EMERGO BY UL SUMMARY OF KEY POINTS:

• The shutdown of a Sterigenics medical device sterilization facility in the midwestern US may disrupt supplies of hundreds of devices, according to US FDA and Health Canada.
• US and Canadian regulators have issues recommendations for manufacturers seeking alternative sterilization sites for their devices.
• Changing sterilization facility sites may affect manufacturers’ current FDA and/or Health Canada registrations.

Medical device regulators in the US and Canada are both investigating whether the recent shuttering of a sterilization facility in Illinois due to environmental concerns may impact supplies of devices, and have provided recommendations for affected manufacturers in need of new sterilization sites.

According to a notice from US FDA’s Center for Devices and Radiological Health (CDRH), the Illinois state government’s order that the Sterigenics Willowbrook Facility cease sterilization processes using ethylene oxide may impact more than 100 device manufacturers and “hundreds” of devices.

US FDA recommendations for affected manufacturers

FDA’s CDRH office has provided the following recommendations for moderate- and high-risk device manufacturers affected by the Sterigenics shutdown:

• Premarket Approval (PMA) holders that have already identified alternative sterilization providers must provide 180-day site change supplements to FDA; the agency will review these submissions within 30 days, and recommends that firms refer to its final guidance on manufacturing site change supplement content and submission.
• 510(k) premarket notification holders that plan to use alternative ethylene oxide sterilization sites should document qualification activities in their internal files. Although manufacturers likely do not have to submit new 510(k)s for affected devices, FDA recommends referencing guidance on determining when new premarket notification applications should be submitted to the agency.
• Manufacturers anticipating device shortage issues due to the Sterigenics closure should follow FDA’s guidelines for reporting potential supply disruptions.

Health Canada recommendations for MDL, MDEL holders

Health Canada has issued a request that any affected manufacturers licensed to sell their devices in Canada via Medical Device License (MDL) or Medical Device Establishment License (MDEL) notify the regulator’s Regulatory Operations and Enforcement Branch via email. Emails should include information on specific issues stemming from the Sterigenics facility shutdown.

Furthermore, Health Canada noted in its request to manufacturers that changing sterilization facility partners may constitute a significant change, which requires pre-market approval in Canada. Although facility changes in and of themselves would not typically fall under significant change rules, such changes in facilities should nonetheless be documented in manufacturers’ annual license renewal reports. Affected companies should also refer to Health Canada’s guidance on significant changes to medical devices.

Emergo by UL will provide updates on the Sterigenics situation as we learn them.

Related US FDA and Health Canada medical device regulatory resources:

• Medical device sterilization and cleaning validation support
• US FDA 510(k) consulting for medical devices and IVDs
• Health Canada MDL and MDL registration consulting
• Whitepaper: FDA 510(k) requirements for devices labeled sterile
• Whitepaper: ISO 11135:2014 and medical device sterilization