FDA reveals 142 cases of tainted duodenoscopes

Agency remains opposed to recalling the devices

FDA last week week 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.

FDA has previously said that it received 75 adverse event reports about duodenoscopes in 2013 and 2014.

Background on superbug outbreaks linked to scopes

As many as 179 patients could have been exposed to Carbapenem-resistant Enterobacteriaceae (CRE) 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.

UCLA is not the only U.S. hospital to report a CRE outbreak spread through the duodenoscopes that are used during ERC procedures. Earlier this year, a hospital in Seattle reported that as many as 11 deaths at the facility may have been linked to CRE spread through duodenoscopes. And on Wednesday of this week, Cedars-Sinai Medical Center reported that four patients had been infected with the bacteria after being exposed to a contaminated scope.

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Meanwhile, Hartford Hospital reported that nearly 300 patients may have been exposed to antibiotic-resistant E. coli through contaminated duodenoscopes.

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 makers. 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 Los Angeles Times, the panel is expected to propose additional steps for device makers, hospitals, and regulators to take to increase the safety of patients undergoing procedures that use duodenoscopes.

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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 opposes recall

FDA reiterated that 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 (Terhune/Petersen, Los Angeles Times, 5/7).

The takeaway: 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. However, the agency remains opposed to a recall, saying the devices serve an important purpose in treating patients.

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