Duodenoscope-Makers Ordered By FDA To Conduct Sec. 522 Postmarket Surveillance Studies
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
‘Numerous’ Adverse Event Reports Of Infections Spark FDA Warning For Urological Endoscopes
The US FDA says it has received more than 450 Medical Device Reports since 2017 that describe patient infections following use of reprocessed cystoscopes, ureteroscopes and cystourethroscopes. Three deaths were reported by Olympus Corp.
US FDA Report Confirms Duodenoscope Contamination Risk
An early look at the results of post-market studies that had been ordered by US FDA for duodenoscopes highlights ongoing sterilization issues.