Kim Newman, BSN, RN, CICBaylor Scott & White – Baylor University

Medical Center Dallas(Kimberly.newman@bswhealth.org)

Kim Newman has nothing to disclose.

1. Learner will be able to identify challenges associated with high level disinfection of scopes.

2. Learner will be able to cite national standards and guidelines regarding high level disinfection of scopes.

3. Learner will be able to discuss how to perform an audit for compliance of practice.

Center for Disease Control (CDC)

Society for Gastroenterology Nurses & Assoc. (SGNA)

Association of Advancement of Medical Instrumentation (AAMI)

Association for Operating Room Nurses (AORN)

American Society for Gastrointestinal Endoscopy (ASGE)

American College of Gastroenterology (ACG)

Association for Professionals in Infection Control (APIC)

Endoscope reprocessing has a narrow margin of safety and any slight deviation from the recommended reprocessing protocol can lead to the survival of microorganisms and increased risk of infection.*

Number of steps is demanding & can easily lead to omission of 1 or more steps

Not adhering to evidence-based guidelines or manufacturer instructions for use (IFU)

Endoscope design itself poses a challenge

*Alfa M: Automated washing with the Reliance Endoscope Processing System and its equivalence to optimal manual cleaning, American Journal of Infection Control, 2006;34(9)561-570

1991 Gorse & Messner surveyed 2030 SGNA members◦ Compliance with existing guidelines ranged from

67% to 93%

1991 FDA & 3 State Health Dept. investigated 26 health care facilities◦ 24% of patient-ready endoscopes were culture

positive

2009 CDC piloted IPC tool of 68 ambulatory surgery centers◦ Adherence to guidelines uniform in 71.6%

Separate from patient procedural area

One-way workflow that separates contaminated area from clean area◦ Negative pressure between rooms

Handwashing sink separate from reprocessing sink

Eyewash stations if required

Education/Training/Competency Initially upon hire◦ Trained by Certified staff

Periodically according to policy When a new model of scope, reprocessing

equipment or chemical is introduced After updates to manufacturer’s IFUs Should always be followed by direct

observation of performance Certification does not mitigate need for

training and competency evaluation

IC 02.02.01 – reduce risk of infection due to medical equipment◦ 2016 74% of “immediate threat to life” findings

were related to HLD or sterilization issues

AHC – Ambulatory Health CenterCAH – Critical Access HospitalHAP – Joint Commission Accredited HospitalsOBS – Office Based Surgery Facility

Sterilization (critical items)◦ Process that destroys or eliminates all forms of

microbial life and is done by physical or chemical methods

High level disinfection (semi-critical items)◦ Process that eliminates many or all pathogenic

microorganisms, except bacterial spores

Cleaning (non-critical items)◦ Removing of visible soil

Follow manufacturer’s recommendations/IFUs

Pre-clean immediately after completion of procedure◦ Wiping exterior with enzymatic detergent

◦ Aspiration of large volume of detergent solution through air/water & biopsy channels

Missing air/water channel cleaning adapter (Olympus scopes)

Visible soil and tissue

Perform after each use and prior to manual cleaning◦ Detects damage to interior/exterior of scope

◦ Prevents damage due to fluid invasion

◦ Extends life of scope & prevents expensive repairs

Brushing and flushing channels and ports following manufacturer's IFUs

Complete within timeframe specified in manufacturer’s IFUs◦ If not done, follow manufacturer’s

recommendations on prolonged soaking time

Most critical step

Must use brushes appropriately sized ◦ Single use or thoroughly cleaned and disinfected

between uses

Consider the use of a rapid cleaning verification test◦ Quantitative tests (detect biological matter)

ATP

EndoCheck/Channel Check

◦ Qualitative tests (swabbing device, noting color change)

Verify® Resi-test™

*Recommended by AAMI, AORN, SGNA

Test Plan◦ Option 1 – monitor every

endoscope after use

◦ Option 2 – categorize by type/risk level

High Risk: duodenoscopes, EUS, ERCP, bronchoscopes

Not High Risk: colonoscopes, gastoscopes

Test Points◦ Instrument/suction channel

◦ Elevator mechanism

◦ Outer distal end

◦ Control Handle

◦ Instrument port

Endoscopy accessories (e.g., biopsy forceps) that come in contact with mucous membranes are classified as semi-critical and should be mechanically cleaned and receive at least high-level disinfection

Water bottles & connecting tube disinfection◦ Daily vs. between uses

Provides additional assurance that endoscope is clean and free of defects◦ Visually inspect for cracks, corrosion, discoloration,

retained debris

◦ Use magnification and adequate lighting

Automated endoscope reprocessors (AER)◦ Recommended when possible

◦ Approved connectors should be utilized

◦ Flush with alcohol and dry using forced filtered air

Liquid chemical disinfectants/sterilants(GUS® System)◦ Exposure time & temperature dependent upon

product used

Gas (EtO)

Run disinfection cycle per manufacturer’s IFUs

Preventive maintenance performed

Filter changes when required

Documentation

Drying the endoscope with medical grade air must be completed after every reprocessing cycle, both between patient procedures and before storage.◦ Moisture allows organisms to survive and multiply

◦ Promotes biofilm development

◦ Flush with 70% isopropyl alcohol followed by use of forced medical grade air

Store in manner that:◦ Prevents recontamination

◦ Protects equipment from damage

◦ Promotes drying

Hang vertically without coiling or

touching sides and bottom of cabinet

Ideally, scopes are not touching

each other

A few things to know

Dependent loops hold in moisture

If the bottom of cabinet has water spots-sign that scopes need longer air dry before storing

The bottom & sides of the cabinet must be clean, scope cannot touch the bottom

Scopes stored longer than hang time policy must be reprocessed prior to use

Shelf life between use◦ SGNA recommends reprocessing within 7 days

◦ APIC – no recommendation

◦ AORN – multi-disciplinary committee to perform risk assessment to determine

Essential for quality assurance & patient tracing if necessary

Policies should be developed by multidisciplinary team◦ Use

◦ Transport

◦ Reprocessing

◦ Storage

◦ Staff education/training/competency

◦ Ongoing quality assurance

Maintain a log to assist in an outbreak investigation if necessary:◦ Patient’s name and medical record number

◦ Date & procedure performed

◦ Serial number/identifier of endoscope

◦ Name of the person performing the cleaning & HLD/sterilization process

Repeat HLD

Culturing* and quarantine until negative

Liquid chemical sterilant processing system

Ethylene oxide (EtO) sterilization◦ EtO sterilization of flexible endoscopes is

infrequent because it requires a lengthy processing and aeration time (e.g., 12 hours) and is a potential hazard to staff and patients.

*Recommended by CDC, ASGE

Service according to manufacturer’s recommendations

Replacement interval is unknown◦ Dependent upon number of times used

Important to monitor scopes for damage & replace/repair per manufacturer’s recommendations

All essential steps of reprocessing are met and maintained

Endoscopes are cleaned at point of use & transported safely

Sufficient number of staff available Manufacturer’s IFUs are readily available & followed Necessary reprocessing equipment & supplies are

available Physical space is adequate HVAC parameters are maintained & monitored Storage of endoscopes is appropriate Documentation providing traceability is maintained Key Leadership involvement

Endoscopes – GI, OR

Bronchoscopes – GI, OR, Pulmonary, ICU

FEES Scopes – Speech therapy, NICU, Rehab

Cystoscopes – Urology unit/clinics, Lithotripsy

Laryngoscopes – ED, Head & Neck units/clinics, ICUs

TEE probes – Cardiopulmonary, OR

To date, nearly all published episodes of pathogen transmission related to GI endoscopy instruments have been associated with failure to follow established cleaning and disinfection/sterilization guidelines or use of defective equipment.

Complex design

Variety of manufacturers/models

Difficulty identifying damage

Inadequate training

Insufficient number of staff

Frequent disruptions during reprocessing

Limited accountability

Time pressures or demands for rapid turn-around.

Lack of certified individuals

Study Location Equipment Outcomes Organism Comments

Naas et al (2010) 9 and Carbonne et al (2010) 12

France Duodenoscope 3 infected10 colonized

Klebsiellapnueumoniae

The hospital changed to a glutaraldehyde decontamination bath followed by automated peracetic acid washer because of concern about Creutzfeldt-Jakob transmission; there may have been deficiencies in cleaning associated with the change in protocol

Koo et al (2012) 13

United Kingdom

Cystoscope 5 infected4 colonized

Klebsiellapneumoniae

Deficiencies noted in cleaning protocol of head of device; outbreak stopped with ETO sterilization

Alrabaa (2013) 14

United States

Duodenoscope 7 infected3 colonized

K. PneumoniaeEscherichia coli

Found to have a deficiency in mechanical removal of debris

Chang et al (2013) 15

China Ureteroscope 15 Enterobactercloacae

OPA sterilization alone failed to clear the device; required weekly ETO treatments

Epstein et al (2014) 11

United States

Duodenoscope 10 cases28colonized/100 screened

NDM-1 E coli HLD with OPA; outbreak terminated when changing to sterilization with ETO

Smith et al (2015) 16

United States

Duodenoscope 4 infected1 colonized

NDM-1 E coli Routine HLD; exact methodology not specified

Occurred even when manufacturer guidelines & professional guidelines followed correctly

Interim guidelines due to recent reports of CRE infections associated with endoscopy◦ Treatment options are typically limited & risk of

mortality is doubled

Since 1990, The FDA Safety Information & Adverse Event Reporting program (www.fda.gov/medwatch). ◦ Medical Device Reports submitted through

“Medwatch” can be reviewed on the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database

Guideline for Disinfection and Sterilization in Healthcare Facilities 2008

◦ https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

Naas T, Cuzon G, Babics A, Fortineau N, Boytchev I, Gayral F, et al. Endoscopyassociated transmission of carbapenem-resistant Klebsiella pneumonia producing KPC-2 beta-lactamase. J AntimicrobChemother 2010;65:1305-6

Carbonne A, Thiolet JM, Fournier S, Fortineau N, Kassis-Chikhani N, Boytchev I, et al. Control of a multi-hospital outbreak of KPC-producing Klebsiella pneumoniae type 2 in France, September to October 2009. Euro Surveill 2010;15

Koo VS, O’Neill P, Elves A. Multidrug-resistant NDM-1 Klebsiella outbreak and infection control in endoscopic urology. BJU Int 2012;110:E922-6

Alrabaa S. Early identification and control of carbapenemase-producing Klebsiella pneumoniae, originating from contaminated endoscopic equipment. Am J Infect Control 2013;41:850

Chang CL, Su LH, Lu CM, Tai FT, Huang YC, Chang KK. Outbreak of ertapenemresistant Enterobactercloacae urinary tract infections due to a contaminated ureteroscope. J Hosp Infect 2013;85:118-24

Epstein L, Hunter JC, Arwady MA, Tsai V, Stein L, Gribogiannis M, et al. New Delhi metallo-beta-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA 2014;312:1447-55

Smith ZL, Oh YS, Saeian K, Edmiston CE, Khan AH, Massey BT, et al. Transmission of carbapenem-resistant Enterobacteriaceae during ERCP: time to revisit the current reprocessing guidelines. Gastrointest Endosc 2015;81:1041-5

Thank you!