CDRH Warns of Device Supply Issues Following Suspension of Illinois Sterilization Facility

Regulatory NewsRegulatory News | 11 March 2019 |  By 

Citing concerns of increased cancer risks, the Illinois Environmental Protection Agency (EPA) last month issued a seal order to halt any new sterilization cycles using ethylene oxide at a Sterigenics facility in Willowbrook, IL.

“Recent elevated sampling results, along with Sterigenics' refusal to voluntarily suspend operations, have resulted in the issuance of the Seal Order,” the Illinois EPA said.

Sterigenics, meanwhile, said in a statement: “The Illinois EPA’s actions to suspend operations at the Sterigenics Willowbrook facility are indefensible. Sterigenics Willowbrook has consistently complied with all state permits and regulations and Sterigenics has been in ongoing cooperation with the Illinois EPA and other officials regarding the safe operation of the facility.”

Since that order from the Illinois EPA was issued, the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) sent out a message warning that the site’s suspension could lead to widespread shortages of medical devices.

“Medical devices account for over 90 percent 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. At this time, the FDA believes that more than 100 manufacturers and hundreds of devices may be affected,” the agency said.

CDRH added that for premarket approval (PMA) holders affected by the cessation of operations at the Willowbrook facility and with plans to use an alternative facility to sterilize products, “you should submit a 180-day site change supplement. However, the FDA intends to review such PMA supplements within 30 days.” For more, FDA recommends manufacturers see the agency’s guidance on manufacturing site change supplements.

For 510(k) holders planning to use an alternative ethylene oxide sterilization facility, CDRH says “submitting a new 510(k) is typically not required. You should document qualification activities supporting this change in your internal files.” Additional guidance for reference can be found here.

FDA is not the only regulator trying to figure out how this Sterigenics site’s closure will impact device supplies. Health Canada last week reached out to device manufacturers to determine which are affected by the site’s shutdown, and to identify potential impacts on the continued availability of their products.

How to Report a Product Shortage or Supply Issue to FDA


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