EMERGO BY UL SUMMARY OF KEY POINTS:

• US FDA identifies more than 600 medical device types potentially impacted by closures of two sterilization facilities;
• FDA has launched a notification system whereby device manufacturers and users may notify the agency of any shortages or related supply issues stemming from sterilization facility shutdowns.
• Facility closures demonstrate the need for developing new and improved sterilization methods for devices.

The US Food and Drug Administration has identified nearly 600 types of medical devices possibly impacted by the recent shutdown of a sterilization facility in the midwestern US, and states that a second sterilization facility will also close this year.

According to a recent statement from FDA, 594 types of devices are listed in the agency’s Establishment Registration & Device Listing database as undergoing sterilization at the Sterigenics facility in Illinois; manufacturers of these devices may need to find alternative sterilization providers in light of the Sterigenics facility closure, ordered by the Illinois state government due to environmental issues related to the firm’s use of ethylene oxide in its sterilization process.

Device types previously undergoing sterilization at Sterigenics in Illinois include sutures, knives, needles, clamps and stents.

Next steps for FDA and affected manufacturers

Challenges stemming from the Sterigenics closure may soon be compounded by the shutdown of another contract sterilizer’s facility in Michigan, Viant, scheduled for later in 2019 because of similar ethylene oxide-related environmental concerns. FDA has identified 46 additional device types including catheters and surgical meshes that undergo sterilization at the Viant facility.

US regulators have begun efforts to identify alternative sterilization facilities for manufacturers affected by the Sterigenics and pending Viant closures. FDA is also recommending that companies consider how these closures could impact their distribution and supply chains as well as patient care.

Preparing for potential device shortages

Following FDA’s regulatory-related recommendations for affected manufacturers that need to change contract sterilization partnerships, the agency has set up a “device shortages mailbox” to receive notifications of any device supply delays or shortages from  manufacturers, patients and users. The regulator may also move to allow availability of affected device types from other sources if necessary.

Rethinking medical device sterilization

 FDA notes that about half of all devices undergoing sterilization in order to be legally marketed in the US are sterilized using ethylene oxide. Given the prospect that more facilities utilizing ethylene oxide sterilization techniques may run afoul of environmental regulators as Sterigenics and Viant have, the agency is collaborating with stakeholders to develop “new and improved” sterilization methods.

Specifically, FDA is looking at validating sterilization methods that use lower levels of ethylene oxide to reduce environmental impact, as well as new sterilization agents that pose lower environmental risks.

Related US FDA medical device regulatory resources:

• Medical device sterilization and cleaning validation
• Whitepaper: ISO 11135:2014 and medical device sterilization