title: Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods.
abstract: A wide variety of medical devices (MDs) used in hospitals are made of flexible plasticized polyvinylchloride (PVC). Different plasticizers are present in variable amounts in the PVC matrix of the devices and can leach out into the infused solutions and may enter into contact with the patients. The ARMED1project aims to assess the migration of these plasticizers from medical devices and therefore the level of exposure in patients. For the first task of the project, eight methods were developed to directly detect and quantify the plasticizers in the PVC matrix of the MDs. We compared the overall performances of the analytical methods using standardized and validated criteria in order to provide the scientific community with the guidance and the technical specifications of each method for the intended application. We have shown that routine rapid screening could be performed directly on the MDs using the FTIR technique, with cost-effective analyses. LC techniques may also be used, but with limits and only with individual quantification of the main plasticizers expected in the PVC matrix. GC techniques, especially GC-MS, are both more specific and more sensitive than other techniques. NMR is a robust and specific technique to precisely discriminate all plasticizers in a MD but is limited by its cost and its low ability to detect and quantify plasticizer contamination, e.g. by DEHP. All these results have been confirmed by a real test, called the " blind test " carried out on 10 MD samples.
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: 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: CHU Clermont-Ferrand, Unité de Biostatistiques, Délégation Recherche Clinique & Innovation, F-63000 Clermont-Ferrand, France.
authors.forename: B
authors.initials: B
authors.lastname: Pereira
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: N
authors.initials: N
authors.lastname: Azaroual
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: C
authors.initials: C
authors.lastname: Barthélémy
authors.affiliation: Centre de Ressources Technologiques 3s'Inpack, 63173 Aubière cedex, France.
authors.forename: C
authors.initials: C
authors.lastname: Breysse
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: P
authors.initials: P
authors.lastname: Chennell
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: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: T
authors.initials: T
authors.lastname: Dine
authors.affiliation: Clermont Université, Université d'Auvergne, EA 4676 C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
authors.forename: T
authors.initials: T
authors.lastname: Eljezi
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: F
authors.initials: F
authors.lastname: Feutry
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: S
authors.initials: S
authors.lastname: Genay
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: N
authors.initials: N
authors.lastname: Kambia
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: M
authors.initials: M
authors.lastname: Lecoeur
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: M
authors.initials: M
authors.lastname: Masse
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: P
authors.initials: P
authors.lastname: Odou
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: T
authors.initials: T
authors.lastname: Radaniel
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: N
authors.initials: N
authors.lastname: Simon
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France.
authors.forename: C
authors.initials: C
authors.lastname: Vaccher
authors.affiliation: Clermont Université, Université d'Auvergne, EA 4676 C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
authors.forename: C
authors.initials: C
authors.lastname: Verlhac
authors.affiliation: Clermont Université, Université d'Auvergne, EA 4676 C-BIOSENSS, BP 10448, F-63000 Clermont-Ferrand, France.
authors.forename: M
authors.initials: M
authors.lastname: Yessad
authors.affiliation: University Lille, EA 7365 - GRITA - Groupe de Recherche sur les formes Injectables et les Technologies Associées, F-59000 Lille, France; CHU Lille, Institut de Pharmacie, F-59000 Lille, France.
authors.forename: B
authors.initials: B
authors.lastname: Décaudin
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
keywords: Analytical methods; Comparison; Medical devices; Plasticizers