Regulatory Focus™ > News Articles > 2019 > 3 > FDA Preps for Device Shortages as Another Sterilization Facility Will Close

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Posted 26 March 2019 | By Zachary Brennan 

FDA Preps for Device Shortages as Another Sterilization Facility Will Close

2991 The US Food and Drug Administration (FDA) on Tuesday set up a new website and is preparing several other measures to combat shortages as two major device sterilizing facilities in Illinois and Michigan will shutter.

Both the Sterigenics facility in Willowbrook, IL, which has already closed, and the contract sterilizer Viant’s facility in Grand Rapids, MI, which will close, sterilize devices with ethylene oxide, with which about half of all sterilized medical devices undergo sterilization, FDA said. Devices impacted by the two closures range from wound dressings to more specialized devices, like stents and catheters, as well as kits used in routine hospital procedures or surgeries that include multiple components made of different materials, FDA noted.

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, while there are a total of 46 types of devices for the Viant facility.

“Because of the shutdown of the Sterigenics Willowbrook facility and the planned closing of the Viant Grand Rapids facility, 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 health care facilities), and ultimately on patient care,” FDA said. “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.”

In addition to creating a new website, which FDA said will act as a resource on ethylene oxide sterilization and future actions the agency takes regarding shortages or other activities, the agency also established a device shortages mailbox so that any user, patient or organization that’s aware of a delay in distribution of a product, and/or anticipates a shortage, can notify FDA.

As far as why the Michigan and Illinois sites are closing, Viant said the sterilization facility is “not part of our core business,” while work at Sterigenics’ site was halted by the Illinois Environmental Protection Agency. Questions have been raised about air quality around both facilities, though Sterigenics and Viant have said their sites were compliant.

FDA added: “In view of the concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways of sterilizing medical devices.

“We’ve already started exploring ways we can continue to ensure sterilization processes are safe and effective, and evolving with the current science. This includes considering validation of methods that would support using lower levels of currently-used agents like ethylene oxide gas, thereby reducing environmental exposure risks, while still ensuring effective device sterilization. There may also be ways to employ—and eventually validate—new sterilization agents or processes that don’t come with the same environmental risks but still enable the safe and effective sterilization of devices,” the agency added.

FDA also said it plans to discuss these issues at a May 2019 CDC committee meeting and will host a public advisory committee meeting, to be announced later in 2019, dedicated to discussing innovation in device sterilization.

“In addition, later in 2019, we will 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,” FDA said.


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