Facility Closure Leads to FDA Statement About Possible Device Shortage

facility closure

Three facilities temporarily unavailable

The recent closure of an ethylene oxide sterilization facility in Illinois was quickly followed by the temporary and potential closure of two more large facilities in Georgia – a Sterigenic facility closing temporarily, with a Becton Dickerson sterilization facility potentially to follow. Concerns about future device availability and possible shortages led the FDA’s acting commissioner to make a statement.

“[The closures] could affect the availability of some sterile medical devices used by health care delivery organizations and patients. We have been working diligently with impacted device manufacturers and health care delivery organizations to ensure that they are aware of these developments and preparing to minimize adverse effects on patients whose care could be negatively affected if medical devices sterilized at these large facilities were not accessible,” said Norman E. “Ned” Sharpless, MD.

“In light of the possibility of continued ethylene oxide sterilization facility closures, we are again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.”

Ethylene oxide is the most effective and thus, most widely practiced means of sterilizing medical devices in the United States. A widely proven means of preventing harmful organisms from causing infections, more than 20 billion devices sold in the U.S. every year are sterilized with ethylene oxide, accounting for approximately 50 percent of devices that require sterilization.

“Medical devices made from certain polymers, metals, or glass—or devices that have multiple layers of packaging or hard-to-reach crevices—are likely to be sterilized with ethylene oxide to avoid product damage during the process,” Sharpless continued. “Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices.”

The FDA suggests hospitals contact the agency with potential shortage information.


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