On Oct. 10, ENA co-signed a letter to the Food and Drug Administration related to supply chain issues caused by damage to a Baxter manufacturing site in North Carolina.

October 10, 2024

Robert M. Califf, MD

Commissioner

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Dr. Califf:

On behalf of the undersigned medical organizations, the Society of Critical Care Medicine (SCCM) is writing to you to express our deep concern about the significant supply chain disruptions resulting from the damage inflicted by Hurricane Helene on Baxter’s North Cove manufacturing site in North Carolina. The undersigned organizations represent hundreds of thousands of clinicians who care for patients in hospital and out-of-hospital settings, emergency medical services (EMS) systems, and other healthcare facilities.

This North Cove facility is crucial to the supply of IV and peritoneal dialysis solutions―essential medical supplies that are widely used across all levels of care. Its closure has the potential to create widespread access issues for EMS providers, hospitals, and healthcare systems, adversely affecting patient care across the nation. It is imperative that everything be done to coordinate efforts to mitigate these supply chain challenges.

We respectfully request the Food and Drug Administration’s assistance in coordinating efforts to:

1. Establish a clear communication channel among manufacturers, distributors, and healthcare facilities to share updates on supply availability and timelines for recovery

2. Identify and prioritize the production of critical medical supplies that are currently affected by the plant’s closure and expedite import of these products from international suppliers to ensure that EMS providers and healthcare facilities can maintain essential operations

3. Encourage and assist manufacturers to explore alternative production facilities or methods to compensate for the loss of output from the Baxter plant

We also support the American Hospital Association’s (AHA) recommendations, attached with this letter, to increase the supply of IV solutions for hospitals, health systems and other healthcare providers. We stand with the AHA in advocating for a stable and sufficient supply of these essential resources to ensure that healthcare providers can continue to deliver safe, effective care to patients, particularly in already overburdened systems.

Thank you for your attention to this urgent matter. The health and safety of patients depend on timely and effective action. Together, we can ensure that our healthcare systems remain resilient in the face of such challenges.

We look forward to your prompt response and to collaborating on solutions that prioritize patient care.

Sincerely,

American Association of Critical-Care Nurses (AACN)

American College of Chest Physicians (CHEST)

American College of Emergency Physicians (ACEP)

American College of Surgeons (ACS)

American Society of Health-System Pharmacists (ASHP)

American Thoracic Society (ATS)

Emergency Nurses Association (ENA)

National Association of Emergency Medical Technicians (NAEMT)

National Association of EMS Physicians (NAEMSP)

Society of Critical Care Medicine (SCCM)

Society of Hospital Medicine (SHM)