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Fighting a Superbug: Breaking the Mold to Protect Against the Spread of CRE

KELLY SHIELDS, BS-B/M

NORTHSIDE HOSPITAL ATLANTA, GEORGIA

CHANGES IMPLEMENTED AT NORTHSIDE HOSPITAL:

References 1. www.fda.gov/medicaldevices/safety/alertsandnotices/ucm434871.htm

2. www.sgna.org/issues/infection-prevention/SGNA-resources

3. www.cdc.gov/hai/organisms/cre/cre-duodenoscope-surveillance-protocol-FAQs.html

SAMPLING/CULTURING LIMITATIONS AND BARRIERS

The CDC methods have not been validated Sensitivity and specificity are not established Limits on quantitation or detection are unknown Protocols are based on “high-concern” organisms rather than overall bioburden What dictates a “negative” result is not specifically defined False negative and false positive results are possible Insufficient data exists on the performance of culturing/sampling Negative cultures do not necessarily mean that a scope has been adequately reprocessed Availability of resources can be limiting (time, manpower, finances)

CDC INTERIM METHODS In the wake of all of the news coverage of CRE outbreaks due to duodenoscopes, endoscopy units across the country have had to take additional precautions to protect their patients and meet standards related to CRE and duodenoscope reprocessing. ERCP is a common and vital procedure for most hospital endoscopy units, and thus this impacts a significant portion of the GI community. Patients and practitioners alike are requesting information on what is being done to eliminate the risk factors for transmission of CRE and other superbugs through endoscopy. Multiple options have been presented to ensure appropriate care is taken, including culturing duodenoscopes, additional reprocessing standards, and increased quality measures.

BACKGROUND Oct 2014 Multiple hospitals begin reporting outbreaks and exposures of CRE as a result of contaminated duodenoscopes

Feb 2015 FDA issues statement that design of duodenoscopes may impede effective cleaning

Mar 2015 FDA reviews and updates statement, making recommendations for enhancements in reprocessing practices but urges facilities to continue to perform ERCP with duodenoscopes (no other alternative, risk of infection low)

Mar 2015 Olympus releases updated reprocessing manual for TJF-180V duodenoscopes

Apr 2015 CDC issues interim protocol for healthcare facilities regarding surveillance for bacterial contamination of duodenoscopes after reprocessing

Aug 2015 CDC issues interim culture and sampling methods for duodenoscopes

FDA releases supplemental measures for enhancing duodenoscope reprocessing

Nov 2015 FDA recommends transition from Custom Ultrasonics AERs to other reprocessing methods

Dec 2015 FUJIFILM validates revised reprocessing instructions for model EED-530XT duodenoscopes

Jan 2016 Olympus validates new reprocessing instructions for model TJF-180V duodenoscopes

Feb 2016 PENTAX validates reprocessing instructions for ED-3490TK video duodenoscopes

Mar 2016 Olympus validates updates to reprocessing instructions for model TJF-160F and TJF- 160VF duodenoscopes

CRE in the NEWS

Immediately removed TJF 180VF scope from circulation until Olympus replaced forceps elevator mechanism and updated reprocessing manual (March 2016) Implemented practice of reprocessing every duodenoscope each morning prior to first case Created documentation in patient chart stating that the duodenoscope used in procedure was reprocessed prior to the procedure Cultured each duodenoscope per CDC method, holding scope out of service until cultures came back negative - no positive cultures were returned, so re-culturing was not necessary Increased frequency of staff reprocessing of duodenoscope competencies to bi-annually (originally annually) following initial re-competency Implemented changes recommended by Olympus including using new cleaning brushes

NEXT STEPS:

Working to implement non-culture sampling of each duodenoscope after every reprocessing cycle using ATP assays

SURVEILLANCE OF DUODENOSCOPES

WHAT IS SURVEILLANCE? Surveillance is the monitoring of practices and ongoing changes to evaluate the effectiveness and adequacy of the reprocessing of endoscopes (in this case, specifically of duodenoscopes) Protocols were developed by the CDC (available online) as a guide for facilities considering cultures. Two methods of surveillance available Culture methods: Completed after full reprocessing cycle Check for microbial growth Delayed results due to allowing for growth time (48hrs or more) Non-culture methods: Completed after manual cleaning process (before HLD) Assays for ATP, protein Immediate feedback about adequacy of manual cleaning process WHY SHOULD WE CONSIDER IMPLEMENTING SURVEILLANCE PRACTICES? Culturing and surveillance are not required, but some facilities have used them as either a starting point or ongoing response to the initial CRE issue Evaluating processes with surveillance can highlight unexpected insufficiencies and allow for change in protocol to enhance reprocessing practices WHAT DO WE DO NEXT TO BEGIN SURVEILLANCE? Complete a needs assessment to determine reprocessing risks (SGNA has resources in the infection prevention section of the website to help determine areas of need) Evaluate staff competencies and determine if any changes need to be made to educate and train staff properly. Ensure that competencies are validated at least annually and after any change in practice. Involve anyone at your facility that has a potential interest in reprocessing and infection prevention practice (infection preventionists, etc) Be aware of ongoing changes in the GI community and communicate these changes to staff immediately Review and consider the interim protocols for sampling and culturing provided by the CDC on their website

Optimal frequency of culturing has not been established. International guidelines recommend intervals ranging from every 4 weeks to annually Examples of durations given by the CDC are monthly cultures, cultures after 60 procedures, weekly, or even after every procedure after reprocessing. Not meant to assure sterility of duodenoscopes

CULTURE METHOD: Purpose is to culture bacteria from fully reprocessed duodenoscope from distal end and instrument channel. Lab processes sample either by looking at absence/presence of growth or quantitatively Five Samples: Instrument channel flush (irrigation water) Internal process positive control (aliquot of channel flush spiked with organisms) Distal end/elevator mechanism (brush submerged in phosphate buffered saline) Negative control of irrigation water Negative control of phosphate buffered saline (PBST) SAMPLING METHOD: Purpose is to sample for bacteria from fully reprocessed duodenoscope specifically located on distal end and for collecting samples from the instrument channel via instrument port to distal end Performed by two individuals (facilitator and sampler) using aseptic technique Two Samples: Distal end/elevator mechanism (brush submerged in PBST) Instrument channel flush (irrigation water HANDLING OF SCOPE AFTER SAMPLING: Holding scope out of use while surveillance culture results are pending is recommended. Scopes found contaminated should not be returned to use until remedial actions have been performed