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Prevention of Infection Due to Endoscopy

Prevention of Infection Due to Endoscopy . William A. Rutala, Ph.D., M.P.H. University of North Carolina (UNC) Health Care System and UNC at Chapel Hill. Disclosure.

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Prevention of Infection Due to Endoscopy

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  1. Prevention of Infection Due to Endoscopy William A. Rutala, Ph.D., M.P.H. University of North Carolina (UNC) Health Care System and UNC at Chapel Hill

  2. Disclosure This educational activity is brought to you, in part, by Advanced Sterilization Products (ASP) and Ethicon. The speaker receives an honorarium from ASP and Ethicon and must present information in compliance with FDA requirements applicable to ASP.

  3. Endoscope ReprocessingLecture Goals • Background • Infections related to endoscopy • Reprocessing of endoscopes and accessories • Cleaning • High-level disinfection/sterilization • Automated endoscope reprocessing • Quality control

  4. GI ENDOSCOPES • Widely used diagnostic and therapeutic procedure • 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 risk of disease transmission

  5. TRANSMISSION OF INFECTION • Gastrointestinal endoscopy • >300 infections transmitted • 70% agents Salmonella sp. and P. aeruginosa • Clinical spectrum ranged from colonization to death (~4%) • 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

  6. Nosocomial Infections via GI Endoscopes • 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

  7. 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 is design of endoscopes or AERs

  8. Endoscope Reprocessing: Current Status of Cleaning and Disinfection • 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, 2008 (in press)

  9. 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

  10. Endoscopes

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

  12. ENDOSCOPE REPROCESSING • 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. ENDOSCOPE DISINFECTION • Cleaning (results in dramatic decrease in bioburden, 4-5 log10 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. Bacterial Bioburden Associated with Endoscopes

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

  16. ENDOSCOPE REPROCESSING • 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. ENDOSCOPE REPROCESSING • 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

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

  20. ENDOSCOPE REPROCESSING • 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. ENDOSCOPE REPROCESSINGUnacceptable Disinfectants for HLD • Benzalkonium chloride • Iodophor • Hexachlorophene • Alcohol • Chlorhexidine gluconate • Cetrimide • Quaternary ammonium compounds • Glutaraldehyde (0.13%) with phenol

  22. ENDOSCOPE REPROCESSING • 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. ENDOSCOPE REPROCESSING • 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. ENDOSCOPE REPROCESSING • 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. High Level Disinfection of “Semicritical Objects” Exposure Time > 12 m-30m (US), 20oC 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. New FDA-Cleared Sterilants/HLD • “Older” • > 2% Glut, 7.5% HP, 1.0% HP and 0.08% PA • Newer • 0.55% ortho-phthalaldehyde (HLD- 5 m worldwide, 12 m in US) • 0.95% glut and 1.64% phenol/phenate (HLD-20 m at 25oC) • 7.5% HP and 0.23% PA (HLD-15 m) • 2.5% Glut (HLD-5 m at 35oC) • Ensure antimicrobial activity and material compatibility

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

  28. Glutaraldehyde • Advantages • Numerous use studies published • Relatively inexpensive • Excellent materials compatibility • Disadvantages • Respiratory irritation from vapor (ACGIH 0.05 ppm) • Pungent and irritating odor • Relatively slow mycobactericidal activity • Coagulate blood and fix tissues to surfaces

  29. Advantages Fast acting HLD No activation Excellent materials compatibility Not a known irritant to eyes and nasal passages Weak odor Disadvantages Stains protein gray Cost ($30/gal);but lower reprocessing costs-soak time, devices per gal) Slow sporicidal activity Eye irritation with contact Exposure may result in hypersensitivity Ortho-phthalaldehyde

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

  31. OPA Research • Alfa and Sitter, 1994. OPA eliminated all microorganisms from 100 different endoscopes used in a clinical setting. • Gregory et al, 1999. OPA achieved a 6 log10 reduction of M. bovis in 5.5 min compared to 32 min for glutaraldehyde • Walsh et al, 1999. OPA effective against glutaraldehyde-resistant M. chelonae strains

  32. 1. Europe, Asia, Latin America 5 min at 20oC 2. Canada and Australia 10 min at 20oC 3. United States 12 min at 20oC 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 OPA Label Claims Worldwide

  33. Ortho-phthalaldehyde (OPA)Contraindication for OPA • 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. • 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). • Risk control measures: residues of OPA minimized; and contraindicated for reprocessing of urological instruments used on patients with history of bladder cancer.

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

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

  36. Endoscope Reprocessing • Disinfectant/Sterilant • Immerse the endoscope in HLD/sterilant (at least 12-20 minutes) and fill the channels with HLD/sterilant until no air bubbles are seen • Reusable endoscopic accessories that break the mucosal barrier (e.g., biopsy forceps) should be mechanically cleaned as described above and then sterilized between each patient use. • Rinsing • Rinse all surfaces and channels and removable parts with clean water to remove disinfectant. Inadequate rinsing of HLD has caused colitis. • Drying and Alcohol Flush • Purge channels with air; flush with alcohol; purge with air; dry • Store-prevent recontamination

  37. ENDOSCOPE REPROCESSING • 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)

  38. Nosocomial Outbreaks via GI EndoscopesInfections Associated with Accessories • 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)

  39. ENDOSCOPE REPROCESSINGManual/AER HLD • High level disinfection is the standard of care for reprocessing GI endoscopes and bronchoscopes • The process can be completed manually or with an AER • Until recently no automated endoscope reprocessor (AER) substitutes for manual cleaning • For manual disinfection, immerse completely in HLD and fill each channel with the HLD • Cover the basin to prevent vaporization and use timer • Flush channels with air before removing the scope from HLD

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

  41. Product Definition: Integrated double-bay AER Eliminates manual cleaning Uses New High-Level Disinfectant (HLD) with IP protection Single-shot HLD Automated testing of endoscope channels and minimum effective concentration of HLD Incorporates additional features (LAN, LCD display) EVOTECH w/Cleaning Claim

  42. Reliance™ EPS Endoscope Processing System Reliance™ DG Endoscope Processing Support Klenzyme®, CIP® 200 Reliance™ PI

  43. Automatic Endoscope Reprocessors • EvoTech-integrates cleaning (FDA-cleared claim) and disinfection. Automated cleaning comparable to manual cleaning. All residual data for cleaning of the internal channels as well as external insertion tube surfaces were below the limit of <8.5ug/cm2 • Reliance-requires a minimal number of connections to the endoscope channels and uses a control boot (housing apparatus the creates pressure differentials to ensure connectorless fluid flow through all channels that are accessible through the endoscope’s control handle channel ports). Data demonstrate that the soil and microbial removal effected by Reliance washing phase was equivalent to that achieved by optimal manual cleaning. Alfa, Olson, DeGagne. AJIC 2006;34:561.

  44. HLD versus Sterilization for Endoscopes

  45. Sterilization (S) or High-Level Disinfection (HLD) • Burns and colleagues compared S versus HLD with glut for arthroscopes and laparoscopes and found no difference (7.5/1000 procedures for S vs. 2.5/1000 procedures for HLD) Burns et al Infect Control Hosp Epidemiol 1996; 17: suppl p42 • Fuselier and Mason examined S (with peracetic acid) and glut and found no clinical difference (no clinical data). S about 10 more costly than HLD. Fuselier and Mason Urology 1997; 50:337 • Thus, no data S is superior to HLD

  46. ENDOSCOPE REPROCESSINGStaff Safety • Personal Protective Equipment • Gloves • Eye protection • Impervious gown • Personnel who use chemicals should be educated about the biologic and chemical hazards present while performing procedures that use disinfectants • Reprocessing Room • Area designated for this function with: adequate space, proper airflow and ventilation (7-15 ACH), work flow patterns

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