Amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO), the Food and Drug Administration (FDA) on Monday announced that its Center for Devices and Radiological Health (CDRH) has recognized a new international consensus standard on the use of low temperature vaporized hydrogen peroxide to sterilize medical devices.
The standard, ISO 22551:2022, 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, offers “an important alternative sterilization method” to device makers, said Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation within CDRH.
The center also recognized two standards from AAMI related to technical information reports related to medical device sterilization “intended to advance device sterilization methods and assist manufacturers making changes to radiation sterilization processes. The two technical information report standards are 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…
