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November 7, 2019

AdvaMed Statement on EtO Air Testing by EPA

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement today from President and CEO Scott Whitaker following release of air testing data from the Environmental Protection Agency (EPA) that looked at levels of ethylene oxide (EtO) across the country:

"As part of EPA’s ongoing effort to protect people and the environment, yesterday’s preliminary test results show that EtO is present and safe at background levels. Those levels are safe whether a sterilization facility is present or not. That’s an important finding, and we appreciate EPA’s commitment to doing further research here.

"EPA's data shows that ambient air levels of EtO are far higher than the proposed standard that some have used as justification to shutter sterilization facilities. This demonstrates that the standard is not a reliable or useful gauge for determining appropriate emission levels of EtO. As we continue to study EtO’s presence in our atmosphere, it’s important to remember that leading toxicologists and epidemiologists confirm that the communities surrounding these facilities are safe. We look forward to working with EPA, FDA and other stakeholders to find a reasonable solution to the issue of EtO use that will allow for the continued safe and responsible sterilization of needed medical devices."