CDRH Announces Radiation Sterilization Pilot Program

By MedTech Intelligence Staff
April 24, 2023


• Categories: 05-Quality/Regulatory, Patient Safety, RC - Medtech Regulatory Resource Center

On the heels of the EPA’s announcement of two new proposed rules to reduce ethylene oxide (EtO) emissions, Jeff Shuren, M.D., J.D., director of the FDA CDRH, announced a radiation sterilization master file pilot program for medical devices. The program is designed 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, including 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.

In his statement, Dr. Shuren noted that 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,” he wrote. “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.”

In addition to the Radiation Master File Pilot Program, the FDA has implemented programs and initiatives to support new methods of medical device sterilization, including:

• 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.
• The Innovation Challenge, which Dr. Shuren says has shown encouraging progress with new strategies to reduce EtO emissions. In addition to reducing emissions by lowering the EtO cycle concentration, Challenge participants are exploring the use of alternative sterilization methods, such as vaporized hydrogen peroxide, supercritical carbon dioxide, and nitrogen dioxide for certain types of medical devices.
• Considering requests to recognize certain consensus standards related to terminal sterilization validation for alternative modalities, using procedures outlined in “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,” stated Dr. Shuren.