Christina Lavoie, Director of Policy, Health Industry Distributors Association
The Health Industry Distributors Association is urging the Environmental Protection Agency (EPA) to act thoughtfully when it comes to pending regulations on the use of ethylene oxide in medical sterilization.
Ethylene oxide (EtO) is a colorless gas used to sterilize equipment and devices that cannot be sterilized by steam. It is often the most effective sterilizing agent for devices that have many packaging layers or hard-to-reach areas.
Approximately 50% of all medical devices are sterilized with EtO. This amounts to more than 20 billion devices annually. Surgical kits, pacemakers, heart valves, and syringes are among the medical products that rely upon EtO sterilization. For many medical devices, EtO is the only sterilization method that does not damage a device during the sterilization process.
In regulatory comment to the EPA, HIDA has cautioned that any changes to EtO policies must include a realistic and feasible plan to address 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. This would have tremendous negative impacts on the medical supply chain.
HIDA is not the only voice raising concerns about pending regulations on medical sterilization:
- Food And Drug Administration: FDA Commissioner Robert M. Califf testified before the House Energy & Commerce Committee, and expressed concerns about the EPA’s approach to EtO. Commissioner Califf warned that “a sudden restriction [in the use of EtO] would create substantial difficulty with critical medical devices. … I wish I could say there’s a ready alternative [to EtO sterilization] in a short period of time. There’s not.”
- Small Businesses: In its comments on EtO regulation, the Small Business Administration warned that “these actions would lead to a significant number of small entities leaving the market for commercial sterilization, and hurting patients needing sterilized medical devices.”
- Hospitals And Providers: The American Hospital Association cautioned that “moving too quickly to implement and enforce new standards will result in the unexpected consequence of reducing EtO sterilization capacity, ultimately leading to delays in patient care.”
Healthcare distributors want to protect public health. In order to do so, they must be able to deliver sterile critical medical products to providers without interruption in the supply chain. Commercial sterilization facilities play a vital role in maintaining an adequate supply of medical devices.
HIDA continues to monitor the regulatory rulemaking process and advocate for common-sense regulations that ensure patients and providers have reliable access to safe, sterilized medical products.