Development of an evaluation process for hospital admission of predicate consumables_Chinese Journal of Evidence-Based Medicine

Authors：

GUO Qiong ^1,2,3 , FENG Kun ⁴ , XIE Yanling ^1,5 , 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. Medical Affairs Department, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
5. West China School of Public Health, 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 device; Medical consumable; Hospital admission; Delphi method; Clinical evaluation; Admission process

DOI：

10.7507/1672-2531.202601079

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To establish a hospital admission evaluation process for predicate consumables. Methods An initial evaluation process for predicate consumables was constructed through a combination of literature review and expert consultation. Subsequently, two rounds of Delphi expert consultation were conducted with 20 specialists to revise and refine the specific steps of the admission evaluation process. Finally, the definitive version of the process was confirmed via an expert consensus conference. Results The finalized hospital admission evaluation process for predicate consumables consisted of 14 specific steps under three core phases: equivalence evaluation, evidence collection, and comprehensive evaluation of consumables. The two rounds of Delphi expert consultation yielded effective response rates of 80% and 100%, and expert authority coefficients (Cr) of 0.86 and 0.92, respectively. In the final consensus voting, the approval rate for all steps reached 100% except for two steps, which achieved an approval rate of 95%. Conclusion The admission evaluation process established in this study is detailed, scientifically rigorous, and practically applicable, which can provide a decision-making framework for the standardized admission of predicate consumables.

Citation： GUO Qiong, FENG Kun, XIE Yanling, LIU Qilin, CHEN Yaolong, XUAN Jianwei, SUN Feng, CHEN Yingyao, FENG Jingyi, LI Zhengchi, HUANG Jin, DU Liang. Development of an evaluation process for hospital admission of predicate consumables. Chinese Journal of Evidence-Based Medicine, 2026, 26(5): 547-552. doi: 10.7507/1672-2531.202601079 Copy

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14.	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.
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18.	田歡歡, 吳素敬, 梁宇, 等. 醫療器械臨床評價等同性論證技術淺析. 中國醫療器械雜志, 2023, 47(3): 328-331.
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26.	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.
27.	王春枝, 斯琴. 德爾菲法中的數據統計處理方法及其應用研究. 內蒙古財經學院學報(綜合版), 2011, 9(4): 92-96.
28.	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.
29.	Liang S, Zhai Z, Feng X, et al. Development of an index system for the scientific literacy of medical staff: a modified Delphi study in China. BMC Med Educ, 2024, 24(1): 397.
30.	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.
31.	雷興菊, 雷子鎮, 張秀香, 等. 醫用耗材準入管理的改進對策與實踐探討. 中國設備工程, 2024, (9): 88-89.
32.	Nambi Gowri K, King MW. A review of barbed sutures-evolution, applications and clinical significance. Bioengineering (Basel), 2023, 10(4): 419.
33.	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.

1. 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.
2. 國家市場監督管理總局. 醫療器械注冊與備案管理辦法(國家市場監督管理總局令第47號). 2021.
3. 劉露, 鐘佑錦, 張宇晶, 等. 真實世界證據與醫療器械上市前臨床評價: 思考與建議. 中國循證醫學雜志, 2019, 19(8): 883-886.
4. 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.
5. 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.
6. Redberg RF, Dhruva SS. Moving from substantial equivalence to substantial improvement for 510(k) devices. JAMA, 2019, 322(10): 927-928.
7. 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.
8. 尹燕玲, 戴偉, 胡偉標, 等. 基于閉環管理的醫用耗材準入遴選管理實踐與探討. 醫療裝備, 2024, 37(14): 48-50, 56.
9. 羅冰潔, 吳曉東, 雍鑫, 等. 基于證據的醫用耗材準入管理體系建設實踐. 華西醫學, 2023, 38(12): 1777-1781.
10. 梁少君. 如何構建規范高效的公立醫院醫用耗材準入遴選體系. 鄉鎮企業導報, 2025, (20): 24-26.
11. Khodyakov D, Grant S, Kroger J, et al. RAND methodological guidance for conducting and critically appraising Delphi panels. Santa Monica, CA: RAND Corporation, 2023.
12. 張桂欣, 王瑋, 王雪瑤, 等. 基于德爾菲法的醫院眼科設備維護模型構建與應用價值研究. 中國醫學裝備, 2025, 22(5): 137-141.
13. 王桾蔓, 文進. 應用德爾菲法構建地震災區健康融入所有政策評價指標體系. 中國循證醫學雜志, 2021, 21(7): 754-759.
14. 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.
15. 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.
16. 郭瓊, 謝艷玲, 馮堃, 等. 同品種醫用耗材醫院準入綜合價值評估指標體系的構建. 中國循證醫學雜志, 2026, 26(4): 467-473.
17. 梁春瀅. 探討臨床評價中兩款臨檢器械的等同性分析要點. 中國醫療器械信息, 2018, 24(21): 9-10, 59.
18. 田歡歡, 吳素敬, 梁宇, 等. 醫療器械臨床評價等同性論證技術淺析. 中國醫療器械雜志, 2023, 47(3): 328-331.
19. The 510(k) program: evaluating substantial equivalence in premarket notifications [510(k)]. 2014.
20. European Commission. Guidelines on medical devices - clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC. 2016.
21. Medical Device Coordination Group (MDCG). Guidance on clinical evaluation (MDR) / performance evaluation (IVDR) of medical device software. 2020.
22. Páez A, Rovers M, Hutchison K, et al. Beyond the RCT: when are randomized trials unnecessary for new therapeutic devices, and what should we do instead. Ann Surg, 2022, 275(2): 324-331.
23. Medical Device Coordination Group (MDCG). Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence. 2023.
24. International Medical Device Regulators Forum (IMDRF). Clinical evaluation. 2019.
25. 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.
26. 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.
27. 王春枝, 斯琴. 德爾菲法中的數據統計處理方法及其應用研究. 內蒙古財經學院學報(綜合版), 2011, 9(4): 92-96.
28. 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.
29. Liang S, Zhai Z, Feng X, et al. Development of an index system for the scientific literacy of medical staff: a modified Delphi study in China. BMC Med Educ, 2024, 24(1): 397.
30. 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.
31. 雷興菊, 雷子鎮, 張秀香, 等. 醫用耗材準入管理的改進對策與實踐探討. 中國設備工程, 2024, (9): 88-89.
32. Nambi Gowri K, King MW. A review of barbed sutures-evolution, applications and clinical significance. Bioengineering (Basel), 2023, 10(4): 419.
33. 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.

Chinese Journal of Evidence-Based Medicine

Development of an evaluation process for hospital admission of predicate consumables

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