FDA addresses sterilization, medical device shortages, amid shutdown of contract sterilizer facilities

March 27, 2019

The Food and Drug Administration says it will take steps to address potential medical device shortages due to the recent closure of the large contract sterilizer, Sterigenics, in Willowbrook, IL. Earlier in the year, the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop Sterigenics from sterilizing medical products and other products with the commonly used ethylene oxide a gas due to unacceptable levels of it detected in air around the facility.

“The FDA has been working to quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility in order to mitigate potential product supply issues,” said FDA Commissioner Scott Gottlieb in a statement released yesterday afternoon. “We’re taking steps to prevent patient harm from potential device shortages that could delay or disrupt critical care.”  FDA said nearly half of all medical devices are sterilized with ethylene oxide but   is taking steps to initiate innovative sterilization methods and improvements to current options.

According to the FDA’s Establishment Registration & Device Listing database, Sterigenics listed a total of 594 types of devices that undergo an ethylene oxide sterilization process at the Willowbrook facility and therefore could be affected by the closure. These include products such as sutures, clamps, knives, stents and needles. However, FDA says no shortages have occurred as a result so far. “There’s a risk that for some sterile packaged products that are already in distribution, existing supply may be diminished - or even depleted - as health care facilities use their inventory before alternative arrangements can be made accommodate the sterilization of new products coming off manufacturing lines,” Gottlieb said, adding that it could cause temporary or “spot” shortages.

Another contract sterilizer, Viant, is also closing its Grand Rapids ethylene oxide sterilization later this year for air quality problems cited by the Michigan Department of Environmental Quality. According to the FDA’s Establishment Registration & Device Listing database, Viant listed a total of 46 types of devices that undergo an ethylene oxide process at the Grand Rapids facility which, in the future, could be affected by the closure of the facility. These include devices such as catheters and surgical mesh.

“The FDA is urging medical device manufacturers that use these facilities to begin assessing any potential downstream impacts of the closures on device distribution through their supply chain to end users (such as healthcare facilities), and ultimately on patient care,” Gottlieb stated. “We’re also encouraging medical device manufacturers to consider alternative contract sterilizers that can process their devices. We’ve already communicated the steps manufacturers need to take to make changes to their contract sterilizers and maintain availability of their devices.”

Any user, patient or organization within the supply chain that’s aware of a delay in distribution of new product, and/or anticipates a shortage, can notify FDA via its device shortages mailbox ([email protected]).

FDA is also collaborating with sterilization experts, medical device manufacturers and other government agencies to identify other methods of sterilization that would not produce the same problems as those occurring at the Willowbrook facility.

Gottlieb said FDA is planning a discussion with the infection control community during the May 2019 Healthcare Infection Control Practices Advisory Committee (HICPAC). FDA will also host a public advisory committee meeting later this year to discuss how best to encourage innovation in medical device sterilization, and will later announce a public innovation challenge to encourage development of novel sterilization methods, which could include new devices or new modalities that are safe and effective for sterilizing medical devices.

To help ensure transparency and communication about the use of ethylene oxide in medical device sterilization, FDA also launched a new resource web page, Ethylene Oxide Sterilization for Medical Devices, which the agency said will be updated as new information arrives.