Pentax Medical announced today that the FDA cleared its DEC duodenoscope compatibility with the Sterrad 100NX sterilizer.
Advanced Sterilization Products (ASP) develops Sterrad as its flagship product. Together, the companies aim to address the ongoing challenges of duodenoscope reprocessing. They hope to reduce the risk of cross-contamination with the scopes, enabling easier access to sterilized scopes with a lower environmental impact.
According to a news release, DEC is the world’s first GI endoscope compatible with hydrogen peroxide gas plasma sterilization. This technology revolutionized infection prevention across a range of medical specialties, Pentax says.
FDA clearance marks Pentax’s second major milestone in enhancing infection prevention and patient safety. Launching the DEC (disposable elevator cap) came as part of the company’s response to FDA and CDC calls for advanced duodenoscope design to reduce cross-contamination risk. The DEC allows physicians to simply and safely dispose of the elevator, which can prove vulnerable to enteric bacteria. All the while, it maintains image quality, performance and handling.
“The low, but persistent risk of duodenoscope contamination post-reprocessing emphasizes the need for a reliable sterilization solution. 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,” said Dr. Klaus Mergener, global head, medical & scientific affairs and chief medical officer at Pentax Medical.
