Medical device companies across the state are scrambling to prevent product shortages after the abrupt closure of a major plant in Illinois that sterilizes finished medical products.
The Illinois Environmental Protection Agency on Feb. 15 ordered the Sterigenics plant in Willowbrook, Ill., to seal its containers of ethylene oxide (EtO) and stop using the chemical to sterilize devices. Although the gas can be used safely to sterilize medical devices, Illinois regulators said the chemical was being emitted from the factory and creating cancer risks for thousands of people near the plant.
With the plant now idle for two months, litigation is ongoing between Sterigenics and Illinois officials in federal and state court over what happens next.
Meanwhile, device makers with big Twin Cities operations like Medtronic, Boston Scientific, Smiths Medical and Teleflex are faced with the prospect of managing customer demand with existing stock or getting regulatory permission to move sterilization functions to another plant.
Medtronic PLC, run from offices in Fridley, said the decision to close the Willowbrook plant is creating “supply challenges” in its surgical-innovations business, which includes minimally invasive surgical stapling devices, vessel-sealing and wound-closure devices, electrosurgery products, hernia mechanical devices, mesh implants and gynecology products.
“Sterilization is a vital requirement for medical technology, and Sterigenics plays an important role as a source of sterilization to Medtronic and others in this industry,” spokesman Fernando Vivanco said in an e-mail.
All eight members of Minnesota’s U.S. House delegation have signed a letter to the FDA urging the agency to act quickly to prevent shortages of medical devices. The letter noted that it normally takes up to six months to get regulatory approval to change a sterilization source for a medical device production system, but many manufacturers affected have only one or two months’ worth of inventory on hand to meet customer demand.
The lawmakers said the environmental concerns in Willowbrook are “very alarming and should continue to be addressed,” but also note in the letter that the sudden closing of the plant ”is posing significant challenges to the supply of lifesaving medical devices.”
All surgical instruments must be sterilized before touching a patient, to prevent microbes left on the device after manufacturing from infecting patients. But many devices are made of soft plastics and other materials that can’t be treated with heat or radiation, which is why the FDA allows companies to use EtO sterilization instead.
EtO is a colorless gas that has long been produced in industrial quantities for a variety of industries, including for materials manufacturing, agricultural fumigation and sterilization of medical products too delicate to be cleaned through other means, like heat or radiation.
“Unfortunately,” the U.S. Labor Department said, “EtO possesses several physical and health hazards that merit special attention.” Chronic exposure, the department said, “has been associated with the occurrence of cancer, reproductive effects, mutagenic changes, neurotoxicity, and sensitization.”
Sterigenics said that on a typical day, the Willowbrook plant sterilized 200 pallets of medical products, including 1,000 cardiac devices, 1,500 surgical-procedure kits, 16,000 catheters, and thousands of diabetes monitoring and care kits, renal care products, neurological devices and respiratory-care products. A letter from the FDA’s medical device branch said that 90% of the work at the plant is related to medical devices, and the closure affects more than 100 manufacturers of devices.
Minnesota health technology trade group the Medical Alley Association said the effect is especially acute for small and midsize companies, for which the Willowbrook plant was the only qualified and validated sterilization source that could handle their smaller product volumes. Medical Alley CEO Shaye Mandle urged the FDA to consider special measures like expediting new requests for sterilization source approvals.
In the wake of the Willowbrook closure, the FDA said it is working with device companies to help them move to another plant or find another acceptable sterilization method.
“Supply issues can lead to shortages of medical devices — and can pose a threat to public health by delaying or disrupting critical care for patients. Mitigating product supply issues and working to prevent patient harm from device shortages are important to the FDA,” the FDA’s web page on the EtO sterilization states.
Teleflex Medical, which in 2017 acquired Minnesota’s Vascular Solutions, said some of its customers may have to go without certain devices, if suitable substitutes can’t be found and the company can’t get a new sterilization process approved by the FDA in time.
Teleflex sells a wide range of products for vascular and interventional procedures, as well as for cardiac and surgical care, anesthesia, respiratory care, urology and emergency medicine. The company sterilizes about 7 million units of products at Willowbrook annually.
“The unplanned shutdown of the Willowbrook facility will affect Teleflex’s ability to supply hospitals and health care providers with the products described above,” Teleflex global procurement director Gregg Twomey said in a declaration filed as an exhibit to a lawsuit filed by Sterigenics against Illinois environmental officials.
Smiths Medical, which has its operations headquarters in Plymouth, has alerted customers to a disruption affecting many of its Bivona tracheostomy tubes, which are used to create airways in the neck. Smiths Medical declined to comment for this story.
Major Minnesota employer Boston Scientific Corp.’s urology and pelvic-health products division sterilizes devices at the Willowbrook plant. The company advised in a Feb. 19 securities filing that it planned to rely on existing stock while accelerating plans to move to existing sterilization facilities that are already in the company’s supply chain.
In an updated statement, the company said the FDA as of March 28 has granted approval for the company to sterilize its men’s health products at a different location.