Earlier this year, the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop a contract sterilizer, Sterigenics, from sterilizing medical products and other products with gas called ethylene oxide at their Willowbrook, Illinois facility. The state EPA order was due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility. These levels presented a health risk to nearby workers and community residents.
Ethylene oxide (EtO) is a colorless, odorless gas that is flammable and highly reactive. Short term exposure to EtO may result in respiratory irritation and lung injury, headache, nausea, vomiting, diarrhea, shortness of breath, and cyanosis (where the skin turns blue due to oxygen shortage). Repeat exposure has been associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, and sensitization. Additional information may be found at this OSHA web site. EtO is commonly used to remove potentially harmful germs and other microorganisms from about 50% of all medical devices in the U.S. The process is carefully controlled to ensure the final device is sterile and low levels of the sterilant and its reaction products are left on the device. The FDA also inspects facilities that use EtO for medical device sterilization to make sure they have validated sterilization processes that meet FDA-recognized standards. Read more about EtO sterilization on this FDA web page.
Because so many medical devices are sterilized using of EtO, the long-term shutdown of this facility could lead to a shortage of medical devices that would negatively affect patient treatment. The FDA is working to prevent these shortages by reaching out to medical device manufacturers and distributors whose products are sterilized at the Willowbrook facility to understand the risk and assess potential impacts. A device shortages mailbox has been established to allow patients, providers, and manufacturers to quickly notify the FDA about potential and actual shortages. You can read more about the agency’s actions in the FDA press release.
Text Copyright © 2019 Katrina Rogers