The two agencies have struggled for months to address growing concern over ethylene oxide, which some fear can cause cancer and damage the environment.
The EPA has pushed for regulations to reduce ethylene oxide emissions, but the FDA has warned that regulations could cause some sterilization facilities to close, which could cause shortages of critical medical devices since there isn’t an alternative sterilization method.
The EPA released a draft version of proposed rulemaking in January asking medical sterilization facilities to use lower volumes of ethylene oxide. But the FDA claimed jurisdiction over ethylene oxide use in sterilization facilities, and the EPA subsequently removed the request from the proposal.
Now, Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, is encouraging the EPA to issue emissions limits on ethylene oxide.
“We recognize the critical role that EPA plays in regulating ethylene oxide to protect human health and the environment. EPA should establish EtO emissions limits based on the levels necessary to protect human health and the environment from EtO toxicity,” Dr. Shuren wrote in a letter to the EPA.
Dr. Shuren added, “If a facility is unable to meet EPA emissions limits and its inability to do so could lead to product availability concerns, FDA will work with the facility and other entities in the supply chain to mitigate these concerns.”
Read the full letter here.
More articles on supply chain:
Medtronic recalls insulin pumps linked to 2,000 injuries, 1 death
6 hospitals that suspended surgeries due to supply chain issues
Cardinal surgical gown recall cost $96M
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
