In vitro quality of whole blood-derived red cell concentrates collected, processed and stored in a blood bag set plasticized with di (2-ethylhexyl) terephthalate.

Background And Objectives: Due to toxicity concerns, di(2-ethylhexyl) phthalate (DEHP)-the most used plasticizer in polyvinyl chloride (PVC) whole blood (WB) collection and processing bag sets-will be effectively prohibited in medical devices in Europe from 2030. Removal of DEHP will primarily impact the in vitro quality of red blood cell (RBC) concentrates (RCCs) and DEHP-free sets with alternate additive solutions (ASs) that better preserve RBCs in the absence of DEHP are being developed. This study compared the in vitro quality of RCCs from di (2-ethylhexyl) terephthalate (DEHT)/phosphate-adenine-glucose-guanosine-saline-mannitol (PAGGSM) and DEHP/saline-adenine-glucose-mannitol (SAGM) sets.

Materials And Methods: WB was collected into citrate-phosphate-dextrose (CPD) in either 500-mL DEHP/SAGM (n = 37) or prototype 475-mL DEHT/PAGGSM bag sets (n = 29). Leucoreduced (LR)-RCCs were produced using semi-automated top/bottom processing within 24 h of collection. RBC quality, including haemolysis, supernatant metabolic parameters and RBC deformability, was measured on D43 (1-day after expiry).

Results: All RCCs in the study had haemolysis <0.8%, and there was no statistically significant difference between haemolysis in DEHT/PAGGSM and DEHP/SAGM RCC (p = 0.083). Tolerance bound analysis indicated that RCCs in DEHT/PAGGSM produced using Canadian Blood Services' main production method would meet current Canadian Standards Association (CSA) CAN/CSA-Z902:25 quality control (QC) requirements for RCCs. There were some differences in metabolic in vitro quality measures, and RBCs in DEHT/PAGGSM were slightly less deformable (lower maximum elongation index [EI]) and required larger amounts of force (K) to physically deform.

Conclusion: RBCs have acceptable in vitro quality at expiry in DEHT/PAGGSM, supporting a 42-day shelf life.