CDRH is establishing a Radiation Sterilization Master File Pilot Program to assist businesses in developing less troublesome regulatory methods for sterilizing licensed medical equipment, such as switching radiation sources. The pilot program, which is optional, will enable businesses that sterilize single-use PMA-approved medical devices with gamma radiation or ethylene oxide (EtO), to submit master files when making specific modifications. In order to encourage and hasten efforts to further ensure sterilization safety, such as reducing the gamma radiation dosage, these adjustments can be made to sterilization locations, sterilization techniques, or other procedures. This experimental approach promotes sterilizing supply chain resilience in response to global supply chain restrictions.
Sterilization is a crucial step in the process of preventing dangerous infections in medical equipment. The CDRH is still dedicated to promoting innovative approaches to sterilizing medical equipment while minimizing negative effects on the environment and public health, as well as creating solutions that avoid any shortages of equipment that the American public depends on. We are always working to ensure that medical device sterilization procedures are successful and applied in a manner that is safe for patients and the healthcare professionals who use them.
EtO is used to sterilize medical devices to prevent bacteria from spreading and infecting people. EtO is used to sterilize more than 20 billion devices marketed in the United States each year, or about 50% of all devices that need to be sterilized. These items include anything from simple bandages for wounds to more complex ones like stents, as well as kits for common medical procedures or operations. Patients undergoing a variety of medical procedures may get life-threatening infections as a result of inadequate sterilization.
We have focused on minimizing the usage of EtO over the past several years and have undertaken programs and efforts to foster innovation in medical device sterilization, in addition to today’s Radiation Master File Pilot Program, including:
- The EtO Sterilization Master File Pilot Program enables changes to sterilization procedures and facilities without sacrificing safety or efficacy.
- The Innovation Challenges have shown progress in reducing EtO emissions by lowering the EtO cycle concentration and exploring alternative sterilization methods, such as vaporized hydrogen peroxide, supercritical carbon dioxide, and nitrogen dioxide.
- Recognizing consensus standards for alternative modalities.
These initiatives support novel approaches to sterilizing medical equipment that lessen the potential harm that it can do to the environment and to people’s health. The FDA is steadfast in its commitment to furthering these initiatives.
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Source: CDRH Announcement
