FDA to Hold Town Halls on Ethylene Oxide Sterilization Following Toxic Leaks

More stringent ethylene oxide standards were enacted last year, following a number of factory leaks that put workers and nearby residents at risk.

Following a number of high-profile leaks and ethylene oxide exposure lawsuits in recent years, federal regulators are seeking public input on efforts to seek a replacement for the toxic gas that is used to sterilize medical instruments.

The U.S. Food and Drug Administration (FDA) is hosting the second in a series of virtual town hall meetings today, to discuss sterilization methods. In addition, the town halls will discuss FDA activities, premarket considerations for sterilization-related review, reducing EtO use, and exploring alternative sterilization methods.

Medical device sterilization is a necessary step in the manufacturing process to ensure devices are adequately sterilized to prevent infections.

Medical devices are sterilized in a number of ways, by using steam, dry heat radiation, ethylene oxide (EtO) gas, vaporized hydrogen peroxide, and other methods, such as chlorine dioxide gas, vaporized per acetic acid, and nitrogen dioxide. However, some methods pose more health risks compared to others.

Ethylene Oxide Concerns

Ethylene oxide exposure can cause respiratory irritation, injury to the lungs, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis. Repeated exposure, such as that from manufacturing, has been linked to cancer, reproductive side effects and neurotoxicity, according to researchers.

Following massive ethylene oxide leaks at a Sterigenics plants in Illinois, Georgia and Michigan in recent years, the FDA issued new ethylene oxide gas standards in April 2023 to prevent or limit the risk to workers from the gas.

Lawsuits filed over ethylene oxide leaks at Sterigenics facilities allege workers and nearby residents developed breast cancer, non-Hodgkin’s lymphoma and other health problems due to exposure. The lawsuits resulted in a $408 million settlement last year from residents in surrounding communities.

Earlier this year, the FDA recategorized vaporized hydrogen peroxide as an approved sterilization method for medical devices. The move now allows medical device manufacturers to use this method in lieu of other more harmful processes.

Medical Device Sterilization Town Halls

The FDA’s virtual town hall will discuss current medical device sterilization methods and work to advance innovation in sterilization methods.

The town hall is the second in a series held by the FDA. Other virtual town halls are planned for February 7, February 29, and March 21, 2024.

Participants don’t need to register for the town halls. Those seeking to participate in the future town halls can send an email to MedicalDeviceSterilization@fda.hhs.gov for more information.