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谢伏瞻
    中国社会科学院学部委员,学部主席团主席,研究员,博士生导师。历任中国社会科学院院长、党组书记,国务院发展中心副主... 详情>>
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李培林
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    2020年我国医疗器械不良事件监测报告

    摘要

    2020年是我国医疗器械不良事件监测工作史上较为特殊的一年,全国医疗器械不良事件监测系统人员积极投身新冠肺炎疫情防控工作,主动作为,为临床医疗和医疗器械产业提供服务和技术支持,为疫情防控工作取得胜利做出了重要的贡献。在抗击新冠肺炎疫情的同时,积极推进《医疗器械不良事件监测和再评价管理办法》的实施,进一步完善不良事件监测规范体系,发布相关指南文件,不良事件监测工作质量得到进一步提高,收集到的可疑不良事件报告数量大幅度增加,通过不良事件监测及时发现和处置产品风险,监测工作取得了新的进展和成绩,为保障医疗器械安全有效发挥了重要作用。

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    Abstract

    The year 2020 is a special year in the history of medical device adverse event monitoring. Medical device adverse event monitors actively devote themselves to the novel coronavirus epidemic prevention and control work,provide services and technical support for the clinical medical treatment and medical device industry,and make important contributions to the success of epidemic prevention and control work. At the same time,actively promote the medical device adverse event monitoring and evaluation measures for the management of the implementation,and further perfect the adverse event monitoring system,three guidelines document issued,adverse event monitoring work to further improve quality,collected dramatically increased the number of suspected adverse event reporting,through timely detection and treatment of product risk adverse event monitoring,monitoring work has made new progress and achievements,and played an important role in ensuring the safety and effectiveness of medical equipment.

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    作者简介
    岳相辉:岳相辉,外科学博士,国家药品监督管理局器械监管司监测抽验处三级调研员。
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