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Ethylene Oxide Sterilization Facility Updates

The FDA is closely monitoring the supply chain effects of closures and potential closures of certain facilities that use ethylene oxide to sterilize medical devices prior to their use. The Agency is concerned about the future availability of sterile medical devices and the potential for medical device shortages that might impact patient care.

Additionally, the FDA is working with device manufacturers and health care delivery organizations to ensure they are aware of the issues and preparing to reduce the patient impact if medical devices sterilized at these sterilization facilities become unavailable.

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Medical devices that are sterilized to remove potentially harmful germs and other microorganisms prior to use are critical to our health care system and a shortage — especially of life-saving, life-sustaining, or critical devices — can present a risk to the public health.

Health care providers and consumers: The FDA encourages health care providers, health care delivery organizations, and the public to email the FDA’s device shortages mailbox (deviceshortages@fda.hhs.gov) if they are encountering any device availability challenges and/or have concerns with the adequacy of medical devices to meet patient needs.

Device manufacturers: The FDA reminds device manufacturers to email the FDA’s device shortages mailbox (deviceshortages@fda.hhs.gov) if they would be impacted by the potential closure of the BD contract sterilization facility and anticipate delays in distribution of devices to their customers as a result.

June 2, 2021 - Steril Milano Facilities in Italy

The FDA is aware that Steril Milano S.R.L Reggiolo and Monza ethylene oxide sterilization facilities, in Italy, have been closed since March 8, 2021, as was announced by the Italian Ministry of Health on March 9, 2021. The FDA understands this stop in operations occurred due to sterility concerns that medical devices were not correctly sterilized. Read more in the FDA's Sterility Issues with Medical Devices Processed at Steril Milano Facilities - Letter to Industry.

January 21, 2020 - Medline Industries in Waukegan, IL

The FDA is aware that the Medline Industries’ medical device ethylene oxide sterilization facility in Waukegan, IL, has been closed since December 13, 2019, as was announced by the Lake County Health Department on January 21, 2020. The FDA understands this was a voluntary stop in operations to finish construction on emissions reduction equipment to bring the facility in line with ethylene oxide exposure standards Illinois approved last year. The FDA is currently in discussions with Medline to determine the potential impact on device availability.

October 21, 2019 - Becton Dickinson and Company (BD) Facility in Covington, GA

The FDA is aware that the Georgia State Attorney General has taken action requesting the potential closure of the Becton Dickinson and Company (BD) medical device sterilization facility in Covington, GA. If this sterilization facility were to be closed, the FDA is concerned that significant additional strains to the supply chain for critical medical devices may lead to shortages, including those needed for critical care in hospitals on a daily basis, such as surgical kits, feeding tubes, and different types of catheters.

See a list of devices sterilized at the BD Covington facility and that may be affected.

The FDA is closely monitoring this issue and will keep the public informed as warranted.

October 18, 2019 – Sterigenics Facility in Willowbrook, IL

The FDA is aware that, as of October 1, 2019, the Sterigenics contract sterilization facility in Willowbrook, IL, announced that they will not reopen. While the facility has been closed since February 15, 2019, the FDA has continued to coordinate with multiple stakeholders on any impacts to medical device availability and communicate with Sterigenics and medical device companies that may be affected.

The FDA is also aware that the Sterigenics facility in Atlanta, GA, remains temporarily closed as of August 26, 2019. While this facility is unable to operate, existing inventory of devices that are terminally sterilized at this facility continues to be used, depleting product in the supply chain. The longer the duration of closure, availability of product becomes a growing concern.

September 13, 2019 - Sterigenics Facility in Atlanta, GA

The FDA is aware of the temporary closure, beginning August 26, 2019, of the Sterigenics contract sterilization facility in Atlanta, GA, while it undergoes construction to reduce ethylene oxide emissions. The FDA has been working to understand the impact it could have on medical device availability and communicating with Sterigenics and medical device companies that may be impacted.

April 12, 2019 - Smiths Medical

In March 2019, the FDA was notified by health care providers, patients, and Smiths Medical that the closure of the Sterigenics Willowbrook sterilization facility caused a potential device shortage for Bivona tracheostomy tubes. The FDA recognizes how important these essential tracheostomy tubes are to families and health care facilities and is taking steps to assure that sterilized, safe, and effective tubes are available.

The FDA worked with Smiths Medical to secure availability of sterilized Bivona tracheostomy tubes for hospitals, health care providers, and patients by helping Smiths Medical transition to another Sterigenics sterilization facility and expedite release of sterilized tubes that still meet the FDA's standards for safety and effectiveness.

Smiths Medical began shipping sterilized Bivona tracheostomy tubes to customers beginning the week of April 22, 2019. Parents, caregivers and health care providers can continue to clean and sterilize these tubes according to the instructions for use that are included with every tube.

March 26, 2019 - Sterigenics and Viant

The FDA is aware that on February 15, 2019, the Illinois Environmental Protection Agency (EPA) issued a Seal Order to stop the Sterigenics facility in Willowbrook, Illinois, from sterilizing medical products and other products with ethylene oxide. Learn more about the Environmental Protection Agency's assessment of Sterigenics Willowbrook Facility on U.S. EPA.gov.

Medical devices account for many of the products that the Sterigenics Willowbrook facility sterilizes. The FDA is reaching out to medical device manufacturers to understand which manufacturers are affected by the cessation of operations at this sterilization facility. See a list of devices sterilized at the Sterigenics Willowbrook facility and that may be affected.

The FDA is aware that Viant informed their customers that their Grand Rapids sterilization facility is planning to close later in 2019. See a list of devices sterilized at the Viant facility and that may be affected.

Contact Us About Device Availability or Supply Chain Challenges

To report a medical device shortage or supply issue, email Deviceshortages@fda.hhs.gov or phone 1-800-638-2041 or 301-796-7100.

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