Experimental study on infusion devices containing polyvinyl chloride: to what extent are they di(2-ethylhexyl)phthalate-free?

摘要: 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 devices: trioctyltrimellitate (TOTM), di-isononyl-cyclohexan-1,2-dicarboxilate (DINCH) and terephthalate (DEHT). To quantify DEHP nine DEHP-free made softened alternative plasticizers, high performance liquid chromatography analysis with ultraviolet detection at 220 nm wavelength was achieved. An NMR spectroscopy performed confirm presence. Only two out the tested were truly without DEHP. One them showed traces exceeding threshold contamination 0.1% plastic mass set REACH regulations. TOTM plasticizer is still incriminated when polyvinyl-chloride (PVC) contaminated Manufacturers must verify purity their raw material, not only on PVC, but also other soft plastics entering composition infusion devices. clinical consequences exposure certain levels have evaluated. A solution could be PVC-free materials.