MedTech Dive October 16, 2023
The agency said it is working closely with the Environmental Protection Agency, which is slated to implement a final rule in March limiting ethylene oxide emissions for medical device sterilizers.
New rules are coming that would limit emissions of ethylene oxide (EtO), a toxic, colorless gas used to sterilize medical devices. The Environmental Protection Agency is slated to issue a final rule by March, which the agency expects will reduce EtO emissions by 80% and lower cancer risks for people who live near sterilization facilities.
Medical device companies have raised concerns about the proposed limits, saying they could cause shortages of medical equipment. At the MedTech Conference last week, officials with the Food and Drug Administration’s Center for Devices and...
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