Better late than never: FDA releases medical device shortage list

por Valerie Dimond, Contributing Reporter | August 17, 2020
Business Affairs
FDA headquarters in Silver Spring, MD
The Food and Drug Administration (FDA) has announced the release of a new device shortage list to inform the public about the disruption of manufacturing and/or delivery of specific categories of medical equipment during the COVID-19 public health emergency (PHE).

In late March, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was passed, which includes section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requiring manufacturers of certain devices to notify the FDA of any interruption or permanent discontinuance in manufacturing.

At that time the FDA said it was not aware of specific widespread shortages of medical devices, although they did say the reports from the Centers for Disease Control and Prevention CDC and partners were noting increased ordering of medical products the U.S. in preparation for increased need if the outbreak became severe—which it did.

Now, as of August 14, 20 specific device shortages have been listed within three categories: personal protective equipment, testing supplies and equipment, and ventilation-related products. Infusion pumps and related accessories are listed on the discontinuance list.

Increased demand is the main reason for disruptions in all categories, however, surgical apparel supplies are also facing disruptions caused by shipping delays. FDA says the aim is to give transparency to the public and stakeholders about device shortages and permanent discontinuations, although the names of those manufacturers will be withheld.

“Disclosure of the manufacturer’s name [in regard to] the devices determined to be in shortage during the COVID-19 PHE will adversely affect the public health by increasing the potential for hoarding or other disruptions in device availability to patients,” said the agency in a news release. “FDA is monitoring the medical product supply chain and working closely with manufacturers and other stakeholders to evaluate the risk of disruptions and to prevent or reduce their impact on patients, health care providers, and the health of the public at large.”

In response to current shortages, FDA is using its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives. Some of those EUAs include non-NIOSH approved PPE products, respiratory assist devices, ventilator accessories, and more.

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