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Gary Evans writes Hospital Infection Control & Prevention (HIC), Hospital Employee Health (HEH) and contributes to IRB Advisor (IRB). As senior writer at AHC, Evans has written numerous articles on infectious disease threats to both patients and health care workers, including pandemic influenza, MERS and Ebola. He has been honored for excellence in analytical reporting five times by the National Press Club in Washington, DC.
After a wave of practically untreatable carbapenem-resistant Enterobacteriaceae (CRE) infections in patients undergoing complex endoscopies, a highly respected independent research group has stepped forward with a solution that will allow the medically necessary procedures to continue at considerably less risk to patients.
But it will cost you.
The problem is that ERCP (Endoscopic retrograde cholangiopancreatography) — an upper endoscopy procedure performed on some half million U.S. patients annually – poses a risk of transmission of CRE, the poster bug of the post-antibiotic era. Intricately designed and hard-to-clean duodenoscopes are used for ERCP, an upper endoscopy procedure to access the pancreas, biliary tract and liver. CRE has found a way to hide out in these scopes, infecting patients even after clinicians follow all the recommended reprocessing steps.
ECRI – sort of the Consumer Reports of medicine and medical devices – put a team on the job and came up with a protocol that sounds similar to the plan one of the outbreak hospitals devised -- Virginia Mason Medical Health System in Seattle. ECRI advises, in a nutshell, don’t use the duodenoscopes until they culture negative.
The fiercely independent non-profit institute based in Plymouth Meeting, PA, issued a Hazard Report that details the method, which would keep these important procedures available to patients at reduced risk of a CRE infection. ECRI recommends that hospitals conduct regular CRE surveillance through duodenoscope culturing, regardless of which reprocessing method they use (e.g., high-level disinfection using a liquid chemical germicide or sterilization using ethylene oxide).
This could be done in many ways, but until further culture recommendations are available ECRI recommends one of the following approaches:
Culture every duodenoscope after reprocessing is completed and wait to release the cultured scopes until negative results are received. Culture incubation typically takes up to 48 hours. “We believe this will provide the highest assurance of preventing CRE infections,” ECRI reported.
Sounds good, but the problem – and we do have one – is that this approach may require increasing duodenoscope inventories by two- or three-fold. Duodenoscopes cost approximately $40,000. Since few hospitals will have the luxury of stocking enough scopes to have a few idle awaiting culture results, plan B would be to culture scopes weekly, starting at the end of the day Friday so the bacteria may grow over the weekend.
“This will not provide the high degree of assurance that culturing after each reprocessing cycle provides,” ECRI notes. “It also bears the risk of unknowingly using contaminated scopes between culturing intervals. However, weekly culturing will be less likely to require increases to duodenoscope inventories. It will also limit the risk of potentially exposing a large number of patients to contaminated scopes as compared to less frequent culturing.”
If a duodenoscope culture is positive, ECRI recommends repeating reprocessing using your standard method and re-culturing the instrument. If this next reprocessing results in a positive culture, consider sending the duodenoscope back to the manufacturer for further assessment or retiring it. Notify your infection preventionist of all positive CRE cultures, ECRI advises. If you get positive cultures back on more than one scope consider the possibility of a CRE reservoir in the reprocessing equipment or other sources, ECRI notes.