Model of an ethylene oxide molecule.
Michigan officials have cited a medical device sterilization plant owned by Medline Industries for excessive emissions of ethylene oxide (EtO).
The Michigan Department of Environment, Great Lakes, and Energy (EGLE) issued an air quality violation notice last week to Centurion Medical Products after air sampling around its Howell, Mich. facility detected unsafe levels of EtO emissions. Medline bought Centurion in 2017.
The EPA, which considers EtO a human carcinogen, asked EGLE in January to review ethylene oxide information submitted by Centurion, according to a news release from the state agency. EGLE determined that further investigation was warranted and conducted an initial round of air sampling over a 24-hour period from March 29-30. The results showed ethylene oxide at concentrations above acceptable health screening levels for long-term exposure, according to EGLE.
The violation notice instructs Centurion to evaluate possible next steps to reduce ethylene oxide emissions and outdoor air exposures. Additionally, Centurion must supply information about how its sterilization process is maintained and how the company will meet its health-based permitted limits and comply with all aspects of its air permit. EGLE will review and approve all responses and actions proposed by the company to ensure nearby residents remain safe, the agency said.
At very high levels in the air, ethylene oxide can cause immediate health effects, like headaches, dizziness, nausea, fatigue, and respiratory irritation. Based on the levels observed around Centurion, immediate health effects are unlikely to occur, EGLE said. Workplace studies in humans and animal studies have shown that prolonged, high-level exposure to ethylene oxide increases the risks for developing lymphoid cancers (including multiple myeloma, leukemia, Hodgkin lymphoma, and non-Hodgkin lymphoma) and breast cancer in females, the agency added.
“The safety of our employees and the surrounding community always has been a top priority, and we operate our facility safely, within all federal regulations and in compliance with our state of Michigan permit,” Medline spokesperson Jesse Greenberg said in an email to Medical Design & Outsourcing. “Ethylene oxide is heavily regulated to ensure its safe use. Medline controls more than 99% of all EtO emissions in the Howell facility through emission control technologies. In addition, we use a variety of sterilization methods based on compatibility with each medical device or supply. For many items, including those sterilized in Howell, EtO is the only FDA-approved sterilization method.
“In response to the Michigan Department of Environment, Great Lakes and Energy’s (EGLE) public notice, Medline looks forward to working with state officials. Medline shares the EGLE’s goals of protecting public health and air quality.”
EGLE plans follow-up air sampling this year and results will be posted to Michigan.gov/EGLECenturion, which includes additional information and resources.
