Red cells stored in non‐
DEHP
containers: The effect of washing, irradiation or storage as paediatric units on in vitro quality parameters
Johan W. Lagerberg, Richard Vlaar, Thomas R. L. Klei Abstract
Background and Objectives
In accordance with European Union (EU) regulations, the use of the polyvinyl chloride (PVC) plasticiser diethylhexyl phthalate (DEHP) in medical devices must be phased out by 2030 in the EU. We recently evaluated the in vitro quality of red cell concentrates (RCCs) in phosphate–adenine–glucose–guanosine–saline–mannitol (PAGGSM) drawn in di(isononyl) cyclohexane‐1,2‐dicarboxylate (DINCH) and stored in BTHC‐plasticised PVC. Here we aimed to evaluate the effects of washing, gamma irradiation, X‐ray irradiation and aliquoting into paediatric RCC units in the DINCH/BTHC hybrid system on in vitro quality during storage.
Materials and Methods
RCCs in PAGGSM were made from whole blood collected in DINCH/BTHC hybrid systems. The study consisted of three independent and separate parts investigating (i) washing, (ii) irradiation of full units and (iii) irradiation of paediatric units. (i) On Day 30, RCCs ( n = 12) were washed with PAGGSM and stored in BTHC‐PVC containers until outdating. (ii) RCCs ( n = 24) were pooled and split (Day 14), and were left untreated, gamma irradiated or X‐ray irradiated and stored until outdating ( n = 8). (iii) Eight RCCs were aliquoted into paediatric units, irradiated on Day 14 and stored until outdating.
Results
Washing efficiently decreased potassium, lactate and protein concentrations in the supernatant. Irradiation led to increased haemolysis on Day 28 (0.18% ± 0.03% for controls vs. 0.35% ± 0.07% for gamma irradiation and 0.39% ± 0.09% for X‐ray irradiation). Splitting into paediatric units mostly resulted in comparable in vitro quality as obtained for adult‐size RCCs.
Conclusion
Secondary processing of RCCs in DINCH/BTHC‐PVC containers results in products that conform to requirements. Gamma or X‐ray irradiation results in comparable in vitro quality.