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

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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/.
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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.	蔣海洪, 楊悅. 我國醫療器械管理制度發展評析與展望. 沈陽藥科大學學報, 2018, 35(5): 419-423, 436.
9.	吳雪梅. 醫院醫療設備管理存在的問題及解決方法. 醫療裝備, 2018, 31(21): 80-81.
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13.	趙琨, 隋賓艷, 郭武棟, 等. 衛生技術評估的國際經驗及啟示. 中國衛生經濟, 2012, 31(2): 87-89.
14.	張鳴明, 李幼平, 艾昌林, 等. WHO 啟動基本衛生技術決策與實踐. 中國循證醫學雜志, 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.
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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.	國家衛生計生委科學技術部. 關于加強衛生與健康科技成果轉移轉化工作的指導意見, 2016. Available at: http://www.gov.cn/xinwen/2016-10/12/content_5117948.htm.
24.	國務院辦公廳. 國務院辦公廳關于改革完善醫療衛生行業綜合監管制度的指導意見. 中國衛生監督雜志, 2018, 25(5): 414-418.
25.	楊宗霞, 沈建通, 李幼平, 等. 螺旋斷層放療系統治療腫瘤的快速衛生技術評估. 中國循證醫學雜志, 2014, 14(9): 1052-1069.
26.	茅藝偉, 陳英耀, 唐檬, 等. 國內部分衛生技術評估機構現狀分析. 中國衛生質量管理, 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. 國家衛生和計劃生育委員會. 中國衛生和計劃生育統計年鑒. 北京: 中國協和醫科大學出版社, 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. 蔣海洪, 楊悅. 我國醫療器械管理制度發展評析與展望. 沈陽藥科大學學報, 2018, 35(5): 419-423, 436.
9. 吳雪梅. 醫院醫療設備管理存在的問題及解決方法. 醫療裝備, 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. 王海銀, 何達, 王賢吉, 等. 國內外衛生技術評估應用進展及建議. 中國衛生政策研究, 2014, 7(8): 19-23.
13. 趙琨, 隋賓艷, 郭武棟, 等. 衛生技術評估的國際經驗及啟示. 中國衛生經濟, 2012, 31(2): 87-89.
14. 張鳴明, 李幼平, 艾昌林, 等. WHO 啟動基本衛生技術決策與實踐. 中國循證醫學雜志, 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. 國家衛生計生委科學技術部. 關于加強衛生與健康科技成果轉移轉化工作的指導意見, 2016. Available at: http://www.gov.cn/xinwen/2016-10/12/content_5117948.htm.
24. 國務院辦公廳. 國務院辦公廳關于改革完善醫療衛生行業綜合監管制度的指導意見. 中國衛生監督雜志, 2018, 25(5): 414-418.
25. 楊宗霞, 沈建通, 李幼平, 等. 螺旋斷層放療系統治療腫瘤的快速衛生技術評估. 中國循證醫學雜志, 2014, 14(9): 1052-1069.
26. 茅藝偉, 陳英耀, 唐檬, 等. 國內部分衛生技術評估機構現狀分析. 中國衛生質量管理, 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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