FDA Warning Letters Sent to Scope Makers for Various Violations

Olympus Medical Systems Corp., Fujifilm Corp and the Pentax division of Hoya Corp., three makers of duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP), have been issued warning letters from the U.S. Food and Drug Administration (FDA) for various violations. The Wall Street Journal reports that the letters criticized the companies for either failing to report infections or provide adequate proof that their cleaning methods were effective. Duodenoscopes are snaked down the esophagus and into the top of the small intestine for various procedures. The devices became a public health concern earlier this year when they were linked to superbug outbreaks.

WSJ reports that the scopes have been linked to hundreds of infections at hospitals in Seattle, Los Angeles, the Chicago area and overseas. The FDA is facing issues with the complex design of the devices, which are extremely difficult to sterilize before re-use. The agency conducted inspections at manufacturing plants in the spring.

The FDA cited a failure to report 16 patient infections Olympus was aware of in 2012, and stated that the company failed to report that one of its devices “may have caused or contributed to a death or serious injury.” Federal regulations require companies to report adverse events to the FDA within 30 days. The letter said Olympus also knew of incidents in November 2013 and again in June 2014, but did not submit these events to the FDA until March; this was one month after widespread media coverage of the superbug outbreaks at UCLA.

Hoya’s warning letter cited a number of violations, one of which included failing to notify the agency of an event within 30 days. The FDA also criticized the company for failing to notify the FDA of other instances that could have lead to serious injury or death. Fujifilm’s warning letter cited a variety of violations associated with manufacturing and complaint handling. The agency said it “reviewed your firm’s responses and concluded that they are not adequate.”

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