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Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies

FDA orders three duodenoscope manufacturers – Olympus America, Fujifilm Medical Systems and Hoya Corp.'s Pentax Life Care Division – to conduct postmarket surveillance studies to better understand how the scopes are being reprocessed and how to reduce the risk of patient infection. The firms told "The Gray Sheet" that they will comply with the agency's request.

Three manufacturers of duodenoscopes associated with contamination incidents over the past three years must conduct postmarket surveillance studies so FDA can evaluate how the devices are being reprocessed between procedures and determine how best to reduce infection risks, the agency ordered on Oct. 5.

Under the order, Olympus America, Inc., Fujifilm Medical Systems USA Inc. and Hoya Corp. (Pentax Life Care Division) will have 30 days to submit postmarket surveillance plans to...

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