[1]龚芳 孙湛.加强医疗技术临床应用事中事后监管的探析[J].中国卫生质量管理,2019,26(01):025-28.[doi:10.13912/j.cnki.chqm.2019.26.1.09]
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加强医疗技术临床应用事中事后监管的探析
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《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R]

卷:
第26卷
期数:
2019年01期
页码:
025-28
栏目:
医疗质量
出版日期:
2019-01-28

文章信息/Info

作者:
龚芳 孙湛
复旦大学附属中山医院
关键词:
医疗机构; 医疗技术; 临床应用; 事中监管; 事后监管
Keywords:
Medical Institutions;  Medical Technology;  Clinical Applications;  In-Event Supervision;  After-Event Supervision
DOI:
10.13912/j.cnki.chqm.2019.26.1.09
摘要:
自2015年起，国家及各省（市、区）卫生计生委陆续宣布取消二、三类医疗技术临床应用行政准入审批，这表明医疗技术监管进入新业态。通过文献研究，梳理了医疗技术监管新要求，从医疗机构角度，提出了加强医疗技术临床应用事中事后监管的对策：做好事前评估准入，完善监管组织架构与制度体系，实施动态及追踪管理，加强日常督导检查，完善风险监测预警及处置机制，加强医疗安全（不良）事件管理，增进医患沟通等。
Abstract:
Since 2015, the national and regional health and family planning commission had successively launched new policies, announcing that the administrative admission approval for the clinical application of the second and third type of medical technologies were to be cancelled. This shows that medical technology regulation has entered a new bussiness mode.Through literature review and policy analysis, the paper summarized the regulation pattern for medical technology under the new circumstances, explored the necessity of strengthening supervision on medical technology in and after the process of clinical application specially from the medical institution’s perspective. Some measures were further put forward for medical institutions to improve the in-event and after-event supervision system of medical technology, which included the improving pre-evaluation of access, improving the structure and system of regulatory organizations, implementing dynamic and tracking management, strengthening routine supervision and inspection, improving risk monitoring, early warning and handling mechanisms, strengthening management of medical safety (adverse) incidents, and enhancing doctor-patient communication.

参考文献/References:

［1］鲁蓓,林芳芳,李志远.第三类医疗技术取消非行政许可审批后的管理与思考［J］.中国医院管理,2015,35(10):28-29.

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更新日期/Last Update: 2019-01-28