The FDA recognizes that there are concerns associated with release of ethylene oxide into the environment if emissions were to occur at unsafe levels. Concerns about ethylene oxide emissions have resulted in certain state actions against sterilization facilities that are currently impacting manufacturers’ ability to use the ethylene oxide process to sterilize their medical devices. In February, the FDA became aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop Sterigenics from sterilizing medical products and other products with 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 the air around the facility. This closure caused a temporary shortage of pediatric breathing tubes.

Another Sterigenics contract sterilization facility, in Atlanta, Georgia, has been closed since August while it undergoes construction to reduce ethylene oxide emissions. In October, the Sterigenics Willowbrook, Illinois, facility announced they would not reopen. As a consequence of these two large sterilization facilities being unavailable, the FDA continues to coordinate with multiple stakeholders on any impacts to medical device availability and to communicate with Sterigenics and medical device companies that may be affected. Because the number of ethylene oxide contract sterilization facilities in the U.S. is limited, we are very concerned that additional facility closures could severely impact the supply of sterile medical devices to health care delivery organizations that depend on those devices to take care of patients. The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care.


This is why today we are urging medical device manufacturers that use ethylene oxide facilities to assess their inventory for any potential downstream impacts of sterilization facility closures on their product distribution. We are committed to working with manufacturers to look for alternative sterilization options. When manufacturers keep the FDA apprised of progress and obstacles encountered, it helps ensure that everyone’s best efforts are being made to mitigate any shortages and prevent potential shortages. When U.S. manufacturers are not able to resolve a shortage and it involves a critical device needed for U.S. patients, the FDA may look for a firm that is willing and able to redirect safe and effective product into the U.S. market to address a shortage.

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