Medical Device Sterilization

Sterilized medical products are critical to healthcare. Poor or incomplete sterilization can lead to transmission of infectious diseases or compromised patient health. One sterilization method is via ethylene oxide (EtO), a common gas that kills microorganisms at low temperatures. For many medical devices, EtO sterilization is the only method that effectively sterilizes and does not damage a device during the sterilization process. Should regulatory policy or actions limit or abolish the use of EtO as a sterilization agent, the negative effect on healthcare providers and patients would be profound.

HIDA recommends a thoughtful approach that considers the impact on the delivery of healthcare nationwide. Any changes to EtO policies must include a realistic and feasible plan to anticipate and address any potential product disruptions and patient care. Disruption at even a single sterilization facility can have a magnified impact across the country as devices sterilized in one facility support patient care in all 50 states.

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Government Affairs Contact

Josh Babb »
Director, Government Affairs
703-838-6113