title: Analytical methods for the determination of DEHP plasticizer alternatives present in medical devices: a review.
abstract: 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.
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676 C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France. Electronic address: l_bernard@chu-clermontferrand.fr.
authors.forename: L
authors.initials: L
authors.lastname: Bernard
authors.affiliation: Université Lille Nord de France, EA4481, GRIIOT, BP83, 59006 Lille, France; CHRU Lille, Pharmacie, Avenue Oscar Lambret, 59037 Lille, France.
authors.forename: B
authors.initials: B
authors.lastname: Décaudin
authors.affiliation: Université Lille Nord de France, EA4481, GRIIOT, BP83, 59006 Lille, France.
authors.forename: M
authors.initials: M
authors.lastname: Lecoeur
authors.affiliation: CHU Clermont-Ferrand, Service de Pharmacologie (CREPTA), Rue Montalembert, 63003 Clermont-Ferrand, France.
authors.forename: D
authors.initials: D
authors.lastname: Richard
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676 C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
authors.forename: D
authors.initials: D
authors.lastname: Bourdeaux
authors.affiliation: Clermont Université, Université d'Auvergne, EA 4676 C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
authors.forename: R
authors.initials: R
authors.lastname: Cueff
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676 C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
authors.forename: V
authors.initials: V
authors.lastname: Sautou
mesh_terms: D000818:Animals; D002152:Calorimetry, Differential Scanning; D002849:Chromatography, Gas; D002853:Chromatography, Liquid; D004051:Diethylhexyl Phthalate / Q000737:chemistry*; D004866:Equipment Contamination; D004868:Equipment Failure; D004864:Equipment and Supplies; D006801:Humans; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D008970:Molecular Weight; D010968:Plasticizers / Q000009:adverse effects / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry; D011143:Polyvinyl Chloride / Q000009:adverse effects / Q000737:chemistry; D051381:Rats; D018570:Risk Assessment; D012997:Solvents / Q000737:chemistry; D013055:Spectrophotometry, Infrared; D017550:Spectroscopy, Fourier Transform Infrared; D019265:Spectroscopy, Near-Infrared; D013818:Thermogravimetry
chemical_list: D010968:Plasticizers; D011108:Polymers; D012997:Solvents; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate
keywords: Analytical methods; Medical devices; Plasticizers; Polyvinyl chloride