我院可疑医疗器械不良事件上报情况分析及思考
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摘要
目的提高全院可疑医疗器械不良事件上报质量,提高医护人员在工作中发现医疗器械风险的能力,控制医疗器械的潜在风险。方法分析我院可疑医疗器械不良事件的管理方法,并对2016年1月至2018年4月可疑医疗器械不良事件上报数量、质量进行分析对比。结果全院各科室可疑医疗器械不良事件上报数量、质量有了大幅度提升,医务人员对医疗器械不良事件的理解更加深刻,医疗器械使用风险得到了很好地监控,有效地保障了患者安全。讨论医疗器械不良事件监测工作作为国家控制医疗器械潜在风险的一项重要举措,能够有效地监控医疗器械上市后风险。医院作为医疗器械不良事件监测的重要组成部分,应在不良事件监测的过程中提高认识,做好基础数据的收集,提高可疑医疗器械不良事件上报的质量,以期提高医院层面的风险管理水平。
Objective To improve the reporting quality of suspicious adverse events of medical devices in the hospital and improve the ability of medical staff to find risks of medical devices in work, so as to control potential risks of medical devices. Methods The management methods of suspected adverse events of medical devices in our hospital were analyzed, and the quantity and quality of reported adverse events of suspected medical devices from January 2016 to April 2018 were analyzed and compared. Results The quantity and quality of suspicious medical device adverse event reporting in all department of my hospital had been greatly improved.Medical personnel had a more profound understanding of medical device adverse event, and the risk of medical devices was well monitored, which effectively protected the patient's safety. Conclusion As an important measure to control the potential risks of medical devices, the monitoring of medical device adverse event reporting can effectively monitor the risk of risk of medical device after listing. As an important part of the monitoring of medical device adverse events, hospitals should raise awareness in the process of monitoring adverse events, collect the basic data and improve the quality of suspicious medical device adverse event reporting, so as to improve the level of risk management in hospitals.
Objective To improve the reporting quality of suspicious adverse events of medical devices in the hospital and improve the ability of medical staff to find risks of medical devices in work, so as to control potential risks of medical devices. Methods The management methods of suspected adverse events of medical devices in our hospital were analyzed, and the quantity and quality of reported adverse events of suspected medical devices from January 2016 to April 2018 were analyzed and compared. Results The quantity and quality of suspicious medical device adverse event reporting in all department of my hospital had been greatly improved.Medical personnel had a more profound understanding of medical device adverse event, and the risk of medical devices was well monitored, which effectively protected the patient's safety. Conclusion As an important measure to control the potential risks of medical devices, the monitoring of medical device adverse event reporting can effectively monitor the risk of risk of medical device after listing. As an important part of the monitoring of medical device adverse events, hospitals should raise awareness in the process of monitoring adverse events, collect the basic data and improve the quality of suspicious medical device adverse event reporting, so as to improve the level of risk management in hospitals.
引文
[1]褚淑贞,王恩楠,都兰娜.我国医疗器械产业发展现状、问题及对策[J].中国医药工业杂志,2017,48(6):930-935.
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[12]宓现强,王聪,潘尔顿,等.国内外医疗器械上市后监督管理的比较及启示[J].中国医院管理,2008,28(12):57-58.
[13]肖蔚.《医疗器械召回管理办法》解读[N].中国工商报,2017-02-18(003).
[14]王艳翚,宋晓亭.医疗产品召回制度及相关法律责任探析[J]前沿,2013,(9):72-73.
[15]温新宇.医院医疗设备质控体系分析与构建和实施[J].医疗装备,2016,29(20):56-57.
[16]毕文艳.对医疗器械不良事件报告制度的分析与思考[J].中国药事,2014,28(8):831-834.
[2]袁斌华.我国现行医疗器械定义调整的必要性[J].中国食品药品监管,2013,(6):74.
[3]刘慧萍.医疗器械不良事件风险管理思考[J].中国医疗器械信息,2017,23(23):133-135.
[4]王兰明.谈我国医疗器械风险管理的法规要求[J].中国医疗器械杂志,2009,33(1):46-50.
[5]张丽.医疗机构医疗器械不良事件监管体系研究[J].中国医疗设备,2016,31(4):177-179.
[6]王兰明.谈我国医疗器械风险管理的法规要求[J].中国医疗器械杂志,2009,33(1):46-50.
[7]刘红光,王银虎,高群.医疗器械风险管理的实施[J].医疗装备,2017,30(2):68-69.
[8]王磊,曲新涛,于秀淳.临床试验用医疗器械管理质量调查及整改[J].中国医疗设备,2016,31(10):122-124.
[9]周珂,孙海宁,于秀淳.医疗器械临床试验不良事件监控质量调查[J].中国医疗设备,2016,31(11):129-132.
[10]王兰明.关于改革和完善中国医疗器械注册管理制度的探讨[J]中国医疗器械杂志,2012,36(06):426-432.
[11]阮吉敏.中美医疗器械监管的比较与分析[J].国际医药卫生导报,2005,(7):98-105.
[12]宓现强,王聪,潘尔顿,等.国内外医疗器械上市后监督管理的比较及启示[J].中国医院管理,2008,28(12):57-58.
[13]肖蔚.《医疗器械召回管理办法》解读[N].中国工商报,2017-02-18(003).
[14]王艳翚,宋晓亭.医疗产品召回制度及相关法律责任探析[J]前沿,2013,(9):72-73.
[15]温新宇.医院医疗设备质控体系分析与构建和实施[J].医疗装备,2016,29(20):56-57.
[16]毕文艳.对医疗器械不良事件报告制度的分析与思考[J].中国药事,2014,28(8):831-834.