AXIOS August 2, 2023
Medical device makers and health care providers want to move away from using a likely carcinogenic gas to sterilize devices — but they say it’s not that simple.
Why it matters: Because eliminating ethylene oxide is expected to take so long, federal regulators must weigh the risks and benefits of using the chemical, also known as EtO, at its current scale — and stakeholder groups are at odds over the right path forward.
Where it stands: FDA in April announced a radiation sterilization pilot program to incentivize companies to find better ways to sterilize medical devices.
- FDA has launched other initiatives to reduce EtO reliance, including one program that has allowed some facilities to cut emissions as much as...
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