FDA updates sterilization standards for medical device makers

The Food and Drug Administration the week of July 24 updated its recognized consensus standards database for medical devices to advance innovation in medical device sterilization processes. The agency said the changes support manufacturers’ use of low-temperature vaporized hydrogen peroxide and provides more options for device sponsors to consider for submission during the premarket review process.
 
The Environmental Protection Agency in April proposed requiring commercial sterilization facilities to comply within 18 months with stricter emission and control standards for ethylene oxide, a type of gas used to sterilize certain medical devices that cannot be sterilized using alternative methods.