Providers could face shortages as sterilization facilities close

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Ben Comer Senior Manager, Health Research Institute, PwC US November 01, 2019


The controversial closures of device sterilization facilities in Illinois and Georgia have prompted worries about shortages of critical medical devices, including those used in emergency C-sections, cardiac surgeries, and hip and knee replacements, according to the FDA. One of the facility closures has already led to a brief shortage of pediatric breathing tubes, according to the agency.

The controversy revolves around large facilities that use ethylene oxide, an air pollutant, to sterilize 20 billion medical devices in the US each year, or about half of all devices that require sterilization, according to the FDA. The closures of facilities in Illinois and Georgia were prompted by community outcry about ethylene oxide emissions. The FDA says there are no good alternatives to using the compound to sterilize devices.

“Because the number of ethylene oxide contract sterilization facilities in the US 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,” Dr. Norman Sharpless, the FDA’s acting commissioner, wrote in an Oct. 25 statement. “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.”

HRI impact analysis

Healthcare providers may find supplies of critical devices running low as the sterilization facility closures persist. The FDA said in its statement that it anticipates national shortages of some devices, including “feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices.”

The agency is asking medical device makers to work with it to understand which devices might be most at risk of shortages. It also noted that it may try to find alternative suppliers of devices for providers if necessary.

Providers, the agency said, should start examining their supplies, plan for shortages and reach out to the FDA for help identifying substitutes. The agency also warned against hoarding, admonishing facilities to “work together” and not try to buy up large quantities in anticipation of low supply.

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Trine K. Tsouderos

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Ben Comer

Senior Manager, Health Research Institute, PwC US

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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