White House Warned of Possible Disruption in Medical Device Supply

AdvaMed President and CEO, Scott Whitaker, recently sent a letter to President Biden outlining concerns about how more stringent ethylene oxide (EtO) requirements could stop medical devices from reaching patients.

“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. EtO sterilization is at capacity. With 80% of surgical kits alone sterilized using EtO, any shutdown-induced disruption could reverberate from screening to the operating room to post-operative care,” Whitaker wrote.

MichBio has been engaged on the issue, both at the federal, as well at the state level, where Michigan regulators have scrutinized industry practices.