The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third.
Potentially affected surgical kits include those used in emergency Caesarean sections and other emergency surgeries, and in routine procedures such as cardiac surgery and hip or knee replacement surgeries, the agency said. Other devices that could go into short supply include feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices.
The Environmental Protection Agency considers EO a carcinogen and is expected to update its regulations of the gas by March 2020. Meanwhile, the state of Illinois tightened its regulations in June and now Georgia officials will look into strengthening their own, that state’s Environmental Protection Division (EPD) said recently. Georgia is seeking a temporary restraining order to close a Becton Dickinson (NYSE:BDX) EO plant in Covington, Ga., where a leak of 54.5 lbs. of the gas went undetected for eight days in September. BD pledged in August to install $8 million worth of emissions-control equipment at its two Georgia EO plants, but the state alleges the company has been dragging its feet.
“It’s important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices,” acting FDA Commissioner Dr. Ned Sharpless said in today’s statement. “In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.”
The FDA first warned of device shortages after state officials temporarily shut down a large EO plant in Willowbrook, Ill. in February over concerns about excess emissions. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. A brief shortage of Bivona neonatal feeding tubes made by Smiths Medical tubes ensued, but the FDA said it helped the company find another sterilizer.
In April, officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) advised customers that certain devices were already in short supply or may experience shortages. Teleflex (NYSE:TFX), which had seven million devices sterilized per year at the Willowbrook plant, warned of shortages as well.
EO is used to sterilize about 50% of all devices sold in the U.S. that require sterilization — more than 20 billion medical devices per year, according to today’s FDA statement. It is a preferred sterilant for devices made from certain polymers (such as plastic or resin), metals, or glass, and devices that have multiple layers of packaging or hard-to-reach crevices, because it has better penetration properties than other methods and is unlikely to damage products during the process.
“Because the number of ethylene oxide contract sterilization facilities in the U.S. is limited, 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,” Sharpless said. “The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care.”
Some large medtech companies sterilize their own devices, but many smaller ones contract out for that service. The FDA urged manufacturers that use EO contract facilities to assess their inventory for any potential downstream impacts of sterilization facility closures on their product distribution.
“We are committed to working with manufacturers to look for alternative sterilization options,” Sharpless said. “When manufacturers keep the FDA apprised of progress and obstacles encountered, it helps ensure that everyone’s best efforts are being made to mitigate any shortages and prevent potential shortages. When U.S. manufacturers are not able to resolve a shortage and it involves a critical device needed for U.S. patients, the FDA 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 healthcare facilities to inventory critical medical supplies that undergo contract terminal EO sterilization and seek the agency’s help in identifying sources of potential substitute devices. It also urged hospitals and clinics not to hoard such devices or try to buy larger quantities than normal, but to email the agency’s shortages mailbox (email@example.com) if they run into shortages or are concerned about the adequacy of medical devices to meet patient needs.
In July, the FDA issued a pair of innovation challenges to identify alternatives to EO and measures to reduce EO emissions. It is planning a public advisory committee meeting Nov. 6-7 to discuss how best to encourage innovation in medtech sterilization.
“We want to be clear that we understand that there are very real consequences that medical device shortages have on patients, and we’re committed to doing everything in our authority to help mitigate the adverse patient impact these sterilization facility closures are expected to have,” Sharpless said. “We’re also calling on all stakeholders — manufacturers, contract sterilizers, government agencies and other public health advocates — to join us and do your part to avert new device shortages and ensure patients have access to important and life-saving medical devices.”