Press Releases

AdvaMed on EPA’s Commercial Sterilization Facilities List

WASHINGTON, D.C. – Scott Whitaker, President and CEO of the Advanced Medical Technology Association (AdvaMed), the world’s largest trade association representing medical device manufacturers, made the following statement on the Environmental Protection Agency’s naming of 23 commercial sterilization facilities as the subject of community meetings over possible health risks. The facilities use ethylene oxide (EtO) to sterilize medical equipment and spices.

“As the EPA, state, local, and tribal agencies monitor air quality and consider any effects of sterilizer plant emissions on workers and neighboring communities, it’s critical that the EPA clearly communicate the facts about the science and actual risk posed by facilities that are meeting and often exceeding state and federal requirements for controlling EtO emissions. It’s also important to note that all of the listed facilities are in compliance with all regulations. 

“The EPA rightly states that EtO is ‘critical for sterilizing medical equipment and necessary to protect public health,’ and also notes that, according to the Food and Drug Administration, ‘EtO is the only sterilization method available for many medical devices’—approximately half of all medical devices manufactured in the United States each year. This makes it all the more vital that EPA be absolutely clear, comprehensive, and accurate in its communications surrounding EtO.  

“The EPA also points out that several states and commercial sterilizers have worked together to reduce EtO emissions. This is consistent with what we know of the performance of these much-needed sterilization facilities, many of which capture emissions beyond federal and state requirements because their No. 1 priority is the safety of their employees and neighbors. 

“The EPA acknowledges the need for continued research to better understand background EtO levels in outdoor air, as well as to better understand acceptable levels to protect health; and for recognizing how important EtO sterilization is to patients and medicine as we all work to improve our understanding of EtO emissions, what levels are safe and under what conditions, and how best to remove emissions to untraceable levels. 

“Again, it is critical that the EPA get this right. Too much is at stake, as the FDA notes: this is a ‘vital process for helping to prevent serious infections’ and ‘other methods of sterilization cannot currently replace the use of EtO for many [medical] devices.’ The agency cites the ‘potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.’  Also, some facilities are doing significant pro-active work to cut emissions from 20 percent to 35 percent, potentially impacting ‘millions of devices.’ The industry continues to make voluntary improvements, even in the absence of specific federal regulation.

“The shutdown of medical device sterilization facilities due to misinformed political pressure, as well as the uncertainty regarding which regulations the facilities must adhere to as EPA works to update the federal rule, would be disastrous to public health under the best of circumstances; it could be catastrophic, in light of the fragile global supply chain, which hospitals are already strained to address.” 

To learn more about EtO and the role it plays in our health care system, as well as what sterilization companies are doing to control emissions, please visit the “Ethylene Oxide & Sterilization” page of AdvaMed’s website by clicking HERE.