Latest From Pentax Corp.
After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.
Pentax Corp. sent out a field correction on Jan. 16, and FDA followed up with a safety communication the next day, warning that cracks and gaps in the company's ED-3490TK duodenosopes could increase risks of patient microbial infections, unless appropriate reprocessing instructions are followed closely.
The agency sped up release of a final guidance on reprocessing reusable devices, including a strict set of protocols for endoscope cleaning, disinfection data, and design guidelines, following reports of serious bacterial infections linked to duodenoscopes.
Inadequate validation testing paired with highly-publicized bacterial outbreaks in Illinois and California involving use of contaminated duodenoscopes has led to stricter reprocessing standards for those devices. And FDA is likely moving towards tougher reprocessing requirements more broadly for reusable devices in an upcoming guidance.
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