FDA publicizes 20 device shortages, 1 discontinuation

Angie Stewart - Print  |

The FDA published a list of medical device shortages and discontinuations that have occurred during the COVID-19 public health emergency.

Five things to know:

1. Under a provision of the Coronavirus Aid, Relief and Economic Security Act, certain device manufacturers are required to notify the FDA of events that could disrupt the supply of a device during the public health emergency, according to the Regulatory Affairs Professionals Society.

2. The CARES Act provision — Section 506J of the Federal Food, Drug and Cosmetic Act — also requires the FDA to maintain lists of these device shortages and discontinuations.

3. The FDA's published shortage list includes 20 different product codes for supplies such as personal protective equipment, testing equipment and ventilation-related products. Shortages for each of the 20 devices reportedly stem from increased demand, and will last for the duration of the crisis.

4. The shortage list notably does not specify the names of the devices in shortage or the names of their manufacturers, as stipulated by the CARES Act. The FDA said naming the devices would increase "the potential for hoarding or other disruptions in device availability to patients."

5. The FDA's discontinuation list has only one entry: Becton Dickinson's BodyGuard infusion pump system, syringe pump system and microsets, which were removed from the market in April after a recall.

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