The American Hospital Association
is pushing the Food and Drug Administration
to be more aggressive in getting manufacturers of saline and other IV fluids to increase production to alleviate shortages.
“The current shortages of IV fluid are unacceptable and must be resolved quickly to prevent a negative impact on patient care,” the AHA wrote in a letter to FDA Commissioner Margaret Hamburg
Hospitals are managing the shortfall by using smaller IV bags, switching patients to appropriate alternatives when possible and prioritizing patients based on clinical factors. But the AHA warns that these are simply stopgap measures and without a permanent fix patients could suffer or lose confidence that they are receiving the best care.
In January, the FDA indicated it was working to relieve the shortage, largely attributed to increased demand during a severe flu season. The agency said it was focusing its efforts Baxter Healthcare Corp., B. Braun Medical, and Hospira—the three largest suppliers of IV fluids to U.S. providers—“to help preserve the supply of these necessary products.”
The AHA indicated it was aware the agency has been working with these companies and also seeking to obtain alternative sources of the products, including from overseas suppliers. However, given the extended duration of the shortages, AHA wants the FDA to push current manufacturers to not only to continue to produce these products at their maximum capacity but also to ask them to make investments to ensure more supply in the future.
Asked to respond to the AHA letter, a Baxter spokeswoman said in an e-mail that the company is “hopeful that inventory will resume shortly to a more predictable state” but also that liminted inventory could persist for several months. “Overall market supply and demand issues, along with Baxter's ongoing efforts to increase production, are variables that can impact timing,” she said.
Hospira, meanwhile, said it is the only supplier now providing historical volumes to its customers. “Hospira is producing product at full capacity, working 24/7 on product releases and expediting shipments to mitigate local and regional disruptions,” said Tareta Adams, a Hospira spokeswoman via e-mail. "Demand is at record highs and we are currently seeing customers who do not usually order from Hospira coming to us for product.”
Representatives from the FDA and B.Braun Medical did not immediately return requests for comment on AHA's letter. Follow Virgil Dickson on Twitter: @MHvdickson