US FDA clearance for PENTAX Medical’s DEC Duodenoscope

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PENTAX Medical, a division of HOYA group, announced FDA clearance of the DEC Duodenoscope (ED34-i10T2s) compatibility with the STERRAD 100NX Sterilizer, the flagship product from Advanced Sterilization Products (ASP), a division of Fortive.

The collaboration between PENTAX Medical and ASP has resulted in advancement in addressing the ongoing challenges of duodenoscope reprocessing. Reducing the risk of cross-contamination with duodenoscopes has been a point of focus in the joint project. The DEC Duodenoscope (ED34-i10T2s) is the world's first GI endoscope compatible with hydrogen peroxide gas plasma sterilization technology.

The launch of the DEC (Disposable Elevator Cap) marked the first medical device manufacturer's response to the FDA's and CDC's call for advancement in duodenoscope design to reduce the risk of cross-contamination. The DEC allows physicians to simply and safely dispose the elevator, the component most vulnerable to enteric bacteria, while maintaining image quality, performance and handling of a reusable duodenoscope in each procedure. The compatibility with STERRAD technology ensures easier access to sterilized duodenoscopes with a lower environmental impact.

Klaus Mergener, MD, PhD, MBA, Global Head, Medical & Scientific Affairs and Chief Medical Officer at PENTAX Medical said, "The partnership between PENTAX Medical and ASP has produced a method that also considers the workflow aspects that matter just as much as meeting sterilization efficacy standards."