An evaluation of diethylhexyl phthalate free top & bottom in‐line blood collection set with a new soft housing filter

Abstract

AbstractBackground and ObjectivesDi (2‐ethylhexyl) phthalate (DEHP) plasticizer must be removed from polyvinylchloride (PVC) medical devices due to toxicity. DEHP/PVC blood bags were shown to provide stable quality under blood component production and to create good storage conditions for red blood cells concentrate (RBC). It is important that substitution of the DEHP maintains the RBC quality during storage, which should be achieved with Di (isononyl) cyclohexane‐1,2‐dicarboxylate (DINCH), although substitution of the plasticizer has been challenging.Materials and MethodsA DEHP‐free Top & Bottom in‐line RBC set was validated in a tertiary hospital blood bank facility. Volunteer blood donors were randomly allocated for blood collection into DINCH/PVC or DEHP/PVC set. The groups were additionally divided according to additive solution/filter combination: PAGGS‐M + DINCH/PVC filter (only with DINCH/PVC set), and SAG‐M + DINCH/PVC filter and SAG‐M + DEHP/PVC filter (only with DEHP/PVC set). Processing and storage effects were assessed in all components.ResultsRBC concentrates, platelet concentrates and plasma that was processed and stored in DEHP‐free set fulfilled European requirements for quality. The cells stored in PAGGS‐M after filtration through DEHP‐free PVC filter showed the same low haemolysis compared with conventional set at 49 days of storage. Platelets stored in DINCH/PVC bag provided a sufficient quality of platelets after 7 days of storage. Plasma maintained the coagulation factors during 12 months of storage.ConclusionA new DINCH/PVC set allows production of blood components of satisfactory quality in DEHP‐free environment.