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Better late than never: FDA releases medical device shortage list

by Valerie Dimond, Contributing Reporter | August 17, 2020
Business Affairs

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.

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“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.”

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