Introduction: Di(2-ethylhexyl) phthalate (DEHP) is a plasticizer commonly used in blood bags. Despite its protective effects on red blood cell (RBC) storage, concerns about its reproductive toxicity exist. This study investigated the in vitro quality of RBC concentrates stored in bags using di(isononyl) cyclohexane-1,2-dicarboxylate (DINCH) as an alternative plasticizer.
Methods: Using a pool-and-split study design, we produced 20 matched homogenous quintets of RBC concentrates in two DINCH bags and three DEHP bags with citrate phosphate dextrose adenine (CPDA-1) anticoagulant. RBC storage quality was assessed weekly for 35 days.
Results: On day 35, the median hemolysis levels in the DINCH bags (0.297-0.342%) were marginally higher ( < 0.05) than the DEHP bags (0.204-0.240%). All DINCH bags showed <0.8% hemolysis. RBCs in the DINCH bags showed increased mean corpuscular volume and decreased eosin 5' maleimide binding than in the DEHP bags. Higher pO and lower pCO levels in the DINCH bags indicated better gas permeability than in DEHP bags. Other metabolic parameters were comparable in both bags. Compared to DEHP, DINCH exhibited considerably lower levels of plasticizer leaching into blood bags.
Conclusion: The quality of RBC concentrates stored for 35 days in DINCH-plasticized blood bags with CDPA-1 is generally comparable to those in DEHP bags. Hence, DINCH can be a viable alternative to DEHP in blood bags for nonleukoreduced RBC storage even without the use of next-generation additive solutions to improve RBC preservation quality.
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http://dx.doi.org/10.1159/000535625 | DOI Listing |
Transfus Med
September 2024
Department of Immunology, Oslo University Hospital, Oslo, Norway.
Background And Objectives: Di (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.
View Article and Find Full Text PDFTransfus Med Hemother
August 2024
Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, South Korea.
Introduction: Di(2-ethylhexyl) phthalate (DEHP) is a plasticizer commonly used in blood bags. Despite its protective effects on red blood cell (RBC) storage, concerns about its reproductive toxicity exist. This study investigated the in vitro quality of RBC concentrates stored in bags using di(isononyl) cyclohexane-1,2-dicarboxylate (DINCH) as an alternative plasticizer.
View Article and Find Full Text PDFEnviron Res
November 2023
Department of Pediatric Cardiac Surgery, University Hospital Erlangen, Loschgestr. 15, 91054, Erlangen, Germany.
Plastic medical devices, e.g. infusion sets, blood bags or tubing material, that are used manifold in the medical treatment of hospital patients, usually contain considerable amounts of plasticizers.
View Article and Find Full Text PDFVox Sang
July 2023
ULR 7365-GRITA-Groupe de Recherche sur les Formes Injectables et Technologies Associées, Université de Lille, CHU Lille, Lille, France.
Background And Objectives: Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is a widely used material for medical transfusion devices. Not covalently bound to PVC, DEHP can migrate into blood products during storage. Recognized as an endocrine disruptor and raising concerns about its potential carcinogenicity and reprotoxicity, DEHP is gradually being withdrawn from the medical device market.
View Article and Find Full Text PDFVox Sang
October 2022
Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, The Netherlands.
Background And Objectives: Di-ethyl-hexyl-phthalate (DEHP) is currently the main plasticizer used for whole blood collection systems. However, in Europe, after May 2025, DEHP may no longer be used above 0.1% (w/w) in medical devices.
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