Weekly Policy Blog: Ethylene Oxide – Critical in Protecting Patient Health

Ethylene Oxide (EtO or EO) is a colorless gas used commercially in a wide variety of ways, including the production of textiles, personal care items, and the sterilization of medical devices, cosmetics, and spices. EtO is one of the most common ways to sterilize medical devices, which is crucial for preventing infection in patients undergoing surgical procedures and other medical treatments.

EtO sterilization is a highly regulated process. Device manufacturers, hospitals, and third-party sterilizers follow rigorous controls established by FDA, EPA, OSHA, and other government agencies to protect patients, workers, and the environment.

The Environmental Protection Agency (EPA) is performing a risk assessment and updating guidance on workers’ and communities’ exposure to EtO emissions. This process has been ongoing since 2006, and guidance is expected by the end of the year. Following a study of 100 commercial sterilizer facilities, the EPA announced on August 3 that it would take steps to inform communities throughout the country about the risks posed by EtO emissions from 23 specific sterilizer facilities. The EPA is engaging with these communities at the “highest risk” to hear their concerns and answer questions as details about this risk assessment are shared.

How is CBSA Engaging?
CBSA and national partners are following this activity very closely and working with the life sciences ecosystem, which uses EtO to sterilize their medical devices to make sure the information being shared about the safety of EtO is accurate. Over the next weeks and months, the EPA will continue to conduct national and local meetings and webinars. CBSA will follow these closely and update our ecosystem on the latest rulings, findings, and outcomes. CBSA will continue advocating for the life sciences ecosystem and patients.

Clear, comprehensive, and accurate communication from EPA about EtO is vital
Clear and accurate communication from EPA about acceptable levels of risk to public health from EtO in general and from commercial sterilizers specifically is critical for avoiding potential disruption to already fragile global supply chains, which could lead to nationwide shortages of needed therapies and be catastrophic for patients.

Learn More
To learn more about EtO and its role in our health care system, as well as what sterilization companies are doing to control emissions, please visit the “Ethylene Oxide & Sterilization” page of our national partner AdvaMed by visiting their website

Categories: CBSA News