Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints
Repeated problems with duodenoscopes and the risk of patient infections have led to industry-wide changes in their design.
Repeated problems with duodenoscopes and the risk of patient infections have led to industry-wide changes in their design.
Standard duodenoscopes were three times as likely to have persistent microbial contamination when compared to duodenoscopes with disposable elevator caps
FDA indicates Olympus failed to report complaints over endoscope products in a timely manner, which is necessary to help regulators monitor infections or reprocessing failures associated with the devices.
The FDA found 6.6% of reusable duodenoscopes carried high-concern organisms after cleaning, while only 0.5% of those with disposable parts carried infection risks.