Health technology assessment: the important tool for scientific regulatory of medical devices_Chinese Journal of Evidence-Based Medicine

Authors：

LI Hailong ^1,2,3 , XU Peipei ^1,2,3,4 , ZENG Linan ^1,2,3 , CHEN Zhe ^1,2,3 , SHEN Jiantong ⁵ , WANG Xi ⁶ , ZHUO Zhi ⁶ , YI Qiusha ^1,2,3 , LI Youping ⁷ ,  ZHANG Lingli ^1,2,3

1. Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, P.R.China;
2. Evidence Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, P.R.China;
3. Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu 610041, P.R.China;
4. West China School of Medicine, Sichuan University, Chengdu 610041, P.R.China;
5. School of Medicine, Huzhou University, Huzhou 313000, P.R.China;
6. Medical Devices Support Department, West China Second University Hospital, Sichuan University, Chengdu 610041, P.R.China;
7. Chinese Evidence Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P.R.China;

Corresponding author：

ZHANG Lingli, Email: zhanglingli@scu.edu.cn

Keywords：

Health technology assessment; Medical device; Regulatory science

DOI：

10.7507/1672-2531.202009031

Video：

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Health technology assessment is a systematic assessment of the nature and impact of health technology. It is a science that solves the problems of health intervention or health technology on society, economy, organization and ethics. Aiming at the current issues of availability, accessibility, affordability, rationality and safety in the field of medical devices, health technology assessment can systematically evaluate the characteristics, effects and impact of medical devices, and provide evidence-based basis for scientific decision-making. Starting from the current status and challenges of medical device management, this paper introduces the origin and development, basic scope, assessment process and main assessment content of health technology assessment, and introduces the application of health technology assessment in medical device management through case studies, so as to promote development of health technology assessment in the field of medical device management and make medical device management more scientific and standardized.

Citation： LI Hailong, XU Peipei, ZENG Linan, CHEN Zhe, SHEN Jiantong, WANG Xi, ZHUO Zhi, YI Qiusha, LI Youping, ZHANG Lingli. Health technology assessment: the important tool for scientific regulatory of medical devices. Chinese Journal of Evidence-Based Medicine, 2021, 21(1): 2-7. doi: 10.7507/1672-2531.202009031 Copy

1.	World Health Organization. Access to medical devices for Universal Health Coverage and achievement of SDGs, 2017. Available at: https://www.who.int/medical_devices/October_2017_Medical_Devices_English.pdf?ua=1.
2.	The United Nations. Sustainable development goals, 2015. Available at: https://sustainabledevelopment.un.org/sdgs.
3.	World Health Organization. Medical devices, 2007. Available at: https://www.who.int/medical_devices/definitions/en/.
4.	World Health Organization. Global Atlas of medical devices: WHO medical devices technical series, 2017. Available at: https://www.who.int/medical_devices/publications/global_atlas_meddev2017/en/.
5.	国家卫生和计划生育委员会. 中国卫生和计划生育统计年鉴. 北京: 中国协和医科大学出版社, 2017.
6.	World Health Organization. Medical device regulations: global overview and guiding principles, 2003. Available at: http://www.who.int/iris/handle/10665/42744.
7.	World Health Organization. Baseline country survey on medical devices, 2014 update: Medical devices lists, 2014. Available at: https://www.who.int/gho/health_technologies/medical_devices/en/.
8.	蒋海洪, 杨悦. 我国医疗器械管理制度发展评析与展望. 沈阳药科大学学报, 2018, 35(5): 419-423, 436.
9.	吴雪梅. 医院医疗设备管理存在的问题及解决方法. 医疗装备, 2018, 31(21): 80-81.
10.	World Health Organization. Health intervention and technology assessment in support of universal health coverage. The Sixty-seventh World Health Assembly, 2014. Available at: https://www.who.int/medical_devices/assessment/resolutionsearo_searc66r4.pdf.
11.	World Health Organization. Health technology assessment, 2014. Available at: https://www.who.int/medical_devices/assessment/zh/.
12.	王海银, 何达, 王贤吉, 等. 国内外卫生技术评估应用进展及建议. 中国卫生政策研究, 2014, 7(8): 19-23.
13.	赵琨, 隋宾艳, 郭武栋, 等. 卫生技术评估的国际经验及启示. 中国卫生经济, 2012, 31(2): 87-89.
14.	张鸣明, 李幼平, 艾昌林, 等. WHO 启动基本卫生技术决策与实践. 中国循证医学杂志, 2007, 7(3): 162-164.
15.	Canadian Agency for Drugs and Technologies in Health. Guidelines for authors of CADTH health technology assessment reports, 2003. Available at: https://www.cadth.ca/guidelines-authors-cadth-health-technology-assessment-reports-0.
16.	Swedish Council on Health Technology Assessment (SBU). Assessment of methods in health care: a handbook, 2016. Available at: https://www.sbu.se/contentassets/76adf07e270c48efaf67e3b560b7c59c/eng_metodboken.pdf.
17.	Velasco M, Perleth M, Drummond M, et al. Best practice in undertaking and reporting health technology assessments. Working group 4 report. Int J Technol Assess Health Care, 2002, 18(2): 361-422.
18.	Indonesian Health Technology Assessment Committee (InaHTAC). Health technology assessment (HTA) guideline, 2017. Available at: http://adphealth.org/upload/resource/FINAL_HTA_ENG_-1.pdf.
19.	National Institute for Health and Care Excellence (NICE). Guide to the processes of technology appraisal, 2018. Available at: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/technology-appraisal-processes-guide-apr-2018.pdf.
20.	Danish Centre for Health Technology Assessment (DACEHTA). Health technology assessment handbook, 2001. Available at: https://www.sst.dk/~/media/ECAAC5AA1D6943BEAC96907E03023E22.ashx.
21.	Institute for Quality and Efficiency in Health Care (IQWiG). General methods 5.0 (benefit assessment), 2017. Available at: https://www.iqwig.de/en/methods/methods-paper.3020.html.
22.	Mayor S. WHO priority list of medical devices for cancer management. Lancet Oncol, 2017, 18(7): 856.
23.	国家卫生计生委科学技术部. 关于加强卫生与健康科技成果转移转化工作的指导意见, 2016. Available at: http://www.gov.cn/xinwen/2016-10/12/content_5117948.htm.
24.	国务院办公厅. 国务院办公厅关于改革完善医疗卫生行业综合监管制度的指导意见. 中国卫生监督杂志, 2018, 25(5): 414-418.
25.	杨宗霞, 沈建通, 李幼平, 等. 螺旋断层放疗系统治疗肿瘤的快速卫生技术评估. 中国循证医学杂志, 2014, 14(9): 1052-1069.
26.	茅艺伟, 陈英耀, 唐檬, 等. 国内部分卫生技术评估机构现状分析. 中国卫生质量管理, 2015, 22(3): 77-80.

1. World Health Organization. Access to medical devices for Universal Health Coverage and achievement of SDGs, 2017. Available at: https://www.who.int/medical_devices/October_2017_Medical_Devices_English.pdf?ua=1.
2. The United Nations. Sustainable development goals, 2015. Available at: https://sustainabledevelopment.un.org/sdgs.
3. World Health Organization. Medical devices, 2007. Available at: https://www.who.int/medical_devices/definitions/en/.
4. World Health Organization. Global Atlas of medical devices: WHO medical devices technical series, 2017. Available at: https://www.who.int/medical_devices/publications/global_atlas_meddev2017/en/.
5. 国家卫生和计划生育委员会. 中国卫生和计划生育统计年鉴. 北京: 中国协和医科大学出版社, 2017.
6. World Health Organization. Medical device regulations: global overview and guiding principles, 2003. Available at: http://www.who.int/iris/handle/10665/42744.
7. World Health Organization. Baseline country survey on medical devices, 2014 update: Medical devices lists, 2014. Available at: https://www.who.int/gho/health_technologies/medical_devices/en/.
8. 蒋海洪, 杨悦. 我国医疗器械管理制度发展评析与展望. 沈阳药科大学学报, 2018, 35(5): 419-423, 436.
9. 吴雪梅. 医院医疗设备管理存在的问题及解决方法. 医疗装备, 2018, 31(21): 80-81.
10. World Health Organization. Health intervention and technology assessment in support of universal health coverage. The Sixty-seventh World Health Assembly, 2014. Available at: https://www.who.int/medical_devices/assessment/resolutionsearo_searc66r4.pdf.
11. World Health Organization. Health technology assessment, 2014. Available at: https://www.who.int/medical_devices/assessment/zh/.
12. 王海银, 何达, 王贤吉, 等. 国内外卫生技术评估应用进展及建议. 中国卫生政策研究, 2014, 7(8): 19-23.
13. 赵琨, 隋宾艳, 郭武栋, 等. 卫生技术评估的国际经验及启示. 中国卫生经济, 2012, 31(2): 87-89.
14. 张鸣明, 李幼平, 艾昌林, 等. WHO 启动基本卫生技术决策与实践. 中国循证医学杂志, 2007, 7(3): 162-164.
15. Canadian Agency for Drugs and Technologies in Health. Guidelines for authors of CADTH health technology assessment reports, 2003. Available at: https://www.cadth.ca/guidelines-authors-cadth-health-technology-assessment-reports-0.
16. Swedish Council on Health Technology Assessment (SBU). Assessment of methods in health care: a handbook, 2016. Available at: https://www.sbu.se/contentassets/76adf07e270c48efaf67e3b560b7c59c/eng_metodboken.pdf.
17. Velasco M, Perleth M, Drummond M, et al. Best practice in undertaking and reporting health technology assessments. Working group 4 report. Int J Technol Assess Health Care, 2002, 18(2): 361-422.
18. Indonesian Health Technology Assessment Committee (InaHTAC). Health technology assessment (HTA) guideline, 2017. Available at: http://adphealth.org/upload/resource/FINAL_HTA_ENG_-1.pdf.
19. National Institute for Health and Care Excellence (NICE). Guide to the processes of technology appraisal, 2018. Available at: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/technology-appraisal-processes-guide-apr-2018.pdf.
20. Danish Centre for Health Technology Assessment (DACEHTA). Health technology assessment handbook, 2001. Available at: https://www.sst.dk/~/media/ECAAC5AA1D6943BEAC96907E03023E22.ashx.
21. Institute for Quality and Efficiency in Health Care (IQWiG). General methods 5.0 (benefit assessment), 2017. Available at: https://www.iqwig.de/en/methods/methods-paper.3020.html.
22. Mayor S. WHO priority list of medical devices for cancer management. Lancet Oncol, 2017, 18(7): 856.
23. 国家卫生计生委科学技术部. 关于加强卫生与健康科技成果转移转化工作的指导意见, 2016. Available at: http://www.gov.cn/xinwen/2016-10/12/content_5117948.htm.
24. 国务院办公厅. 国务院办公厅关于改革完善医疗卫生行业综合监管制度的指导意见. 中国卫生监督杂志, 2018, 25(5): 414-418.
25. 杨宗霞, 沈建通, 李幼平, 等. 螺旋断层放疗系统治疗肿瘤的快速卫生技术评估. 中国循证医学杂志, 2014, 14(9): 1052-1069.
26. 茅艺伟, 陈英耀, 唐檬, 等. 国内部分卫生技术评估机构现状分析. 中国卫生质量管理, 2015, 22(3): 77-80.

Chinese Journal of Evidence-Based Medicine

Health technology assessment: the important tool for scientific regulatory of medical devices

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