These Are the Medical Devices in Short Supply During Pandemic, FDA Says

The Food and Drug Administration (FDA) released a list of medical devices that are in short supply amid the COVID-19 pandemic on Friday.

The list shows 20 items that are in short supply; the type of item it is; the reason for interrupting; the estimated length of the shortage; and availability. Most of the items on the list are available in limited supplies and the shortages are expected to last for "the duration of the COVID-19 [Public Health Emergency]."

Almost all items cite a "demand increase for the device" as the reason for the shortage, except for surgical apparel, which also lists "Delay in shipping of the device" and "Shortage or discontinuances of a component or part."

The shortage list breaks down the short supply items into three categories: personal protective equipment (PPE), ventilation-related products, and testing supplies and equipment. Next to each product code, the FDA describes what the product is.

The following PPE items are on the device shortage list:

  • Examination gown
  • Surgical apparel
  • Surgical gown
  • Latex, non-powdered patient examination glove
  • Vinyl patient examination glove
  • Polymer, non-powdered patient examination glove
  • Specialty, non-powdered patient examination glove
  • Surgical respirator
  • Non-surgical isolation gown

The following testing supplies and equipment are on the list:

  • Clinical sample concentrator
  • Transport culture medium
  • Sterile swabs
  • Microbiological specimen collection and transport device
  • Instrumentation for clinical multiplex test systems
  • Real time nucleic acid amplification system
  • General purpose reagents for in vitro diagnostic tests
  • Microbial nucleic acid storage and stabilization device

The following ventilation-related products are on the list:

  • Non-continuous ventilator
  • Continuous ventilator, facility use
  • Continuous ventilator, home use

Before listing the items that are in short supply, the FDA wrote that it was working to make sure that patients and medical professionals had access to necessary medical equipment amid the coronavirus pandemic. The agency said that it was "issuing Emergency Use Authorizations (EUAs) and guidance documents to provide recommendations and help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 public health emergency." It said that it would keep tabs on medical devices for further information regarding the shortages.

The FDA also said that the CARES Act provided the agency with authority to prevent future shortages. The act requires manufacturers to notify the FDA if there's a "permanent discontinuance" of an item or if manufacturing gets interrupted.

Besides the list of medical supplies that have experienced shortages, the FDA also has a list of products that have been discontinued, which only lists two items. Both are infusion pumps made by Becton Dickinson and Company, one of which is a patient-controlled analgesic.

Media contacts for the FDA did not respond to Newsweek's emailed request for comment in time for publication.

PPE
A healthcare worker uses a swab to collect a sample from a man at a temporary testing centre for the novel coronavirus in Spanish Basque city of Azpeitia on August 15, 2020 following a new outbreak in the city. The FDA released a list of medical supplies that are in short supply in the U.S. during the COVID-19 pandemic. ANDER GILLENEA / AFP/Getty
These Are the Medical Devices in Short Supply During Pandemic, FDA Says | U.S.