title: Experimental study on infusion devices containing polyvinyl chloride: to what extent are they di(2-ethylhexyl)phthalate-free?
abstract: The use of medical devices containing highly criticized phthalates including di(2-ethylhexyl) phthalate (DEHP) has been challenged by European directive 2007/47/CE, put into effect in March 2010. New plasticizers are now being used to soften PVC in medical devices: trioctyltrimellitate (TOTM), di-isononyl-cyclohexan-1,2-dicarboxilate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT). To quantify DEHP in nine DEHP-free medical devices made of PVC softened by alternative plasticizers, high performance liquid chromatography analysis with ultraviolet detection at 220 nm wavelength was achieved. An NMR spectroscopy was performed to confirm DEHP presence. Only two medical devices out of the nine tested were truly without DEHP. One of them showed traces of DEHP exceeding the threshold contamination of 0.1% in plastic mass set by REACH regulations. TOTM plasticizer is still incriminated when polyvinyl-chloride (PVC) is contaminated with DEHP. Manufacturers must verify the purity of their raw material, not only on PVC, but also on other soft plastics entering into the composition of medical infusion devices. The clinical consequences of exposure to certain levels of DEHP have not been evaluated. A solution could be to use alternative PVC-free materials.
authors.affiliation: Department of Biopharmacy, Galenic and Hospital Pharmacy (EA 4481, IFR114), Université Lille Nord de France, F-59000 Lille, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Genay
authors.forename: Chiara
authors.initials: C
authors.lastname: Luciani
authors.forename: Bertrand
authors.initials: B
authors.lastname: Décaudin
authors.forename: Nicolas
authors.initials: N
authors.lastname: Kambia
authors.forename: Thierry
authors.initials: T
authors.lastname: Dine
authors.forename: Nathalie
authors.initials: N
authors.lastname: Azaroual
authors.forename: Piera
authors.initials: P
authors.lastname: Di Martino
authors.forename: Christine
authors.initials: C
authors.lastname: Barthélémy
authors.forename: Pascal
authors.initials: P
authors.lastname: Odou
mesh_terms: D057785:Catheters / Q000592:standards; D002851:Chromatography, High Pressure Liquid; D004051:Diethylhexyl Phthalate / Q000032:analysis*; D052244:Endocrine Disruptors / Q000032:analysis*; D004864:Equipment and Supplies / Q000592:standards; D005062:European Union; D019983:Guideline Adherence; D007263:Infusions, Parenteral / Q000295:instrumentation*; D007883:Legislation, Medical; D057230:Limit of Detection; D009682:Magnetic Resonance Spectroscopy; D008422:Materials Testing; D010968:Plasticizers / Q000032:analysis*; D011143:Polyvinyl Chloride / Q000737:chemistry* / Q000592:standards; D013056:Spectrophotometry, Ultraviolet
chemical_list: D052244:Endocrine Disruptors; D010968:Plasticizers; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate