Transcript Endoscope Reprocessing - TSICP Texas Society of Infection Control

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
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.
Endoscope Reprocessing
Lecture Goals
Background
 Infections related to endoscopy
 Reprocessing of endoscopes and accessories
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Cleaning
 High-level disinfection/sterilization
 Automated endoscope reprocessing
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Quality control
GI ENDOSCOPES
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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 crosstransmission
In the inanimate environment, although the incidence remains very
low, endoscopes represent a risk of disease transmission
TRANSMISSION OF INFECTION
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Gastrointestinal endoscopy
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>300 infections transmitted
70% agents Salmonella sp. and P. aeruginosa
Clinical spectrum ranged from colonization to death (~4%)
Bronchoscopy
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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
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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)
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Spach DH. Ann Int Med 1993;118:117 and Weber DJ, Rutala, WA. Gastroint Dis 2002
Nosocomial Infections via GI Endoscopes
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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
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Guidelines
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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)
Endoscope Reprocessing, Worldwide
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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
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Schembre DB. Gastroint Endoscopy 2000;10:215
Endoscopes
ENDOSCOPE DISINFECTION
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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
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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
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)
Bacterial Bioburden Associated with Endoscopes
Gastroscope, log10
CFU
After procedure
6.7
Colonoscope, log10
CFU
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
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
7/20
1/20
0/20
0/20
0/20
0/7
Bronchoscopes
HIV (cDNA) 7/7
HBsAg
1/10
0/7
0/10
0/7
0/10
Gastroscopes
HIV (PCR)
HBsAg
ENDOSCOPE REPROCESSING
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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 airwater 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.
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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
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ENDOSCOPE REPROCESSING
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Cleaning (continued)
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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
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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
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Benzalkonium chloride
Iodophor
Hexachlorophene
Alcohol
Chlorhexidine gluconate
Cetrimide
Quaternary ammonium compounds
Glutaraldehyde (0.13%) with phenol
ENDOSCOPE REPROCESSING
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Inappropriate disinfectants
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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
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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)
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ENDOSCOPE REPROCESSING
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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 (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
New FDA-Cleared Sterilants/HLD
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“Older”
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> 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)
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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
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Glutaraldehyde
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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
Ortho-phthalaldehyde
Advantages
 Fast acting HLD
 No activation
 Excellent materials
compatibility
 Not a known irritant to eyes
and nasal passages
 Weak odor
Disadvantages
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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
Comparison of Glutaraldehyde and OPA
>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
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 glutaraldehyderesistant M. chelonae strains
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OPA Label Claims Worldwide
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
Ortho-phthalaldehyde (OPA)
Contraindication for OPA
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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.
Peracetic Acid/Hydrogen Peroxide
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Advantages
No activation required
 No odor or irritation issues
 Effective in the presence of organic matter
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Disadvantages
Material compatibility issues for lead, brass, copper, zinc (both
cosmetic and functional damage for 1% HP with 0.08% PA)
 Limited clinical use
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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
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Endoscope Reprocessing
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Disinfectant/Sterilant
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Rinsing
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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.
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
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ENDOSCOPE REPROCESSING
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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
1988;84:590)
drying (no alcohol). (Classen DC. Am J Med
Nosocomial Outbreaks via GI Endoscopes
Infections Associated with Accessories
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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)
ENDOSCOPE REPROCESSING
Manual/AER HLD
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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
Automated Endoscope Reprocessors (AERs)
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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
EVOTECH w/Cleaning Claim
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Product Definition:
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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)
Reliance™ EPS
Endoscope Processing System
Reliance™ DG
Endoscope Processing
Support
Klenzyme®, CIP® 200
Reliance™ PI
Automatic Endoscope Reprocessors
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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.
HLD versus Sterilization for Endoscopes
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)
 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
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Burns et al Infect Control Hosp Epidemiol 1996; 17: suppl p42
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Thus, no data S is superior to HLD
ENDOSCOPE REPROCESSING
Staff Safety
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Personal Protective Equipment
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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
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Area designated for this function with: adequate space, proper airflow and
ventilation (7-15 ACH), work flow patterns
Disinfection of Emerging Pathogens
Disinfection and Sterilization of
Emerging Pathogens
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Hepatitis C virus
Clostridium difficile
Cryptosporidium
Helicobacter pylori
E.coli 0157:H7
SARS coronavirus
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
Clostridium difficile
Disinfectants and Antiseptics
C. difficile spores at 10 and 20 min, Rutala et al, 2006
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~4 log10 reduction (3 C. difficile strains including BI-9)
Clorox, 1:10, ~6,000 ppm chlorine (but not 1:50, ~1,200 ppm)
 Clorox Clean-up, ~1,910 ppm chlorine
 Tilex, ~25,000 ppm chlorine
 Steris 20 sterilant, 0.35% peracetic acid
 Cidex, 2.4% glutaraldehyde
 Cidex-OPA, 0.55% OPA
 Wavicide, 2.65% glutaraldehyde
 Aldahol, 3.4% glutaraldehyde and 26% alcohol
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Control Measures
C. difficile
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Handwashing (soap and water) , contact precautions, and meticulous
environmental cleaning (disinfect all surfaces) with an EPA-registered
disinfectant should be effective in preventing the spread of the organism.
McFarland et al. NEJM 1989;320:204.
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In units with high endemic C. difficile infection rates or in an outbreak
setting, use dilute solutions of 5.25-6.15% sodium hypochlorite (e.g., 1:10
dilution of bleach) for routine disinfection. (Category II)
For semicritical equipment, glutaraldehyde (20m), OPA (12m) and
peracetic acid (12m) reliably kills C. difficile spores using normal exposure
times
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

Prevention of Infection Due to Endoscopy
Background
 Infections related to endoscopy
 Processing of endoscopes and accessories

Cleaning
 High-level disinfection/sterilization
 Automated endoscope reprocessing


Quality control
Thank you
References
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Rutala WA, Weber DJ. Disinfection of endoscopes: Review of new chemical
sterilants for high-level disinfection. Infect Control Hosp Epidemiol
1999;20:69-76.
Rutala WA, Weber DJ. Creutzfeldt-Jakob Disease: Recommendations for
disinfection and sterilization. Clin Inf Dis 2001;32:1348-1356.
Society of Gastroenterology Nurses and Associates. Standards. 2000.
Weber DJ, WA Rutala, AJ DiMarino. Prevention of infection following
gastrointestinal endoscopy. Gastro Dis. 2002;87-107
Rutala WA, Weber DJ, HICPAC. Disinfection and sterilization in healthcare
facilities. MMWR. In press.