The design of the DEC maintains the performance and image quality of a reusable duodenoscope. Credit: Stasis Photo / Shutterstock.

Pentax Medical has secured approval from the US Food and Drug Administration (FDA) for its DEC Duodenoscope (ED34-i10T2s) compatibility with Advanced Sterilization Products’ (ASP) STERRAD 100NX steriliser.

The approval allows for Pentax Medical’s duodenoscope to be used with ASP’s STERRAD sterilizers, enhancing infection prevention.

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This marks a significant advancement in the reprocessing of duodenoscopes, aiming to reduce the risk of cross-contamination and enhance patient safety.

The collaboration between Pentax Medical and ASP has led to what it claims to be the world’s first GI endoscope that is compatible with hydrogen peroxide gas plasma sterilisation technology known for its effectiveness in infection prevention across various medical fields.

Pentax Medical’s chief medical officer Klaus Mergener said: “The low but persistent risk of duodenoscope contamination post-reprocessing emphasises the need for a reliable sterilisation 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 sterilisation efficacy standards.”

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The DEC allows for the elevator component, which is highly susceptible to bacterial contamination, to simply and safely be disposed of after each use.

Its design maintains the performance, image quality, and handling characteristics of a reusable duodenoscope.

Pentax Medical’s chief product officer Harald Huber said: “The collaboration with ASP marks a pivotal step forward in our continued effort to enhance patient safety through innovative endoscope designs; the compatibility with STERRAD technology ensures easier access to sterilised duodenoscopes with a lower environmental impact.”