FDA is warning of a possible shortage of sterilized medical devices — and an accompanying threat to public health — due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide.
Agency officials believe that more than 100 medtech manufacturers and hundreds of devices may be affected by the shutdown. The Illinois Environmental Protection Agency issued an order Feb. 15 to stop the facility from sterilizing medical and other products using ethylene oxide, after the U.S. Center for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry concluded that “an elevated cancer risk exists for residents and off-site workers in the Willowbrook community surrounding the Sterigenics facility,” referencing a “30-fold increase in cancer potency.”
Medical devices account for more than 90% of the products that the Sterigenics Willowbrook facility sterilizes, according to FDA. Sterigenics, which is owned by Sotera Health, called the Illinois EPA’s order “indefensible,” but said it would comply pending legal action.
“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,” the company said in a prepared statement. “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.”
FDA said it is contacting medical device manufacturers to ascertain which companies are affected by the shutdown. The agency added that it is not aware of any device shortages. If one occurs, FDA said it will work to limit or mitigate the impact on patients and also ask unaffected manufacturers to consider whether they can increase production.
In a letter to customers, Sterigenics president Philip Macnabb said the shutdown is already having an impact on healthcare. “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,” Macnabb said. “We will continue to communicate and work with you regarding our available capacity in this evolving situation.”
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.
The company also decried “the false and negative portrayal of our company in the media” and said it is “conducting detailed libel reviews of two major media outlets’ coverage to hold them accountable for their defamatory articles and broadcasts.” It did not identify the media outlets. Print and television news outlets around Chicago have been extensively covering the Willowbrook plant’s troubles.
“Their inaccurate and one-sided reporting damages our hard-earned reputation, puts your business at risk, and more importantly puts patients at risk,” Macnabb added. “We are committed to refuting it and defending the trust and positive reputation that we have rightfully earned in the industry.”
Illinois elected officials have taken action to force stronger federal regulation of sterilization companies, including Sterigenics, according to the Chicago Tribune. Separately, an Illinois state senator and state representative have introduced bills that would force the sterilization industry to phase out the use of ethylene oxide in the state, the newspaper reported.
FDA advised medtech companies whose devices underwent the agency’s premarket approval process and who wish to use another sterilization facility to submit a site-change request. The agency said it would review those requests within 30 days rather than the standard 180 days. Companies whose devices FDA cleared through its 510(k) process and who want to use another ethylene oxide sterilization facility need not submit another 510(k) application, the agency added.
More information from FDA on dealing with medical device shortages is available by emailing Deviceshortages@fda.hhs.gov.
