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October • 30 • 2024

Sterile Solution Shortage: Managing the Risk

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Marlene Icenhower, JD, BSN, RN, CPHRM

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Summary

Consider this information as you evaluate your response to the sterile solutions shortage.

On October 9, 2024, Xavier Becerra, United States Secretary of Health and Human Services (HHS), issued a letter to healthcare leaders and stakeholders regarding the shortage of sterile solutions that resulted from Hurricane Helene, which caused extensive damage in the southeastern United States. Storm-related flooding had led to a supply disruption at the Baxter International, Inc. (Baxter) facility in Marion, North Carolina, which supplies a significant portion of intravenous (IV) solutions, irrigation fluids, and peritoneal solutions to medical facilities in the United States. 

After the storm, the HHS and its subagencies acted swiftly to partner with other government agencies to explore ways to protect patients and restore the supply of sterile solutions. Those efforts included rapidly restoring key production sites, allowing compounding of some solutions, importing solutions from other countries, and invoking the Defense Production Act to assist Baxter in obtaining materials needed to clean and rebuild the North Carolina facility. Supplies have increased by 50% due to these interventions, but shortages are expected to persist through the end of the year. 

Until supplies are restored, HHS encourages healthcare organizations to evaluate product inventories, allocate sterile solutions strategically, and implement conservation strategies to maximize availability of solutions and maintain patient safety. Consider the following in evaluating your response to the sterile solutions shortage: 
  • Monitor the situation and plan accordingly. Assemble a multidisciplinary team that includes pharmacy, clinical, quality, and supply chain leaders to develop a plan for ordering, distributing, and rationing sterile solutions. Develop clear, evidence-based guidelines with input from departments that use sterile solutions (e.g., emergency, surgery, and nephrology) regarding procedures that will be prioritized or delayed during the shortage. Continuously monitor the HHS and Baxter websites for updates. Keep detailed records of the organization’s ongoing mitigation and management efforts along with all supply chain issues and relevant dates. Develop a system to carefully track fluid consumption and communicate regularly with leadership.
  • Look for ways to conserve. In some cases, alternative therapies or treatments may be administered, such as oral rehydration for some patients or using smaller volumes or concentrated forms of solutions where clinically appropriate. Work with pharmacy leaders and other department leaders to explore ways to optimize fluid management protocols and minimize waste, such as providing flexibility in the use of solutions for admixtures, reducing IV bolus volumes, reducing maintenance IV fluids, or switching to alternate therapies such as enteral feeding.
  • Communicate with ordering providers. In some cases, it may be decided to delay treatment or provide alternative therapies due to the solution shortage. If so, communicate that decision in real time to the ordering provider along with key information, including:
    • Why it was decided to delay treatment or perform an alternative therapy.
    • What modifications were made to the patient’s treatment plan. 
    • How the patient will be impacted by the delay or modification.
    • Specific follow-up recommendations, if any. 
    • Thoroughly document the conversation in the medical record.
  • Enlist care teams. Educate clinical care teams about the sterile solution shortage and ask for their help in implementing the organization’s conservation strategies. Ensure they understand the rationale behind those strategies and provide regular updates on the status of the shortage. 
  • Communicate with patients. Work with your public relations or corporate communications department to advise the public of the sterile solutions shortage and why some procedures or therapies may be canceled or delayed. Place a plain language advisory on the patient portal and/or facility website notifying patients of the sterile solution shortage. Encourage patients to speak to their provider if they have questions about the shortage or how it affects them. 

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  • Healthcare Trends

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