EtO causes cancer. Device sterilizers are scrambling to find alternatives. MedTechDive
No one solution can match the scope and scale of ethylene oxide, but a “multi-pronged approach” can help reduce emissions, an FDA official said.
he Environmental Protection Agency finalized new regulations in March that will enforce tighter regulations on ethylene oxide, one of the most common sterilants for medical devices. The final rule is designed to reduce emissions of EtO, a carcinogenic gas, from commercial sterilizers by more than 90%.
Anticipating the new rule, industrial sterilizers have been upgrading emissions controls and looking at other chemicals. Medtech trade group Advamed has warned that new regulations on EtO emissions could limit capacity for sterilizing medical devices, potentially creating shortages. However, proponents of other technologies have said they can meet some of the industry’s sterilization needs.
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