Advanced Sterilization Products (ASP), a division of Fortive, in collaboration with PENTAX Medical, a division of HOYA, proudly announces the 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.
Revolutionizing Sterilization Practices
The FDA clearance marks a significant milestone in advancing patient safety and addressing the challenges associated with current reprocessing methods for duodenoscopes. This groundbreaking sterilization cycle is set to revolutionize sterilization practices in healthcare facilities, ensuring a new standard of safety and efficacy.
Addressing Contamination Concerns
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 resulted in an innovative method that not only meets but exceeds industry standards, providing healthcare professionals with a powerful tool to enhance patient safety.
Also Read: Life Spine Announces FDA 510(k) Clearance for the ARx SAI Spinal Fixation System
“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.”
“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,” said Ivan Salgo, MD, Chief Medical & Scientific Officer at ASP. “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.”
SOURCE: Businesswire