« Back to Company News

FDA issues superbug safety alert related to scope use

The Food and Drug Administration (FDA) released an adverse event warning Feb. 19 on superbug infection risks associated with the use of ERCP endoscopes (side-viewing duodenoscopes). The warning was issued in response to reports of  CRE infections at Ronald Reagan UCLA Medical Center, the latest in a series of occurrences tied to the use of duodenoscopes in the U.S.

Endoscopes are flexible, lighted tubes that are threaded through the mouth and into the body.

The FDA said it is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. The FDA reports that given their complex design, even with meticulous cleaning duodenoscopes may still pose a risk. Possible solutions such as new disinfection protocols are under investigation.

The UCLA Health System notified 179 patients on Feb. 18 that they may have been exposed last fall to CRE bacteria during an endoscopic procedure. The health system said seven patients were infected; the infection was a contributing factor in the death of two patients.

Refer to the FDA medical device page for specific recommendations.