Why do containers used to ship blood components need to be validated?

Blood and blood components are validated to ensure that temperatures remain within acceptable limits for patient safety and to ensure optimal benefits of transfusion.  For example:

  • RBC stored at too low a temperature will become fragile leading to reduced survival and will ultimately hemolyse. Hemolysed red cells can trigger life-threatening hemolytic transfusion reactions.
  • RBC stored at too high a temperature can facilitate¬† bacterial growth
  • RBC stored at too high a temperature will ultimately hemolyse. Hemolysed red cells can trigger life-threatening hemolytic transfusion reactions.
  • Components with labile coagulation factors such as FFP and cryoprecipitate, if stored at too high a temperature, will become ineffective at maintaining hemostasis.
  • Platelets stored at too low a temperature will lose their functionality.