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.
Director of Policy