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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
2. Copyright © 2004 WA Rutala
Endoscope Reprocessing
Lecture Goals
Background
Infections related to endoscopy
Reprocessing of endoscopes and accessories
Cleaning
High-level disinfection/sterilization
Automated endoscope reprocessing
Quality control
3. Copyright © 2004 WA Rutala
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
4. Copyright © 2004 WA Rutala
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
5. Copyright © 2004 WA Rutala
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
6. Copyright © 2004 WA Rutala
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
7. Copyright © 2004 WA Rutala
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)
8. Copyright © 2004 WA Rutala
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
11. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
Bacterial Bioburden Associated with Endoscopes
Gastroscope, log10
CFU
Colonoscope, log10
CFU
After procedure 6.7 8.5 Gastro Nursing 1998;22:63
6.8 8.5 Am J Inf Cont 1999;27:392
9.8 Gastro Endosc 1997;48:137
After cleaning 2.0 2.3
4.8 4.3
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
Dirty Cleaned Disinfected
Gastroscopes
HIV (PCR) 7/20 0/20 0/20
HBsAg 1/20 0/20 0/7
Bronchoscopes
HIV (cDNA) 7/7 0/7 0/7
HBsAg 1/10 0/10 0/10
16. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
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)
18. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
ENDOSCOPE REPROCESSING
Unacceptable Disinfectants for HLD
Benzalkonium chloride
Iodophor
Hexachlorophene
Alcohol
Chlorhexidine gluconate
Cetrimide
Quaternary ammonium compounds
Glutaraldehyde (0.13%) with phenol
22. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
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. Copyright © 2004 WA Rutala
High Level Disinfection of
“Semicritical Objects”
Exposure Time > 12 m-30m, 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. Copyright © 2004 WA Rutala
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 25oC)
0.55% ortho-phthalaldehyde (HLD-12 m)
7.35% HP and 0.23% PA (HLD-15 m)
2.5% Glut (HLD-5 m at 35oC)
Hypochlorite (650-675ppm free chlorine)
Ensure antimicrobial activity and material compatibility
27. Copyright © 2004 WA Rutala
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
28. Copyright © 2004 WA Rutala
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
29. Copyright © 2004 WA Rutala
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.
31. Copyright © 2004 WA Rutala
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
32. Copyright © 2004 WA Rutala
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
33. Copyright © 2004 WA Rutala
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)
34. Copyright © 2004 WA Rutala
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
35. Copyright © 2004 WA Rutala
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)
36. Copyright © 2004 WA Rutala
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
37. Copyright © 2004 WA Rutala
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
39. Copyright © 2004 WA Rutala
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)
40. 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
41. Copyright © 2004 WA Rutala
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
42. Copyright © 2004 WA Rutala
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
43. Copyright © 2004 WA Rutala
Endoscope Reprocessing
Lecture Goals
Background
Infections related to endoscopy
Reprocessing of endoscopes and accessories
Cleaning
High-level disinfection/sterilization
Automated endoscope reprocessing
Quality control
45. Copyright © 2004 WA Rutala
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.