile) Protozoal oocysts Helminth eggs Mycobacteria Small, non-enveloped viruses (papillomavirus, polio) Protozoal cysts Fungal spores Gram-negative bacilli (Acinetobacter) Vegetative fungi and algae Large, non-enveloped viruses’ Gram-positive bacteria (MRSA, VRE) Enveloped viruses (coronavirus) Most Resistant Most Susceptible

76. C. difficile spores

77. DISINFECTANTS AND ANTISEPSIS C. difficile spores at 10 and 20 min, Rutala et al, 2006 ~4 log 10 reduction (3 C. difficile strains including BI-9) Bleach, 1:10, ~6,000 ppm chlorine (but not 1:50) Chlorine, ~19,100 ppm chlorine Chlorine, ~25,000 ppm chlorine 0.35% peracetic acid 2.4% glutaraldehyde OPA, 0.55% OPA 2.65% glutaraldehyde 3.4% glutaraldehyde and 26% alcohol

78. C. difficile 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

79. Decreasing Order of Resistance of Microorganisms to Disinfectants/Sterilants Prions (CJD) Bacterial spores (C. difficile) Protozoal oocysts Helminth eggs Mycobacteria Small, non-enveloped viruses (norovirus) Protozoal cysts Fungal spores Gram-negative bacilli (Acinetobacter) Vegetative fungi and algae Large, non-enveloped viruses’ Gram-positive bacteria (MRSA, VRE) Enveloped viruses (coronavirus) Most Resistant Most Susceptible

80. 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-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)

81. Disinfection and Sterilization: What’s New Current Issues and New Technologies Sterilization of critical items  Biological indicators, cleaning indicators, washer disinfectors High-level disinfection for semi-critical items  Endoscope reprocessing issues, new high-level disinfectants Low-level disinfection of non-critical items  New low-level disinfectants, curtain decontamination, green products, contact time, iPads, touchscreens, selecting a disinfectant D/S and Emerging Pathogens  MERS, HPV, C. difficile, Prions

82. Disinfection and Sterilization: What’s New New D/S technologies (new disinfectants, BIs) and practices (e.g., curtain decontamination) could reduce risk of infection associated with devices and surfaces. Endoscope represent a nosocomial hazard. Urgent need to understand the gaps in endoscope reprocessing. Reprocessing guidelines must be followed to prevent exposure to pathogens that may lead to infection. Endoscopes have narrow margin of safety and manufacturers should be encouraged to develop practical sterilization technology. The contaminated surface environment in hospital rooms is important in the transmission of healthcare-associated pathogens (MRSA, VRE, C. difficile, Acinetobacter ). Thoroughness of cleaning should be monitored (e.g., fluorescence). In general, emerging pathogens are susceptible to currently available disinfectants. However, some pathogens need additional information (e.g., HPV).

83. THANK YOU! www.disinfectionandsterilization.org

84. PROPERTIES OF AN IDEAL DISINFECTANT Rutala, 1995. Modified from Molinari 1987. Broad spectrum-wide antimicrobial spectrum Fast acting-should produce a rapid kill Not affected by environmental factors-active in the presence of organic matter Nontoxic-not irritating to user Surface compatibility-should not corrode instruments and metallic surfaces Residual effect on treated surface-leave an antimicrobial film on treated surface Easy to use Odorless-pleasant or no odor Economical-cost should not be prohibitively high Soluble (in water) and stable (in concentrate and use dilution) Cleaner (good cleaning properties) and nonflammable