Sterigenics Facility Closures Raising Concerns Of Device Shortage Ahead Of FDA Hearing

The medical industry may soon face a shortage of certain sterilized medical devices, following the closure of two sterilization facilities and the potential shut down of a third.

The FDA issued a press release on October 25, urging medical device manufacturers to warn the agency about any future inventory problems that result from the permanent shutdown of a Sterigenics facility in Illinois, and the temporary closure of another Sterigenics plant in Georgia; both of which were leaking high amounts of ethylene oxide, a toxic gas used in medical device sterilization.

In March, the agency warned that the Sterigenics plant in Willowbrook, Illinois was being shut down due to ethylene oxide leaks. Another facility in Michigan was also closed down for similar reasons. In August, Georgia health officials determined similar leaks were occurring at a Sterigenics facility outside of Atlanta. That facility has been temporarily shut down to address the problem.

At about the same time the Georgia investigation was launched, at least 32 complaints were filed in Cook County Circuit Court, in Chicago, alleging cancer caused by the release of ethylene oxide into the air near the Sterigenics Willowbrook facility in Illinois. The cases join 11 other previously filed claims.

This latest press release comes on the heels of an announcement earlier this month that the Willowbrook facility will not be reopening.  It also comes ahead of a policy advisory committee meeting on November 6 and 7 on encouraging innovation in medical device sterilization.

The agency is expressing concern that the closures, as well as the potential closure of a Becton Dickinson sterilization facility, also in Georgia, could result in shortages in the near future, and wants to be warned ahead of time so that it can attempt to address those shortages.

Ethylene oxide is a highly carcinogenic compound, but it is used to sterilize 50% of medical devices that require sterilization, according to the FDA. It is useful for sterilizing devices made of some polymers, metals, glass, or made with multiple layers with hard-to-reach crevices.

“Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices. 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,” the press release warns. “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 warning appears to be aimed in part at state regulators, indicating the agency is concerned that additional closures of the few facilities left in the country may exacerbate the problem. It also calls on manufacturers to notify the FDA if there is a problem before it gets out of hand, suggesting the agency may be able to assist.

The Sterigenics leaks in Georgia were only discovered after a newspaper investigation tipped off state regulators. And critics have accused Sterigenics of knowing about the leaks and trying to hide them.

The FDA is calling on device manufacturers and health care providers to warn the agency on potential shortages before they happen. The agency can be notified by users, patients, manufacturers, or anyone within the supply chain of a problem through its device shortages mailbox.