June 29, 2023 – The Health Industry Distributors Association released its public comment letters to the Environmental Protection Agency, urging a thoughtful approach to regulation of ethylene oxide (EtO) gas in medical sterilization in a manner that safeguards the medical supply chain.
In its comment letters to EPA Administrator Michael S. Regan, HIDA noted that “Healthcare distributors also want to protect public health, and to do so they must be able to deliver sterile critical medical products to providers without interruption in the supply chain. Regulatory policies that limit or abolish the use of EtO as a sterilization agent would have a profound negative effect on healthcare providers and patients.”
Furthermore, HIDA stressed that “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.”