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Duodenoscope Makers Receive FDA Warning Letters

Aug 20, 2015

The three makers of duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP), Olympus Medical Systems Corp., Fujifilm Corp and the Pentax division of Hoya Corp., have received warning letters from the U.S. Food and Drug Administration (FDA). According to the Wall Street Journal, the agency said the companies either failed to properly report infections or show that their cleaning protocols worked. The specialized scopes, which are snaked down the esophagus and into the top of the small intestine, came under scrutiny earlier this year when they were linked to outbreaks of antibiotic-resistant infections.

The letters were sent in response to inspections the agency conducted at US and Japanese manufacturing sites in the spring, in addition to bacterial infection incidents. In a warning a letter to Olympus, the FDA cited a failure to report 16 patient infections the company knew of in 2012. The FDA chastised the company for failing 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. In addition to these incidents, the FDA pointed to two other instances where Olympus failed to report adverse events in a timely manner; the company learned of incidents in November 2013 and again in June 2014. Data on these events was not submitted to the FDA until March, one month after widespread media coverage of the superbug outbreaks at UCLA.

The FDA's letter to Hoya cited a number of violations, one of which included failing to notify the agency of an event within 30 days. The company was also criticized 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."

According to WSJ, the scopes have been linked to hundreds of infections at hospitals in Seattle, Los Angeles, the Chicago area and overseas. The FDA is struggling with the complex design of the devices, which are extremely difficult to sterilize before re-use.

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