WASHINGTON, D.C. – In a letter to the White House, the Advanced Medical Technology Association (AdvaMed) outlined four key priorities in pending regulations for facilities sterilizing medical devices with ethylene oxide (EtO).
AdvaMed, one, welcomed the regulations; two, sought consideration of the potential threat to patient care if any facilities shut down; three, asked the Environmental Protection Agency (EPA) to embrace technology-neutral solutions to meet emissions targets; and four, asked the EPA to consider background EtO levels in ambient air and the tiny proportion of EtO used in medical device sterilization compared to other uses and sources.
“With 20 billion medical devices sterilized using EtO each year in the U.S. at about only 100 facilities, the closure of even a small percentage of facilities could harm patient access to health care,” Scott Whitaker, AdvaMed president and CEO, wrote to President Biden. “EtO sterilization is at capacity. With 80 percent of surgical kits alone sterilized using EtO, any shutdown-induced disruption could reverberate from screening to the operating room to post-operative care.”
Updated EtO emissions standards for sterilization facilities from the EPA are pending at the Office of Management and Budget. AdvaMed welcomes the update on behalf of the companies that rely on EtO sterilization of their devices to supply the hospitals and doctors’ offices serving patients nationwide.
Despite not having updated the standards since 2006, the EPA last August identified 23 facilities as presenting an elevated cancer risk and is holding meetings in the adjacent communities. Alarming verbal messages at the meetings undermine the agency’s caveats of the risk as a “worst-case scenario.”
“We ask the EPA to carefully reconsider language that might unreasonably alarm residents near sterilization facilities,” Whitaker wrote. “When a facility is in compliance with all applicable regulations, in the absence of updated federal regulations, and regularly reducing emissions even more than required, and risk projections are based on highly conservative modeling rather than actual data, the public condemnation from a federal agency is unfair and undeserved.”
Millions of medical devices can be sterilized only with EtO. If facilities shut down, supplies could be constrained, and patient care could be delayed. Also, the medical technology industry uses only half of one percent of commercially produced EtO, which has multiple commercial uses. AdvaMed asked the White House to consider these facts as the updated regulation is reviewed and finalized.
# # #
AdvaMed is the world’s largest medical technology association, representing device, diagnostics, and digital technology manufacturers that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments.