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Charles E. Edmiston Jr., PhD., CICEmeritus Professor of Surgery - Department of Surgery

Medical College of WisconsinMilwaukee, Wisconsin USA

edmiston@mcw.edu

Endoscope Reprocessing:

An Infection Control Perspective of Risk

Acknowledgement

I would like to thank Bill Rutala, PhD MPH, the CDC and the Wisconsin Division of

Public Health for the gracious use of selective slides in this presentation

Acknowledgement

I would like to thank Bill Rutala, PhD MPH, the CDC and the Wisconsin Division of

Public Health for the gracious use of selective slides in this presentation

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A Provocative Statement

“To date, all published occurrences of pathogen transmisssion related to GI endoscopy have

been associated with failure to follow establish cleaning and disinfection/sterilization guidelines

of use of defective equipment.”

ASGE, SHEA Multisociety Guidelines Gsatrointestinal Endoscopy 2011;73:1-10

Case StudyCase Study• May 2013 a patient identified with NDM-1 E coli (index patient 57

y.o. from India) – anecdotal finding.• May – November 3 additional patients had undergone ERCP

with same duodenoscope.• Scope removed from service after 3rd case (November) and

evaluated in house – cultures negative.• 27 patients who underwent ERCP during same period contacted

– 13 agreed to testing - all cultures negative.• Validated that scope had been reprocessed as per societal/

industry guidelines after each patient use.• Duodenoscope transported to manufacturer where it was

cultured again (5 months after taken out of service) – culture positive for E. coli.

Smith Z, Oh Y, Saeian K, Edmiston CE, Khan AH, Massey BT, Dua KS. Transmission of Carbapenem Resistant Enterobacteriaceae during ERCP: Time to Revisit the Current Reprocessing Guidelines. Gastrointestinal Endoscopy 2015;81(4):1041-5.

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A Superbug Exposes Vulnerability of Endoscope Reprocessing

A Superbug Exposes Vulnerability of Endoscope Reprocessing

• Carbapenem-resistant Enterobacteriaceae (CRE).• In 1987, it was reported that duodenoscope after

appropriate reprocessing responsible for Ps. aeruginosa infections resulting in cholecystitis, abscess formation and death.

• Multiple “high-profile” medical centers have reported CRE cases associated with duodenoscopes.

• Why do current societial guidelines appear to be inadequate to prevent current cases of CRE and “other” infections following endoscopy?

• “The contamination of an endoscope by CRE should be a never-event.”

Keswani RN, Soper NJ. Endoscopes and the Superbug Outbreak. JAMA Surgery 2015;150(Sept): 831 -832; Edmiston CE, Spencer M. AORN 2014;100(Dec):609-615

A Historical Perspective

Nashville VA – 1975 – Suggested (Olympus) Manufacturer’s

Recommendations

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Medical Device ClassificationSpaulding Classification

Determines the degree of disinfection or sterilization required for various medical devices.

Critical: A device that enters normally sterile tissue, including the vascular system. These devices should be sterilized.

Semicritical: A device that comes into contact with intact mucous membranes and does not ordinarily penetrate sterile tissue. These devices are cleaned followed by High Level Disinfection (HLD).

Noncritical: Devices that do not ordinarily touch the patient or touch only intact skin. These devices may be cleaned by low-level disinfection.

Semi-Critical Medical DevicesSemi-Critical Medical Devices• Reprocessing semi-critical items has been shown to

have a narrow margin of safety.

• Generally, the narrow margin of safety attributed to high microbial load and complex instruments with lumens.

• Any deviation from the recommended reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection.

• Problems encountered with reprocessing semicriticalequipment often related to improper cleaning.

Infection Prevention Considerations For Endoscopy Personnel

Infection Prevention Considerations For Endoscopy Personnel

• To ensure that the facility has appropriate infection prevention policies and procedures in place and supplies to allow healthcare personnel to provide safe care.

• To systematically assess personnel adherence to correct infection prevention practices. (Assessment of adherence should be conducted by direct observation of healthcare personnel during the performance of their duties).

a. Facility Policies 7. Injection Safety

b. General IC Education and Training 8. Respiratory Hygiene

c. Occupational Health 9. Environmental Cleaning

d. Surveillance and Disease Reporting 10. Reprocessing P & P

e. Hand Hygiene 11. Sterilization (Reusables)

f. Personal Protective Equipment 12. High-Level Disinfection (Reusables)

http://www.cdc.gov/HAI/pdfs/guidelines/ambulatory-care-checklist-07-2011.pdf

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Bacterial Bioburden Associated with Endoscopes

Bacterial Bioburden Associated with Endoscopes

Gastroscope, log10

CFUColonoscope, 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

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Environmental Tour Checklist for Endoscope Reprocessing Areas

Physical space: Is the area sized appropriately in relation to the volume of equipment processed? Do staff put on personal protective equipment (PPE) before entering the area? Are staff wearing suitable PPE? Is there sufficient work space? Are cleaning supplies, storage areas, and other critical items clearly labeled? Is there an appropriate hand washing station? Is there an appropriate eyewash station? Are “dirty” areas physically separated from “clean” ones? Are there suitable storage areas for cleaned endoscopes? Do do these areas look clean, free of debris and dry If a cabinet serves as storage, does the cabinet have doors? Are endoscope storage containers dry and located off the ground”? What is the route from the processor to the cabinet? (The route should not cross through the soiled processing area.)

Ventilation: Is there negative air pressure to surrounding areas? Are air exchange rates and filtration efficiencies appropriate? Are there a minimum of 10 exchanges per hour, with at least two being with fresh, outside air? Is exhaust vented directly outside?

Documentation and training: Are staff aware of the number of endoscopes in the department? Does staff know how frequently these are maintained and how that maintenance occurs? When staff members are questioned, can they show where evidence-based practices and guidelines are located? When staff are asked about their training, does it appear they were trained using the guidelines? Are staff given periodic refresher training?

Environmental Tour Checklist for Endoscope Reprocessing Areas

Physical space: Is the area sized appropriately in relation to the volume of equipment processed? Do staff put on personal protective equipment (PPE) before entering the area? Are staff wearing suitable PPE? Is there sufficient work space? Are cleaning supplies, storage areas, and other critical items clearly labeled? Is there an appropriate hand washing station? Is there an appropriate eyewash station? Are “dirty” areas physically separated from “clean” ones? Are there suitable storage areas for cleaned endoscopes? Do do these areas look clean, free of debris and dry If a cabinet serves as storage, does the cabinet have doors? Are endoscope storage containers dry and located off the ground”? What is the route from the processor to the cabinet? (The route should not cross through the soiled processing area.)

Ventilation: Is there negative air pressure to surrounding areas? Are air exchange rates and filtration efficiencies appropriate? Are there a minimum of 10 exchanges per hour, with at least two being with fresh, outside air? Is exhaust vented directly outside?

Documentation and training: Are staff aware of the number of endoscopes in the department? Does staff know how frequently these are maintained and how that maintenance occurs? When staff members are questioned, can they show where evidence-based practices and guidelines are located? When staff are asked about their training, does it appear they were trained using the guidelines? Are staff given periodic refresher training?

Joint Commission Online April 9, 2014 (http://www.jointcommission.org/assets/1/23/jconline_april_9_14.pdf

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Endoscope Reprocessing –Impact of Human Factors

Endoscope Reprocessing –Impact of Human Factors

• Employee perception of the importance of endoscope reprocessing.

• Least popular task – Leak Testing.

• Occupational health issue attributed to reprocessing endoscopes.

• Reprocessing efficiency – truncating selective steps to move the process along.

• Significant difference in number of reprocessing steps skips in manual vs automated reprocessing (p=0.001).

• Alcohol flush and forced-air drying commonly skipped.Ofstead CL, et a.l. Gastroenterol Nurs 2010;33;304-311

Healthcare-Acquired Outbreaks via GI Endoscopes

Infections Associated with Accessories

Healthcare-Acquired 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.

TRANSMISSION OF INFECTIONTRANSMISSION 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, RutalaWA Gastroint Dis 2002

Nelson DB, Muscarella LF. World J Gastroenterology 2007;12:3953-3964

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Healthcare-Associated Infections via GI Endoscopes

Healthcare-Associated 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 and Weber DJ, Rutala, WA. Gastroint Dis 2002

Healthcare-Associated Infections via GI Endoscopes

Healthcare-Associated 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 DisinfectionEndoscope Reprocessing: Current Status of Cleaning and Disinfection

No Lack of Guidelines• Multi-Society Guideline, 11 professional organizations• Society of Gastroenterology Nurses Associates• European Society of Gastrointestinal Endoscopy• British Society of Gastroenterology Endoscopy• Gastroenterological Society of Australia• Gastroenterological Nurses Society of Australia• American Society for Gastrointestinal Endoscopy• Association for Professional in Infection Control and

Epidemiology• Centers for Disease Control and Prevention • Association for peri-Operative Registered Nurses• AAMI Guidelines

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Evidence-Based Hierarchy

Manufacturer’s Recommendations

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Processing Flexible Endoscopes

Where Are We Now – What Was The Game Changer?

JAMA 2014;312:1447-1455

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Carbapenem-Resistant Enterobacteriaceae

Carbapenem-Resistant Enterobacteriaceae

• Klebsiella pneumoniae or Escherichia coli

• ERCP

• Scope – elevator – risk factor

• Failure to remove bioburden

• Epidemiologically linked

• Careful attention to manual cleaning

© Aurora Health Care, Inc.

CRE – What Is It?

• CRE are in a class known as multi-drug resistant organisms (MDROs)

• You have heard of other MDROs before– MRSA

– VRE

• First reported in North Carolina in 2001, the U.S. is finding more and more cases of these bacteria every year

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© Aurora Health Care, Inc.

Why Are CRE Considered Important?

• Resistant to multiple classes of antimicrobials limiting treatment options.• Some Enterobacteriaceae have become resistant to all

or almost all antibiotics.

• CRE can share their resistance with other Enterobacteriaceae, causing resistance to spread

• High mortality rate

• Up to 50% case mortality rate associated with invasive infections

© Aurora Health Care, Inc.

Who Can Get An Infection With CRE?

• Healthy people usually don’t get CRE infections.

• CRE primarily affect patients in acute and long-term healthcare settings

• CRE are more likely to affect immunocompromised patients or those with invasive devices (i.e. central lines, urinary catheters).

© Aurora Health Care, Inc.

How Are CRE Spread?

• To get a CRE infection, a person must be exposed to CRE bacteria.

• CRE are usually spread person to person through contact with infected or colonized people, particularly contact with wounds or stool.

• CRE can cause infections when they enter the body, often through medical devices like ventilators, intravenous catheters, urinary catheters, wounds or flexible endoscopic equipment.

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Sources of Microbial Contamination Sources of Microbial Contamination

Endoscopic ReprocessingEndoscopic Reprocessing

• 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

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Lee et al. Am J Infect Control 2015;43:e13-e17

Lee et al. Am J Infect Control 2015;43:e13-e17

Surface alteration can occur in flexible endoscopes and changes in

surface topology that results in residual contamination – Is this

residual contamination recalcitrant to high-level disinfection?

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Microbial Biofilms

Microbial Biofilms – Surface Recalcitrant To Cleaning

Microbial Biofilms – Surface Recalcitrant To Cleaning• Dental plaque

• Heart valves

• Ear infections

• Renal staghorn calculi

• Gallbladder stone formation

• Miscellaneous biomedical devices • stents

• surgical instruments

• endoscopic devices (channels, cul de sacs)

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Ofstead et al. Am J Infect Control 2015;43:794-801

GI endoscopes are highly contaminated post use and residual

organic material including viable biofilm microorganisms will persist on the surface of the device despite

reprocessing in accordance to societal guidelines

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CDC/FDA Panel May 14-15, 2015

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OK – How About Hang Time?

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes

Multi-Society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes

Unresolved IssuesInterval 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 suggest 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).

Hang Time ConsiderationsHang Time Considerations• AAMI (ST91:2015) – determined by institution following

risk assessment

• AORN (2015) – 5 days

• ASGE (2015) – Not addressed

• CDC (2015) – Not addressed

• ECRI – Not addressed

• USFDA – Not addressed

• Multi-societal (APIC, SHEA, ASGE) – Unresolved

• SGNA (2015) – Warrants further data

• JB Database – 7 days (if effectively reprocessed)

• Gastrointest Endoscopy 2015;81:1150 – 21 days

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ENDOSCOPE SAFETYQuality Control IssuesENDOSCOPE SAFETYQuality Control Issues

• 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.

Standards of Practice to Protect the Endoscope Healthcare Worker

Standards of Practice to Protect the Endoscope Healthcare Worker

• Knowledge of mechanisms of disease transmission,

• Routine Practices and Additional Precautions,

• The appropriate use of personal protective equipment,

• Occupational health and safety regulations,

• Reprocessing procedures for flexible endoscopes and accessories,

• Safe work practices,

• Safe handling of chemicals used in reprocessing,

• Safe waste management.

Final Consideration -Accountability

Final Consideration -Accountability

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Weber D. Infect Control Hosp Epidemiol 20120;33:657-660

“A Need to Shift from Disinfection to Sterilization”

“A Need to Shift from Disinfection to Sterilization”

• 10 million GI endoscopy procedures performed annually in US.• Flexible GI endoscopes are heat labile – HLD or low temperature

technologies (ethylene oxide) only current risk reduction strategies.• Margin of safety is minimal due to high microbial contamination

(burden) following endoscopy.• For example in the inner channel:

start with 8-10 logs > cleaning step, 4-6 logs > HLD, 4-6 logs = 10-12 log reduction – margin of safety assocatedwith reprocessing 0-2 logs (traditional sterilization associated with a 17 log margin of safety)

• How can we assess the efficacy of reprocessing: cultures, ATPase testing – but what is the cutoff to define proper disinfection (<10, 0)?

Rutula WA, Weber DJ. Gastrointestinal Endoscopes: A Need to Shift from Disinfection to Sterilization JAMA 312 (Oct): 1405-1406.

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“Meticulous cleaning of duodenoscopesmay not eliminate infection risk, US watchdog warns” - BMJ Feb 20, 2015

“Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication” –Update March 4, 2015

“Meticulous cleaning of duodenoscopesmay not eliminate infection risk, US watchdog warns” - BMJ Feb 20, 2015

“Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication” –Update March 4, 2015

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CDC Facility Guidance for Control of CRE CDC Facility Guidance for Control of CRE • Hand Hygiene

• Contact Precautions

• Healthcare Personnel Education

• Device Utliization

• Laboratory Notification

• Inter-facility Communication – Identification of CRE Patients at Admission

• Antimicrobial Stewardship

• Environmental Cleaning

• Patient and Staff Cohorting

• Screening Contacts of CRE Patients

• Active Surveillance

• Chlorhexidine Bathing

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We Don’t Know What We Don’t Know!

We Don’t Know What We Don’t Know!