FDA's CDRH Announces Radiation Sterilization Master File Pilot Program to Advance Medical Device Sterilization Methods

The FDA's Center for Devices and Radiological Health (CDRH) has announced a Radiation Sterilization Master File Pilot Program, aimed at facilitating the advancement of alternative and innovative methods for sterilizing approved medical devices. The program encourages companies to make changes to sterilization sites, methods, or other processes, such as lowering gamma radiation dose, by allowing them to submit master files. This voluntary pilot program is a response to global supply chain constraints and aims to support the resiliency of the sterilization supply chain.

Sterilization of medical devices is crucial in preventing serious infections, and the CDRH is committed to encouraging novel sterilization methods while minimizing adverse effects on the environment and public health. The FDA oversees sterilization methods to ensure their effectiveness and safe use for patients and healthcare professionals.

Ethylene oxide (EtO) is currently the most commonly used method in the U.S. for sterilizing medical devices and is widely employed by manufacturers and contract sterilizers worldwide. EtO is scientifically proven to prevent harmful microorganisms from reproducing on medical devices and causing infections, without degrading the product.

Over 20 billion devices sold in the U.S. annually are sterilized with EtO, accounting for approximately 50% of devices requiring sterilization. Inadequate sterilization can lead to life-threatening infections in patients undergoing various medical procedures.

The U.S. Environmental Protection Agency (EPA) has proposed stricter air emissions standards for EtO, along with measures to reduce risks for workers using EtO for sterilization purposes. The FDA has been actively collaborating with federal agencies and medical device sterilizers to reduce EtO usage and meet the EPA's emission standards while ensuring effective sterilization. The FDA is also working with companies on the development of alternative sterilization methods to replace EtO where feasible.

While some innovations show promise, there are currently no alternative methods that can completely replace EtO for many devices. The FDA is concerned about the potential impact of shortages of sterilized medical devices resulting from disruptions in commercial sterilizer facility operations.

In addition to the Radiation Master File Pilot Program, the FDA has implemented other initiatives to reduce EtO usage and promote innovation in medical device sterilization. These include the EtO Sterilization Master File Pilot Program, which allows certain changes between sterilization processes and facilities to reduce EtO usage without compromising safety and effectiveness. The FDA has also launched the Innovation Challenges, which have shown progress in reducing EtO emissions and exploring alternative sterilization methods. The agency is considering requests to recognize consensus standards related to terminal sterilization validation for alternative modalities.

These programs collectively aim to encourage new sterilization methods that reduce the potential impact of EtO on the environment and public health, and the FDA is committed to advancing these efforts.