Objective Trioctyl trimellitate(TOTM), a new plasticizer, is considered an alternative to bis(2-ethylhexyl) phthalate (DEHP) in order to improve the safety of polyvinyl chloride (PVC)-based medical infusion pipes. The release of the two plasticizers from medical infusion tubes is compared in this study for a safety analysis of TOTM. Methods To simulate clinical situation, nitroglycerin solution, isosorbidemononitrate solution and 45% ethanol aqueous solution were allowed to transfuse through both types of tubes, respectively, and were collected at multiple time points for a quantitative determination of the plasticizers content using HPLC. Results No plasticizer was found in the nitroglycerin or the isosorbidemononitrate solutions, whilst both TOTM and DEHP were detected in the ethanol water simulation solution, and the content of TOTM was higher than DEHP. Conclusions The simulation solution is insufficient to evaluate the safety of the plasticizer migration. Therefore, it calls for a closer collaboration between the medical device manufacturers and relevant regulatory bodies for the evaluations in mimicking clinical practices to guarantee the safety of infusion sets.
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