医院手术器械管理的最佳证据总结

doi:10.3761/j.issn.0254-1769.2025.08.018

摘要/Abstract

摘要：

目的检索和评价手术器械管理的相关证据，并对证据进行整合，为临床手术器械管理实践提供循证依据。方法系统检索国内外数据库及相关网站中关于手术器械管理的证据，包括指南、专家共识、临床决策等。检索时限为建库至2024年11月4日。由2名研究人员对文献进行筛选、评价及证据整合。结果共纳入16篇文献，其中系统评价2篇、类实验性研究1篇、临床决策2篇、专家共识4篇、指南5篇、证据总结2篇，共获得27条证据，包括管理要求、处理一般原则、物流和供应链管理、预处理及灭菌流程、人员培训5个方面。结论该研究总结了目前关于医院手术器械管理的最佳证据，为医护人员对手术器械的管理提供了循证依据，可提高手术器械处置质量和效率，并有效保障手术患者安全。

关键词: 医院, 外科器械, 医疗器械管理, 循证护理学

Abstract:

Objective To retrieve and evaluate the evidence related to surgical instrument management，and to integrate the evidence to provide an evidence-based basis for clinical surgical instrument management practice. Methods Evidence on surgical instrument management，including guidelines，expert consensuses，and clinical decision-making，was systematically searched from domestic and international databases and related websites. The search timeframe was from database construction to 4 November 2024. Literature was screened and evaluated，and the evidence was integrated by 2 researchers. Results A total of 16 papers were included，including 2 systematic evaluations，1 class experimental study，2 clinical decisions，4 expert consensuses，5 guidelines，and 2 evidence summaries，resulting in a total of 33 pieces of evidence in 5 areas，including requirements for surgical instrument management，general principles of surgical instrument handling，logistics and supply chain management of surgical instruments，surgical instrument pre-treatment and cleaning，disinfection，and sterilisation processes，and personnel training. Conclusion This study summarises the best available evidence on the management of surgical instruments in hospitals and provides an evidence-based basis for healthcare professionals to manage surgical instruments，thereby improving the quality and efficiency of surgical instrument disposal.

Key words: Hospitals, Surgical Devices, Medical Device Management, Evidence-Based Nursing

梁元元, 高兴莲, 戴张章, 周荣超, 胡娟娟, 王曾妍, 沈剑辉. 医院手术器械管理的最佳证据总结[J]. 中华护理杂志, 2025, 60(8): 1005-1011.

LIANG Yuanyuan, GAO Xinglian, DAI Zhangzhang, ZHOU Rongchao, HU Juanjuan, WANG Zengyan, SHEN Jianhui. Summary of the best evidence for surgical instrument management strategies in medical institutions[J]. Chinese Journal of Nursing, 2025, 60(8): 1005-1011.

图/表 5

表1 PubMed检索策略

Table 1 PubMed search strategy

图1 文献筛选流程

Figure 1 Literature screening process

表2 纳入文献的一般特征（n=16）

Table 2 General characteristics of the included literature（n=16）

表3 纳入指南的质量评价结果（n=5）

Table 3 Quality evaluation of the included guidelines（n=5）

表4 手术器械管理的最佳证据总结

Table 4 Summary of best evidence on surgical instrument management

参考文献 31

[1]	钱黎明, 季侃雯, 张青. 医院消毒供应中心实施信息化质量追溯的现况调查[J]. 中华护理杂志, 2020, 55(1):123-127. DOI URL
	Qian LM, Ji KW, Zhang Q. Current status of information track-ing system in central sterile supply departments[J]. Chin J Nurs, 2020, 55(1):123-127.
[2]	沈红梅, 莫军军, 郭立, 等. 262所医院消毒供应中心精密器械干燥技术的现状调查[J]. 中华护理杂志, 2023, 58(5):531-536. DOI URL
	Shen HM, Mo JJ, Guo L, et al. A study on the current situa-tion of precision instrument drying technology in 262 hospital sterile supply centers[J]. Chin J Nurs, 2023, 58(5):531-536.
[3]	朱娟, 尹世玉, 黄璐璐, 等. 281所医院消毒供应中心复用医疗器械功能检测的现状调查[J]. 中华护理杂志, 2023, 58(5):524-530. DOI URL
	Zhu J, Yin SY, Huang LL, et al. Investigation of the functional testing of reusable medical devices in central sterile supply departments of 281 hospitals in China[J]. Chin J Nurs, 2023, 58(5):524-530. DOI URL
[4]	Ling ML, Ching P, Widitaputra A, et al. APSIC guidelines for disinfection and sterilization of instruments in health care facilities[J]. Antimicrob Resist Infect Control, 2018,7:25.
[5]	朱政, 胡雁, 邢唯杰, 等. 不同类型循证问题的构成[J]. 护士进修杂志, 2017, 32(21):1991-1994.
	Zhu Z, Hu Y, Xing WJ, et al. Components of different types of evidence-based questions[J]. J Nurses Train, 2017, 32(21):1991-1994.
[6]	Brouwers MC, Kho ME, Browman GP, et al. AGREE Ⅱ:advan-cing guideline development,reporting and evaluation in health care[J]. J De L’association Med Can, 2010, 182(18):E839-E842.
[7]	周英凤, 胡雁, 朱政, 等. JBI循证卫生保健中心文本证据的质量评价清单[J]. 护士进修杂志, 2024, 39(10):1075-1080.
	Zhou YF, Hu Y, Zhu Z, et al. Critical appraisal checklist for textual evidence developed by JBI Center of Evidence-Based Health Care[J]. J Nurses Train, 2024, 39(10):1075-1080.
[8]	顾莺, 张慧文, 周英凤, 等. JBI循证卫生保健中心关于不同类型研究的质量评价工具:系统评价的方法学质量评价[J]. 护士进修杂志, 2018, 33(8):701-703.
	Gu Y, Zhang HW, Zhou YF, et al. JBI evidence-based health center’s quality assessment tool for different types of research:the quality evaluation of diagnostic and economic evaluation[J]. J Nurses Train, 2018, 33(8):701-703.
[9]	周英凤, 顾莺, 胡雁, 等. JBI 循证卫生保健中心关于不同类型研究的质量评价工具:干预性研究的质量评价(二)[J]. 护士进修杂志, 2018, 33(2):112-113.
	Zhou YF, Gu Y, Hu Y, et al. JBI evidence-based health center’s quality assessment tool for different types of research:quality evaluation of intervention research[J]. J Nurses Train, 2018, 33(2):112-113.
[10]	王春青, 胡雁. JBI证据预分级及证据推荐级别系统(2014版)[J]. 护士进修杂志, 2015(11):964-967.
	Wang CQ, Hu Y. JBI evidence pre-classification and evidence recommendation level system(2014 edition)[J]. J Nurses Train, 2015(11):964-967.
[11]	Meyer GW. Preventing infection transmitted by gastrointestinal endoscopy[EB/OL].(2024-04-30)[2024-05-25]. https://www.up-todate.com/contents/zh-Hans/preventing-infection-transmitted-by-gastrointestinal-endoscopy?search=%E9%A2%84%E9%98%B2%E6%B6%88%E5%8C%96%E9%81%93%E5%86%85%E9%95%9C&source=search_result &selectedTitle=2%7E150&usage_type=default&display_rank=2.
[12]	William AR, David JW. Guideline for disinfection and sterili-zation in health care facilities[EB/OL].(2023-12-07)[2024-05-25]. https://www.cdc.gov/infection-control/hcp/disinfection-and-steri-lization/.
[13]	崔倩, 李漫春, 詹朦, 等. 2008—2021年医院CSSD外来医疗器械及植入物管理现状Meta分析[J]. 中国感染控制杂志, 2022, 21(5):430-438.
	Cui Q, Li MC, Zhan M, et al. Current management status of loaner medical instruments and implants in hospital central sterile supply department from 2008 to 2021:a Meta-analysis[J]. Chin J Infect Contr, 2022, 21(5):430-438.
[14]	杨小燕, 田泽芳, 时桂娟, 等. 两种手术器械清洗质量评价方法的Meta分析[J]. 中华医院感染学杂志, 2021, 31(22):3496-3499.
	Yang XY, Tian ZF, Shi GJ, et al. Meta analysis of two me-thods for evaluation of cleaning quality of surgical instru-ments[J]. Chin J Nosocomiol, 2021, 31(22):3496-3499.
[15]	翟海英, 翟梦梅. 信息化追溯系统在消毒供应中心复用器械管理中的应用效果研究[J]. 中国社区医师, 2022, 38(25):166-168.
	Zhai HY, Zhai MM. Research on application effect of infor-mation traceability system in management of reusable ins-truments in disinfection supply center[J]. Chin Commun Doc-tors, 2022, 38(25):166-168.
[16]	Deverick JA, Deborah F. Infection prevention: General principles[EB/OL].(2022-08-17)[2024-05-25]. https://www.uptodate.com/contents/zh-Hans/infection-prevention-general-principles?search=%E6%84%9F%E6%9F%93%E9%A2%84%E9%98%B2%E7%9A%84%E4%B8%80%E8%88%AC%E5%8E%9F%E5%88%99&source =search_result&selectedTitle=1%7E150&usage_type=default&display_rank=1.
[17]	何丽, 曾玉, 喻晓芬, 等. 机器人手术护理配合中国专家共识(2024版)[J]. 机器人外科学杂志(中英文), 2024, 5(2):288-298.
	He L, Zeng Y, Yu XF, et al. Chinese expert consensus on robotic surgical nursing cooperation(2024)[J]. Chin J Robot Surg, 2024, 5(2):288-298.
[18]	中华护理学会消毒供应中心专业委员会. 重复使用医疗器械包装技术专家共识[J]. 中华护理杂志, 2023, 58(5):517-523. DOI URL
	Sterilization Supply Committee of Chinese Nursing Associa-tion. Expert consensus on packaging techniques of reusable medical instruments[J]. Chin J Nurs, 2023, 58(5):517-523. DOI URL
[19]	秦利荣, 刘军, 孙志坚, 等. 医用耗材供应链(SPD)管理专家共识[J]. 中国医药导刊, 2023, 25(4):343-354.
	Qin LR, Liu J, Sun ZJ, et al. Expert consensus on medical consumables supply chain(SPD) management[J]. Chin J Med Guide, 2023, 25(4):343-354.
[20]	郭莉, 吴安华, 万敏, 等. 软器械建立手术无菌屏障专家共识[J]. 中华医院感染学杂志, 2023, 33(24):3681-3685.
	Guo L, Wu AH, Wan M, et al. Experts consensus on setting up surgical sterile barrier with soft medical device[J]. Chin J Nosocomiology, 2023, 33(24):3681-3685.
[21]	AORN. Guideline at a glance:retained surgical items[J]. AORN J, 2016, 104(5):474-477.
[22]	AORN. Guideline quick view:instrument cleaning[J]. AORN J, 2020, 112(5):585-592.
[23]	Loveday HP, Wilson JA, Pratt RJ, et al. epic3:national evide-nce-based guidelines for preventing healthcare-associated infec-tions in NHS hospitals in England[J]. J Hosp Infect, 2014, 86(Suppl 1):S1-S70.
[24]	柳玉林, 曲华, 杜金库, 等. 白内障摘除手术感染防控措施的最佳证据总结[J]. 上海护理, 2023, 23(1):44-49.
	Liu YL, Qu H, Du JK, et al. Summary of best evidence for infection prevention and control measures after cataract extraction surgery[J]. Shanghai Nurs, 2023, 23(1):44-49.
[25]	张艺之, 欧阳静, 何丹丹, 等. 医院手术器械预处理方案的证据总结[J]. 护士进修杂志, 2023, 38(20):1880-1885.
	Zhang YZ, Ouyang J, He DD, et al. Evidence summary of pretreatment scheme of surgical instruments in hospitals[J]. J Nurses Train, 2023, 38(20):1880-1885.
[26]	Adler DG. Colonic strictures:dilation and stents[J]. Gastroin-test Endosc Clin N Am, 2015, 25(2):359-371.
[27]	Shin M, Joh JW. Advances in endoscopic management of biliary complications after living donor liver transplantation:compre-hensive review of the literature[J]. World J Gastroenterol, 2016, 22(27):6173-6191.
[28]	Shoman N, Gheriani H, Flamer D, et al. Prospective,double-blind,randomized trial evaluating patient satisfaction,bleed-ing,and wound healing using biodegradable synthetic polyure-thane foam(NasoPore) as a middle meatal spacer in functio-nal endoscopic sinus surgery[J]. Le J D’oto Rhino Laryngol De Chir Cervico Faciale, 2009, 38(1):112-118.
[29]	孙育红, 钱蒨健, 王维, 等. 二级及以上医院手术器械管理现状及问题分析[J]. 中国护理管理, 2019, 19(5):729-734.
	Sun YH, Qian QJ, Wang W, et al. Analysis on the present situation of surgical instruments management in hospitals of level Ⅱ and above[J]. Chin Nurs Manag, 2019, 19(5):729-734.
[30]	陈丽圆, 董春贺, 岳丽萍. 复用医疗器械清洗、消毒及灭菌处置现状调查[J]. 中国医疗器械信息, 2024, 30(7):151-153.
	Chen LY, Dong CH, Yue LP. Investigation on the status quo of cleaning,disinfection and sterilization of reusable medical devices[J]. China Med Device Inf, 2024, 30(7):151-153.
[31]	卢昕, 汪磊, 胡美丽, 等. 内窥镜常用消毒剂及其杀菌机制的探讨[J]. 中国医疗器械信息, 2020, 26(19):45-47.
	Lu X, Wang L, Hu ML, et al. Discussion on common disin-fectants of endoscope and bactericidal mechanism[J]. China Med Device Inf, 2020, 26(19):45-47.