title: Migrability of PVC plasticizers from medical devices into a simulant of infused solutions.
abstract: Medical devices (MD) for infusion and artificial nutrition are essentially made of plasticized PVC. The plasticizers in the PVC matrix can leach out into the infused solutions and may enter into contact with the patients. In order to assess the risk of patient exposure to these plasticizers we evaluated the migration performance of DEHP, DEHT, DINCH, and TOTM using a model adapted to the clinical use of the MDs. Each PVC tubing sample was immersed in a simulant consisting of a mixture of ethanol/water (50/50v/v) at 40°C and migration tests were carried out after 24h, 72h, and 10 days.DEHP had the highest migration ability, which increased over time. The amount of TOTM released was more than 20 times less than that of DEHP, which makes it an interesting alternative. DEHT is also promising, with a migration level three times smaller than DEHP. However, the migration ability of DINCH was similar to DEHP, with the released amounts equaling 1/8th of the initial amount in the tubing after 24h of contact. Taking into account the available toxicological data, TOTM and DEHT appear to be of particular interest. However, these data should be supplemented and correlated with clinical and toxicological studies on plasticizers and their metabolites.
authors: CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 6300 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 467 C-BIOSENSS, BP 10448, F-6300 Clermont-Ferrand, France. Electronic address: l_bernard@chu-clermontferrand.fr.
authors: L
authors: L
authors: Bernard
authors: Clermont Université, Université d'Auvergne, EA 467 C-BIOSENSS, BP 10448, F-6300 Clermont-Ferrand, France.
authors: R
authors: R
authors: Cueff
authors: Centre de Ressources Technologiques CASIMIR, 63173 AUBIERE Cedex, France.
authors: C
authors: C
authors: Breysse
authors: CHRU Lille, Pharmacie, Avenue Oscar Lambret, 59037 Lille, France; Université Lille Nord de France, EA4481, GRIIOT, BP83, 59006 Lille, France.
authors: B
authors: B
authors: Décaudin
authors: CHU Clermont-Ferrand, Pôle Pharmacie, rue Montalembert, 6300 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 467 C-BIOSENSS, BP 10448, F-6300 Clermont-Ferrand, France.
authors: V
authors: V
authors: Sautou
mesh_terms: D001565:Benzoates / Q000032:analysis; D003509:Cyclohexanecarboxylic Acids / Q000032:analysis; D003998:Dicarboxylic Acids / Q000032:analysis; D004051:Diethylhexyl Phthalate / Q000032:analysis; D004058:Diffusion; D004867:Equipment Design; D000431:Ethanol / Q000737:chemistry; D006801:Humans; D007263:Infusions, Parenteral / Q000009:adverse effects / Q000295:instrumentation*; D008422:Materials Testing; D018529:Nutritional Support / Q000009:adverse effects / Q000295:instrumentation*; D010968:Plasticizers / Q000009:adverse effects / Q000032:analysis*; D011143:Polyvinyl Chloride / Q000009:adverse effects / Q000032:analysis*; D018570:Risk Assessment; D012995:Solubility; D013997:Time Factors; D014867:Water / Q000737:chemistry
chemical_list: D001565:Benzoates; D003509:Cyclohexanecarboxylic Acids; D003998:Dicarboxylic Acids; D010968:Plasticizers; C558012:diisononyl 1,2-cyclohexanedicarboxylic acid; D014867:Water; D000431:Ethanol; D011143:Polyvinyl Chloride; C034367:trioctyl trimellitate; D004051:Diethylhexyl Phthalate