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Fragmented regulations exacerbate saline shortage

Published in: Modern Healthcare

The vials and syringes that hospitals use to administer saline are classified as medical devices while the bags and solution are regulated as drugs. The Food and Drug Administration has more authority over the pharmaceutical supply chain than the medical device sector.

"During a drug shortage, there are a lot of levers the FDA can utilize to get products to market," said Soumi Saha, vice president of advocacy at Premier, adding that the agency can extend a drug's expiration date or expedite the approval of new products. "Those parallels don't exist in the device space."

Saline solution, similar to other sterile injectables, is prone to shortages because it is expensive to produce and store. Manufacturers often stop making it and shift to higher-margin items, rendering the supply chain more vulnerable. The war in Ukraine has constrained the supply of plastics. The medical device and pharmaceutical sectors, similar to the rest of the healthcare industry, are also facing staffing shortages that have limited their output.

"Much of this shortage should be alleviated over next 90 days, however, it is going to depend upon those downstream shortages of plastic and resin and all of the componentry," Saha said.

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