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.
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ANSI/AAMI ST91:2021 offers best practices for cleansing the notoriously difficult-to-clean devices and strongly recommends health care providers transition from manual, sink-based cleaning to sterilization.
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.
A former Olympus exec who took personal responsibility for the company’s failure to submit duodenoscope-related adverse event reports has been sentenced to one year’s probation and a $5,000 fine.