ABSTRACT
OBJECTIVE@#To improve the monitoring mode of diagnostic medical devices adverse events.@*METHODS@#By discussing the objective laws of the characteristics, performances and causes of diagnostic medical devices adverse events, the key points of monitoring work were clarified.@*RESULTS@#The whole-process cloud monitoring mode for adverse events of diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated.@*CONCLUSIONS@#The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.
Subject(s)
China , Equipment and Supplies , Reagent Kits, Diagnostic , Risk ManagementABSTRACT
In this study, in-depth observation and investigation of blood-brain barrier permeability and neuroprotective effect of Trichosanthes Kirilowii cassia twing particles on rats with cerebral ischemia-reperfusion injury were performed. focal cerebral ischrmia-reperfusion injury model was established by middle cerebral artery occlusion method, reperfusion was implemented 2 hours after ischemia; qualitative analysis and investigation of trichosanthes kirilowii cassia twing particles in olasma, brain tissue and cerebrospinal fluid in normal and middle cerebral artery occlusion [MCAO] rats were done by high-performance liquid chromatography-tandem mass spectrometry [HPLC-MS/MS]; changes in neurological deficites, cerebal infarction stereometry, blood-brain barrier permeability and histopathological cahnges of MCAO model rats werer observes. Qualitative analysis by HPLC-MS/MS results showed that ingredients, paeoniflorin, albiflorin, liquiritin in Trichosanthes Kirilowii cassia twig particles can reach the brain through the blood-brain barrier. In the model group, glycyrrhizic acid can be detected in brain tissue or cerebrospinal fluid. In addition, Trichosanthes Kirilowii cassia twig particles can significantly lower neurological deficits of rats in middle cerebral artery occlusion model, reduce the Evans blue penetration, contract infarct size, and reduce pathological tissue injury of cerebral ischemia reperfusion. The ingredients of Trichosanthes Kirilowii cassia twig particles can reach the brain tissue through the blood-brain barrier and play a role in neuroprotection of rats with cerebral ischemia-reperfusion injury, which has important research significance and brings scientific experimental, theoretical basis for clinical drug use