Analytical methods for the determination of DEHP plasticizer alternatives present in medical devices: A review

被引:110
作者
Bernard, L. [1 ,2 ]
Decaudin, B. [3 ,4 ]
Lecoeur, M. [3 ]
Richard, D. [5 ]
Bourdeaux, D. [1 ,2 ]
Cueff, R. [2 ]
Sautou, V. [1 ,2 ]
机构
[1] CHU Clermont Ferrand, Pole Pharm, F-63003 Clermont Ferrand, France
[2] Clermont Univ, Univ Auvergne, EA C BIOSENSS 4676, F-63003 Clermont Ferrand, France
[3] Univ Lille Nord France, EA4481, GRIIOT, F-59006 Lille, France
[4] CHRU Lille, F-59037 Lille, France
[5] CHU Clermont Ferrand, Serv Pharmacol CREPTA, F-63003 Clermont Ferrand, France
关键词
Plasticizers; Polyvinyl chloride; Medical devices; Analytical methods; DI-2-ETHYLHEXYL TEREPHTHALATE DEHT; CHROMATOGRAPHY-MASS-SPECTROMETRY; DI-2-(ETHYLHEXYL) ADIPATE DEHA; INTERNAL PHTHALATE EXPOSURE; ISO-NONYLPHTHALATE DINP; POLY(VINYL CHLORIDE); POLYVINYL-CHLORIDE; HUMAN URINE; SUPERCRITICAL-FLUID; IN-VITRO;
D O I
10.1016/j.talanta.2014.04.069
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Until 2010, diethylhexylphthalate (DEHP) was the plasticizer most commonly used to soften PVC medical devices (MDs), because of a good efficiency/cost ratio. In flexible plasticized PVC, phthalates are not chemically bound to PVC and they are released into the environment and thus may come into contact with patients. The European Directive 2007/47/CE, classified DEHP as a product with a toxicity risk and restricted its use in MDs. MD manufacturers were therefore forced to quickly find alternatives to DEHP to maintain the elasticity of PVC nutrition tubings, infusion sets and hemodialysis lines. Several replacement plasticizers, so-called "alternative to DEHP plasticizers" were incorporated into the MDs. Nowadays, the risk of exposure to these compounds for hospitalized patients, particularly in situations classified "at risk", has not yet been evaluated, because migrations studies, providing sufficient exposure and human toxicity data have not been performed. To assess the risk to patients of DEHP plasticizer alternatives, reliable analytical methods must be first developed in order to generate data that supports clinical studies being conducted in this area. After a brief introduction of the characteristics and toxicity of the selected plasticizers used currently in MDs, this review outlines recently analytical methods available to determine and quantify these plasticizers in several matrices, allowing the evaluation of potential risk and so risk management. (C) 2014 Elsevier B.V. All rights reserved.
引用
收藏
页码:39 / 54
页数:16
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