关键词: 医疗器械, 不良事件, 重点监测

Abstract: ObjectiveTo investigate the connotation and the method of intensive surveillance for medical devices. MethodsPrevious studies of intensive surveillance of medical devices were summarized. Then, the main difference between routine monitoring and intensive surveillance for medical device was presented. The data analysis technique and its application to intensive surveillance was also provided. Resultsand ConclusionCurrently, there are three approaches for medical device intensive surveillance, which include sentinel surveillance based on forward-looking epidemiology research, strengthened routine monitoring and retrospective study based on research literature and monitoring data. Furthermore, the evaluations of case report and mass incidents are two key points of data analysis in intensive surveillance. To summarize the evidence in this work indicates that the combination of the aforementioned multiple methods in medical device intensive surveillance were necessary and helpful.

Key words: medical device, adverse event, intensive surveillance