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

2. DISCLOSURES Consultation ASP (Advanced Sterilization Products)-2014 Clorox-2014, 2015 Honoraria (2014, 2015)  3M, ASP, Clorox Grants CDC, CMS, Nanosonics

3. Disinfection, Sterilization and Antisepsis  Provide overview of disinfection, sterilization and antisepsis Indications and methods for sterilization, high-level disinfection and low-level disinfection Cleaning of patient-care devices Sterilization Disinfection (high-level and low-level disinfection) Antisepsis

4. CDC Guideline for Disinfection and Sterilization Rutala, Weber, HICPAC. November 2008. www.cdc.gov

5. Disinfection and Sterilization WA 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).

7. Processing “Critical” Patient Care Objects Classification: Critical objects enter normally sterile tissue or vascular system, or through which blood flows. Object:Sterility. Level germicidal action: Kill all microorganisms, including bacterial spores. Examples:Surgical instruments and devices; cardiac catheters; implants; etc. Method: Steam, gas, hydrogen peroxide gas plasma, vaporized hydrogen peroxide, ozone or chemical sterilization.

8. Sterilization of “Critical Objects” Steam sterilization Hydrogen peroxide gas plasma Ethylene oxide Ozone Vaporized hydrogen peroxide Steam formaldehyde

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

10. FDA Panel, May 2015, Recommended Sterilization of Duodenoscopes

11. Disinfection and Sterilization WA 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).

12. Disinfection and Sterilization WA 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 (modified). CRITICAL - objects which directly or secondarily (i.e., via a mucous membrane such as duodenoscopes) 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).

14. Processing “Semicritical” Patient Care Objects Classification:Semicritical objects come in contact with mucous membranes or skin that is not intact. Object:Free of all microorganisms except high numbers of bacterial spores. Level germicidal action: Kills all microorganisms except high numbers of bacterial spores Examples:Respiratory therapy and anesthesia equipment, GI endoscopes, endocavitary probes, etc. Method:High-level disinfection

15. 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

17. Processing “Noncritical” Patient Care Objects Classification:Noncritical objects will not come in contact with mucous membranes or skin that is not intact. Object:Can be expected to be contaminated with some microorganisms. Level germicidal action: Kill vegetative bacteria, fungi and lipid viruses. Examples:Bedpans; crutches; bed rails; EKG leads; bedside tables; walls, floors and furniture. Method:Low-level disinfection (or detergent for housekeeping surfaces)

18. Low-Level Disinfection for “Noncritical” Objects 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 0.5%, 1.4% _____________________________________________________________ UD=Manufacturer’s recommended use dilution

19. Methods in Sterilization

20. 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.

21. 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

23. Washer/Disinfector Rutala WA, Gergen MF, Weber DJ, Unpublished results, 2013 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

24. Washer Disinfector Removal/Inactivation of Inoculum (Exposed) on Instruments Rutala, Gergen, Weber. 2013 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

25. Washer/disinfectors are very effective in removing/inactivating microorganisms from instruments

26. 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/cm 2 for protein Less than 12 µg/cm 2 for total organic compound Less than 2.2 µg/cm 2 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)

27. IS THERE A STANDARD TO DEFINE WHEN A DEVICE IS CLEAN? There is currently no standard to define when a device is “clean”, cleanliness controlled by visual Potential methods: level of detectable bacteria; protein (6µg/cm 2 ); endotoxin; ATP; lipid This is due in part to the fact that no universally accepted test soils to evaluate cleaning efficiency and no standard procedure for measuring cleaning efficiency At a minimum, a cleaning process should: reduce the natural bioburden; remove organic/inorganic contaminants; provide devices that when sterilized have a SAL 10 -6

28. Cleaning Indicators for Washer Disinfector Monitor the automated washer and instrument cleaning chemistry functionality Indicator includes proteins, lipids, and polysaccharides to mimic common challenging test soils

29. Disinfection Practices

30. 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 but high numbers of bacterial spores. NONCRITICAL -objects that touch only intact skin require low- level disinfection.

31. RECENT ENDOSCOPY-RELATED OUTBREAKS OF MRDO WITHOUT REPROCESSING BREACHES MDROScopeNo.Recovered From ScopeMolecular LinkReference P. aeruginosa (VIM-2) Duodenoscope22Yes, under forceps elevatorYes Verfaillie CJ, 2015 E. coli (AmpC) Duodenoscope 7Yes (2 scopes)Yes (PFGE) Wendort, 2015 K. pneumoniae (OXA) Duodenoscope 5 No Kola A, 2015 E. coli (NDM-CRE) Duodenoscope39YesYes (PFGE) Epstein L, 2014 Additional Outbreaks (not published; news media reports) UCLA, 2015, CRE, 179 patients exposed (2 deaths), 2 colonized duodenoscopes CMC, 2015, CRE, 18 patients exposed (7 infected), duodenoscopes Cedars-Sinai, 2015, CRE, 67 patients exposed (4 infected), duodenoscopes Wisconsin, 2013, CRE, (5 infected), duodenoscopes University of Pittsburgh, 2012, CRE, 9 patients, duodenoscopes

32. ENDOSCOPE REPROCESSING: CHALLENGES NDM-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)

33. Reprocessing Channeled Endoscopes Cystoscopes, Ureteroscopes, Hysteroscopes

35. ENVIRONMENTAL CONTAMINATION LEADS TO HAIs There is increasing evidence to support the contribution of the environment to disease transmission This supports comprehensive disinfecting regimens (goal is not sterilization) to reduce the risk of acquiring a pathogen from the healthcare environment/equipment

36. Thoroughness of Environmental Cleaning Carling P. AJIC 2013;41:S20-S25 Mean = 32% >110,000 Objects

37. MONITORING THE EFFECTIVENESS OF CLEANING Cooper et al. AJIC 2007;35:338; Carling P AJIC 2013;41:S20-S25 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)

38. NEW “NO TOUCH” APPROACHES TO ROOM DECONTAMINATION Supplement Surface Disinfection Rutala, Weber. Infect Control Hosp Epidemiol. 2011;32:743

39. This technology should be considered for terminal room disinfection (e.g., after discharge of patients under CP, during outbreaks) if studies continue to demonstrate a benefit.

40. Norovirus, C. difficile spores, MERS-CoV, Enterovirus D68, Ebola, MDR organisms such carbapenemase- producing Enterobacteriaceae (CRE), HPV, avian influenza A (H7N9)

41. Antisepsis

42. Antiseptic Agents (used alone or in combination) Alcohols, 60-95% Chlorhexidine, 2% and 4% aqueous Iodophors PCMX Triclosan

43. Antiseptics Hand Hygiene-improvement and compliance monitoring Preoperative showers Preoperative skin preparation Surgical hand scrub Skin preparation prior to insertion of catheters Routine daily bathing of patients

44. Summary of Best Antiseptics JM Boyce, 2007 Disinfection, Sterilization, Antisepsis, Rutala WA ed. 237-248 Preoperative showers -CHG is preferred; significant impact on SSIs not proven Preoperative skin preparation -alcohol-containing products Surgical hand scrub -alcohol-containing products reduce bacteria on hands best Vascular access site preparation -CHG preferred; alcoholic CHG most effective in reducing CLABSI Routine daily bathing of patients -CHG appear to be more effective than standard soap and water

45. Disinfection, Sterilization and Antisepsis Provide overview of disinfection, sterilization and antisepsis Indications and methods for sterilization, high-level disinfection and low-level disinfection Cleaning of patient-care devices Sterilization Disinfection (high-level and low-level disinfection) Antisepsis

46. Summary D/S evidenced-based recommendations must be followed to prevent exposure to pathogens that may lead to infection Antiseptics must be used optimally to prevent infections that originate from the skin and patient contact

47. THANK YOU! www.disinfectionandsterilization.org