STAT+: FDA OKs — but doesn’t require — a non-cancer-causing chemical for sterilizing devices
Medical device manufacturers can now more easily use a chemical that doesn't cause cancer to sterilize their devices, after the FDA's decision.
The chemical used to sterilize half of all medical devices in the United States is also known to cause cancer. After years of deliberating on alternatives, the Food and Drug Administration this month deemed a safer gas, vaporized hydrogen peroxide, a legitimate way to decontaminate devices.
It’s a small step in pushing the medical device industry away from the carcinogenic chemical, called ethylene oxide. The move comes as the Environmental Protection Agency prepares to finalize restrictions on ethylene oxide in March. Medical device manufacturers will have 18 months to comply.
Environmental activists organizing against the sterilizing facilities in their communities commend the EPA for curtailing the chemical. But they also want the FDA to more adamantly push device makers toward alternatives, which the FDA’s endorsement does not do.
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