AABB Updates Considerations for Managing Sterile Saline Shortages After Hurricane Helene

AABB’s Clinical Transfusion Medicine Committee (CTMC) released updated considerations for the blood community regarding the saline supply shortage and anticipated challenges following Hurricane Helene. The update includes potential mitigation strategies to assist member facilities in managing their inventory of 0.9% sterile saline solution. AABB will continue to provide updates as more information becomes available. 

Current Shortages

As of Oct. 10, the Food and Drug Administration has not declared any new shortages related to Hurricane Helene. However, the agency noted that the following products are currently in shortage and supplies may be further impacted: 

• Dextrose 5% IV solution.
• Dextrose 10% IV Solution.
• Sodium Chloride 0.9% IV Solution (Normal Saline).
• Sodium Chloride 0.9% for Irrigation.
• Sterile Water for Injection.  
• Sterile Water for Irrigation.

Baxter’s Plan to Address Supply Constraints

Baxter International, one of the largest manufacturers of intravenous and peritoneal dialysis solutions in the U.S., experienced unprecedented flooding due to the storm at the company’s North Cove facility in Marion, N.C.

Baxter outlined several allocation measures that it will employ while the company works to restore production at the facility in an Oct. 9 update. First, the company will limit orders based on historical purchases and medical necessity to manage inventory and prevent stockpiling. Baxter is also increasing U.S. allocation levels for its highest-demand IV fluids and peritoneal dialysis products.

Baxter also detailed plans to restore operations at North Cove in phases by the end of 2024. In the meantime, it will scale production at other facilities and import products to bridge supply gaps. Baxter issued a guidance to help facilities manage their inventory and conserve products during this period.

Federal Government Response

A coalition of federal government agencies is working with Baxter to restore operations at the company’s North Cove facility. In a recent communication to health leaders and stakeholders, Secretary of Health and Human Services Xavier Becerra confirmed that disruptions at the Baxter facility due to Hurricane Helene will likely exacerbate existing constraints on IV fluid supplies.

To mitigate these challenges, the Food and Drug Administration is expediting reviews of temporary imports, alternative manufacturing sites and shelf-life extensions for critical products. FDA introduced a web page to provide stakeholder updates. Additionally, the Administration for Strategic Preparedness and Response is providing technical support to Baxter and other suppliers while preparing for the potential impact of Hurricane Milton on the supply chain.