Background/Case Studies: Since 1955, polyvinyl chloride (PVC) copolymer plasticized with bis(2-ethylhexyl) phthalate (DEHP) has been the primary material used in blood bag systems. While there are many benefits to DEHP in blood bag systems, growing literature has identified negative impacts of DEHP exposure, including its ability to leach into blood components and solutions, causing toxic effects on reproduction and fertility. As such, the European Chemicals Agency (ECHA) has established a sunset date for the manufacturing and importing of blood bag systems containing DEHP. The transition away from a well-established plasticizer leaves a data gap of non-DEHP research that must be filled. Therefore, the objective of this scoping review was to systematically evaluate the previous 20 years of literature related to alternative, non-DEHP plasticizers for research and/or transfusion to map the themes used in the blood and cell technology industry.
Study
Design/Methods: A scoping review was conducted in accordance with the JBI methodology for scoping reviews and in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. A scoping review is broad in scope and is used to identify the key concepts that underpin the contemporary research of a subject, identify the size and breadth of a body of literature, and highlight potential gaps in the cumulative knowledge about a topic.
Results/Findings: A total of 26 articles were included in this scoping review with 14 articles coming from European countries. There were six themes identified, including ‘Comparison of DEHP to Non-DEHP Plasticizers’ and ‘Comparison of Various Non-DEHP Plasticizers’, and seven sub-themes, including ‘In Vitro’, ‘Review’, and ‘Recommendations’. Overall, 19 plasticizers were evaluated in the included articles. This scoping review revealed that the top five most commonly assessed plasticizers were bis(2-ethylhexyl) phthalate (DEHP), N,N'-bis(trifluoroacetyl)-S,S'-bis-L-homocysteine (BTHC), bis(2-ethylhexyl) terephthalate (DEHT), 1,2-cyclohexanedicarboxylic acid, 1,2-diisononyl ester (DINCH), and tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate (TOTM). Conclusions: This scoping review systematically mapped the themes of the literature related to the evaluation of DEHP and non-DEHP plasticizers. Over the last 20 years, the four alternative, non-DEHP plasticizers that have been the most commonly investigated were BTHC, DEHT, DINCH, and TOTM. As a result of the established sunset date of DEHP in Europe, changes in blood bag system plasticizers will likely have effects outside of Europe and gaps in existing literature should be recognized.
