1. Copyright © 2004 WA Rutala Endoscope Reprocessing: Current Status of Disinfection Recommendations William A. Rutala, Ph.D., M.P.H. University of North Carolina (UNC) Health Care System and UNC at Chapel Hill

2. Copyright © 2004 WA Rutala Endoscope Reprocessing Lecture Goals l Background l Infections related to endoscopy l Reprocessing of endoscopes and accessories Cleaning High-level disinfection/sterilization Automated endoscope reprocessing l Quality control

3. Copyright © 2004 WA Rutala GI ENDOSCOPES l Widely used diagnostic and therapeutic procedure l Endoscope contamination during use (10 9 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 risk of disease transmission

4. Copyright © 2004 WA Rutala TRANSMISSION OF INFECTION l Gastrointestinal endoscopy >300 infections transmitted 70% agents Salmonella sp. and P. aeruginosa Clinical spectrum ranged from colonization to death (~4%) l Bronchoscopy 90 infections transmitted M. tuberculosis, atypical Mycobacteria, P. aeruginosa Spach DH et al Ann Intern Med 1993: 118:117-128 and Weber DJ, Rutala WA Gastroint Dis 2002

5. Copyright © 2004 WA Rutala Nosocomial Infections via GI Endoscopes l Observations Number of reported infections is small, suggesting a very low incidence Endemic transmission may go unrecognized (e.g.inadequate surveillance, low frequency, asymptomatic infections) Spach DH. Ann Int Med 1993;118:117 and Weber DJ, Rutala, WA. Gastroint Dis 2002

6. Copyright © 2004 WA Rutala Nosocomial Infections via GI Endoscopes l 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 is design of endoscopes or AERs

7. Copyright © 2004 WA Rutala Endoscope Reprocessing: Current Status of Cleaning and Disinfection l Guidelines Multi-Society Guideline, 11 professional organizations, 2003 Society of Gastroenterology Nurses and Associates, 2000 European Society of Gastrointestinal Endoscopy, 2000 British Society of Gastroenterology Endoscopy, 1998 Gastroenterological Society of Australia, 1999 Gastroenterological Nurses Society of Australia, 1999 American Society for Gastrointestinal Endoscopy, 1996 Association for Professional in Infection Control and Epidemiology, 2000 Centers for Disease Control and Prevention, 2004 (in press)

8. Copyright © 2004 WA Rutala Endoscope Reprocessing, Worldwide l 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

9. Copyright © 2004 WA Rutala Endoscopes

10. Copyright © 2004 WA Rutala

11. ENDOSCOPE DISINFECTION l CLEAN-mechanically cleaned with water and enzymatic cleaner l HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels for exposure time l RINSE-scope and channels rinsed with sterile water, filtered water, or tap water followed by alcohol l DRY-use forced air to dry insertion tube and channels l STORE-prevent recontamination

12. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Source of contamination for infections (36 outbreaks) transmitted by GI endoscopes from 1974-2001: Cleaning-3 (12%) Disinfection-19 (73%) Rinse, Dry, Store-3 (12%) Etiology unknown-11

13. Copyright © 2004 WA Rutala ENDOSCOPE DISINFECTION l Cleaning (results in dramatic decrease in bioburden, 4-5 log 10 reduction) No brushing biopsy channel. (Schousboe M. NZ Med J 1980;92:275) No precleaning before AER. (Hawkey PM. J Hosp Inf 1981;2:373) Biopsy-suction channel not cleaned with a brush. (Bronowicki JP. NEJM 1997;337:237)

14. Copyright © 2004 WA Rutala Bacterial Bioburden Associated with Endoscopes Gastroscope, log 10 CFU Colonoscope, log 10 CFU After procedure6.78.5 Gastro Nursing 1998;22:63 6.88.5 Am J Inf Cont 1999;27:392 9.8 Gastro Endosc 1997;48:137 After cleaning2.02.3 4.84.3 5.1

15. Copyright © 2004 WA Rutala Viral Bioburden from Endoscopes Used with AIDS Patients Hanson et al. Lancet 1989;2:86; Hanson et al. Thorax 1991;46:410 DirtyCleanedDisinfected Gastroscopes HIV (PCR)7/200/20 HBsAg1/200/200/7 Bronchoscopes HIV (cDNA)7/70/7 HBsAg1/100/10

16. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Precleaning After removal from patient, wipe the insertion tube with a wet cloth and alternate suctioning the enzymatic cleaner and air through the biopsy/suction channel until solution clean. The air- water channel is flushed or blown out per instructions. Transport the endoscope to the reprocessing area. Enyzmatic cleaner should be prepared per instructions. Some data suggest enzymes are more effective cleaners than detergents. Enyzmatic cleaners must be changed after use.

17. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Cleaning Immerse in a compatible low-sudsing, enzymatic cleaner Wash all debris from exterior by brushing and wiping Remove all removal parts of the endoscope and clean each reusable part separately After exterior cleaning, brush accessible channels with appropriate-sized cleaning brush (bristles contact all surfaces)

18. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Cleaning (continued) After each passage, rinse the brush, remove debris before reinserting. Continue until no visible debris on brush. Attach cleaning adapters for each channel per manufacturer’s instructions and flush with enzymatic cleaner to remove debris. After cleaning is complete, rinse the endoscope with clean water. Purge water from channels using forced air. Dry exterior of the endoscope with a soft, lint-free cloth.

19. Copyright © 2004 WA Rutala ENDOSCOPE DISINFECTION l CLEAN-mechanically cleaned with water and enzymatic detergent l HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels for exposure time l RINSE-scope and channels rinsed with sterile water, filtered water, or tap water followed by alcohol l DRY-use forced air to dry insertion tube and channels l STORE-prevent recontamination

20. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Source of contaminations for infections (36 outbreaks) transmitted by GI endoscopes from 1974-2001: Cleaning-3 (12%) Disinfection-19 (73%) Rinse, Dry, Store-3 (12%) Etiology unknown-11

21. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING Unacceptable Disinfectants for HLD l Benzalkonium chloride l Iodophor l Hexachlorophene l Alcohol l Chlorhexidine gluconate l Cetrimide l Quaternary ammonium compounds l Glutaraldehyde (0.13%) with phenol

22. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Inappropriate disinfectants Benzalkonium chloride (Greene WH. Gastroenterol 1974;67:912) 70% alcohol (Elson CO. Gastroenterol 1975;69:507) QUAT (Tuffnell PG. Canad J Publ Health 1976;67:141) Hexachlorophene (Dean AG. Lancet 1977;2:134) Hexachlorophene (Beecham HJ. JAMA 1979;1013) 70% alcohol (Parker HW. Gastro Endos 1979;25;102) Povidone-iodine (Low DE. Arch Intern Med 1980;1076) Cetrimonium bromide. (Schliessler KH. Lancet 1980;2:1246)

23. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Inappropriate disinfectants 3% hexachlorophene. (Schousboe M. NZ Med J 1980;92:275) 0.5% CHG in alcohol, 0.015% CHG and 0.15% cetrimide; 87 s exposure to 2% glut. (Hawkey PM. J Hosp Inf 1981;2:373) 1% Savlon (cetrimide and CHG).(O’Connor BH. Lancet 1982;2:864) 0.0075% iodophor. (Dwyer DM. Gastroint Endosc 1987;33:84) 0.13% glut with phenol. (Classen DC. Am J Med 1988;84:590) 70% ethanol for 3 min. (Langenberg W. J Inf Dis 1990;161:507)

24. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Inappropriate disinfection Air/water channel not exposed to glut. (Birnie GG. Gut 1983;24:171) Air/water channel not exposed to glut. (Cryan EMJ. J Hosp Inf 1984;5:371) No glut (water only) between patients. (Earnshaw JJ. J Hosp Inf 1985;6:95)

25. Copyright © 2004 WA Rutala High Level Disinfection of “Semicritical Objects” Exposure Time > 12 m-30m, 20 o C Germicide Concentration_____ Glutaraldehyde > 2.0% Ortho-phthalaldehyde (12 m) 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 Glut and phenol/phenate** 1.21%/1.93%___ * May cause cosmetic and functional damage; **efficacy not verified

26. Copyright © 2004 WA Rutala New FDA-Cleared Sterilants l “Old” > 2% Glut, 7.5% HP, 1.0% HP and 0.08% PA l New 1.21% glut and 1.93% phenol/phenate (HLD-20 m at 25 o C) 0.55% ortho-phthalaldehyde (HLD-12 m) 7.35% HP and 0.23% PA (HLD-15 m) 2.5% Glut (HLD-5 m at 35 o C) Hypochlorite (650-675ppm free chlorine) l Ensure antimicrobial activity and material compatibility

27. Copyright © 2004 WA Rutala Ideal HLD/Chemical Sterilant l Rapid HLD (< 10 min) l No disinfectant residue after rinsing l Excellent material compatibility l Long shelf-life l Nontoxic (no odor or irritation issues) l No disposal problems l Monitor minimum effective concentration

28. Copyright © 2004 WA Rutala Glutaraldehyde l Advantages Numerous use studies published Relatively inexpensive Excellent materials compatibility l Disadvantages Respiratory irritation from vapor Pungent and irritating odor Relatively slow mycobactericidal activity Coagulate blood and fix tissues to surfaces Allergic contact dermatitis

29. Copyright © 2004 WA Rutala Ortho-phthalaldehyde Advantages l Fast acting HLD l No activation l Excellent materials compatibility l Not a known irritant to eyes and nasal passages l Weak odor l No ACGIH or OSHA limit Disadvantages l Stains protein gray l Cost ($30/gal); but lower reprocessing costs-soak time, devices per gal l Slow sporicidal activity l Hypersensitivity in some patients with a history of bladder cancer

31. Copyright © 2004 WA Rutala Comparison of Glutaraldehyde and OPA >2.0% Glutaraldehyde l HLD: 45 min at 25 o C l Needs activator l 14 day use life l 2 year shelf life l ACGIH ceiling limit, 0.05ppm l Strong odor l MEC, 1.5% l Cost - $12/gallon 0.55% Ortho-phthalaldehyde l HLD: 12 min at 20 o C l No activator needed l 14 day use life l 2 year shelf life l No ACGIH or OSHA limit l Weak odor l MEC, 0.3% l Cost - $30/gallon

32. Copyright © 2004 WA Rutala OPA Research l Alfa and Sitter, 1994. OPA eliminated all microorganisms from 100 different endoscopes used in a clinical setting. l Gregory et al, 1999. OPA achieved a 6 log 10 reduction of M. bovis in 5.5 min compared to 32 min for glutaraldehyde l Walsh et al, 1999. OPA effective against glutaraldehyde- resistant M. chelonae strains

34. Copyright © 2004 WA Rutala OPA Label Claims Worldwide 1. Europe, Asia, Latin America 5 min at 20 o C 2. Canada and Australia 10 min at 20 o C 3. United States 12 min at 20 o C 1. Antimicrobial tests support 5 min exposure time. 2. Canadian regulatory authority requires 6-log reduction in mycobacteria (5.5 m) and only 5 min intervals. 3. FDA requires 6-log reduction of mycobacteria suspended in organics and dried onto scope without cleaning

35. Copyright © 2004 WA Rutala Ortho-phthalaldehyde (OPA) New Contraindications for OPA l Repeated exposure to OPA, following manual reprocessing of urological instruments, may have resulted in hypersensitivity in some patients with a history of bladder cancer undergoing repeated cystoscopy. l Out of approximately 1 million urological procedures, there have been reports of 24 patients who have experience ‘anaphylaxis-like’ reactions after repeated cystoscopy (typically after 4-9 treatments). l Risk control measures: residues of OPA minimized; and contraindicated for reprocessing of urological instruments used on patients with history of bladder cancer.

36. Copyright © 2004 WA Rutala Hydrogen Peroxide l Advantages No activation required Enhanced removal of organisms No disposal issues No odor or irritation issues Does not coagulate blood or fix tissues to surfaces Use studies published l Disadvantages Material compatibility concerns for brass, zinc, copper, and nickel/silver plating (cosmetic and functional damage) Eye damage with contact

37. Copyright © 2004 WA Rutala Peracetic Acid/Hydrogen Peroxide l Advantages No activation required No odor or irritation issues Effective in the presence of organic matter l Disadvantages Material compatibility issues for lead, brass, copper, zinc (both cosmetic and functional damage for 1% HP with 0.08% PA) Limited clinical use

39. Copyright © 2004 WA Rutala Minimum Effective Concentration (MEC) High Level Disinfectant (HLD) l Dilution of HLD occurs during use l Test strips are available for monitoring MEC l For example, test strips for glutaraldehyde monitor 1.5% l Test strip not used to extend the use-life beyond the expiration date (date test strips when opened) l Testing frequency based on how frequently the solutions are used (used daily, test at least daily) l Record results

40. Copyright © 2004 WA Rutala ENDOSCOPE DISINFECTION l CLEAN-mechanically cleaned with water and enzymatic detergent l HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels for exposure time l RINSE-scope and channels rinsed with sterile water, filtered water, or tap water followed by alcohol. Inadequate rinsing of HLD has caused colitis. l DRY-use forced air to dry insertion tube and channels l STORE-prevent recontamination

41. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING l Rinse, Dry, Store Irrigating water bottle. (Doherty DE. Dig Dis Sci 1982;27:169) Inadequate drying (no alcohol). (Allen JI. Gastroenterol 1987;92:759) Inadequate drying (no alcohol). (Classen DC. Am J Med 1988;84:590)

42. Copyright © 2004 WA Rutala ENDOSCOPE DISINFECTION l CLEAN-mechanically cleaned with water and enzymatic detergent l HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels for exposure time l RINSE-scope and channels rinsed with sterile water, filtered water, or tap water followed by alcohol l DRY-purge channels with air, flush with alcohol (assists drying), purge channels with air, dry the exterior l STORE-prevent recontamination

43. Copyright © 2004 WA Rutala ENDOSCOPE DISINFECTION l CLEAN-mechanically cleaned with water and enzymatic detergent l HLD/STERILIZE-immerse scope and perfuse HLD/sterilant through all channels for exposure time l RINSE-scope and channels rinsed with sterile water, filtered water, or tap water followed by alcohol l DRY-use forced air to dry insertion tube and channels l STORE-prevent recontamination (e.g., hang the endoscope vertically in a cabinet or clean area)

44. Copyright © 2004 WA Rutala Nosocomial Outbreaks via GI Endoscopes Infections Associated with Accessories l Infections associated with biopsy forceps Contaminated biopsy forceps. (Dwyer DM. Gastroint Endosc 1987;33:84) Contaminated biopsy forceps (no cleaning between cases). Graham DY. Am J Gastroenterol 1988;83:974) Biopsy forceps not sterilized (glut exposed,? time) Bronowicki JP. NEJM 1997;334:237) l Reusable endoscopic accessories that break the mucosal barrier should be mechanically cleaned and sterilized between patients

45. Copyright © 2004 WA Rutala Automated Endoscope Reprocessors (AERs) l Advantages: automate and standardize reprocessing steps, reduce personnel exposure to chemicals, filtered tap water l Disadvantages: failure of AERs linked to outbreaks, does not eliminate precleaning, does not monitor HLD concentration l Problems: incompatible AER (side-viewing duodenoscope); biofilm buildup; contaminated AER; inadequate channel connectors l MMWR 1999;48:557. Used wrong set-up or connector l Must ensure exposure of internal surfaces with HLD/sterilant

46. Copyright © 2004 WA Rutala ENDOSCOPE REPROCESSING Staff Safety l Personal protective equipment (e.g., gloves, gowns, eyewear, respiratory protection devices) should be available and used, as appropriate, to protect workers l Reprocessing Room Area designated for this function with: adequate space, proper airflow and ventilation (e.g., 10 ACH), work flow patterns

47. Copyright © 2004 WA Rutala Disinfection of Emerging Pathogens

48. Copyright © 2004 WA Rutala Disinfection and Sterilization of Emerging Pathogens l Hepatitis C virus l Clostridium difficile l Cryptosporidium l Helicobacter pylori l E.coli 0157:H7 l SARS coronavirus l Noroviruses l Antibiotic-resistant microbes (MDR-TB, VRE, MRSA) l Creutzfeldt-Jakob disease (no brain, eye, spinal cord contact)

49. Copyright © 2004 WA Rutala Disinfection and Sterilization of Emerging Pathogens Standard disinfection and sterilization procedures for patient care equipment are adequate to sterilize or disinfect instruments or devices contaminated with blood and other body fluids from persons infected with emerging pathogens

50. Copyright © 2004 WA Rutala ENDOSCOPE SAFETY Quality Control l Ensure protocols equivalent to guidelines from professional organizations (APIC, SGNA, ASGE) l Are the staff who reprocess the endoscope specifically trained in that job? l Are the staff competency tested at least annually? l Conduct IC rounds to ensure compliance with policy l Consider microbiologic sampling of the endoscope

51. Copyright © 2004 WA Rutala Conclusions l Endoscopes represent a nosocomial hazard l Proper cleaning and disinfection will prevent nosocomial transmission l Current guidelines should be strictly followed l Compliance must be monitored l Safety and efficacy of new technologies must be validated

52. Copyright © 2004 WA Rutala Endoscope Reprocessing Lecture Goals l Background l Infections related to endoscopy l Reprocessing of endoscopes and accessories Cleaning High-level disinfection/sterilization Automated endoscope reprocessing l Quality control

53. Copyright © 2004 WA Rutala Thank you

54. Copyright © 2004 WA Rutala References l Rutala WA, Weber DJ. Disinfection of endoscopes: Review of new chemical sterilants for high-level disinfection. Infect Control Hosp Epidemiol 1999;20:69-76. l Nelson DB, Jarvis WR, Rutala WA, et al. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. AJIC 2003;31:309-315. l Posters: www.olympusamerica.com/msg_section/msg_Reprocessing.aspwww.olympusamerica.com/msg_section/msg_Reprocessing.asp l Questions/Slides: www.disinfectionandsterilization.org (WA Rutala)www.disinfectionandsterilization.org l Weber DJ, Rutala WA, DiMarino AJ. Prevention of infection following gastrointestinal endoscopy. In DiMarino AJ. Gastro Dis. 2002;87-107 l Rutala WA, Weber DJ. Reprocessing endoscopes: United States perspective. J Hosp Infect 2004;56:S27-S39.