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CDRH Announces Radiation Sterilization Master File Pilot Program

April 11, 2023

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health

Today, CDRH is announcing a Radiation Sterilization Master File Pilot Program to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. The pilot program is voluntary and intends to allow companies that sterilize single-use PMA-approved medical devices using gamma radiation or ethylene oxide (EtO) to submit master files when making certain changes. These changes include those made to sterilization sites, sterilization methods, or other processes to incentivize and expedite actions to further assure sterilization safety, such as lowering the gamma radiation dose. This pilot program is in response to global supply chain constraints and supports sterilization supply chain resiliency.

The sterilization of medical devices is a vital process to help prevent serious infections. 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.

EtO is currently the most commonly used method in the U.S. to sterilize medical devices and is widely used by medical device manufacturers and contract sterilizers worldwide. Use of EtO is a well-established and scientifically-proven method of preventing harmful microorganisms from reproducing on medical devices and causing infections in patients. Unlike some other sterilization methods, EtO does not degrade the product.

More than 20 billion devices sold in the U.S. every year are sterilized with EtO, accounting for approximately 50% of devices that require sterilization. These devices range from wound dressings to more specialized devices, such as stents, as well as kits used in routine hospital procedures or surgeries. Inadequate sterilization can lead to life-threatening infections in patients undergoing a wide range of medical procedures.

Today, the U.S. Environmental Protection Agency (EPA) proposed more stringent air emissions standards for EtO and new measures to decrease risk for workers who use EtO to sterilize medical equipment and other things. We have been proactively working with federal agencies and medical device sterilizers to reduce the amount of EtO used to help ensure they meet the EPA's standards for EtO emission levels, while still effectively sterilizing products. In addition, we have been working with companies on the development of novel sterilization methods to replace the use of EtO where it may be feasible to do so.

While some innovations appear promising, other methods of sterilization cannot currently replace the use of EtO for many devices. We are equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.

In addition to today's Radiation Master File Pilot Program, we have prioritized reducing the use of EtO over the past few years and have implemented programs and initiatives to support innovation in medical device sterilization, including:

  • Launched the EtO Sterilization Master File Pilot Program for premarket approval (PMA) holders of high-risk devices that enables certain changes between sterilization processes and facilities that reduce the amount of EtO used to sterilize medical devices without compromising safety and effectiveness. To date, 5 sterilizers are participating in the EtO Sterilization Master File Pilot Program.
  • Launched the Innovation Challenges, which has shown encouraging progress with new strategies to reduce EtO emissions. Early observations suggest that some facilities have cut emissions ranging from 20-35%, with the potential to impact millions of devices. In general, manufacturers are targeting an EtO cycle concentration that is 11-66% less than the typical EtO concentration range. In addition to reducing emissions by lowering the EtO cycle concentration, Challenge participants are also exploring the use of alternative sterilization methods, such as vaporized hydrogen peroxide, supercritical carbon dioxide, and nitrogen dioxide for certain types of medical devices. In some cases, device manufacturers are working collaboratively with contract sterilizers to validate new or different sterilization methods as well as the feasibility for scale up.
  • Considering requests to recognize certain consensus standards related to terminal sterilization validation for alternative modalities, using procedures outlined in our guidance, "Recognition and Withdrawal of Voluntary Consensus Standards."

Collectively, these programs encourage new ways to sterilize medical devices that reduce the potential impact of EtO on the environment and public health. The FDA remains committed to continuing to advance these efforts.

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