FDA CDRH Takes Additional Steps To Advance Innovation in Medical Device Sterilization

In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health is taking additional steps to advance innovation in medical device sterilization, including recognition of new standards and updates to technical information reports.

In response to safety concerns and proposed regulatory action related to industrial use of ethylene oxide (EtO), the FDA Center for Devices and Radiological Health (CDRH) is taking additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022) and two Technical Information Reports (AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020).

The sterilization standard, ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices, supports the use of low temperature vaporized hydrogen peroxide as an important alternative sterilization method.

CDRH also recognized two Technical Information Reports associated with medical device sterilization intended to advance device sterilization methods and assist manufacturers making changes to radiation sterilization processes: AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization and AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources.

The Federal Register notice with modifications to the listing of recognized consensus standards for this list will be published later in 2023, although manufacturers may now cite these new and revised standards in device submissions.

In a statement announcing the updates, Suzanne Schwartz, M.D., M.B.A., director, Office of Strategic Partnerships and Technology Innovation, CDRH, noted that 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. “Inadequate sterilization can lead to life-threatening infections in patients undergoing a wide range of medical procedures. While some innovations appear promising, other methods of sterilization cannot currently replace the use of EtO for many devices,” she wrote. “CDRH continues to oversee sterilization processes 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. We will continue to work with companies on the development of novel sterilization processes.”

The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.

The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.

The voluntary 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 Experiential Learning Program (ELP) provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review. The 2023 ELP Site Visit Proposal period is open now until September 6, 2022.

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