Medical device trade groups raised concerns about the capacity to sterilize medical devices in response to proposed ethylene oxide regulations by the Environmental Protection Agency. The EPA seeks to reduce emissions of the gas, which it says can cause cancer over a long period of exposure, but medical device companies said the new rules could disrupt the supply of equipment.
Each year, 20 billion devices — roughly half of all medical devices — are sterilized using ethylene oxide, medical device trade group AdvaMed wrote in a Tuesday statement. It’s the only effective sterilization method for heat- or moisture-sensitive materials, the group said.
