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Utah Life Sciences News & Events

EPA Updated Assessment of Cancer Risk and Ethylene Oxide Used to Sterilize Medical Devices

August 4, 2022

Ethylene Oxide (EtO) is used to sterilize many types of medical devices – about 20 billion annually. For some devices, EtO is currently the only safe and effective sterilization method. 

While short-term or infrequent exposure to EtO doesn’t appear to pose a health risk, EPA, has been raising concerns about long-term exposure to EtO emissions and increased cancer risk. To address these concerns, later this year, EPA will propose strengthening current regulations for Ethylene Oxide Commercial Sterilizers. EPA will consider risk as part of the proposed regulations.

To inform this upcoming rule making, EPA recently completed a risk assessment for localities near the approximately 100 commercial sterilizers now operating in U.S. The analysis shows that EtO emissions from some of these sterilizers may contribute to elevated cancer risk for people living in nearby communities. EPA’s risk assessment for commercial sterilizers focused on the extra cancer risk that would occur if a person breathed air containing EtO at the level expected in a residential community near each sterilizer for an entire lifetime (24 hours a day for 70 years). The agency intends to use the assessment to better understand where the risk is highest and how to reduce it.

Impact on Medical Device Safety

At present, in many cases, there are no practical alternatives to EtO. Utilizing less effective sterilization methods could result in unsafe medical supplies and harm to patients.

EPA says that medical sterilization is a “critical function that ensures a safe supply of medical devices for patients and hospitals”. The agency notes that it’s “committed to addressing the pollution concerns associated with EtO in a comprehensive way that ensures facilities can operate safely in communities while also providing sterilized medical supplies”.

Utah Efforts and EtO

EPA is working with the State of Utah to reduce emissions at the BD Medical facility in Sandy. EPA has provided technical support and is also reviewing controls on regulated equipment and processes that emit EtO to determine whether additional air pollution controls are needed. EPA has also provided the Utah Department of Environmental Quality (UDEQ) with a Community-Scale Air Toxics Ambient Monitoring grant to evaluate ethylene oxide.

The BD facility in Sandy, Utah has been identified among the areas of high risk (elevated cancer risk at or above 100 additional cancer cases per million people exposed (or 1 additional cancer case per 10,000 people exposed. 

EPA Community Outreach

EPA plans to hold a public webinar on August 10 to focus on the national scope of EtO risks. After this national webinar, EPA will host individual meetings in each of the communities where the agency has found the highest risk. A community meeting for Sandy area residents will be held on October 20.

BioUtah is working closely with our local medical device facilities, national partners, such as AdvaMed, as well as state officials to address the issue while protecting patient access to safe, sterile medical devices (heart valves, catheters, pacemakers etc.)

Register HERE for the national public webinar. 

Register HERE to attend the community meeting

Register HERE to attend the DEQ Virtual Meeting