A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements.
The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. The FDA said it isn’t aware of any device shortages attributable to the Willowbrook facility closure but that existing supplies could be diminished or depleted, leading to spot shortages.
Later this year, Viant will close a plant that uses ethylene oxide to sterilize medical devices in Grand Rapids, Mich., because, as it told nearby residents in a letter dated March 4, “that work is not part of our core business.” The Viant plant sterilizes 46 types of devices, including catheters and surgical mesh, according to the FDA. Viant had self-reported an ethylene oxide leak to the Michigan Department of Environmental Quality (MDEQ) in 2017. The department issued a violation to Viant then and another following an MDEQ inspection in November 2018.
Medplast changed its name to Viant in July 2018 after it acquired Integer’s advanced surgical and orthopedics products lines for $600 million in cash. Medplast acquired the plant in 2015, and only 12 of its 450 employees in Grand Rapids work there, the company letter said.
“Because of the shutdown of the Sterigenics Willowbrook facility and the planned closing of the Viant Grand Rapids facility, the FDA is urging medical device manufacturers that use these facilities to begin assessing any potential downstream impacts of the closures on device distribution through their supply chain to end users (such as health care facilities), and ultimately on patient care,” FDA commissioner Dr. Scott Gottlieb said in a statement issued today. “We’re also encouraging medical device manufacturers to consider alternative contract sterilizers that can process their devices. We’ve already communicated the steps manufacturers need to take to make changes to their contract sterilizers and maintain availability of their devices. We’re committed to working closely with manufacturers to expedite our review of any site change submissions to ensure they can efficiently switch to other contract sterilizer facilities while still ensuring safe and effective sterilization of their devices.”
Gottlieb said the FDA is closely monitoring the situation and is ready to act quickly to limit the impact of device supply interruptions on patients, including making devices available from other sources. It has established a device shortages mailbox for any user, patient or organization in the supply chain that’s aware of a delay in distribution of a product, and/or anticipates a shortage, to notify the agency. Messages may be emailed to deviceshortages@fda.hhs.gov. It also established a new web page about ethylene oxide sterilization for medical devices.
The FDA is working with sterilization experts, medtech manufacturers and other government agencies to identify new ways to sterilize medical devices “that don’t raise the same concerns as those identified at the Willowbrook facility,” Gottlieb’s statement said. “About half of all sterilized medical devices undergo sterilization using ethylene oxide. In view of the concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways of sterilizing medical devices.”
The FDA will discuss alternative sterilization methods with infection control experts at the Centers for Disease Control and Prevention’s (CDC) Healthcare Infection Control Practices Advisory Committee in May. The agency also plans to hold a public advisory committee meeting later this year on encouraging innovation in medical device sterilization. Later in 2019, the FDA will announce a public innovation challenge to encourage the development of novel sterilization methods.
FDA officials said earlier this month that more than 100 medtech manufacturers and hundreds of devices may be affected by the Willowbrook plant 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 CDC’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.”
A Viant spokeswoman declined to comment beyond what the company said in its letter.
