title: Analysis of PVC plasticizers in medical devices and infused solutions by GC-MS.
abstract: In 2008, di-(2-ethylhexyl) phthalate (DEHP), was categorized as CMR 1B under the CLP regulations and its use in PVC medical devices (MD) was called into question by the European authorities. This resulted in the commercialization of PVC MDs plasticized with the DEHP alternative plasticizers tri-octyl trimellitate (TOTM), di-(2-ethylhexyl) terephthalate (DEHT), di-isononyl cyclohexane-1,2-dicarboxylate (DINCH), di-isononyl phthalate (DINP), di-(2-ethylhexy) adipate (DEHA), and Acetyl tri-n-butyl citrate (ATBC). The data available on the migration of these plasticizers from the MDs are too limited to ensure their safe use. We therefore developed a versatile GC-MS method to identify and quantify both these newly used plasticizers and DEHP in MDs and to assess their migration abilities in simulant solution. The use of cubic calibration curves and the optimization of the analytical method by an experimental plan allowed us to lower the limit of plasticizer quantification. It also allowed wide calibration curves to be established that were adapted to this quantification in MDs during migration tests, irrespective of the amount present, and while maintaining good precision and accuracy. We then tested the developed method on 32 PVC MDs used in our hospital and evaluated the plasticizer release from a PVC MD into a simulant solution during a 24h migration test. The results showed a predominance of TOTM in PVC MDs accompanied by DEHP (<0.1% w/w), DEHT, and sometimes DEHA. The migration tests showed a difference in the migration ability between the plasticizers and a non-linear kinetic release.
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676C-BIOSENSS, 63000 Clermont-Ferrand, France. Electronic address: dbourdeaux@chu-clermontferrand.fr.
authors.forename: Daniel
authors.initials: D
authors.lastname: Bourdeaux
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France.
authors.forename: Mouloud
authors.initials: M
authors.lastname: Yessaad
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676C-BIOSENSS, 63000 Clermont-Ferrand, France.
authors.forename: Philip
authors.initials: P
authors.lastname: Chennell
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Larbre
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France.
authors.forename: Teuta
authors.initials: T
authors.lastname: Eljezi
authors.affiliation: CHU Clermont-Ferrand, Pôle Pharmacie, Rue Montalembert, 63003 Clermont-Ferrand, France; Clermont Université, Université d'Auvergne, EA 4676C-BIOSENSS, 63000 Clermont-Ferrand, France.
authors.forename: Lise
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 4676C-BIOSENSS, 63000 Clermont-Ferrand, France.
authors.forename: Valerie
authors.initials: V
authors.lastname: Sautou
mesh_terms: D004864:Equipment and Supplies / Q000592:standards; D008401:Gas Chromatography-Mass Spectrometry / Q000379:methods*; D019999:Pharmaceutical Solutions / Q000032:analysis* / Q000592:standards; D010968:Plasticizers / Q000032:analysis*; D011143:Polyvinyl Chloride / Q000032:analysis*
chemical_list: D019999:Pharmaceutical Solutions; D010968:Plasticizers; D011143:Polyvinyl Chloride
keywords: DEHP alternatives; GC–MS; Medical devices; Migration tests; Plasticizers; Polyvinyl chloride