Medical device trade groups raised concerns about the capacity to sterilize medical devices in response to proposed ethylene oxide regulations by the Environmental Protection Agency. The EPA seeks to reduce emissions of the gas, which it says can cause cancer over a long period of exposure, but medical device companies said the new rules could disrupt the supply of equipment.
Each year, 20 billion devices — roughly half of all medical devices — are sterilized using ethylene oxide, medical device trade group AdvaMed wrote in a Tuesday statement. It’s the only effective sterilization method for heat- or moisture-sensitive materials, the group said.
“This issue is critical for patients, and as a result, the stakes are high. Ethylene oxide sterilization facilities are at capacity,” AdvaMed CEO Scott Whitaker said in a statement. “As the FDA recognizes, many medical devices simply cannot be sterilized by another method. If new EPA regulations force sterilization facilities to close, patients could face treatment delays as sterile technology supplies, such as pacemakers and surgical equipment, fall short.”
The Medical Device Manufacturers Association, another trade group, raised similar concerns.
“Reducing an already stretched supply chain would be catastrophic for patient care, and our sincere hope is that the EPA and the Administration will listen to hospitals, FDA and others to ensure that nothing is done that would compromise patient access to safe and effective medical technologies,” Mark Leahey, CEO of the association, said in a statement.
On Tuesday, the EPA proposed a rule regulating ethylene oxide emissions for medical device sterilizers under the Clean Air Act. The agency also introduced mitigation measures to decrease the risk for workers and community members who live near the facilities under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The agency said the proposal could reduce EtO emissions from 86 commercial sterilizers by 80% per year, bringing emission levels down so that risk falls below the EPA’s Clean Air Act benchmark for elevated cancer risk.
AdvaMed raised concerns with two points in particular. First, the group said that 18 months would not be enough time to meet the new emissions monitoring requirements.
“It could take many months for abatement equipment to arrive,” AdvaMed wrote. “Supply chains and manufacturing are still recovering from the pandemic.”
Second, AdvaMed said the preliminary employee safety requirements don’t account for the most current science, overstating the risk to employees and not accounting for protections already in place.
Becton Dickinson, a medical device manufacturer that also operates ethylene oxide sterilization facilities, said “recent investments and innovations to reduce residual emissions” and employee safety practices make its facilities “well positioned to comply with any new final rules with the EPA.”
The company declined to comment on the specifics of the proposed rule, saying it would provide written comments to the agency. Last year, two of BD’s facilities were put on a list of sterilization sites that pose a higher cancer risk to nearby communities.
Some facilities have reduced their emissions, but others use up to twice as much as needed for sterility assurance, said Anita Pease, director of the EPA’s Antimicrobials Division, in a Tuesday press briefing. The goal is to ensure all 86 commercial sterilizers meet the new requirements. Pease did not say how many facilities would still need to come into compliance.
