title: Evaluation of the Di(2-ethylhexyl)phthalate released from polyvinyl chloride medical devices that contact blood.
abstract: Extraction methods that simulate those used in the clinic are recommended for obtaining extraction solutions. For polyvinyl chloride (PVC) medical devices that have contact with human blood, an alternative medium (ethanol/water mixture) is suggested as an extraction screening vehicle to evaluate the di(2-ethylhexyl)phthalate (DEHP) released. A test comparing the extraction ability between the alternative medium and whole blood from three healthy volunteers has been conducted. An experimental method is provided outlining the chemical analysis of the DEHP released from medical devices made with polyvinyl chloride (PVC). Gas chromatography-mass spectrometry (GC-MS) in the selective ion monitoring (SIM) mode was used to analyze and quantify the extracted DEHP. The linear range of the SIM method was 0.1-200 μg/mL, and the recoveries were 89.6-101.5% and 91.0-98.9% when using the ethanol/water mixture and whole blood as the extraction media, respectively. The validated method demonstrates that it is suitable for the determination of the DEHP released from PVC medical devices that have contact with blood. The results from the determination of the DEHP released will be compared with the limits derived from toxicological data for the parenteral exposure route and certain population groups, and the results will be used in the risk assessment of medical devices.
authors: CFDA Jinan Quality Inspection Center for Medical Devices, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China ; Shandong Provincial Key Laboratory of Biological Evaluation of Medical Device, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.
authors: Hongyu
authors: H
authors: Luo
authors: CFDA Jinan Quality Inspection Center for Medical Devices, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China ; Shandong Provincial Key Laboratory of Biological Evaluation of Medical Device, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.
authors: Guangyu
authors: G
authors: Sun
authors: CFDA Jinan Quality Inspection Center for Medical Devices, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China ; Shandong Provincial Key Laboratory of Biological Evaluation of Medical Device, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.
authors: Yanping
authors: Y
authors: Shi
authors: Shandong Hengxin Inspection Technology Development Center, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.
authors: Yong
authors: Y
authors: Shen
authors: Shandong Hengxin Inspection Technology Development Center, 99 Tianluo Road H-T Industrial Development Zone, Jinan, 250000 China.
authors: Kai
authors: K
authors: Xu
keywords: Blood contact; Di(2-ethylhexyl) phthalate (DEHP); Ethanol/water mixture; Gas chromatography/mass spectrometry (GC-MS); Medical devices; Polyvinyl chloride (PVC)