The medical-device industry, federal regulators and state authorities continue to debate how to best balance medical-device production and environmental impacts as they review ethylene oxide standards for sterilization facilities.
The Advanced Medical Technology Association urged the Environmental Protection Agency to roll back its proposed limitations on ethylene oxide, or EtO, emissions, claiming that restricting the most common medical-device sterilization process would disrupt patient access to devices and compromise their safety. Meanwhile, state attorneys general are pushing the EPA and Food and Drug Administration to implement stronger emission standards for ethylene oxide, which has been linked to cancer.
While medical-device manufacturers are looking for alternative sterilization methods and ways to reduce EtO emissions, the EPA's proposed framework would upend the supply chain, jeopardize safety and cut off access to patients, said Scott Whitaker, president and CEO of AdvaMed, the medical-device lobbying group.
"EPA's EtO risk assessment standard is unworkable and not based on the best available science," he said in prepared remarks. "The agency's failure to address these valid scientific concerns surrounding their value threatens not only the medical technology supply chain but the tens of millions of American patients that rely on EtO-sterilized devices. We ask the agency to follow its own scientific recommendations and develop a revised EtO risk assessment standard that will effectively protect the public health and not disrupt patient access to needed medical technology."
The EPA's proposed rule would reduce chemical plants' EtO emissions—more than 111 tons were produced in 2018—by about 10 tons per year, the agency estimated. The agency looks to require manufacturers to control emissions from storage tanks, vents and leaky components, which account for about 40% of total emissions, according to the EPA's 2018 report.
About half of medical devices used in the U.S. are sterilized with ethylene oxide—a relatively cheap process that easily penetrates surfaces, making it an attractive choice for devicemakers.
A letter from 16 state attorneys general cited a recent EPA assessment that the cancer risk of inhaling EtO is 30-times higher than previously estimated. Ethylene oxide "is among the most hazardous air pollutants posing the greatest health risks in the largest number of urban areas in the country," the AGs wrote, pointing to a 2018 analysis of EPA data.
"Stricter emissions standards for EtO are necessary to safeguard exposed populations nationwide from the harmful effects of this pollutant," the letter reads. "The over-reliance on EtO sterilization must end."
AdvaMed disputes EPA's estimation of EtO's cancer risk.
It is hard to pinpoint the source of a carcinogen like EtO, said Logesh Chokkalingam, a project manager at healthcare software developer HCL Technologies. It is best to wait for the results of the FDA's pilot program, which aims to identify new sterilization methods, he said.
"Closing the plants is not going to help anybody," said Chokkalingam, adding that could have a major impact on the supply chain and patient care.
Most third-party EtO sterilization facilities are operating at 90% capacity, according to a analysis from Premier, a group purchasing and consulting organization.
Illinois Attorney General Kwame Raoul forced Sterigenics to close a suburban Chicago EtO sterilization plant last year following residents' health concerns. Other manufacturers in the state and across the country have temporarily closed as they bolster emission reductions protocol. Two more sterilization facility closures would send the healthcare supply chain into a "tailspin" and would be "catastrophic for patient care," Premier said.
While it wouldn't be safe to close more plants, more research needs to be done, Chokkalingam said.
"We need to find new technology," he said.
