重复使用医疗器械包装技术专家共识  

Expert consensus on packaging techniques of reusable medical instruments

作　　者：中华护理学会消毒供应中心专业委员会 姚卓娅[2] 张青 钱黎明[4] 康洁[5] Professional Committee of Central Sterile Supply Departments,Chinese Nursing Association;YAO Zhuoya;ZHANG Qing;QIAN Liming;KANG Jie

机构地区：[1]不详 [2]河南省人民医院消毒供应中心,郑州市450003 [3]中国医学科学院北京协和医院消毒供应中心 [4]上海交通大学医学院附属瑞金医院消毒供应中心 [5]北京大学肿瘤医院消毒供应中心

出　　处：《中华护理杂志》2023年第5期517-523,共7页Chinese Journal of Nursing

基　　金：北京协和医院中央高水平医院临床科研专项(2022-PUMCH-B-130);河南省医学科技攻关计划省部共建项目(SB201901089)。

摘　　要：目的规范医院消毒供应中心重复使用医疗器械的包装技术。方法2021年10月—2022年8月,中华护理学会消毒供应中心专业委员会针对重复使用医疗器械包装的关键问题,以临床实践为基础,运用文献分析法,结合消毒供应专家的工作经验,形成重复使用医疗器械包装技术专家共识(以下简称“《共识》”)初稿。通过2轮专家函询及3轮专家论证会,对各条目进行调整、修改与完善。结果2轮函询专家积极系数均为100%,专家权威系数分别为0.957和0.973,各条目重要性赋值均数>4.00分,且变异系数<0.25,专家肯德尔和谐系数分别为0.181和0.338(P<0.001)。最终对《共识》术语及定义、基本原则、人员要求、环境要求、包装设备要求、包装材料与灭菌监测材料要求、包装辅助工具要求、包装前评估、包装操作及包装质量确认等10部分内容达成一致意见。结论该《共识》内容涵盖重复使用医疗器械包装技术的各个环节,具有较强的实用性和科学性,有助于指导消毒供应专业人员规范执行包装技术,提高无菌物品质量,保证医疗质量和患者生命安全。Objective To standardize the packaging techniques of reusable medical instruments in central sterile supply departments.Methods From October 2021 to August 2022,the Professional Committee of the Central Sterile Supply Department of Chinese Nursing Association addresses the key problems of reusable medical instruments packaging.On the basis of clinical practice,literature analysis and the operation experience of the national central sterile supply department experts,we made the initial version of Expert Consensus on Packing Techniques of Reusable Medical Instruments(hereinafter referred to as the Consensus).Experts were invited to complete 2 rounds of Delphi expert consultations and 3 rounds of expert meetings.Each item was adjusted,revised and improved,and the final version of the Consensus was formulated.Results The positive coefficients of experts in 2 rounds of Delphi expert consultations were all 100%,and the degrees of expert authority were 0.957 and 0.973,respectively.The average importance value of each item was higher than 4.00;the variation coefficient of each item was less than 0.25.The Kendall’W were 0.181 and 0.338,respectively(all P<0.001).Finally,an agreement was reached on the terms and definitions,basic principles,personnel requirements,environmental requirements,packaging equipment requirements,packaging materials and sterilization monitoring material requirements,packaging auxiliary tools requirements,pre-packaging evaluation,packaging operation and packaging quality confirmation of the reusable medical devices packaging techniques.Conclusion The Consensus covers all aspects of the reusable medical instruments packaging techniques,which is highly practical and scientific,and it also helps to guide the sterile supply professionals to standardize the implementation of packaging techniques,improve the quality of aseptic supplies,and ensure the quality of medical treatment and the life safety of patients.

关 键 词：重复使用医疗器械 包装技术 中心供应室 医院 感染控制 专家共识 

分 类 号：R472.1[医药卫生—护理学]