FDA Tries New Strategies as IV Bag Shortage Continues

Marcia Frellick

February 02, 2018

New strategies aim to help ease the shortage of intravenous fluid bags, made worse by a particularly severe influenza season and the devastating effects of Hurricane Maria, says Scott Gottlieb, MD, commissioner of the US Food and Drug Administration (FDA).

In a memo released Thursday, Dr Gottlieb updated the public on the situation, saying that the agency has been able to extend the expiration dates of some products, including some of the 500-mL saline bags, after manufacturer Baxter submitted data showing the extended use would meet FDA safety standards. The FDA has a guide to product extensions.

Baxter is one of the few large suppliers of the bags, and its operations in Puerto Rico, where most of the bags are made, were severely damaged when Hurricane Maria hit the island in September.

Dr Gottlieb said in the memo that the FDA has been working with primary manufacturers, including Baxter and B. Braun, to import bags from their facilities in other countries. Baxter, for instance, has recently added products from its facility in Brazil.

"We're also working to identify the specific features of products that are preferred or required by health care providers, such as size or function of the containers," he said. "We're using this aggregated information — and sharing it with existing and new manufacturers — to help identify existing supply gaps."

He said several companies have said they can either start or increase production of empty intravenous containers to help address the current critical demand.

"We're communicating directly with these companies, which include Douglas Medical Products Inc., Summit Medical Products Inc. and Valmed SRL," he said.

Courtney Burke, chief operating officer for the Healthcare Association of New York State (HANYS), said that just as New York hospitals started to see some relief with more supplies at the end of January, the spike of flu cases sharply increased the demand for the bags.

"We're nervous because there was quite a spike last week in influenza cases in New York and it varies by region," she said.

The Centers for Disease Control and Prevention reports that all states but Hawaii and Oregon continue to report widespread flu cases.

Burke said that extending the expiration dates will help, but she wishes that decision had been made earlier.

"Anything will help at this point, but how many of them were already disposed of?" she said.

Most of the reason supplies have lasted as long as they have in New York, she told Medscape Medical News, is that hospitals have been finding alternatives such as administering fluids and medications orally or through injection or flushing the bags.

She said HANYS put on a webinar to share best practices among hospitals and that led to greater uptake of workarounds.

"I can't say enough good things about how the hospitals have been managing this," she said.

Not All Experiencing Severe Shortages

Brian Murray, MBA, director of supply chain, NorthShore University Health System, Evanston, Illinois, said that NorthShore has used a different supplier, ICU Medical (formerly Hospira), and it has not experienced the severity of the shortages reported elsewhere.

"We have been able to pivot and transition to alternatives relatively easily," he told Medscape Medical News. "We do get our full allocation each month."

As to how the supplies are divided nationally, he said, "I think the market is pretty split. It's about 40% ICU Medical, 40% Baxter, and about 10% B. Braun."

All the companies were affected by Hurricane Maria, he said, "because many of Baxter's and B. Braun's customers initially tried to shift over to ICU so it made things tighter for the whole market as well. We had to manage things a lot tighter than we were used to."

Dr Gottlieb said he is optimistic that flu season will peak soon and supplies will better meet demand.

"We remain committed to looking at innovative ways that we can connect partners across the supply chain to find solutions and foster communication," he said in the memo. "The hurricanes and flu season have underscored the importance of preparedness and connectivity across the agency, the industries we regulate, as well as distributors and health care providers to best serve patients that need access to these critical products."

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