关键词: 三级医疗机构, 医疗器械不良事件

Abstract: ObjectiveTo assess the status of medical device adverse event monitoring system in the third grade medical institutions of Beijing, identify the existing problems and put forward the related countermeasures, promote the further development of medical device adverse event monitoring work in Beijing. MethodsIdentified the evaluation indicators of the medical device adverse event monitoring system in the third grade medical institutions of Beijing, developed the evaluation methods and made the questionnaires. We finished the assessment through visiting 54 third grade medical institutions of Beijing, reviewing documents and related information, and interviewing relevant persons. The monitoring system status and gaps were analysed, and the suggestions for improvement were proposed. Resultsand ConclusionThe medical institutions need to continue the perfection of medical device adverse events monitoring system in terms of personnel construction, financial support and research projects, take various measures to further enhance the level of adverse event monitoring. At the same time, regulators must strengthen technical guidance to medical device adverse event monitoring in the medical institutions.

Key words: third grade medical institution, medical device adverse event