ASP, Pentax Medical Win FDA Nods for Duodenoscope with New Sterilization Tech

Advanced Sterilization Products (ASP) and Pentax Medical have earned U.S. Food and Drug Administration (FDA) clearance of the DEC duodenoscope (ED34-i10T2s) compatibility with the STERRAD 100NX Sterilizer’a Ultra GI cycle. The DEC duodenoscope (ED34-i10T2s) is the first GI endoscope compatible with hydrogen peroxide gas plasma sterilization.
 
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 lets physicians 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 Ultra GI cycle is designed to reprocess duodenoscopes using hydrogen peroxide gas plasma sterilization. The new sterilization cycle aims to revolutionize sterilization in healthcare facilities to ensure a new level of safety.
 
Because of their relatively high contamination rates, duodenoscopes have been under increased scrutiny. The collaborative effort, according to ASP and Pentax, has created an innovative method to exceed industry standards and resulted in a powerful tools to boost patient safety.
 
“We’re proud and excited to receive FDA clearance for our new ULTRA GI Cycle, developed in partnership with PENTAX Medical,” said Chad Rohrer, President of ASP. “Both of our organizations are deeply committed to ensuring the safety of patients, and duodenoscopes have historically presented one of the greatest risks to patients in healthcare facilities. By using hydrogen peroxide gas plasma sterilization to reprocess duodenoscopes, we are achieving an increased level of certainty of sterility for healthcare professionals.”