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    • 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
    • Endoscope Reprocessing Lecture Goals
      • Background
      • Infections related to endoscopy
      • Reprocessing of endoscopes and accessories
        • Cleaning
        • High-level disinfection/sterilization
        • Automated endoscope reprocessing
      • Quality control
    • GI ENDOSCOPES
      • Widely used diagnostic and therapeutic procedure
      • 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 risk of disease transmission
    • 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
    • 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
    • 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
    • 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, 2004 (in press)
    • 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
    • Endoscopes
    •  
    • 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
    • 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
    • ENDOSCOPE DISINFECTION
      • 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)
    • Bacterial Bioburden Associated with Endoscopes 5.1 4.3 4.8 2.3 2.0 After cleaning 9.8 Gastro Endosc 1997;48:137 8.5 Am J Inf Cont 1999;27:392 6.8 8.5 Gastro Nursing 1998;22:63 6.7 After procedure Colonoscope, log 10 CFU Gastroscope, log 10 CFU
    • Viral Bioburden from Endoscopes Used with AIDS Patients Hanson et al. Lancet 1989;2:86; Hanson et al. Thorax 1991;46:410 0/10 0/10 1/10 HBsAg 0/7 0/7 7/7 Bronchoscopes HIV (cDNA) 0/7 0/20 1/20 HBsAg 0/20 0/20 7/20 Gastroscopes HIV (PCR) Disinfected Cleaned Dirty
    • 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.
    • 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 (bristles contact all surfaces)
    • 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.
    • 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
    • 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
    • ENDOSCOPE REPROCESSING Unacceptable Disinfectants for HLD
      • Benzalkonium chloride
      • Iodophor
      • Hexachlorophene
      • Alcohol
      • Chlorhexidine gluconate
      • Cetrimide
      • Quaternary ammonium compounds
      • Glutaraldehyde (0.13%) with phenol
    • 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)
    • 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)
    • 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)
    • 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
    • New FDA-Cleared Sterilants
      • “ Old”
        • > 2% Glut, 7.5% HP, 1.0% HP and 0.08% PA
      • 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)
      • Ensure antimicrobial activity and material compatibility
    • 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
    • Glutaraldehyde
      • Advantages
        • Numerous use studies published
        • Relatively inexpensive
        • Excellent materials compatibility
      • Disadvantages
        • Respiratory irritation from vapor
        • Pungent and irritating odor
        • Relatively slow mycobactericidal activity
        • Coagulate blood and fix tissues to surfaces
        • Allergic contact dermatitis
    • Ortho-phthalaldehyde
      • Advantages
      • Fast acting HLD
      • No activation
      • Excellent materials compatibility
      • Not a known irritant to eyes and nasal passages
      • Weak odor
      • No ACGIH or OSHA limit
      • Disadvantages
      • Stains protein gray
      • Cost ($30/gal); but lower reprocessing costs-soak time, devices per gal
      • Slow sporicidal activity
      • Hypersensitivity in some patients with a history of bladder cancer
    •  
    • Comparison of Glutaraldehyde and OPA
      • >2.0% Glutaraldehyde
      • HLD: 45 min at 25 o C
      • 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 20 o C
      • No activator needed
      • 14 day use life
      • 2 year shelf life
      • No ACGIH or OSHA limit
      • Weak odor
      • MEC, 0.3%
      • Cost - $30/gallon
    • 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 log 10 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
    •  
    • 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
    • Ortho-phthalaldehyde (OPA) New Contraindications 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.
    • Hydrogen Peroxide
      • 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
      • Disadvantages
        • Material compatibility concerns for brass, zinc, copper, and nickel/silver plating (cosmetic and functional damage)
        • Eye damage with contact
    • 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
    •  
    • 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
    • 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. Inadequate rinsing of HLD has caused colitis.
      • DRY-use forced air to dry insertion tube and channels
      • STORE-prevent recontamination
    • 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)
    • 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-purge channels with air, flush with alcohol (assists drying), purge channels with air, dry the exterior
      • STORE-prevent recontamination
    • 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 (e.g., hang the endoscope vertically in a cabinet or clean area)
    • Nosocomial Outbreaks via GI Endoscopes Infections Associated with Accessories
      • 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)
      • Reusable endoscopic accessories that break the mucosal barrier should be mechanically cleaned and sterilized between patients
    • 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
    • ENDOSCOPE REPROCESSING Staff Safety
      • Personal protective equipment (e.g., gloves, gowns, eyewear, respiratory protection devices) should be available and used, as appropriate, to protect workers
      • Reprocessing Room
        • Area designated for this function with: adequate space, proper airflow and ventilation (e.g., 10 ACH), work flow patterns
    • Disinfection of Emerging Pathogens
    • Disinfection and Sterilization of Emerging Pathogens
      • Hepatitis C virus
      • Clostridium difficile
      • Cryptosporidium
      • Helicobacter pylori
      • E.coli 0157:H7
      • SARS coronavirus
      • Noroviruses
      • Antibiotic-resistant microbes (MDR-TB, VRE, MRSA)
      • Creutzfeldt-Jakob disease (no brain, eye, spinal cord contact)
    • 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
    • ENDOSCOPE SAFETY Quality Control
      • Ensure protocols equivalent to guidelines from professional organizations (APIC, SGNA, ASGE)
      • Are the staff who reprocess the endoscope specifically trained in that job?
      • Are the staff competency tested at least annually?
      • Conduct IC rounds to ensure compliance with policy
      • Consider microbiologic sampling of the endoscope
    • Conclusions
      • Endoscopes represent a nosocomial hazard
      • Proper cleaning and disinfection will prevent nosocomial transmission
      • Current guidelines should be strictly followed
      • Compliance must be monitored
      • Safety and efficacy of new technologies must be validated
    • Endoscope Reprocessing Lecture Goals
      • Background
      • Infections related to endoscopy
      • Reprocessing of endoscopes and accessories
        • Cleaning
        • High-level disinfection/sterilization
        • Automated endoscope reprocessing
      • Quality control
    • Thank you
    • References
      • Rutala WA, Weber DJ. Disinfection of endoscopes: Review of new chemical sterilants for high-level disinfection. Infect Control Hosp Epidemiol 1999;20:69-76.
      • Nelson DB, Jarvis WR, Rutala WA, et al. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. AJIC 2003;31:309-315.
      • Posters: www.olympusamerica.com/msg_section/msg_Reprocessing.asp
      • Questions/Slides: www.disinfectionandsterilization.org (WA Rutala)
      • Weber DJ, Rutala WA, DiMarino AJ. Prevention of infection following gastrointestinal endoscopy. In DiMarino AJ. Gastro Dis. 2002;87-107
      • Rutala WA, Weber DJ. Reprocessing endoscopes: United States perspective. J Hosp Infect 2004;56:S27-S39.