Reprocessing Flexible Endoscopes: What’s New

1. Reprocessing Flexible Endoscopes: What’s New William A. Rutala, Ph.D., M.P.H. Director, Hospital Epidemiology, Occupational Health and Safety Program, UNC Health Care; Professor of Medicine, Director, Statewide Program for Infection Control and Epidemiology, University of North Carolina (UNC) at Chapel Hill, NC, USA

2. DISCLOSURES • Consultation and Honoraria • ASP (Advanced Sterilization Products), Clorox • Honoraria • 3M • Grants • CDC, CMS • No funds from Medivator, session sponsor

3. Reprocessing Flexible EndoscopesObjectives • Risks associated with reprocessing flexible endoscopes • Causes of contamination and infection • Gaps in current reprocessing standards • Establish scientific rationale and evidence requirements for enhancing safe practices

4. Reprocessing Flexible EndoscopesTopics • Risks associated with reprocessing flexible endoscopes • Audits-cleaning (ATP) and microbiological sampling • Outbreaks when no reprocessing deficiencies identified • Patient notification after failure to follow guidelines • Endoscopes reprocessed if unused at 5 days • Human papilloma virus • C. difficile spores • Biofilms • Unsafe injection practices • Reprocessing steps performed in compliance with guidelines • AERs • Newer high-level disinfectants • Fecal transplants

5. Reprocessing Flexible EndoscopesObjectives • Risks associated with reprocessing flexible endoscopes • Margin of safety and evidence of transmission, patient notification • Causes of contamination and infection • Gaps in current reprocessing standards • Establish scientific rationale and evidence requirements for enhancing safe practices

6. ENDOSCOPE REPROCESSING

7. 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 .

8. ENDOSCOPES • Widely used diagnostic and therapeutic procedure (11-22 million GI procedures annually in the US) • GI endoscope contamination during use (109 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

9. Endoscope Reprocessing: Current Status of Cleaning and Disinfection • Guidelines • Multi-Society Guideline, 12 professional organizations, 2011 • Centers for Disease Control and Prevention, 2008 • Society of Gastroenterology Nurses and Associates, 2010 • AAMI Technical Information Report, Endoscope Reprocessing, In preparation • Food and Drug Administration, 2009 • Endoscope Reprocessing, Health Canada, 2010 • Association for Professional in Infection Control and Epidemiology, 2000

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

11. ENDOSCOPE REPROCESSINGMulti-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 test • 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 20oC). 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

12. 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 .

14. Critical ItemsSterilization-Huge Margin of Safety • Huge margin of safety associated with sterilization of critical items • Surgical instrument contaminated with <100 microorganisms • Decontamination by washer-disinfector eliminates >5 logs (or 100,000 fold reduction) • Sterilization processes inactivate 12 logs of spores (or 1,000,000,000,000 spores) • Unlikely sterilized instrument will transmit infection when compliant with recommendations

15. FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES • Require low temperature disinfection • Long narrow lumens • Right angle turns • Blind lumens • May be heavily contaminated with pathogens, 109 • Cleaning (4-6 log10 reduction) and HLD (4-6 log10 reduction) essential for patient safe instrument

16. GI EndoscopesHLD-Narrow Margin of Safety • Narrow margin of safety associated with high-level disinfection of semicritical items • Instrument contaminated with 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

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

18. TRANSMISSION OF INFECTION • Gastrointestinal endoscopy • >150 infections transmitted • Salmonella sp. and P. aeruginosa • Clinical spectrum ranged from colonization to death (~4%) • 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

19. Endoscope Reprocessing, Worldwide • Worldwide, endoscopy reprocessing varies greatly • India, of 133 endoscopy centers, only 1/3 performed even a minimum disinfection (1% glut for 2 min) • Brazil, “a high standard …occur only exceptionally” • Western Europe, >30% did not adequately disinfect • Japan, found “exceedingly poor” disinfection protocols • US, 25% of endoscopes revealed >100,000 bacteria Schembre DB. Gastroint Endoscopy 2000;10:215

20. 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

24. Reprocessing Flexible EndoscopesObjectives • Risks associated with reprocessing flexible endoscopes • Causes of contamination and infection • Complex device/complex reprocessing • Gaps in current reprocessing standards • Establish scientific rationale and evidence requirements for enhancing safe practices

25. FEATURES OF ENDOSCOPES THAT PREDISPOSE TO DISINFECTION FAILURES • Require low temperature disinfection • Long narrow lumens • Right angle turns • Blind lumens • May be heavily contaminated with pathogens, 109 • Cleaning (4-6 log10 reduction) and HLD (4-6 log10 reduction) essential for patient safe instrument

26. Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes, 2011 • Transmission categorized as: • Non-endoscopic and related to care of intravenous lines and administration of anesthesia or other medications • Multidose vials • Reuse of needles and syringes • Intravenous sedation tubing • Endoscopic and related to endoscope and accessories • Failure to sterilize biopsy forceps between patients • Lapses in reprocessing tubing used in channel irrigation

27. HCV from Unsafe Injection Practices at an Endoscopy Clinic in Las Vegas, 2007-2008Fischer et al. Clin Infect Dis. 2010;51; 267 • Background-in January 2008, 3 persons with acute HCV underwent endoscopy at a single facility in Nevada. • Method-reviewed clinical and laboratory data • Results- 5 additional cases of HCV were identified and quasispecies analysis identified two clusters. 7/38 (17%) who followed source patient were HCV infected. Reuse of syringes on single patients with use of single-use propofol vials for multiple patients was observed. • Conclusion- patient-to-patient transmission of HCV resulted from contamination of single-use medication vials that were used for multiple patients during anesthesia administration. The resulting notification of >50,000 persons was the largest of its kind in US health care.

28. Unsafe Injection PracticesHCV patient-new needle, same syringe, contaminated vial propofol

29. SAFE INJECTION PRACTICES

30. Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204

31. Endoscope Reprocessing MethodsOfstead , Wetzler, Snyder, Horton, Gastro Nursing 2010; 33:204 Performed all 12 steps with only 1.4% of endoscopes using manual versus 75.4% of those processed using AER

32. Automated Endoscope Reprocessors

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

34. Automated Endoscope ReprocessorsGastro Endoscopy 2010;72:675 • All AERs have disinfection and rinsing cycles; some detergent cleaning; alcohol flush and/or forced-air drying • Additional features may include: variable cycle times; printed documentation; HLD vapor recovery systems; heating; automated leak testing; automated detection of channel obstruction, MEC • Not all AERs compatible with all HLDs or endoscopes; some models designed with specific HLDs • Some AERs consume and dispose of HLD and other reuse HLD • Some AERs have an FDA-cleared cleaning claim (eliminates soil and microbes equivalent to optimal manual cleaning-<6.4µg/cm2 protein)

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

36. ENDOSCOPE REPROCESSING: CHALLENGESNDM-Producing E. coli Associated ERCPMMWR 2014;62:1051 NDM-producing E.coli recovered from elevator channel

37. ENDOSCOPE REPROCESSING: CHALLENGESNDM-Producing E. coli Associated ERCPMMWR 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)

38. ENDOSCOPE REPROCESSING: CHALLENGESNDM-Producing E. coli Associated ERCPMMWR 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

39. DECREASING ORDER OF RESISTANCE OF MICROORGANISMS TO DISINFECTANTS/STERILANTS Prions Spores (C. difficile) Mycobacteria Non-Enveloped Viruses (norovirus, polio, HPV, parvo) Fungi Bacteria (MRSA, VRE,Acinetobacter) Enveloped Viruses Most Resistant Most Susceptible

40. ENDOSCOPE REPROCESSING: CHALLENGESSusceptibility of Human PapillomavirusJ Meyers et al. J Antimicrob Chemother, Epub Feb 2014 • High-level disinfectants no effect on HPV • Finding inconsistent with other small, non-enveloped viruses such as polio and parvovirus • Further investigation warranted: test methods unclear; organic matter; comparison virus • Use HLD consistent with FDA-cleared instructions (not altered reprocessing)

41. Monitoring Endoscope Cleaning

42. Endoscope Cleaning • Endoscope 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 HLD or 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 endoscopes.

43. Bacterial Bioburden Associated with Endoscopes

44. Viral Bioburden from Endoscopes Used with AIDS PatientsHanson et al. Lancet 1989;2:86; Hanson et al. Thorax 1991;46:410

45. 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/cm2); 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

46. Audit Manual Cleaning of EndoscopesEstablishing Benchmarks • Alfa et al. Am J Infect Control 2012;40:860. Rapid Use Scope Test detects organic residuals: protein (<6.4µg/cm2); hemoglobin (<2.2.µg/cm2); and carbohydrate (<1.2µg/cm2) • Alfa et al. Am J Infect Control 2013;41:245-248. If <200 RLUs of ATP, the protein, hemoglobin and bioburden (<4-log10 CFU/cm2 [>106 per scope]) were achieved. • Alfa et al. Am J Infect Control 2014;42:e1-e5. 200 RLU adequate for ATP.

47. Audit Manual Cleaning of Endoscopes • Issues for consideration • What is the clinical importance of <6.4µg/cm2 for protein and <4 log10 CFU/cm2 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).

48. ATP and Microbial ContaminationRutala, Gergen, Weber. Unpublished 2014 ATP no correlation to microbes

49. C. difficile: A GROWING THREAT

50. C. difficilespores