On a call today hosted by Department of Health and Human Services Secretary Xavier Becerra, officials from the federal government and Baxter provided updates on the ongoing efforts to address the IV solution supply disruptions caused by the temporary closure of a Baxter manufacturing plant in North Carolina.

Among other highlights:

• Baxter officials announced that they have set up a dedicated email address that will be active on Oct. 11 that hospitals can use to contact the company with questions related to the IV solution situation, particularly if they are in dire need of product. The email address is [email protected].
• Baxter officials said they would provide updates about the situation on their dedicated webpage on Mondays and Thursdays.
• Baxter acknowledged that last week direct customers received 40% allocation of the various products, but that distributors were given a 10% allocation because Baxter was aware many distributors had additional product in storage that could be distributed. Baxter announced that going forward, distributors would receive the same allocation as direct customers.
• FDA instructed hospitals to hold onto expired products. FDA anticipates that it will extend the shelf life of some products by working with manufacturers.
• FDA is working to temporarily import some products in shortage to help meet patient needs. In this situation, FDA is carefully assessing the overseas product for quality, making sure that it is safe for U.S. patients. Please see the FDA webpage and table for more information.
• FDA clarified that the 1-mile rule is no longer in effect. Hospitals and health systems can distribute these products among their facilities without concern for the distance.

In addition, B. Braun, which is another major manufacturer of the kind of solutions made in the Baxter plant that is offline, today said its Daytona Beach IV solutions manufacturing site and distribution center were not seriously impacted by Hurricane Milton and will resume operations as planned on Friday, Oct. 11. “To safeguard the supply of finished products, we worked closely with the federal government, specifically the Administration for Strategic Preparedness and Response (ASPR), to leverage their resources which allowed us to move IV solutions inventory from our Daytona Beach distribution center to a secure, temperature-controlled facility north of Florida,” the B. Braun statement said.

BAXTER OCT. 9 UPDATES ON ALLOCATIONS

Baxter yesterday announced that it is increasing the current U.S. allocation levels of its highest demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%, effective Oct. 9. Baxter also said it is increasing high concentration dextrose and sterile water for injection allocations and expects to be in a position to make additional increases for certain product codes by early November. In addition, due to the vulnerable patient population they serve, allocations for IV solutions and nutrition products for designated children’s hospitals were increased to 100%, Baxter said. See the AHA Special Bulletin shared yesterday for more details on the announcement and a letter from the HHS Secretary on actions the department is taking.

BACKGROUND

The AHA is continuing efforts on multiple fronts to provide updates and assist members related to the supply chain issues resulting from the closure of a Baxter manufacturing plant in North Carolina because of damage from Hurricane Helene. The plant manufactures approximately 60% — or 1.5 million bags — of the IV solutions used every day in the U.S.

ADDITIONAL CONSERVATION RESOURCES AND QUESTIONS

Please visit our webpage for more information and resources, including conservation strategies, on the situation. If you have further questions, please contact Nancy Foster, vice president for quality and patient safety policy, at [email protected], or Roslyne Schulman, director of policy at [email protected].