FDA: Some types of PPE in low supply in the U.S.

By Melissa Busch, DrBicuspid.com assistant editor

August 24, 2020 -- The U.S. Food and Drug Administration (FDA), which is tasked with monitoring supply chains during public health emergencies, has announced that supplies of personal protective equipment (PPE), including surgical respirators, are limited due to the pandemic.

The agency listed the following items as limited as of August 14:

  • Examination gowns
  • Surgical apparel
  • Surgical gowns
  • Surgical respirators
  • Latex, nonpowdered patient exam gloves
  • Vinyl patient exam gloves
  • Polymer, nonpowdered patient exam gloves
  • Specialty, nonpowdered patient exam gloves

Supplies are limited for all items due to an increase in demand during the pandemic. Surgical apparel supplies are also down due to a delay in shipping and a shortage or discontinuation of a component. Shortages are estimated to continue throughout the duration of the COVID-19 public health emergency, according to the agency.

The Coronavirus Aid, Relief, and Economic Security (CARES) Act, which was signed into law on March 27, added a section to the Federal Food, Drug, and Cosmetic Act, giving the agency the authority to help prevent or mitigate medical device shortages during or in advance of a public health emergency. The provision also requires manufacturers of these specific devices to notify the agency when an interruption in the manufacture of the device may lead to a "meaningful disruption" in supply of that product in the U.S. Furthermore, the new law requires the FDA to keep an up-to-date list of the items that may be in short supply and make it available to the public throughout a public health emergency.

The ADA's Health Policy Institute (HPI) also has been monitoring supply chains. Dentists have reported that gowns and N95 and KN95 masks have been the most difficult to obtain. Of those dentists who reported having difficulties obtaining N95 masks, 38% said they couldn't get them due to inadequate supply and 56% pointed to both inadequate supply and cost as factors, according to HPI data.


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