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FDA Issues Warning Letters to Duodenoscope Manufacturers

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Jarod Cassidy2 years ago

The U.S. Food and Drug Administration (FDA) has issued warning letters to manufacturers of specific type of medical endoscope that was linked to an outbreak of Carbapenem-Resistant Enterobacteriaceae (CRE) earlier this year.

FDA Letters Cite Health Violations

According to Reuters, the August 12 letters cited violations observed during inspections of the facilities at which the medical devices are manufactured. The letters were addressed to Olympus Corp, Fujifilm Holdings Corp, and Pentax Medical.

The devices in question, duodenoscopes, are long flexible tubes used during a procedure called endoscopic retrograde cholangiopancreatography (ERCP). During the procedure, the duodenoscopes are inserted down the throat in order to drain fluids from the pancreatic or biliary ducts.

The FDA estimates that 500,000 ERCPs are completed using duodenoscopes every year.

While the devices have been linked to sporadic infections in the past, a recent outbreak at the UCLA Ronald Reagan Medical Center has sparked new controversy.

At Least 2 Dead in Ronald Reagan Medical Center Outbreak

Between October 2014 and January 2015, roughly 180 patients were exposed to the CRE superbug while undergoing endoscopic procedures at the UCLA Ronald Reagan Medical Center.

The mass exposure event resulted in seven confirmed CRE infections and at least two deaths. The event was linked to the use of Olympus’ Q180V reusable duodenoscopes.

Investigators found evidence that Olympus may have failed to update sterilization protocols for the medical scopes following a redesign. Several lawsuits were filed against the manufacturer following the event.


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