Temporary Facility Closure Leads to FDA Efforts to Mitigate Breathing Tube Shortage

Part of new agency commitment to keeping public informed promptly

As part of the FDA’s ongoing efforts to minimize impacts of medical product shortages, last month the agency alerted the public of the potential for medical device shortages to arise from the closure of a large ethylene oxide sterilization facility in Willowbrook, Illinois, plus a future planned closure of a similar facility in Michigan.

Since the announcement of the closure, the agency has been taking steps to prevent patient harm from potential device shortages that could delay or disrupt critical care, including working to quickly and proactively secure alternative locations and methods for the sterilization of devices that were previously processed at the Willowbrook facility.

As a result, a recent FDA release alerted health care professionals of a shortage of a tracheostomy tube manufactured by Smiths Medical. The release expressed optimism that the shortage could be resolved by the end of this month.

During the shortage, health care professionals with patients urgently in need of a new tube are urged to contact the manufacturer directly.

“We recognize the very real consequences that medical device shortages have on patients,” the release concluded. “We’ll continue to work directly with manufacturers, contract sterilizers, government agencies and other public health stakeholders to do all we can to avert new device shortages.”

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