Ethylene Oxide Issues Resurfacing after EPA Announcement

The Environmental Protection Agency has restarted the process of evaluating emissions standards for ethylene oxide (EtO), the sterilant responsible for sterilization of billions of medical products in the U.S. each year. In response, the Advanced Medical Technology Association (AdvaMed) has urged the EPA to be careful in the language it uses in communicating with residents near EtO sterilization facilities because of the risk of causing undue alarm.

AdvaMed sent a Jan. 18 letter to the White House stating that two U.S. states have enacted legislation regarding EtO emissions since the EPA last updated its standards for EtO emissions in 2006. Several other states are also considering legislation, but even some local governments are intent on regulating these sterilization facilities. The EPA had identified 23 facilities in August 2022 that the agency said may elevate the risk of cancer in nearby communities in a worst-case scenario, but AdvaMed said the public reaction failed to recognize many of the caveats in that EPA assessment.

The EPA submitted a Nov., 23, 2022, information collection request to the Office of Management and Budget, and AdvaMed CEO and President Scott Whitaker asked the White House to consider the potential threat to patient care if any of the EtO sterilization facilities in the U.S. were forced to shut down. There are approximately 100 EtO facilities in the U.S. that are responsible for sterilizing 20 billion medical devices and other products each year, but Whitaker said there is almost no reserve capacity in the U.S. domestic EtO sterilization infrastructure, and thus the closure of even a small number of facilities could result in access problems for patients in critical situations.

Whitaker stated that a previous closure of a single facility had caused a temporary shortage of pediatric breathing tubes, a problem identified by the FDA, which has expressed concern about device availability should more facilities cease operations.

Lucy Frasier, a consulting toxicologist, explained the dilemma facing medical device manufacturers regarding crimped EtO sterilization capacity. While there are other modalities that can be used to sterilize a medical device, Frasier said that methods such as steam sterilization would damage many products that are safely sterilized with EtO. She gave the example of a single-use syringe used to administer a flu shot or a booster shot for a COVID-19 vaccine. In order to adequately control for bioburden, steam must achieve temperatures that would melt the plastic the syringe is made of, but there are other advantages seen in the use of EtO.

EtO is capable of penetrating layers of packaging in ways that other methods cannot, Frasier said, a feature that makes the use of this sterilant a tremendous asset when it comes to convenience kits used in hospital operating rooms. Compared to gamma radiation, the facilities needed for EtO sterilization can be small and inexpensive to establish, making this a critical method of sterilization for health care facilities that need only a low volume of sterilization services.

Frasier said that EPA’s communication about EtO risks often lacks context, such as the fact that background levels of EtO are already higher than the amount contributed by device sterilization facilities. Data obtained by AdvaMed demonstrates that a number of ordinary articles emit or create EtO in excess of EPA’s benchmarks, such as lawn mowers, school buses and charcoal grills. The EPA’s modeling exercises include a scenario in which residents in areas near an EtO sterilization facility are exposed to the substance in the air 24 hours a day, every day for 70 years. Frasier said this approach is problematic in that a failure to inform the public about these other sources of EtO ensures that the public is “going to be more alarmed than if they knew that ethylene oxide was in the air all around.”