| Experimental study on infusion devices containing polyvinyl chloride: To what extent are they di(2-ethylhexyl)phthalate-free? | |
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MedLine Citation:
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PMID: 21497186 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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 220nm wavelength. An NMR spectroscopy was performed to confirm DEHP presence. Only two medical devices out of the nine tested were truly without DEHP. Two 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. |
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Authors:
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Stéphanie Genay; Chiara Luciani; Bertrand Décaudin; Nicolas Kambia; Thierry Dine; Nathalie Azaroual; Piera Di Martino; Christine Barthélémy; Pascal Odou |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-4-8 |
Journal Detail:
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Title: International journal of pharmaceutics Volume: - ISSN: 1873-3476 ISO Abbreviation: - Publication Date: 2011 Apr |
Date Detail:
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Created Date: 2011-4-18 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7804127 Medline TA: Int J Pharm Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011. Published by Elsevier B.V. |
Affiliation:
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Department of Biopharmacy, Galenic and Hospital Pharmacy Department (EA 4481, IFR114), Université Lille Nord de France, F-59000 Lille, France. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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