Resources Available to Assist Blood Community With Disaster Preparedness

As the blood community continues working to ensure the adequacy and stability of the blood supply amidst several challenges this summer, the Food and Drug Administration has resources available to assist with facilities’ disaster planning and emergency preparedness.

First, AABB reminds the community that in the event of a significant disruption in the blood supply, blood collection facilities and transfusion services should consider whether the disruption meets the criteria for reporting to FDA under 21 CFR 600.82. Blood collection facilities should also consider FDA’s previously released guidelines for reporting disruptions to the blood supply in its draft guidance titled “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients.” 

Additionally, FDA’s previously published guidance on cold-stored platelets, “Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical,” offers options for facilities to consider in the event of disruptions to the blood supply, since cold-stored platelets have a longer shelf life and can be used for transfusion in trauma patients.

The Blood Supply Contingency and Emergency Plan (B-SCEP), posted by the European Directorate for the Quality of Medicines and Healthcare, is informative and helpful for blood collection facilities and transfusion services to consider in their disaster preparedness and contingency plans in the event of future significant disruptions. 

These resources are intended to inform and assist blood collection facilities and transfusion services as they consider their disaster preparedness plans. 

AABB is planning additional resources and updates in the coming weeks and months to assist the blood community in managing inventory and addressing potential additional disruptions to the blood supply.