The FDA is looking for companies to join a voluntary pilot program that encourages the use of radiation sterilization for medical devices instead of ethylene oxide (EtO).
The FDA is scheduled to publish details of the pilot program in the Federal Register tomorrow. The agency announced the program just days after the EPA proposed new rules to measure and reduce EtO emissions from chemical plants due to health risks. The EPA also said it plans to propose updated regulations for commercial sterilization facilities that emit EtO, which is used for around half of all medical device sterilization each year.
With medtech industry group AdvaMed warning that medical device EtO sterilization facilities are already at capacity and could choose to shut down if new regulations are too burdensome, the FDA’s latest move could give EtO alternatives a boost.
“This voluntary pilot is intended to help contract sterilizers and medical device manufacturers to make changes to or advance alternative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach,” the FDA said in announcing the program.
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The FDA said the pilot will accept up to nine sterilization providers that sterilize single-use, PMA-approved devices using gamma radiation or EtO and intend to submit master files when making certain changes to sterilization sites, sterilization methods or other processes.
To be eligible, sterilization providers must be in good compliance standing with the FDA, have an approved gamma radiation or fixed-chamber EO sterilization process for the device in an existing PMA, and propose one of the following changes:
- A change from gamma radiation sterilization at a PMA-approved sterilization site to the same process at a different site;
- A change from gamma radiation sterilization at an existing PMA-approved sterilization site to X-ray or electron beam radiation sterilization at the same or different site;
- A change from a gamma radiation sterilization at an existing PMA-approved sterilization site to gamma radiation with a lower radiation dose at the same or different site;
- A change from fixed-chamber EO sterilization at an existing PMA-approved sterilization site to X-ray or electron beam radiation sterilization method at the same or different site
Like EtO, radiation sterilization can penetrate product packaging, but it’s less ideal for electronics and plastics. Gamma radiation is the most commonly used method of radiation sterilization for medical devices. Electron beam sterilization is growing because it’s faster and less expensive than X-ray and safer than gamma radiation, which uses radioactive material.
FAQ: What is electron beam sterilization?
A similar program launched in 2019 to reduce EtO emissions, the EtO Sterilization Master File Pilot Program for PMA holders, accepted five participants: Boston Scientific, Becton, Dickinson & Co., Medtronic, Oscor and Steris Corp.
“The sterilization of medical devices is a vital process to help prevent serious infections,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement. “CDRH remains committed to encouraging novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon. We are continuously working to oversee sterilization methods for medical devices to ensure they are effective and used in amounts that are safe for the patients and health care professionals who use them.”
