Advanced Sterilization Products Announces FDA Clearance for Innovative Sterilization Cycle for Duodenoscopes

Advanced Sterilization Products (ASP), a division of Fortive (NYSE: FTV) is pleased to announce 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 uniquely designed to reprocess duodenoscopes using hydrogen peroxide gas plasma sterilization*. ASP is partnering with global medical device manufacturers to introduce GI scopes, beginning with the Duodenoscope, that will be compatible with the new ULTRA GI™ Cycle and sterilizable using the STERRAD™ 100NX Sterilizer with ALLClear™ Technology.

Transforming Sterilization Practices

This FDA clearance represents a major advancement in patient safety and addresses the challenges associated with current duodenoscope reprocessing methods. This innovative sterilization cycle is poised to transform sterilization practices in healthcare facilities, setting a new standard for safety and efficacy.

Tackling Contamination Issues

Duodenoscopes have faced scrutiny due to their high contamination rates, highlighting the need for a robust sterilization solution. This new sterilization method that not only meets but exceeds industry standards, providing healthcare professionals with a powerful tool to enhance patient safety.

“We are proud and excited to receive FDA clearance for our new ULTRA GI™ Cycle”, said Chad Rohrer, President of ASP. “We are deeply committed to ensuring patient safety, and duodenoscopes have historically posed significant risks to patients in healthcare settings. By using hydrogen peroxide gas plasma sterilization to reprocess duodenoscopes, we are achieving a higher level of sterility assurance for healthcare professionals.”

“The use of hydrogen peroxide gas plasma marks a significant shift, establishing it as the gold standard for duodenoscope sterilization 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 in terms of sterilization and environmental safety, providing healthcare professionals and their patients with greater assurance that duodenoscopes are being sterilized safely and effectively.”

About Advanced Sterilization Products (ASP)

Advanced Sterilization Products (ASP) has a long history of designing and delivering innovative infection prevention solutions that significantly enhance healthcare and safety for those who matter most. Our pioneering technology, global distribution, and established leadership position enable us to simplify the process of purchasing and operating infection prevention products and services for thousands of medical facilities worldwide. This allows our customers to focus on their primary mission – preventing infection and saving lives. For more information, please visit www.asp.com/en-gb

*pending regulatory approvals for Europe.