March 9, 2018

FDA warns duodenoscope manufacturers on postmarket study noncompliance

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration (FDA) on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with federal requirements to conduct postmarket surveillance studies to assess the effectiveness of reprocessing their devices.

Olympus failed to start data collection, and Pentax and Fujifilm failed to provide sufficient data for sampling and culturing reprocessed duodenoscopes in clinical use. Olympus and Pentax also have not complied with requirements to assess how well hospital staff are following reprocessing instructions. Fujifilm has been meeting hospital staff reprocessing requirements. 

The FDA expects the three companies to submit a plan by March 24 that outlines how study milestones will be achieved.

The U.S. Food and Drug Administration today issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

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