FDA warns of critical medical device shortages

Hospitals could soon face shortages of critical medical devices due to the closures of several sterilization plants, the FDA warned Oct. 25.

Two Sterigenics facilities in Illinois and Georgia closed earlier this year and another plant in Georgia may close as Gov. Brian Kemp is seeking a temporary injunction against it.

All of the closures were due to concerns that ethylene oxide, the most commonly used chemical to sterilize medical devices, causes cancer.

There are no alternatives to ethylene oxide sterilization, which the FDA calls "a well-established, scientifically-proven method of preventing harmful microorganisms from reproducing and causing infections.

Because ethylene oxide is used to sterilize more than half of the medical devices on the market, shutting down plants that use the chemical would create a shortage that would be "difficult to reverse."

"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," the FDA wrote.

Without ethylene oxide sterilization, the FDA said to expect a national shortage of devices including feeding tubes used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices.

The FDA is urging medical devicemakers that use ethylene oxide facilities to assess their inventory for any potential effects of sterilization facility closures on their product distribution. The agency is also encouraging healthcare facilities to perform similar inventory assessments of critical medical supplies that are sterilized at ethylene oxide facilities and reach out to the FDA for assistance in locating any possible alternative sources.

"Hospitals and other healthcare delivery organizations should also work with their purchasing departments, group purchasing organizations and distributors, as appropriate, to help obtain product needed for patient care," the FDA wrote. "So as to not exacerbate anticipated product availability concerns, we urge facilities to work together and not hoard product or attempt to purchase larger quantities of devices beyond their normal purchase volume."

Read the full news release here.

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