142 Adverse Events Related to Duodenoscopes Reported Since 2010

This week, FDA said it had received 142 adverse event reports between 2010 and Feb. 17, 2015, on patient harm from duodenoscopes, which have been linked to recent superbug outbreaks at U.S. hospitals, the Los Angeles Times reports (Terhune/Petersen, Los Angeles Times, 5/7).

Background

As many as 179 patients could have been exposed to Carbapenem-Resistant Enterobacteriaceae after undergoing a procedure with a duodenoscope -- also called an endoscopic retrograde cholangiopancreatography -- at UCLA's Ronald Reagan Medical Center between October 2014 and January 2015. Seven patients were confirmed to have CRE infections, and two of those patients died.

Meanwhile, Cedars-Sinai Medical Center in Los Angeles in March reported that four patients had been infected with CRE and up to 67 more might have been exposed after being treated with the same type of scope (California Healthline, 4/21).

Details of FDA Report

FDA compiled the data using information from its adverse event report database. The reports are filed by medical device makers and by cleaning equipment manufacturers. They can include adverse events involving numerous patients.

The FDA report was compiled in preparation for an agency advisory panel meeting on May 14 to May 15 that will review the recent superbug outbreaks at U.S. hospitals. According to the Times, the panel is expected to propose additional steps for devicemakers, hospitals and regulators to take to increase the safety of patients undergoing procedures that use duodenoscopes.

FDA Calls Events a 'Serious Public Health Concern'

FDA found that it received 142 adverse event reports on patient harm from duodenoscopes dating back to 2010 and four additional reports dating back to 1997.

An FDA spokesperson said she did not have data on the number of individuals affected in the reports.

Of the 146 adverse events:

• 121 involved patient injuries;
• 13 involved patient deaths; and
• The remaining reports involved malfunctioning equipment or other unspecified adverse events.

FDA said in the report, "The transmission of infectious material from patient to patient during ERCP, although uncommon, represents a serious public health concern."

Agency Against Recall

FDA reiterated that duodenoscopes serve an important purpose in treating patients and should not be recalled.

The agency said that it "believes that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand" and "believes the benefits of the ERCP procedure outweigh the risks in appropriately selected patients."

FDA said that providers had performed 668,000 duodenoscope procedures in 2014, up by 15% since 2010 (Los Angeles Times, 5/7).