Innovative FDA program advances alternatives for radiation and EO sterilization of medical devices
Facilitates more timely changes to alternative sterilization methods, processes, or sites
November 7, 2023 — STERIS is pleased to announce that its Applied Sterilization Technologies (AST) business has been accepted to participate in the U.S. Food and Drug Administration (FDA) Radiation Sterilization Master File Pilot Program (Pilot Program), first announced by the FDA in April 2023. STERIS’s participation in the Radiation Pilot Program complements its prior acceptance into the Ethylene Oxide (EO) Master File Pilot Program in 2021.
The FDA developed the Radiation Sterilization Master File Pilot Program in response to global supply chain constraints and to support supply chain resiliency. The voluntary Pilot Program allows companies that sterilize single-use PMA-approved medical devices using gamma radiation or EO to submit master files when making certain changes, including:
- Changing sterilization processing locations or adding processing redundancy
- Switching from one sterilization technology to another (i.e, changing from gamma to X-ray)
- Implementing other processes to incentivize and expedite actions to further assure sterilization safety, such as lowering the gamma radiation dose
Eligible participants making any of the changes described above at a STERIS AST facility may be eligible to reference the Master File submitted by STERIS in a Letter of Intent/Letter of Authorization, rather than a PMA supplement. Please reference our FAQ document for more information.
“The FDA’s Pilot Programs align with the STERIS MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. Following our prior acceptance into the EO Master File Pilot Program, we are excited to be the only contract sterilization provider accepted into both the EO and radiation programs,” comments Ken Kohler, vice president and general manager, STERIS AST Americas. “The Pilot Programs support our efforts to provide sterilization supply chain resiliency through a technology-neutral processing option that utilizes both radiation and gas technologies.”
STERIS will be hosting an educational webinar on the FDA’s Pilot Program, providing an overview of the initiative, its impact on our Customers, device eligibility and process. Go here to register for the webinar, which will be held on Thursday, November 30 at 11:00am EST. For more information regarding the program, please go here to view our frequently asked questions.
About STERIS
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. For more information, visit www.steris.com.
