FDA advisory panel to investigate duodenoscope safety

The Food and Drug Administration received 142 reports of possible infections of patients undergoing procedures with the type medical scope responsible for outbreaks at two medical centers over the past six months.

The figure was included in a report issued in advance of a two-day FDA advisory committee meeting scheduled May 14-15 that will examine the efficacy of the cleaning processes for duodenoscopes recommended by their manufacturers. The panel is expected identify best practices providers can follow that will further reduce the risk of contamination.

An FDA review of incident reports dating from 1997 up to this past February found there 146 reports of “patient infection, exposure or device contamination” associated with the use of duodenoscopes for endoscopic retrograde cholangiopancreatography procedures. Nearly all of those reports came in the past five years.

The agency also revealed that it received 152 medical device reports of patient exposure to infection associated with the use of automated endoscope reprocessors, the machines used to disinfect the scopes, between 1992 and March this year.

The agency concludes in the report that it still believes the benefits of the procedure “outweigh the risks in appropriately selected patients.” It adds, however that the transmission of infection, “although uncommon, represents a serious public health concern.”

Efforts to improve disinfection methods have been given greater attention over the last several months in the wake of two outbreaks of carbapenum-resistant enterobacteriaceae, or CRE, between August 2014 and January 2015 at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center. As many as 250 people were exposed to the drug-resistant bacteria, leading to 11 infections and two deaths.

More than 668,000 ERCPs were performed in 2014, according to the report. The procedures are done to evaluate and treat conditions within the pancreatic and bile ducts. Given the vital role duodenoscopes play in identifying and treating such diseases, the FDA has continued to recommend their use despite recognizing the difficulties involved in disinfecting the devices, even when guidelines are followed.

“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” according to a safety warning about the devices the FDA issued in February. “Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible.”

In March the FDA issued final guidance on processes to clean and disinfect reusable medical devices, including duodenoscopes. The guidance requires manufacturers to submit testing data to validate that their cleaning instructions are effecting in reducing the risk of bacterial contamination.