The FDA may move to allow the temporary importation of intravenous fluids and related products from overseas manufacturing sites to address critical shortages exacerbated by Hurricane Helene, the agency told Becker's Oct. 9.
"We are expediting evaluation of new sites/manufacturing lines, which will help increase supply and [are] actively considering temporary importation," an FDA spokesperson said in a statement. "We will expedite any necessary regulatory actions, including any that are needed to help bring North Cove back online."
More than 86% of U.S. healthcare providers are experiencing IV fluid shortages, according to a Premier survey published Oct. 10. More than half of respondents said they had 10 days or less worth of supplies on hand and some smaller providers reported receiving zero percent of their ordered quantities. Nearly 17% of surveyed providers have also canceled elective surgeries and other procedures, with 58% considering the option in the near term.
Here are five more shortage updates:
- Flooding from Hurricane Helene damaged a Baxter plant in Marion, N.C., which produces about 60% of the U.S.' supply of IV fluids. On Oct. 3, Baxter customers received a letter from the company alerting them they would be receiving 40% of IV solutions. The company provided an update Oct. 9 saying it would increase allocations to 60% of normal levels as they anticipate deliveries from foreign plants. In an email shared with Becker's on Oct. 9, Durham, N.C.-based Duke Health said that on Oct. 8, Baxter communicated that it would be able to increase the allocation up to 60%. Baxter said due to the vulnerable population it serves, allocations for IV solutions and nutrition products for designated children's hospitals were increased to 100%, according to an Oct. 9 news release from the company. Baxter is working to resume production at the North Cove facility in phases and expects to be able to return to 90% to 100% of allocation levels for its customers by the end of the year.
- On Oct. 8, employees at a B. Braun plant in Daytona Beach, Fla., began loading trucks with IV fluid products ahead of Hurricane Milton, which is expected to make landfall late Oct. 9. The company manufactures about 25% of the nation's IV fluids and has been moving products north to safer locations, The New York Times reported Oct. 9. The company's staff is temporarily off work but plans to return once the storm passes.
- Due to the supply crunch, some hospitals are facing tough decisions regarding patient care. Chris DeRienzo, MD, chief physician executive of the American Hospital Association, told the Times, "There are so many special populations impacted by the shortage, what it really leads to is an impact on the whole population." In Chicago, Northwestern Medicine physicians have been working to shore up supply of IV fluids for around 90 patients in the health system's home dialysis program. Vikram Aggarwal, MD, medical director of the program, told the news outlet the program is currently unable to accept new patients due to the shortage.
- In an Oct. 9 letter to healthcare providers, HHS Secretary Xavier Beccera said around 400 agency workers would be deployed to assist communities with recovery efforts in the wake of Helene. Mr. Beccera also said the department has been working with Baxter to ensure the safety of company staff and to address the supply shortage.
Mr. Becerra said HHS' Administration for Strategic Preparedness and Response "is actively working with Baxter and other [federal] partners to support infrastructure repairs and ensure the facility can resume operations as quickly as possible." The agency is also deploying resources to minimize supply disruptions caused by Hurricane Milton. - Some experts have raised alarms about the over-concentration of critical supplies. Tom Cotter, executive director of Healthcare Ready, told the Times there is a need for increased investment in supply chain resiliency to prevent future disruptions. "There is an increased need to widen the scope of what we think is vulnerable in our medical supply chain," he said.