[1]朱丹丹高关心王学军夏慧琳李岳飞张晓燕边立军.医疗器械临床试验准入评估模型构建及应用[J].中国卫生质量管理,2021,28(07):6-9.[doi:10.13912/j.cnki.chqm.2021.28.7.02 ]
　ZHU Dandan,GAO Guanxin,WANG Xuejun.Construction and Application of Admittance Evaluation Model for Clinical Trials of Medical Devices[J].Chinese Health Quality Management,2021,28(07):6-9.[doi:10.13912/j.cnki.chqm.2021.28.7.02 ]

点击复制

医疗器械临床试验准入评估模型构建及应用

《中国卫生质量管理》[ISSN:1006-7515/CN:CN 61-1283/R] 卷: 第28卷期数: 2021年07期页码: 6-9 栏目: 特别关注出版日期: 2021-07-28

Title:: Construction and Application of Admittance Evaluation Model for Clinical Trials of Medical Devices

作者:: 朱丹丹高关心王学军夏慧琳李岳飞张晓燕边立军; 内蒙古自治区人民医院

Author(s):: ZHU Dandan; GAO Guanxin; WANG Xuejun; Inner Mongolia People's Hospital, Hohhot

关键词:: 医疗器械; 临床试验; 准入评估; 卫生技术评估

Keywords:: Medical Devices; Clinical Trial; Admittance Evaluation; Health Technology Assessment

分类号:: R197.39

DOI:: 10.13912/j.cnki.chqm.2021.28.7.02

文献标志码:: B

摘要:: 依据《医疗器械临床试验质量管理规范》，参考丹麦卫生技术评估中心制定的Mini-卫生技术评估清单，结合医院实际，建立了医疗器械临床试验准入评估模型。该模型主要包括医院评估、器械评估、患者评估、机构评估及经济评估等5项指标、26项内容。实际应用中，确保了所承接的临床试验能在规定时间节点内顺利完成，并保障了试验质量和受益者权益。

Abstract:: According to the "Quality Management Practice for Clinical Trials of Medical Devices", referring to the Mini Health Technology Assessment List made by the Danish Center for Health Technology Assessment, and combining with the actual situation of the hospital, the admittance evaluation model for clinical trials of medical devices was established. The model mainly included five indexes, namely,hospital evaluation, instrument evaluation, patient evaluation, institution evaluation and economic evaluation,and 26 content. The practical application ensured that the clinical trials undertaken can be successfully completed within the specified time node,and the test quality and the beneficiary's rights were guaranteed.

参考文献/References:

［1］World Health Organization.Health technology assessment of medical devices (WHO medical device technical series)［EB/OL］.(2011-05-12)［2020-01-27］.https://apps.who.int/Irisbitstream/handle/10665/44564/9789241501361_eng.pdf;jsessionid=0AF003D0458A4168F4CD693A7878 FDC6?sequence=1. ［2］聂海鑫.卫生技术评估及其在医用耗材管理中的应用［J］.中国医学装备,2020,17(9):213-217. ［3］夏慧琳,赵国光.临床工程技术评估与评价［M］.北京：人民卫生出版社,2017：25-30. ［4］费敏.基于卫生技术评估的新品医用耗材准入流程探索［J］.中国医疗设备,2020,35(7):24-28. ［5］张晓燕,高关心,王学军,等.我院医疗器械临床试验机构质量监管体系构建的探讨［J］.中国医疗设备,2020,35(4):131-134. ［6］计敏,乐丽芳,曾文干,等.PDCA循环理论对医疗服务质量管理的效果观察［J］.中国卫生标准管理,2020,11(5):10-12. ［7］张宇斐,柴建军,胡冰水,等.基于德尔菲法和层次分析法的现代医院门诊医疗质控指标体系构建与应用［J］.中国医院,2021,25(3):36-39. ［8］蒋文春,温贤秀,顾凤娇.应用德尔菲法和层次分析法构建血液透析室护理管理质量评价标准体系［J］.护理学报,2018,25(18):16-21. ［9］Chang AM, Gardner GE, Duffield C, et al. A delphi study to validate an Advanced Practice Nursing tool［J］.Journal of Advanced Nursing, 2010, 66(10):2320-2330. ［10］陈园园,朱滨海,唐大龙.应用德尔菲法构建三级综合性医院医教研综合质量评价指标体系［J］.中国医院,2015,19(4):35-37. ［11］任琳,李少武,王蓉.信效度评价在住院患者体检表设计中的应用研究［J］.中国卫生质量管理,2016,23(5):9-11. ［12］张咸伟.善待临床研究受试者：从《赫尔辛基宣言》看受试者权益保护［J］.中华疼痛学杂志,2020，16(2):83-84. ［13］朱丹丹,张淼,王学军.医疗器械临床试验全周期质量控制探讨［J］.医疗卫生装备,2016,37(10):114-116，127. ［14］王琪,梁新华.全程质控视角下口腔医疗器械临床试验高质量管理对策［J］.口腔疾病防治,2020,28(5):279-284. ［15］张健,陈永华,吴建军,等.严格设备质量控制管理着力提高使用效能［J］.医疗卫生装备,2010,31(9):125-126.

相似文献/References:

[1]曹蔚玮翟慧文李济宾潘旭芝张妮洁彭望清.肿瘤专科医院药物临床试验质量规范管理体系研究[J].中国卫生质量管理,2020,27(01):36.[doi:10.13912/j.cnki.chqm.2020.27.1.09]
[2]叶华张志尧陈晓怡谢卫华黄二亮全贞裕卜祥磊孟晓玫.医疗器械供应链弹性管理的实践探讨[J].中国卫生质量管理,2021,28(06):98.[doi:10.13912/j.cnki.chqm.2021.28.6.26 ]
　YE Hua,ZHANG Zhiyao,CHEN Xiaoyi.The Practice of Flexible Management of Medical Device Supply Chain[J].Chinese Health Quality Management,2021,28(07):98.[doi:10.13912/j.cnki.chqm.2021.28.6.26 ]
[3]李玉培乔建红温慧马帅.基于ClinicalTrials.gov的护理质量临床试验特征分析[J].中国卫生质量管理,2023,30(03):60.[doi:10.13912/j.cnki.chqm.2023.30.3.12 ]
　LI Yupei,QIAO Jianhong,WEN Hui.Characteristics Analysis of Clinical Trials on Nursing Quality Based on ClinicalTrials.gov[J].Chinese Health Quality Management,2023,30(07):60.[doi:10.13912/j.cnki.chqm.2023.30.3.12 ]
[4]龚睿婕茅淑倩刘景壹吴强松周祺刘敏林婉靖李梦郭翔.预防性疫苗注册临床试验项目分析[J].中国卫生质量管理,2025,32(02):77.[doi:10.13912/j.cnki.chqm.2025.32.2.18]
　GONG Ruijie,MAO Shuqian,LIU Jingyi.Analysis of Clinical Trial Items of Preventive Vaccine Registration[J].Chinese Health Quality Management,2025,32(07):77.[doi:10.13912/j.cnki.chqm.2025.32.2.18]
[5]赵同香马丽萍庞华蒋向明.医疗器械临床试验立项审查环节质量分析及防范策略[J].中国卫生质量管理,2024,31(02):76.[doi:10.13912/j.cnki.chqm.2024.31.2.18]
　ZHAO Tongxiang,MA Liping,PANG Hua.Quality Analysis and Preventive Measures in the Project Approval Review Link of Medical Device Clinical Trials[J].Chinese Health Quality Management,2024,31(07):76.[doi:10.13912/j.cnki.chqm.2024.31.2.18]

更新日期/Last Update: 2021-07-28