Brenda Goodman is a senior news writer for WebMD. Andy Miller is editor and CEO of Georgia Health News.
Oct. 28, 2019 -- Medical device makers and federal regulators are on edge after the closure of two major sterilization facilities and the potential shuttering of a third next week.
They’re warning of potential shortages of medical devices if a court allows the state of Georgia to temporarily shut down sterilization operations of a Becton Dickinson, or BD, facility in suburban Atlanta. Georgia’s attorney general asked a judge to grant a temporary restraining order and an injunction to shut the BD facility down until it can upgrade its pollution controls.
On Monday, the state announced it had reached an agreement with BD that would allow the facility to close for just a week and then reopen with a reduced production schedule.
“It's kind of like a tipping point right now. If there were to be any more closures, then the likelihood is we will not only see spot or local shortages, it will have a ripple effect nationally,” says Suzanne Schwartz, MD, the acting director of the Office of Strategic Partnerships & Technology Innovation at the FDA’s Center for Devices and Radiological Health.
The FDA said in a statement Friday there may be medical device shortages if ethylene oxide sterilization is taken offline too quickly in the U.S.
“The FDA recognizes that there are concerns associated with the release of ethylene oxide into the environment if emissions were to occur at unsafe levels,” the statement says. It also says the FDA has launched two innovation challenges to look for other ways of bulk sterilization and also to cut emissions from the ethylene oxide sterilization process. The agency is holding public meetings in November to discuss ethylene oxide sterilization.
The statement says that since the closures of two large Sterigenics sterilization facilities -- one in Willowbrook, IL, and another in Cobb County, GA -- the FDA has been working behind the scenes to lessen effects on patients. Those plants, along with the BD plant in Georgia and many others around the country, use a gas called ethylene oxide to sterilize products.
After the U.S. Environmental Protection Agency (EPA) last year found ethylene oxide to be much more toxic than previously known, communities and governments in Illinois, Georgia, and other states began to investigate plants in their area. Where emissions are higher than the EPA’s recommended limits, protests and court actions have followed.
Last year, the federal agency identified 109 census tracts that have a higher risk of cancer from air pollution, mostly driven by ethylene oxide.
Two of those tracts are near the Cobb County Sterigenics plant, and another is in Covington, GA, the site of the BD facility.
Independent air testing in September found high levels of ethylene oxide in areas near the BD plant in Covington.
Cobb County’s government has told Sterigenics that it must upgrade its safety and pollution controls before it can reopen.
Schwartz says there are no device shortages now. But, she says, the FDA has heard from about a dozen medical device companies with low inventory of sterilized devices that say they don’t have anywhere they can go. “They tend to be smaller manufacturers and start-ups,” she says. If Sterigenics in Georgia doesn’t reopen, she says, “they are kind of out of commission.”
Schwartz says a team at the Center for Devices and Radiological Health has been compiling a database of products that could substitute for those sterilized by ethylene oxide if they suddenly are not available because of plant closures.
But she admits the agency has had its hands tied, to a degree, because device makers are not required to report shortages to the FDA, as drugmakers are.
Schwartz says the agency has requested new authority to require those kinds of notifications, but Congress would have to pass a bill to grant it.
In the meantime, the FDA is relying on manufactures to self-report shortages. Some companies are reluctant to do that because they don’t want to lose a competitive advantage, she says.
One thing she says people don’t understand is that manufacturers can’t simply ship a device sterilized by ethylene oxide to a different ethylene oxide facility. Such as switch requires a review and approval by the FDA.
The agency has agreed to fast-track sterilization site changes for class III medical devices -- those intended to sustain or support life -- cutting their review of those changes from 180 days to just 30 days.
Katherine Watson, a spokeswoman for Northside Hospital in Atlanta, said Friday that her health system is aware of the device warning situation and “is tracking these developments and continues to evaluate any potential implications.’’
Changing the method used for sterilizing a device -- from ethylene oxide to gamma radiation, for example -- is even harder. Those kinds of changes require several months of study and a careful review to make sure the device isn’t harmed by the new process.
Jeff Sauter, director of business development for Steri-Tek in Castro Valley, CA, which uses e-beam and X-ray radiation for sterilization, says some companies are exploring exactly that difficult and expensive switch.
“There are companies scrambling. It’s a big deal -- a big, big deal,” he says of the Sterigenics closures.
Sauter says the closures of sterilization facilities in Illinois and Georgia are creating major disruption in the industry, and one that was probably overdue.
“There has not been a big driver to create better technology,” he says. “Now, with these emissions, it’s coming to the fore.”
“A lot of companies are now rethinking their sterilization strategies,” Sauter says. “It had to come to this point of a crisis. Now it’s a crisis.”