Duodenoscope Still Dirty? FDA Has More Reprocessing Advice

Marie Thibault

Almost six months after news broke of the carbapenem-resistant enterobacteriaceae (CRE) outbreak at Los Angeles's Ronald Reagan UCLA Medical Center, FDA has come out with more steps to try to ensure healthcare facilities can reprocess duodenoscopes effectively. Contaminated duodenoscopes were found to have transmitted the CRE infections in the UCLA cases and other outbreaks around the country.

In an August 4 safety communication, FDA outlines additional ways to get a clean, contaminant-free duodenoscope. The agency notes that these recommendations came out of the duodenoscope-focused May 2015 meeting of the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee. 

FDA's recommends considering at least one of these additional measures: 

Interestingly, FDA also describes some of the potential drawbacks of these extra steps. For instance, on microbiological culturing, FDA writes that this can help test the effectiveness of reprocessing and find culprit duodenoscopes that continue to be contaminated after reprocessing. But the agency also points out that false positive and negative rates, as well as detection thresholds, aren't yet clear. Additionally, FDA calls culturing "resource-intensive" and says "results take time to produce."

In a March 2015 MD+DI article on FDA's final device reprocessing guidance, Dr. Frank Nemec, patient advocate and board member of Hepatitis Outbreaks National Organization for Reform (HONOReform), also pointed out the time-consuming nature of culturing. Culturing and duodenoscope quarantining is not practical for centers that need to keep enough scopes usable to meet patient volume demands, Nemec said.

While FDA has published a number of updates and communications on duodenoscope reprocessing, an August 2 article in the Los Angeles Times calls attention to the fact that duodenoscopes aren't the only medical endoscopes making patients sick. The report notes that among cases reported to FDA, bronchoscopes, cystoscopes, and gastroscopes have all been found to be contaminated with infectious pathogens. 

Unfortunately, this likely means this won't be the last we hear about contaminated scopes. 

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

 [Image courtesy of DAVID CASTILLO DOMINICI/FREEDIGITALPHOTOS.NET]