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FDA releases first pandemic supply shortage list

August 17, 2020 By Nancy Crotti

Respirator masks are among the most effective forms of protection health care workers have against contracting COVID-19. (Image courtesy of Sandia)

Months into the coronavirus pandemic, the FDA has released its first official list of shortages of items needed by healthcare workers.

The list notes limited supplies of personal protective equipment (PPE) such as gowns and gloves to testing supplies and ventilation-related products for the sickest patients. The list also includes  Becton Dickinson (NYSE:BDX) BodyGuard infusion pump and syringe pump systems, which were discontinued in April following a Class 1 recall.

Frontline healthcare workers have spoken out about PPE shortages since the pandemic began hitting the U.S. hard earlier this year, even setting up their own supply lines such as GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic. GetUsPPE’s website lists several items that remain in short supply, including respirators and masks, gloves, goggles, face shields, disinfectant, coveralls, booties and gowns.

The FDA said in a news release that it has “taken many actions to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively to the COVID-19 public health emergency.” These actions include issuing emergency use authorizations (EUAs) and guidance documents to boost critical supplies.

The U.S. has had 5.34 million cases of the virus, including 54,686 new cases added today, according to the Centers for Disease Control and Prevention. The CDC reported 168,696 deaths to date, including 1,150 new deaths today.

“The FDA continues to monitor the healthcare landscape and supply chain for resulting shortages, or meaningful disruptions to U.S. supply, of certain medical devices,” the agency concluded.

“Under President Trump’s leadership, the federal government has taken great strides to meet the nation’s critical medical supply needs, and at this time, all requests have been filled or are being filled, while additional requests from states are minimal,” said an HHS spokesperson in an email to MDO. “The FDA provided a device shortage list as part of the implementation of section 506J of the Federal Food, Drug, and Cosmetic Act, signed into law as part of the CARES Act. Under section 506J, manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing. The shortage list was never intended to indicate there is a shortage of PPE or equipment to support patients, but allows for transparency to the public and stakeholders about devices.”
This article has been updated with information from the U.S. Department of Health and Human Services.

 

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