How stricter EtO regs could shape the medtech industry
May 14, 2024
Source: drugdu
94
The Environmental Protection Agency recently implemented new regulations to limit emissions of a common but cancer-causing medical device sterilant, after years of health meetings, lawsuits and debate about how to handle the issue.
Medical device companies will need to comply with new requirements governing ethylene oxide (EtO) emissions, and some device sterilizers are searching for suitable alternatives.
In April, the EPA published a final rule that sets new limits for medical device sterilizers that use EtO. Now, companies will have three years to comply with the new standards. The agency is also working on a separate set of requirements to reduce EtO exposure for workers in sterilization plants. Long-term exposure to the chemical can increase a person’s lifetime cancer risk.
In the meantime, the Food and Drug Administration has been evaluating other ways of sterilizing medical devices and changes companies can make to reduce EtO emissions. It has also launched programs to make it easier for companies to switch sterilization modalities for devices already on the market.
Source:
https://www.medtechdive.com/news/roundup-ethylene-oxide-sterilizers-medical-device/715783/
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