FDA Clears New Duodenoscope Sterilization Cycle

Advanced Sterilization Products (ASP)—together with PENTAX Medical—has secured U.S. Food and Drug Administration (FDA) clearance of the new ULTRA GI Cycle in its flagship product, the STERRAD 100NX Sterilizer with ALLClear Technology. The ULTRA GI Cycle is specifically and uniquely designed to reprocess duodenoscopes using hydrogen peroxide gas plasma sterilization.
 
The FDA clearance marks a significant milestone in advancing patient safety and addressing the challenges associated with current duodenoscope reprocessing methods, according to ASP. “We’re proud and excited to receive FDA clearance for our new ULTRA GI Cycle, developed in partnership with PENTAX Medical,” ASP President Chad Rohrer said. “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.”
 
Duodenoscopes have been under scrutiny due to their relatively high contamination rates, prompting the urgent need for a robust sterilization solution. The collaborative effort between ASP and PENTAX Medical has generated in a method that not only meets but exceeds industry standards, providing healthcare professionals with a powerful tool to enhance patient safety, both companies claim.
 
“The use of hydrogen peroxide gas plasma represents a significant shift in making it the gold standard of sterilization for duodenoscopes and thereby improving safety for patients, technicians, and the environment,” ASP Chief Medical & Scientific Officer Ivan Salgo, M.D., stated. “The ULTRA GI Cycle sets a new benchmark for the entire industry on sterilization and environmental safety and will give healthcare professionals and their patients a heightened level of assurance that the duodenoscopes used are now being sterilized in a safe and effective way.”
 
A division of Fortive, Advanced Sterilization Products designs and delivers infection prevention solutions. Its pioneering technology and global distribution enables the firm to simplify the process of buying and operating infection prevention products and services for medical facilities worldwide. The firm is based in Irvine, Calif.