FDA Warns Duodenoscope Manufacturers for Compliance Failures

Agency issues warning letters to Olympus, Fujifilm and Pentax for failure to comply with required postmarket surveillance studies to assess contamination risk.

Agency issues warning letters to Olympus, Fujifilm and Pentax for failure to comply with required postmarket surveillance studies to assess contamination risk.
Agency issues warning letters to Olympus, Fujifilm and Pentax for failure to comply with required postmarket surveillance studies to assess contamination risk.

March 9, 2018 was not a good day for duodenoscope makers Olympus, Fujifilm and Pentax, all of whom were issued FDA warning letters for failing to comply with the agency’s 2015 order to conduct a postmarket surveillance study to determine whether healthcare facilities were able to properly clean and disinfect the devices.

In making the announcement, FDA noted, “Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine (duodenum) and are used during endoscopic retrograde cholangiopancreatography, a potentially life-saving procedure to diagnose and treat problems in the pancreas and bile ducts.”

The agency pointed out further action could be taken if the companies fail to respond to the warning letter, saying the following: “FDA expects that Olympus, Fujifilm and Pentax will submit a plan by March 24, 2018 that outlines how study milestones will be achieved. For the sampling and culturing study, the FDA expects 50% of samples collected in the study to be processed by August 31, 2018 and 100% by the end of 2018. For Olympus’s and Pentax’s human factors studies, the agency expects 50% of testing to be completed by May 31, 2018 and 100% by June 30, 2018. If the companies fail to adequately respond to the warning letter, the FDA may take additional action such as seizure, injunction and civil money penalties.”

Market Research Future recently predicted the duodenoscopes market to increase at a Compound Annual Growth Rate of 6.83% through 2023, when it will reach a value of $4.8 billion. Despite that optimistic outlook, MRF noted that a “duodenoscope is a more complex device as compared to other endoscopes and is tough to clean and disinfect. … increasing FDA recalls for duodenoscopes due to challenging cleaning and high-level disinfection procedures and rising multidrug-resistant bacterial infections may affect the growth of the global duodenoscopes market negatively.”

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