New rules are coming that would limit emissions of ethylene oxide (EtO), a toxic, colorless gas used to sterilize medical devices. The Environmental Protection Agency is slated to issue a final rule by March, which the agency expects will reduce EtO emissions by 80% and lower cancer risks for people who live near sterilization facilities.
Medical device companies have raised concerns about the proposed limits, saying they could cause shortages of medical equipment. At the MedTech Conference last week, officials with the Food and Drug Administration’s Center for Devices and Radiological Health said they are working closely with the EPA to help the agency understand the impact.
“We have had a very loud voice, and we continue to speak to our concerns with regard to the potential for shortages of medical devices,” said Suzanne Schwartz, director of the Office of Strategic Partnerships and Technology Innovation Center at CDRH.
Schwartz added that the FDA has been working closely with the EPA and other government partners “in terms of really giving them an understanding of what the potential devastating impact would be as a result of the rules as they have been proposed.”
The agency has said EtO is used to sterilize about half of all medical devices, roughly 20 billion, sold in the U.S. every year.
The FDA reviews device sterilization information as part of premarket submissions. If the sterilization method, process or facility is changed for an approved device, normally the company would need to file a supplement with the FDA.
Creative solutions
The FDA is analyzing the supply chain of sterilized medical devices, including those sterilized using EtO and other modalities, such as radiation or steam. The regulator is considering “what might be in the art of the possible” for transitioning some of the devices from EtO to other modalities, Schwartz said.
The agency has also launched multiple pilot programs, including one for devices that have received premarket approval and use radiation or EtO, and another for 510(k) cleared medical devices to help them change from EtO to another method.
It is also looking for creative solutions through innovation challenges to identify effective alternatives to EtO, although Schwartz acknowledged it will take “several years” to develop the science, logistics and understanding of the new modalities.
AdvaMed CEO Scott Whitaker told reporters the EPA regulation is “progressing in a direction that makes us feel better than we would have felt a year ago at this time.”
There are two parts to the EPA’s rulemaking that the medical device industry group is watching. The first, which updates National Emission Standards for Hazardous Air Pollutants with EtO limits for sterilization facilities, is “trending in the right direction,” Whitaker said.
The second part is a proposed interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act, which would limit the permissible amount of EtO per sterilization cycle to 500 mg/L, require certain engineering controls and protective equipment for workers, and require real-time monitoring of EtO levels.
“We still have a lot of concerns about what that looks like,” Whitaker said.
He added that AdvaMed continues to meet regularly with the EPA.
“To the EPA’s credit, they’ve always been open and willing to have the conversations,” Whitaker said. “And so it leads me to believe they want to do the right thing, and they understand the challenge now.”