Impact of the pathogen inactivation process on the migration of di(2‐ethylhexyl) phthalate from plasma bags

Abstract

Background and Objectives: Di(2-ethylhexyl) phthalate (DEHP) is a toxic plasticizer that is commonly used in the manufacture of polyvinyl chloride (PVC) blood bags. It is well known that DEHP can migrate from a medical device into the blood plasma.For safety reasons, pathogens in plasma must be inactivated; however, this process may increase DEHP migration. Here, we assessed the impact of illumination-based pathogen inactivation on the migration of DEHP from PVC bags into plasma.Materials and Methods: Pairs of native PVC-DEHP plasma bags were pooled. Each pool was then split into a pathogen-inactivated bag and a control bag. After illumination, the plasma concentrations of DEHP and its main metabolite (mono (2-ethylhexyl) phthalate, MEHP) in each bag were assayed and compared using liquid chromatography-tandem mass spectrometry. Concentrations were evaluated in repeated-measures, two-way analyses of variance. Results:The MEHP concentration was significantly associated with storage but not with illumination (p = 0.0001). The DEHP concentration stayed constant throughout the storage period. The DEHP equivalent concentration (corresponding to the overall plasticizer migration rate into plasma) was not significantly associated with illumination (p = 0.3) or storage (p = 0.09; mean AE standard deviation of the mean DEHP concentration for all conditions: 147.9 AE 11.3 μg/ml). Conclusion:Illumination-based inactivation of pathogens in plasma did not increase the DEHP equivalent concentration, relative to control (non-inactivated) plasma.DEHP, di(2-ethylhexyl) phthalate, metabolite, pathogen inactivation process, plasma Highlights• We studied the impact of illumination-based pathogen inactivation on di(2-ethylhexyl) phthalate migration from a polyvinyl chloride bag into the blood plasma.• The illumination process promoted the degradation of di(2-ethylhexyl) phthalate into mono (2-ethylhexyl) phthalate.• The illumination process did not increase the di(2-ethylhexyl) phthalate equivalent concentration, relative to non-inactivated plasma.

Prevalence and clinical implications of heightened plastic chemical exposure in pediatric patients undergoing cardiopulmonary bypass

“…3,4 Notably, phthalates are not covalently bound to the PVC matrix, which makes them highly susceptible to leaching-particularly in the presence of lipophilic solutions. [5][6][7] Historically, phthalate leaching was considered beneficial to red blood cell (RBC) storage, as plasticizers interact directly with RBC membranes thus imparting resistance to storage hemolysis [8][9][10][11] however safety concerns surrounding phthalate exposure have increased since the 1970's. 4,[12][13][14] Biomonitoring studies indicate that the general population incurs daily phthalate exposures, with DEHP metabolites detected in nearly 80% of the United States population.…”

“…DEHP often contributes 40%–80% of the finished weight of medical‐grade tubing and blood storage bags 3,4 . Notably, phthalates are not covalently bound to the PVC matrix, which makes them highly susceptible to leaching—particularly in the presence of lipophilic solutions 5–7 . Historically, phthalate leaching was considered beneficial to red blood cell (RBC) storage, as plasticizers interact directly with RBC membranes thus imparting resistance to storage hemolysis 8–11 however safety concerns surrounding phthalate exposure have increased since the 1970's 4,12–14 …”