Alternative to Ethylene Oxide for Medical Device Sterilization Sees CDRH Recognition
CDRH has recognized low temperature vaporized hydrogen peroxide as an alternative to ethylene oxide (EtO) for medical device sterilization and is updating its reference documentation to assist manufacturers in making changes to sterilization procedures.
EtO is the most commonly used method in the U.S. to sterilize medical devices, but has come under fire recently for its potential carcinogenic effects and has been the subject of new Environmental Protection Agency regulations that would significantly curtail its use.
More than 20 billion devices are sterilized with EtO each year, CDRH says, representing about 50 percent of devices that require sterilization. To advance the use of this alternative method, the FDA is updating the Recognized Consensus Standards database to include the complete recognition of one International Organization for Standardization (ISO) sterilization standard and two Technical Information Reports (TIR).
However, the agency also advised that the Federal Register notice with these modifications will not be published until later in 2023, “although manufacturers may now cite these new and revised standards in device submissions.”
Read the ISO standard here.
To read the full story, click here to subscribe.
Related Topics