- The U.S. Food and Drug Administration has created a pilot program to help companies adopt new ways to sterilize approved, single-use medical devices.
- Officials have opened the voluntary program to up to nine companies that plan to change their sterilization sites or methods, for example by switching to x-ray or electron beam radiation.
- The FDA shared details of the program on the same day as the U.S. Environmental Protection Agency proposed new limits on the emission of ethylene oxide (EtO) from sterilization facilities.
The FDA outlined plans to pilot alternative approaches to sterilization last year as it considered how to help manufacturers address global supply chain constraints and adapt to anticipated limits on EtO emissions while ensuring patients can continue to access medical devices.
Under normal FDA procedures, manufacturers of devices with premarket approval (PMA) need to submit a supplement to change their sterilization facility, process or method. However, the FDA “recognizes the need to facilitate more timely changes,” both because manufacturers of the 50% of devices sterilized by EtO may need to cut emissions, and because of constraints on the supply of radioactive cobalt. The cobalt enables the gamma radiation approach used to sterilize 40% to 45% of devices.
The pilot program is open to in-house and contract sterilization providers that plan to: move a gamma radiation sterilization process to a different site; switch from gamma radiation or EtO to x-ray or electron beam radiation; or use a lower dose of gamma radiation.
Sterilization providers that are accepted into the program will submit a Master File when making the changes. Once the FDA has accepted the Master File into the pilot program, the PMA holder may reference the document in a postapproval report to describe the sterilization changes. The reference will free manufacturers from having to submit PMA supplements for the changes.
“This pilot program is intended to provide expeditious review and feedback to sterilization providers on Master File submissions used to support certain changes made to sterilization sites, methods, or processes, and to PMA holders on the ability to reference such Master Files in a postapproval report rather than a PMA supplement,” the FDA wrote.
The FDA is asking sterilization providers to submit details of changes to the Master File every six months, and will also evaluate the progress of the program every six months “to inform possible longer term initiatives related to device sterilization methods.”