FDA headquarters in Silver Spring, MD

Better late than never: FDA releases medical device shortage list

August 17, 2020
by Valerie Dimond, Contributing Reporter
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.

Meanwhile, hospitals across the country have been facing a stream of walkouts by clinical teams fed up with what they say are unsafe working conditions due to lack of PPE, medical equipment, and staffing shortages.

According to an earlier survey conducted by Premier Inc., nearly 90 percent of healthcare providers were contributing to stockpiles of critical medical supplies and drugs intended to last as long as 90 days, with either the health system or the state directing the majority of stockpiling efforts. However, product back orders had hindered requests to replenish the stockpiles and provide timely care.

“During the pandemic, the nation experienced a fragmented approach to securing supply that led to competition rather than coordination,” said Blair Childs, senior vice president of public affairs at Premier, in a press statement. “Absent a clear national strategy, we risk not being able to support providers through a regional surge in cases. To protect our front-line workers and patients, we must reinforce providers’ efforts with a national strategy that ensures coordination and reliability across stockpiles.”

Some hospitals are taking matters into their own hands, forgoing U.S. suppliers and ordering direct from China. Baptist Memorial Health Care just chartered its own FedEx plane to deliver a big supply of PPE, 400,000 isolation gowns, to its facility this past weekend, reported WMC Action News 5 in Tennessee.

“We’ve never had to order product from China before COVID. We always got the product we needed from our domestic suppliers, but then they were running into shortages,” John Finger, system director corporate supply chain at Baptist Health Care System told Action News 5. He says the shipment is even more important to have on hand with flu season approaching, and will probably do it again. Right now they have about a one-month supply. “I think within several months we’ll continue to do the same.”

FDA says the new shortage list will also be updated regularly as the pandemic evolves.

Premier applauded the move and said the shortage lists should enable greater resiliency in the healthcare supply chain.

“Over time, as this list evolves, we'd like it to more closely resemble the drug shortage list, which is more specific around the exact product and the manufacturers in the market,” Blair said. “This information is key to enable purchasers to identify alternatives and adjust buying. Premier also hopes the FDA will work with private sector partners to get a better sense of real-⁠time supply and surge demand. This specificity is also key to incentivize more domestic manufacturing, where companies need to understand the market and the potential demand so that they can feel confident in business plans and investments.”