Ensuring that blood transfusion sets administer an effective dose of functional blood components

Proposed changes to ISO 1135-4 will require that blood transfusion administration sets are demonstrated by the manufacturers to be suitable for the range of cellular and plasma blood components for which they are designated.

To design a test protocol to asses the depletion of the blood components by transfusion sets and damage and activation of blood components during their passage through the set.

Transfusion giving sets (CareFusion Ref no. 60895 180311 and Fresenius Ref no. 2900032) were assessed by comparing samples of the blood component taken prior to and after passage through the transfusion set in strict accordance with the manufacturer's instructions. As well as depletion of red cells, platelets and FVIIIc, the following markers of damage/activation were assessed: red cells-supernatant haemolysis and potassium; FFP-prothrombin fragments 1 and 2 and fibrinopeptide A and platelets-pH, CD62P, CD63 and sP-selectin.

The CareFusion and the Fresenius transfusion sets gave less than 5% depletion of blood components and caused negligible and clinically insignificant effects on red cells, platelet concentrates and FFP.

A practical test protocol has been established to assess the depletion, damage to and activation of the key constituents of commonly requested blood components. This protocol would provide a valuable addition to ISO 1135-4 in assuring the suitability of transfusion sets.