Reprocessing Flexible Endoscopes: What

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Reprocessing Flexible Endoscopes Whats New

• William A. Rutala, Ph.D., M.P.H.
• Director, Hospital Epidemiology, Occupational
  Health and Safety Program, UNC Health Care
  Professor of Medicine, Director, Statewide
  Program for Infection Control and Epidemiology,
  University of North Carolina (UNC) at Chapel
  Hill, NC, USA

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DISCLOSURES

• Consultation and Honoraria
• ASP (Advanced Sterilization Products), Clorox
• Honoraria
• 3M
• Grants
• CDC, CMS
• No funds from Medivator, session sponsor

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Reprocessing Flexible EndoscopesObjectives

• Risks associated with reprocessing flexible
  endoscopes
• Causes of contamination and infection
• Gaps in current reprocessing standards
• Establish scientific rationale and evidence
  requirements for enhancing safe practices

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Reprocessing Flexible EndoscopesTopics

• Risks associated with reprocessing flexible
  endoscopes
• Audits-cleaning (ATP) and microbiological
  sampling
• Outbreaks when no reprocessing deficiencies
  identified
• Patient notification after failure to follow
  guidelines
• Endoscopes reprocessed if unused at 5 days
• Human papilloma virus
• C. difficile spores
• Biofilms
• Unsafe injection practices
• Reprocessing steps performed in compliance with
  guidelines
• AERs
• Newer high-level disinfectants
• Fecal transplants

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Reprocessing Flexible EndoscopesObjectives

• Risks associated with reprocessing flexible
  endoscopes
• Margin of safety and evidence of transmission,
  patient notification
• Causes of contamination and infection
• Gaps in current reprocessing standards
• Establish scientific rationale and evidence
  requirements for enhancing safe practices

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ENDOSCOPE REPROCESSING
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Disinfection and Sterilization

• EH Spaulding believed that how an object will be
  disinfected depended on the objects intended
  use.
• CRITICAL - objects which enter normally sterile
  tissue or the vascular system or through which
  blood flows should be sterile.
• SEMICRITICAL - objects that touch mucous
  membranes or skin that is not intact require a
  disinfection process (high-level disinfection
  HLD) that kills all microorganisms but high
  numbers of bacterial spores.
• NONCRITICAL -objects that touch only intact skin
  require low-level disinfection .

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ENDOSCOPES

• Widely used diagnostic and therapeutic procedure
  (11-22 million GI procedures annually in the US)
• GI 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 significant risk of disease transmission

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Endoscope Reprocessing Current Status of
Cleaning and Disinfection

• Guidelines
• Multi-Society Guideline, 12 professional
  organizations, 2011
• Centers for Disease Control and Prevention, 2008
• Society of Gastroenterology Nurses and
  Associates, 2010
• AAMI Technical Information Report, Endoscope
  Reprocessing, In preparation
• Food and Drug Administration, 2009
• Endoscope Reprocessing, Health Canada, 2010
• Association for Professional in Infection Control
  and Epidemiology, 2000

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MULTISOCIETY GUIDELINE ON REPROCESSING GI
ENDOSCOPES, 2011Petersen et al. ICHE.
201132527
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ENDOSCOPE REPROCESSINGMulti-Society Guideline on
Endoscope Reprocessing, 2011

• PRECLEAN-point-of-use (bedside) remove debris by
  wiping exterior and aspiration of detergent
  through air/water and biopsy channels leak test
• CLEAN-mechanically cleaned with water and
  enzymatic cleaner
• HLD/STERILIZE-immerse scope and perfuse
  HLD/sterilant through all channels for exposure
  time (gt2 glut at 20m at 20oC). If AER used,
  review model-specific reprocessing protocols from
  both the endoscope and AER manufacturer
• RINSE-scope and channels rinsed with sterile
  water, filtered water, or tap water. Flush
  channels with alcohol and dry
• DRY-use forced air to dry insertion tube and
  channels
• STORE-hang in vertical position to facilitate
  drying stored in a manner to protect from
  contamination

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Disinfection and Sterilization

• EH Spaulding believed that how an object will be
  disinfected depended on the objects intended
  use.
• CRITICAL - objects which enter normally sterile
  tissue or the vascular system or through which
  blood flows should be sterile.
• SEMICRITICAL - objects that touch mucous
  membranes or skin that is not intact require a
  disinfection process (high-level disinfection
  HLD) that kills all microorganisms but high
  numbers of bacterial spores.
• NONCRITICAL -objects that touch only intact skin
  require low-level disinfection .

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Critical ItemsSterilization-Huge Margin of Safety

• Huge margin of safety associated with
  sterilization of critical items
• Surgical instrument contaminated with lt100
  microorganisms
• Decontamination by washer-disinfector eliminates
  gt5 logs (or 100,000 fold reduction)
• Sterilization processes inactivate 12 logs of
  spores (or 1,000,000,000,000 spores)
• Unlikely sterilized instrument will transmit
  infection when compliant with recommendations

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FEATURES OF ENDOSCOPES THAT PREDISPOSE TO
DISINFECTION FAILURES

• Require low temperature disinfection
• Long narrow lumens
• Right angle turns
• Blind lumens
• May be heavily contaminated with pathogens, 109
• Cleaning (4-6 log10 reduction) and HLD (4-6 log10
  reduction) essential for patient safe instrument

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GI EndoscopesHLD-Narrow Margin of Safety

• Narrow margin of safety associated with
  high-level disinfection of semicritical items
• Instrument contaminated with 1,000,000,000
  microorganisms
• Cleaning eliminates 5 logs (or 100,000 fold
  reduction)
• High-level disinfection process inactivates 5
  logs of microbes (100,000 fold)
• Likely exposed to previous patients pathogens if
  reprocessing protocol is not followed precisely

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Transmission of Infection by EndoscopyKovaleva
et al. Clin Microbiol Rev 2013. 26231-254
Scope Outbreaks Micro (primary) Pts Contaminated Pts Infected Cause (primary)
Upper GI 19 Pa, H. pylori, Salmonella 169 56 Cleaning/Dis-infection (C/D)
Sigmoid/Colonoscopy 5 Salmonella, HCV 14 6 Cleaning/Dis-infection
ERCP 23 Pa 152 89 C/D, water bottle, AER
Bronchoscopy 51 Pa, Mtb, Mycobacteria 778 98 C/D, AER, water
Totals 98 1113 249
Based on outbreak data, if eliminated
deficiencies associated with cleaning,
disinfection, AER , contaminated water and drying
would eliminate about 85 of the outbreaks.
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TRANSMISSION OF INFECTION

• Gastrointestinal endoscopy
• gt150 infections transmitted
• Salmonella sp. and P. aeruginosa
• Clinical spectrum ranged from colonization to
  death (4)
• Bronchoscopy
• 100 infections transmitted
• M. tuberculosis, atypical Mycobacteria, P.
  aeruginosa
• Endemic transmission may go unrecognized (e.g.,
  inadequate surveillance, low frequency,
  asymptomatic infections)
• Kovaleva et al. Clin Microbiol Rev 2013.
  26231-254

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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, gt30 did not adequately disinfect
• Japan, found exceedingly poor disinfection
  protocols
• US, 25 of endoscopes revealed gt100,000 bacteria
• Schembre DB. Gastroint Endoscopy 200010215

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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 and complexity in design of endoscopes or
  AERs

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Reprocessing Flexible EndoscopesObjectives

• Risks associated with reprocessing flexible
  endoscopes
• Causes of contamination and infection
• Complex device/complex reprocessing
• Gaps in current reprocessing standards
• Establish scientific rationale and evidence
  requirements for enhancing safe practices

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FEATURES OF ENDOSCOPES THAT PREDISPOSE TO
DISINFECTION FAILURES

• Require low temperature disinfection
• Long narrow lumens
• Right angle turns
• Blind lumens
• May be heavily contaminated with pathogens, 109
• Cleaning (4-6 log10 reduction) and HLD (4-6 log10
  reduction) essential for patient safe instrument

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Multi-Society Guideline for Reprocessing Flexible
Gastrointestinal Endoscopes, 2011

• Transmission categorized as
• Non-endoscopic and related to care of intravenous
  lines and administration of anesthesia or other
  medications
• Multidose vials
• Reuse of needles and syringes
• Intravenous sedation tubing
• Endoscopic and related to endoscope and
  accessories
• Failure to sterilize biopsy forceps between
  patients
• Lapses in reprocessing tubing used in channel
  irrigation

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HCV from Unsafe Injection Practices at an
Endoscopy Clinic in Las Vegas, 2007-2008Fischer
et al. Clin Infect Dis. 201051 267

• Background-in January 2008, 3 persons with acute
  HCV underwent endoscopy at a single facility in
  Nevada.
• Method-reviewed clinical and laboratory data
• Results- 5 additional cases of HCV were
  identified and quasispecies analysis identified
  two clusters. 7/38 (17) who followed source
  patient were HCV infected. Reuse of syringes on
  single patients with use of single-use propofol
  vials for multiple patients was observed.
• Conclusion- patient-to-patient transmission of
  HCV resulted from contamination of single-use
  medication vials that were used for multiple
  patients during anesthesia administration. The
  resulting notification of gt50,000 persons was the
  largest of its kind in US health care.

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Unsafe Injection PracticesHCV patient-new
needle, same syringe, contaminated vial propofol
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SAFE INJECTION PRACTICES
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Endoscope Reprocessing MethodsOfstead ,
Wetzler, Snyder, Horton, Gastro Nursing 2010
33204
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Endoscope Reprocessing MethodsOfstead ,
Wetzler, Snyder, Horton, Gastro Nursing 2010
33204
Performed all 12 steps with only 1.4 of
endoscopes using manual versus 75.4 of those
processed using AER
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Automated Endoscope Reprocessors
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Automated Endoscope Reprocessors (AER)

• Manual cleaning of endoscopes is prone to error.
  AERs can enhance efficiency and reliability of
  HLD by replacing some manual reprocessing steps
• AER Advantages automate and standardize
  reprocessing steps, reduce personnel exposure to
  chemicals, filtered tap water, reduce likelihood
  that essential steps will be skipped
• AER Disadvantages failure of AERs linked to
  outbreaks, may not eliminate precleaning BMC
  Infect Dis 201010200
• Problems incompatible AER (side-viewing
  duodenoscope) biofilm buildup contaminated AER
  inadequate channel connectors used wrong set-up
  or connector MMWR 199948557
• Must ensure exposure of internal surfaces with
  HLD/sterilant

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Automated Endoscope ReprocessorsGastro Endoscopy
201072675

• All AERs have disinfection and rinsing cycles
  some detergent cleaning alcohol flush and/or
  forced-air drying
• Additional features may include variable cycle
  times printed documentation HLD vapor recovery
  systems heating automated leak testing
  automated detection of channel obstruction, MEC
• Not all AERs compatible with all HLDs or
  endoscopes some models designed with specific
  HLDs
• Some AERs consume and dispose of HLD and other
  reuse HLD
• Some AERs have an FDA-cleared cleaning claim
  (eliminates soil and microbes equivalent to
  optimal manual cleaning-lt6.4µg/cm2 protein)

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Automated Endoscope Reprocessors with Cleaning
Claim (requires procedure room pre-cleaning)

• Medivator Advantage Plus Endoscope Reprocessing
  System

• Evo-Tech (eliminates soil and microbes equivalent
  to optimal manual cleaning. BMC ID 201010200)

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ENDOSCOPE REPROCESSING CHALLENGESNDM-Producing
E. coli Associated ERCPMMWR 2014621051
NDM-producing E.coli recovered from elevator
channel
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ENDOSCOPE REPROCESSING CHALLENGESNDM-Producing
E. coli Associated ERCPMMWR 2014621051

• March-July 2013, 9 patients with cultures for New
  Delhi Metallo-ß-Lactamase producing E. coli
  associated with ERCP
• History of undergoing ERCP strongly associated
  with cases
• NDM-producing E.coli recovered from elevator
  channel
• No lapses in endoscope reprocessing identified
• Hospital changed from automated HLD to ETO
  sterilization
• Due to either failure of personnel to complete
  required process every time or intrinsic problems
  with these scopes (not altered reprocessing)

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ENDOSCOPE REPROCESSING CHALLENGESNDM-Producing
E. coli Associated ERCPMMWR 2014621051

• Recommendations
• Education/adherence monitoring
• Certification/competency testing of reprocessing
  staff
• Enforcement of best practices-preventive
  maintenance schedule
• Improved definition of the scope of the issue and
  contributing factors
• Development of innovative approaches to improve
  and assess the process
• Systematic assessment of the ability of
  AERs/technicians to clean/disinfect scopes
• Disinfection evaluation testing that relates to
  risk of pathogen transmission

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DECREASING ORDER OF RESISTANCE OF MICROORGANISMS
TO DISINFECTANTS/STERILANTS
Most Resistant

• Prions
• Spores (C. difficile)
• Mycobacteria
• Non-Enveloped Viruses (norovirus,
  polio, HPV, parvo)
• Fungi
• Bacteria (MRSA, VRE, Acinetobacter)
• Enveloped Viruses

Most Susceptible
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ENDOSCOPE REPROCESSING CHALLENGESSusceptibility
of Human PapillomavirusJ Meyers et al. J
Antimicrob Chemother, Epub Feb 2014

• High-level disinfectants no effect on HPV
• Finding inconsistent with other small,
  non-enveloped viruses such as polio and
  parvovirus
• Further investigation warranted test methods
  unclear organic matter comparison virus
• Use HLD consistent with FDA-cleared instructions
  (not altered reprocessing)

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Monitoring Endoscope Cleaning
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Endoscope Cleaning

• Endoscope must be cleaned using water with
  detergents or enzymatic cleaners before
  processing.
• Cleaning reduces the bioburden and removes
  foreign material (organic residue and inorganic
  salts) that interferes with the HLD or
  sterilization process.
• Cleaning and decontamination should be done as
  soon as possible after the items have been used
  as soiled materials become dried onto the
  endoscopes.

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Bacterial Bioburden Associated with Endoscopes
Gastroscope, log10 CFU Colonoscope, log10 CFU
After procedure 6.7 8.5 Gastro Nursing 19982263
6.8 8.5 Am J Inf Cont 199927392
9.8 Gastro Endosc 199748137
After cleaning 2.0 2.3
4.8 4.3
5.1
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Viral Bioburden from Endoscopes Used with AIDS
Patients Hanson et al. Lancet 1989286 Hanson
et al. Thorax 199146410
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
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IS THERE A STANDARD TO DEFINE WHEN A DEVICE IS
CLEAN?

• There is currently no standard to define when a
  device is clean, cleanliness controlled by
  visual
• Potential methods level of detectable bacteria
  protein (6µg/cm2) endotoxin ATP lipid
• This is due in part to the fact that no
  universally accepted test soils to evaluate
  cleaning efficiency and no standard procedure for
  measuring cleaning efficiency

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Audit Manual Cleaning of EndoscopesEstablishing
Benchmarks

• Alfa et al. Am J Infect Control 201240860.
  Rapid Use Scope Test detects organic residuals
  protein (lt6.4µg/cm2) hemoglobin (lt2.2.µg/cm2)
  and carbohydrate (lt1.2µg/cm2)
• Alfa et al. Am J Infect Control 201341245-248.
  If lt200 RLUs of ATP, the protein, hemoglobin and
  bioburden (lt4-log10 CFU/cm2 gt106 per scope)
  were achieved.
• Alfa et al. Am J Infect Control 201442e1-e5.
  200 RLU adequate for ATP.

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Audit Manual Cleaning of Endoscopes

• Issues for consideration
• What is the clinical importance of lt6.4µg/cm2 for
  protein and lt4 log10 CFU/cm2 bioburden that is,
  has it been related epidemiologically or
  clinically to decrease or increase risk of
  infection?
• ATP may be related to markers (e.g., protein) but
  markers may have no relationship to
  microbes/disease and providing patient safe
  instrument.
• Ideally, validation of benchmarks should include
  correlation with patients clinical outcome. The
  CDC has suggested that sampling be done when
  there are epidemiological data that demonstrate
  risk (e.g., endotoxin testing and microbial
  testing of water used in dialysis correlated to
  increased risk of pyrogenic reactions in patient).

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ATP and Microbial ContaminationRutala, Gergen,
Weber. Unpublished 2014
ATP no correlation to microbes
Pathogen Microbial Load ATP
C. difficile 106 lt100
Acinetobacter baumannii 104 lt100
MRSA 104 lt100
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C. difficile A GROWING THREAT
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C. difficile spores
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DECREASING ORDER OF RESISTANCE OF MICROORGANISMS
TO DISINFECTANTS/STERILANTS
Most Resistant

• Prions
• Spores (C. difficile)
• Mycobacteria
• Non-Enveloped Viruses (norovirus)
• Fungi
• Bacteria (MRSA, VRE, Acinetobacter)
• Enveloped Viruses

Most Susceptible
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C. difficile MICROBIOLOGY AND EPIDEMIOLOGY

• Gram-positive bacillus Strict anaerobe,
  spore-former
• Colonizes human GI tract
• Increasing prevalence and incidence
• New epidemic strain that hyper-produces toxins A
  and B
• Causes virtually all cases of antibiotic-associate
  d pseudomembranous colitis.
• Introduction of CDI from the community into
  hospitals
• High morbidity and mortality in elderly
• Inability to effectively treat fulminant CDI
• Absence of a treatment that will prevent
  recurrence of CDI

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Disinfectants and AntisepticsC. difficile spores
at 10 and 20 min, Rutala et al, 2006

• 4 log10 reduction (3 C. difficile strains
  including BI-9)
• Chlorine, 110, 6,000 ppm chlorine (but not
  150, 1,200 ppm)
• Chlorine, 1,910 ppm chlorine
• Chlorine, 25,000 ppm chlorine
• 0.20 peracetic acid
• 2.4 glutaraldehyde
• 2.65 glutaraldehyde
• 3.4 glutaraldehyde and 26 alcohol

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Control MeasuresC. difficile

• No reports document the transmission of C.
  difficile by a GI endoscope.
• Current guidelines should be effective in
  preventing transmission via GI endoscope (i.e.,
  HLD such as glutaraldehyde and peracetic acid
  reliably kills C. difficile spores using normal
  exposure times)

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BIOFILMSPajkos, Vickery, Cossart. J Hosp Infect
200458224
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BIOFILMS(Multi-Layered Bacteria Plus
Exopolysaccharides That Cement Cell to Surface
Develop in Wet Environments)
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BIOFILMS(Multi-Layered Bacteria Plus
Exopolysaccharides That Cement Cell to Surface
Develop in Wet Environments)
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BIOFILMS

• Bacteria residing within biofilms are many times
  more resistant to chemical inactivation than
  bacteria is suspension
• Does formation of biofilms within endoscopic
  channels contribute to failure of decontamination
  process? Not known
• Could be a reason for failure of adequate HLD
  processes but if reprocessing performed promptly
  after use and endoscope dry the opportunity for
  biofilm formation is minimal

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Reprocessing Flexible EndoscopesObjectives

• Risks associated with reprocessing flexible
  endoscopes
• Causes of contamination and infection
• Gaps in current reprocessing standards
• Establish scientific rationale and evidence
  requirements for enhancing safe practices
• New HLDs, TJC, AERs, reprocessing if unused for
  5-7 days, microbiologic sampling, fecal
  transplants

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High-Level Disinfection of Semicritical Objects

• Exposure Time gt 8m-45m (US), 20oC
• Germicide
  Concentration_____
• Glutaraldehyde
  gt 2.0
• Ortho-phthalaldehyde
  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
• Accelerated hydrogen peroxide 2.0
• Peracetic acid 0.2
• Glut and isopropanol 3.4/26
• Glut and phenol/phenate
  1.21/1.93___
• May cause cosmetic and functional damage
  efficacy not verified

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ResertTM HLD

• High Level Disinfectant - Chemosterilant
• 2 hydrogen peroxide, in formulation
• pH stabilizers
• Chelating agents
• Corrosion inhibitors
• Efficacy (claims need verification)
• Sporicidal, virucidal, bactericidal,
  tuberculocidal, fungicidal
• HLD 8 mins at 20oC
• Odorless, non-staining, ready-to-use
• No special shipping or venting requirements
• Manual or automated applications
• 12-month shelf life, 21 days reuse
• Material compatibility/organic material
  resistance (Fe, Cu)?

The Accelerated Hydrogen Peroxide technology and
logo are the property of Virox Technologies, Inc.
Modified from G MacDonald. AJIC 200634571
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ACCREDITING AGENCIESThe Joint Commission/CMS

• Recommendations for Improvement must be based on
  evidence-based guidelines
• 7-day endoscope reprocessing (challenged, removed
  from report)
• Storage
• Handling disinfected endoscopes with clean hands
  versus gloves (challenged, removed from report)

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MULTISOCIETY GUIDELINE ON REPROCESSING GI
ENDOSCOPES, 2011Petersen et al. ICHE.
201132527
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Multi-Society Guideline for Reprocessing Flexible
Gastrointestinal Endoscopes, 2011

• Unresolved Issues
• Interval of storage after which endoscopes should
  be reprocessed before use
• Data suggest that contamination during storage
  for intervals of 7-14 days is negligible,
  unassociated with duration, occurs on exterior of
  instruments and involves only common skin
  organisms
• Data are insufficient to proffer a maximal outer
  duration for use of appropriately cleaned,
  reprocessed, dried and stored endoscopes
• Without full data reprocessing within this
  interval may be advisable for certain situations
  (endoscope entry to otherwise sterile regions
  such as biliary tree, pancreas)

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Endoscopes Reprocessed If Unused 5 DaysAORN, 2010
Provided all channels thoroughly reprocessed and
dried, reuse within 10-14 appears safe. Data are
insufficient to offer maximum duration for use.
Investigator Shelf Life Contamination Rate Recommendation
Osborne, Endoscopy 2007 18.8h median 15.5 CONS, Micrococcus, Bacillus Environmental /process contamination
Rejchrt, Gastro Endosc 2004 5 days 3.0 (4/135), skin bacteria (CONS, diphteroids) Reprocessing before use not necessary
Vergis, Endoscopy 2007 7 days 8.6 (6/70), all CONS Reprocessing not necessary for at least 7d
Riley, GI Nursing, 2002 24,168h 50 (5/10), lt3 CFU CONS, S. aureus, P. aeurginosa, Micrococcus Left for up to 1 week
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Multi-Society Guideline for Reprocessing Flexible
Gastrointestinal Endoscopes, 2011

• Unresolved Issues
• Optimal frequencies for replacement of clean
  water bottles and tubing for insufflation of air
  and lens wash water, and waste vacuum canisters
  and suction tubing
• Concern related to potential for backflow from a
  soiled endoscope against the direction of forced
  fluid and air passage into clean air/water source
  or from tubing/canister against a vacuum into
  clean instruments
• Microbiologic surveillance testing after
  reprocessing
• Detection of non-environmental pathogens
  indicator of faulty reprocessing equipment,
  inadequate solution, or failed human process

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Audit Manual Cleaning of EndoscopesEstablishing
Benchmarks

• Lack of consensus regarding the clinical value of
  routine microbiological monitoring of endoscopes.
  We perform to assess the efficacy of
  reprocessing.
• Alfa et al. Am J Infect Control 201240233.
  Recommends a bioburden residual of lt100 CFU/ml.
• Beilenhoff et al. Endoscopy 200739 175.
  ESGE-ESGENA allows bioburden count of lt20 CFU/
  channel.
• Heeg et al. J Hosp Infect 20045623.
  Contamination should not exceed 1 CFU/ml. Certain
  organisms should not be detected in any amount
  (e.g., P. aeruginosa, E. coli, S. aureus)

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Fecal Transplants for Refractory C. difficile
Infection

• Criteria for eligibility -failed standard
  therapy, no contraindication to colonoscopy,
  confirmed C. difficile toxin positive, etc
• Self-identified donor-donor will respond to
  eligibility questions no GI cancer, no metabolic
  disease, no prior use of illicit drugs, etc
• Donor Testing-Stool-C. difficile toxin, OP,
  bacterial pathogen panel (Salmonella, Shigella,
  Giardia, norovirus, etc). Serum-RPR, HIV-1,
  HIV-2, HCV Ab, CMV viral load, HAV IgM and IgG,
  HBsAg, liver tests, etc
• Stool preparation-fresh sample into 1 liter
  sterile bottle, 500ml saline added, vigorously
  shaking to liquefy, solid pieces removed with
  sterile gauze so sample is liquid, liquid stool
  drawn up into 7 sterile 50ml syringes, injected
  into terminal ileum, cecum, ascending colon,
  traverse colon, descending colon, sigmoid colon.
  Colonoscope reprocessed by HLD.

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Reprocessing Flexible EndoscopesObjectives

• Risks associated with reprocessing flexible
  endoscopes
• Causes of contamination and infection
• Gaps in current reprocessing standards
• Establish scientific rationale and evidence
  requirements for enhancing safe practices

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Conclusions

• Endoscopes represent a nosocomial hazard. Narrow
  margin of safety associated with high-level
  disinfection of semicritical items. Guidelines
  must be strictly followed.
• AERs can enhance efficiency and reliability of
  HLD of endoscopes by replacing some manual
  reprocessing steps and reducing the likelihood
  that essential steps are not skipped
• Urgent need to better understand the gaps in
  endoscope reprocessing-CRE, C. difficile spores,
  HPV, biofilms, etc. Industry must support
  research to answer questions.
• Data are insufficient to recommend ATP monitoring
• Data suggest that contamination during storage
  for 7-14 days is negligible.

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THANK YOU!www.disinfectionandsterilization.org
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Endoscopes Delayed Reprocessing and Drying

• Delayed Reprocessing (GI Endoscopy 201173853)
• Reprocess immediately after use do not allow to
  sit idle and soiled for hours before being
  processed. If precleaning not initiated within an
  hour, soak in detergent before cleaning.
• Endoscope Drying (J Hosp Infect 20086859)
• Microbial contamination lower when stored in
  drying and storage cabinet.