FDA Warns of National Shortage of Devices Due to Closures of Ethylene Oxide Sterilization Facilities
The FDA said Oct. 25 that it anticipates a national shortage of some medical devices — including surgical kits, feeding tubes used in neonatal intensive care units, drug-eluting cardiac stents, catheters and shunts — in the wake of recent and potential closures of facilities that use ethylene oxide to sterilize the products.
Since February 2019, two major sterilization facilities — one in Illinois and one in Georgia — have closed due to state environmental regulators’ concerns about ethylene oxide emissions from the facilities. Another facility in Georgia has been closed since August due to ongoing construction aimed at reducing ethylene oxide emissions. Also, a facility in Michigan will stop its use of ethylene oxide to sterilize devices by Dec. 31.
Meanwhile, stakeholders are weighing in against proposed legislation in Illinois that would phase in additional ethylene oxide emission restrictions.
Environmental concerns related to ethylene oxide have intensified since August 2018, when the U.S. Environmental Protection Agency (EPA) issued a National Air Toxics Assessment (NATA) that identified the chemical as “a potential concern in several areas of the country.”
Long-term and occupational exposure to ethylene oxide has been linked to various forms of cancer as well as to brain and nervous system damage, and the substance can irritate the eyes, skin, nose, throat and lungs.
About half of the devices that require sterilization — in all, 20 billion devices sold in the United States annually — are sterilized using ethylene oxide. In July 2019, the FDA issued two public innovation challenges aimed at identifying possible alternative device sterilization methods and reducing emissions of ethylene oxide.
In an Oct. 25 statement, Acting Commissioner of Food and Drugs Dr. Norman E. Sharpless alerted the public to “growing concerns about the future availability of sterile medical devices and impending medical device shortages.”
In particular, Sharpless raised concerns about possible shortages of devices made from metal, glass or certain polymers, such as plastic or resin, as well as devices that have multiple layers of packaging or hard-to-reach crevices. These devices, he said, are more likely than others to be sterilized with ethylene oxide because of the potential for product damage if other sterilization techniques are used.
These devices include surgical kits used in emergency procedures, including emergency C-sections, as well as in routine procedures such as cardiac surgery and hip or knee replacements.
“There are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices,” Sharpless said. “This method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”
In his statement, Sharpless outlined the closing of several ethylene oxide contract sterilization facilities, including the closing of two facilities operated by Sterigenics U.S. L.L.C.:
- Sterigenics’ Willowbrook, Ill., facility was ordered to stop sterilizing devices and other products with ethylene oxide by the Illinois EPA in February 2019 because levels of the substance in the air around the facility were higher than acceptable. The closure led to a temporary shortage of pediatric breathing tubes, according to the FDA. Sterigenics announced Sept. 30 that it was abandoning efforts to reopen the facility, citing an “unstable legislative and regulatory landscape.”
- A second Sterigenics plant, located in Atlanta, has been shuttered since August while it is being renovated to reduce ethylene oxide emissions.
In addition, the Environmental Protection Division of Georgia’s Department of Natural Resources has scrutinized a Becton, Dickinson and Co. sterilization facility in Covington, Ga. A valve leak at the facility in September allowed 54.5 pounds of ethylene oxide to be released into the air. The state alleged that the leak was caused by “a lack of diligence and prolonged operator error rather than an equipment malfunction.” On Oct. 21, the state filed a complaint and a motion for a temporary restraining order in Newton County Superior Court, seeking to enjoin the company from operating the facility until the company implemented emission control improvements. On Oct. 28, the company agreed to close the plant for eight days. The facility was to reopen Nov. 7 and to operate at reduced capacity while “certain operational modifications” to cut emissions were implemented.
A sterilization facility operated by Viant Medical Inc. in Grand Rapids, Mich., is also slated to close after the company received a series of violation notices issued by the Michigan Department of Environment, Great Lakes and Energy’s Air Quality Division. The agency accused the company of violating state and federal regulations, violating the requirements specified in the company’s air permit and failing to conduct timely stack testing. Under the terms of a proposed consent order, the company agreed to shut down its sterilization activities at the facility by the end of 2019 and to pay a $110,000 penalty to the state. A hearing on the proposed consent order was scheduled for November.
“Because the number of ethylene oxide contract sterilization facilities in the U.S. is limited,” Sharpless said, “we are very concerned that additional facility closures could severely impact the supply of sterile medical devices to health care delivery organizations that depend on those devices to take care of patients.”
He added that the impact of past and possible future sterilization facility closures “will be difficult to reverse, and ultimately could result in years of spot or national shortages of critical medical devices.”
Suggestions for Manufacturers, Health Care Facilities
The FDA called for device manufacturers that use ethylene oxide sterilization facilities to assess their inventories “for any potential downstream impacts of sterilization facility closures on their product distribution.” If a manufacturer cannot resolve a shortage that involves “a critical device needed for U.S. patients,” Sharpless said, the agency “may look for a firm that is willing and able to redirect safe and effective product into the U.S. market to address a shortage.”
The agency also encouraged health care facilities to inventory “critical” medical supplies and to ask for the FDA’s help if needed to identify sources of potential substitute devices. “Hospitals and other health care delivery organizations should also work with their purchasing departments, group purchasing organizations and distributors, as appropriate, to help obtain product needed for patient care,” Sharpless said. He also urged health care facilities not to hoard devices and not to try to purchase larger quantities of devices “beyond their normal purchase volume.”
Both manufacturers and health care facilities should provide the FDA with information about potential supply issues, the agency said. Sharpless noted that “any user, patient, manufacturer or organization within the supply chain that is aware of a delay in distribution of new product and/or anticipates a shortage” can notify the agency about the situation. The FDA maintains a device shortages mailbox at email@example.com. Potential device shortages also can be reported at 1-888-INFOFDA or 301-796-3400.
“We continue to communicate directly with manufacturers and monitor the supply of devices sterilized in facilities that have closed or that may close,” Sharpless said, “paying special attention to life-saving, life-sustaining, and other critical devices.” For example, he reported, the FDA expedited a sterilization site change for Smiths Medical Bivona tracheostomy breathing tubes that previously were sterilized at the Sterigenics facility in Illinois.
In addition, the FDA scheduled a public advisory committee meeting for Nov. 6-7 to consider “how best to encourage innovation in medical device sterilization.”
AdvaMed, State Association Warnings
In an Oct. 25 statement, the Advanced Medical Technology Association (AdvaMed) also warned that “critical medical devices might not make it into doctors’ and surgeons’ hands if we aren’t careful as we have this important conversation about the true risk of [ethylene oxide] sterilization plants.”
“We absolutely understand why those who live around these plants are deeply concerned based on what they’ve heard and read,” said AdvaMed President and Chief Executive Officer Scott Whitaker. “But leading toxicologists and epidemiologists are certain that media reports have been misleading, and that the communities surrounding these plants are safe. These experts need to be a much bigger part of the conversation within these neighborhoods and with policymakers.”
In addition, 15 state medical technology associations issued a statement warning that the closure of sterilization facilities “will disrupt the health care supply chain in every state and territory in the U.S.,” depriving “millions of patients” of critical medical treatments.
On Oct. 17, AdvaMed also warned against the possible shutdown of Medline Industries Inc.’s ethylene oxide sterilization plant in Waukegan, Ill. The association’s statement came as the Illinois House Energy and Environment Committee considered legislation that would impose additional ethylene oxide emission limitations on sterilization facilities, hospitals and other facilities. Medela L.L.C., an Illinois-based manufacturer of sterile breast milk pumping kits and other devices used in neonatal health care facilities, said that it opposed the legislation because it “would led to the inevitable elimination of [ethylene oxide] sterilization in the state and will likely lead to further restrictions in other states.”