Medical device shortage possible due to Sterigenics plant shutdown

The Illinois Environmental Protection Agency has shut down the Sterigenics plant in Willowbrook on suspicion of links to ethylene oxide emissions after the U.S. Center for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry said “an elevated cancer risk exists for residents and off-site workers in the Willowbrook community surrounding the Sterigenics facility.” Over 90% of the products sterilised at the Sterigenics Willowbrook facility are medical devices, and the FDA has highlighted the risk to public health due to a potential shortage thereof, with the potential for over 100 medtech manufacturers and hundreds of devices to be affected by the shutdown. Sterigenics said it is seeking a preliminary injunction against the Illinois EPA, with a hearing on the matter scheduled for April 9 in U.S. District Court.

A Sterigenics statement read: “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. Unilaterally preventing a business that is operating in compliance with all state permits and regulations from carrying out its vital function sets a dangerous precedent. The Illinois EPA’s decision will place the health and lives of thousands of patients who rely on the critical medical products sterilized at Willowbrook at risk.”

Philip Macnabb, Sterigenics president, said: “While we are working closely with our customers to minimize the impact on the supply chain, we are not able to serve all of our customers’ needs at this time. We will continue to communicate and work with you regarding our available capacity in this evolving situation.”