Construction of a comprehensive value evaluation index system for hospital admission of predicate consumables_Chinese Journal of Evidence-Based Medicine

Authors：

GUO Qiong ^1,2,3 , XIE Yanling ^1,4 , FENG Kun ⁵ , GONG Hanchun ^1,4 , LIU Qilin ¹ , CHEN Yaolong ⁶ , XUAN Jianwei ⁷ , SUN Feng ⁸ , CHEN Yingyao ⁹ ,  FENG Jingyi ^10,11 ,  LI Zhengchi ¹² ,  HUANG Jin ¹ ,  DU Liang ^1,2,3,12

1. Innovation Institute for Integration of Medicine and Engineering, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. West China Medical Publishers, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
3. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
4. West China School of Public Health, Sichuan University, Chengdu 610041, P. R. China;
5. Medical Affairs Department, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
6. Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
7. Health Economic Research Institute, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou 510006, P. R. China;
8. School of Public Health, Peking University, Beijing 100191, P. R. China;
9. School of Public Health, Fudan University, Shanghai 200032, P. R. China;
10. Clinical Engineering Department, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P. R. China;
11. Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P. R. China;
12. Center for Education of Medical Humanities, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;

Corresponding?author：

FENG Jingyi, Email: feng.jingyi@zju.edu.cn; LI Zhengchi, Email: zhengchili@scu.edu.cn; HUANG Jin, Email: michael_huangjin@163.com; DU Liang, Email: duliang0606@vip.sina.com

Keywords：

Predicate devices; Medical consumable; Hospital admission; Index system; Delphi method; Analytic hierarchy process

DOI：

10.7507/1672-2531.202601071

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To construct a comprehensive value evaluation index system for the hospital admission of predicate consumables, providing a reference for the admission evaluation of predicate consumables in hospitals. Methods An initial pool of comprehensive value evaluation indexes for the hospital admission of predicate consumables was established through literature research and expert consultation. The evaluation indexes were screened and optimized via two rounds of Delphi expert consultation, and the final admission evaluation index system was determined through an expert consensus meeting, and the analytic hierarchy process was adopted to determine the weights of the indexes. Results The final comprehensive value evaluation index system comprised six first-level indexes: clinical effectiveness (0.372 3), reliability (0.273 3), economic efficiency (0.113 8), hospital management (0.093 1), values and preferences (0.087 2), and enterprise services (0.060 3), along with 14 second-level indexes. Among these, "failure rate" (0.273 3), "safety" (0.215 5), and "effectiveness" (0.156 8) carried relatively higher weights. The effective response rates for the two rounds of expert consultation were 80% and 100%, with expert authority coefficients of 0.86 and 0.92, and Kendall's coefficients of concordance of 0.208 and 0.205, respectively. Conclusion The hospital admission evaluation system constructed in this study integrates multi-dimensional indexes, which can provide a scientific reference for the admission of predicate consumables in hospitals.

Citation： GUO Qiong, XIE Yanling, FENG Kun, GONG Hanchun, LIU Qilin, CHEN Yaolong, XUAN Jianwei, SUN Feng, CHEN Yingyao, FENG Jingyi, LI Zhengchi, HUANG Jin, DU Liang. Construction of a comprehensive value evaluation index system for hospital admission of predicate consumables. Chinese Journal of Evidence-Based Medicine, 2026, 26(4): 467-473. doi: 10.7507/1672-2531.202601071 Copy

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2.	國家藥品監督管理局. 醫療器械臨床評價等同性論證技術指導原則(2021年第73號通告附件3). 2021.
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9.	Rahmani K, Karimi S, Rezayatmand R, et al. Value-based procurement for medical devices: a scoping review. Med J Islam Repub Iran, 2021, 35: 134.
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13.	譚寶瀅, 林艾靈, 孫黃穎, 等. 人工晶狀體多維度價值評估指標體系構建探索. 醫療衛生裝備, 2023, 44(11): 83-89.
14.	蔡葵, 宣建偉. 心臟電生理醫療器械綜合價值評估專家共識. 中國醫學裝備, 2024, 21(7): 1-16.
15.	姚振閣, 周佳薇, 陸夢依, 等. 基于德爾菲法構建真實世界證據評價體系. 中國循證醫學雜志, 2024, 24(10): 1156-1161.
16.	景城陽, 劉瑞雪, 褚紅玲, 等. 醫學研究領域德爾菲法實施和報告標準(CREDES)解讀. 中國循證醫學雜志, 2023, 23(2): 233-239.
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18.	黃進, 張永剛, 劉鈺琪, 等. Mini衛生技術評估簡介. 中國循證醫學雜志, 2014, 14(8): 901-904.
19.	Freitas L, Vieira ACL, Oliveira MD, et al. Which value aspects are relevant for the evaluation of medical devices. Exploring stakeholders' views through a Web-Delphi process. BMC Health Serv Res, 2023, 23(1): 593.
20.	中國醫學裝備協會應用評價分會. 超聲手術系統綜合評估專家共識. 中國醫學裝備, 2023, 20(2): 176-188.
21.	王琳. 高值醫用耗材準入的指標體系構建研究. 青島: 青島大學, 2017.
22.	中華醫學會醫學工程學分會. 基于循證的免打結縫線醫院管理共識. 中國醫療設備, 2023, 38(9): 1-11.
23.	孫黃穎, 孫巧, 李彎, 等. 建立醫用耗材綜合價值評估指標體系初探. 中國醫療保險, 2021, (11): 34-38.
24.	華婷, 鄭焜, 酈柏平, 等. 醫療機構高值耗材準入管理中衛生技術評估指標量表的探索. 中國醫療設備, 2022, 37(1): 1-4, 19.
25.	萬彬, 吳平, 李鑫, 等. 醫療機構醫用耗材準入遴選綜合價值評估量表體系研究. 中華醫院管理雜志, 2022, 38(1): 1-7.
26.	Lee H, Kim DJ, Han JW. Developing nursing standard guidelines for nurses in a neonatal intensive care unit: a Delphi study. Healthcare (Basel), 2020, 8(3): 320.
27.	Lu Y, Liu C, Yu D, et al. Conditions required to ensure successful detection and management of mild cognitive impairment in primary care: a Delphi consultation study in China. Front Public Health, 2022, 10: 943964.
28.	Jiang N, Hu Q, He J, et al. Development and initial evaluation of a digital service package for community-dwelling older females with pelvic floor dysfunction. BMC Health Serv Res, 2025, 25(1): 1439.
29.	劉曉玉, 馬培宏, 劉志順, 等. 針刺臨床試驗中假針刺對照報告指南與清單(SHARE). 中國循證醫學雜志, 2024, 24(7): 745-750.
30.	Saaty TL. Decision making with the analytic hierarchy process. Int J Serv Sci, 2008, 1(1): 1-11.
31.	張娜, 龍囿霖, 王心怡, 等. 臨床實踐指南透明度評價工具2. 0的循證構建. 中國循證醫學雜志, 2023, 23(9): 1066-1071.
32.	高雷, 毛瑞, 何曉荔, 等. 基于專家調查的醫用耗材遴選評價指標影響因素研究. 中國衛生事業管理, 2024, 41(12): 1355-1359, 1414.
33.	Takashima M, Hyun A, Gibson V, et al. Invasive device-associated skin complications and mechanical dysfunctions in paediatric healthcare: a systematic review and meta-analysis. J Adv Nurs, 2024, 80(10): 4034-4049.
34.	國家藥品監督管理局. 醫療器械臨床評價技術指導原則(2021年第73號通告附件1). 2021.
35.	Govindarajulu US, Stillo M, Goldfarb D, et al. Learning curve estimation in medical devices and procedures: hierarchical modeling. Stat Med, 2017, 36(17): 2764-2785.
36.	鄭國管, 王小合, 錢宇, 等. 患者滿意度測評問題與治理路徑思考. 中國衛生政策研究, 2019, 12(3): 8-16.
37.	Arunyanart S, Khumpang P. A decision-making framework for evaluating medical equipment suppliers under uncertainty. Sci Rep, 2025, 15(1): 9858.

1. The 510(k) program: evaluating substantial equivalence in premarket notifications [510(k)]. 2014.
2. 國家藥品監督管理局. 醫療器械臨床評價等同性論證技術指導原則(2021年第73號通告附件3). 2021.
3. 中華人民共和國國務院. 醫療器械監督管理條例(中華人民共和國國務院令第739號). 2021.
4. Zargar N, Carr A. The regulatory ancestral network of surgical meshes. PLoS One, 2018, 13(6): e0197883.
5. Kadakia KT, Dhruva SS, Caraballo C, et al. Use of recalled devices in new device authorizations under the US Food and Drug Administration's 510(k) pathway and risk of subsequent recalls. JAMA, 2023, 329(2): 136-143.
6. Lefkovich C, Rothenberg S. Identification of predicate creep under the 510(k) process: a case study of a robotic surgical device. PLoS One, 2023, 18(3): e0283442.
7. Ardaugh BM, Graves SE, Redberg RF. The 510(k) ancestry of a metal-on-metal hip implant. N Engl J Med, 2013, 368(2): 97-100.
8. 國家衛生健康委, 國家中醫藥局. 醫療機構醫用耗材管理辦法(試行). 2019.
9. Rahmani K, Karimi S, Rezayatmand R, et al. Value-based procurement for medical devices: a scoping review. Med J Islam Repub Iran, 2021, 35: 134.
10. Khodyakov D, Grant S, Kroger J, et al. RAND methodological guidance for conducting and critically appraising Delphi panels. Santa Monica, CA: RAND Corporation, 2023.
11. Linstone HA, Turoff M. Delphi: a brief look backward and forward. Technol Forecast Soc Change, 2011, 78(9): 1712-1719.
12. 中華醫學會醫學工程學分會. 止血材料綜合價值評估專家共識. 中國醫療設備, 2022, 37(12): 1-8.
13. 譚寶瀅, 林艾靈, 孫黃穎, 等. 人工晶狀體多維度價值評估指標體系構建探索. 醫療衛生裝備, 2023, 44(11): 83-89.
14. 蔡葵, 宣建偉. 心臟電生理醫療器械綜合價值評估專家共識. 中國醫學裝備, 2024, 21(7): 1-16.
15. 姚振閣, 周佳薇, 陸夢依, 等. 基于德爾菲法構建真實世界證據評價體系. 中國循證醫學雜志, 2024, 24(10): 1156-1161.
16. 景城陽, 劉瑞雪, 褚紅玲, 等. 醫學研究領域德爾菲法實施和報告標準(CREDES)解讀. 中國循證醫學雜志, 2023, 23(2): 233-239.
17. Jünger S, Payne SA, Brine J, et al. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: recommendations based on a methodological systematic review. Palliat Med, 2017, 31(8): 684-706.
18. 黃進, 張永剛, 劉鈺琪, 等. Mini衛生技術評估簡介. 中國循證醫學雜志, 2014, 14(8): 901-904.
19. Freitas L, Vieira ACL, Oliveira MD, et al. Which value aspects are relevant for the evaluation of medical devices. Exploring stakeholders' views through a Web-Delphi process. BMC Health Serv Res, 2023, 23(1): 593.
20. 中國醫學裝備協會應用評價分會. 超聲手術系統綜合評估專家共識. 中國醫學裝備, 2023, 20(2): 176-188.
21. 王琳. 高值醫用耗材準入的指標體系構建研究. 青島: 青島大學, 2017.
22. 中華醫學會醫學工程學分會. 基于循證的免打結縫線醫院管理共識. 中國醫療設備, 2023, 38(9): 1-11.
23. 孫黃穎, 孫巧, 李彎, 等. 建立醫用耗材綜合價值評估指標體系初探. 中國醫療保險, 2021, (11): 34-38.
24. 華婷, 鄭焜, 酈柏平, 等. 醫療機構高值耗材準入管理中衛生技術評估指標量表的探索. 中國醫療設備, 2022, 37(1): 1-4, 19.
25. 萬彬, 吳平, 李鑫, 等. 醫療機構醫用耗材準入遴選綜合價值評估量表體系研究. 中華醫院管理雜志, 2022, 38(1): 1-7.
26. Lee H, Kim DJ, Han JW. Developing nursing standard guidelines for nurses in a neonatal intensive care unit: a Delphi study. Healthcare (Basel), 2020, 8(3): 320.
27. Lu Y, Liu C, Yu D, et al. Conditions required to ensure successful detection and management of mild cognitive impairment in primary care: a Delphi consultation study in China. Front Public Health, 2022, 10: 943964.
28. Jiang N, Hu Q, He J, et al. Development and initial evaluation of a digital service package for community-dwelling older females with pelvic floor dysfunction. BMC Health Serv Res, 2025, 25(1): 1439.
29. 劉曉玉, 馬培宏, 劉志順, 等. 針刺臨床試驗中假針刺對照報告指南與清單(SHARE). 中國循證醫學雜志, 2024, 24(7): 745-750.
30. Saaty TL. Decision making with the analytic hierarchy process. Int J Serv Sci, 2008, 1(1): 1-11.
31. 張娜, 龍囿霖, 王心怡, 等. 臨床實踐指南透明度評價工具2. 0的循證構建. 中國循證醫學雜志, 2023, 23(9): 1066-1071.
32. 高雷, 毛瑞, 何曉荔, 等. 基于專家調查的醫用耗材遴選評價指標影響因素研究. 中國衛生事業管理, 2024, 41(12): 1355-1359, 1414.
33. Takashima M, Hyun A, Gibson V, et al. Invasive device-associated skin complications and mechanical dysfunctions in paediatric healthcare: a systematic review and meta-analysis. J Adv Nurs, 2024, 80(10): 4034-4049.
34. 國家藥品監督管理局. 醫療器械臨床評價技術指導原則(2021年第73號通告附件1). 2021.
35. Govindarajulu US, Stillo M, Goldfarb D, et al. Learning curve estimation in medical devices and procedures: hierarchical modeling. Stat Med, 2017, 36(17): 2764-2785.
36. 鄭國管, 王小合, 錢宇, 等. 患者滿意度測評問題與治理路徑思考. 中國衛生政策研究, 2019, 12(3): 8-16.
37. Arunyanart S, Khumpang P. A decision-making framework for evaluating medical equipment suppliers under uncertainty. Sci Rep, 2025, 15(1): 9858.

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