外来医疗器械质量管理要求的国内外现状
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摘要
本文系统回顾了国内外外来医疗器械质量管理和清洁灭菌处理的现状,并比较两者的差异。我国各级医疗机构对外来医疗器械的管理较重视,但管理环节及细节有待完善,医疗机构应将外来医疗器械纳入医院的程序化管理,规范供应商行为,重视器械在各流程、环节的质量管理,借鉴国外先进的管理理念和处置方式,提高我国外来医疗器械的管理质量,有效控制医院感染,确保患者安全。
This article systematically reviews the current situation of quality management,cleaning and sterilization of loaner medical devices at home and abroad,and compares the differences between them.All levels of medical institutions in China attach importance to the management of loaner medical devices,but management links and details need to be improved,medical institutions should incorporate loaner medical devices into procedural management of hospital,standardize the behavior of suppliers,attach importance to the quality management of devices in various processes and links,learn from foreign advanced management concepts and disposal methods,and improve management quality of loaner medical devices in China,effectively control healthcare-associated infection to ensure safety of patients.
This article systematically reviews the current situation of quality management,cleaning and sterilization of loaner medical devices at home and abroad,and compares the differences between them.All levels of medical institutions in China attach importance to the management of loaner medical devices,but management links and details need to be improved,medical institutions should incorporate loaner medical devices into procedural management of hospital,standardize the behavior of suppliers,attach importance to the quality management of devices in various processes and links,learn from foreign advanced management concepts and disposal methods,and improve management quality of loaner medical devices in China,effectively control healthcare-associated infection to ensure safety of patients.
引文
[1]Duro M.New IAHCSMM loaner instrumentation position paper and policy template[J].Aorn J,2011,94(3):287-289.
[2]Huter-Kunish GG.Processing loaner instruments in an ambulatory surgery center[J].AORNJ,2009,89(5):861-870.
[3]张宇,冯秀兰,任伍爱,等.中国9省市医院消毒供应中心3项标准执行现状与分析[J].中华医院感染学杂志,2014,24(10):2549-2551.
[4]陆蕾,董卫红,黄明芬.医院外来医疗器械管理存在的问题与对策[J].中华医院管理杂志,2014,30(5):370-371.
[5]周彬,巩玉秀,张宇,等.外来医疗器械与植入物处理现况分析[J].中国医院,2014,18(11):3-4.
[6]俞桂珍,叶旭琴,汤秋芳,等.外来医疗器械管理现状及管理对策研究[J].中华医院感染学杂志,2017,27(10):2393-2396.
[7]Seavey R.Reducing the risks associated with loaner instrumentation and implants[J].AORN J,2010,92(3):322-331.
[8]Nestman C,Mckinley M.Loaner instrument tray management:A shared responsibility[EB/OL].(2010-1)[2018-5].https://www.hpnonline.com/.
[9]Winthrop TG,Sion BA,Gaines C.Loaner instrumentation:processing the unknown[J].AORN J,2007,85(3):566-573.
[10]Young M.Putting teeth in your loaner set policy[J].ORManager,2011,27(9):22-23,26.
[11]Chobin N.Effective management of loaner instrumentation[J].Perioperative Nurs Clin,2010,5(3):393-396.
[12]Tosh PK,Disbot M,Duffy JM,et al.Outbreak of Pseudomonas aeruginosa surgical site infections after arthroscopic procedures:Texas,2009[J].Infect Control Hosp Epidemiol,2011,32(12):1179-1186.
[13]Lipscomb IP,Sihota AK,Keevil CW.Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteina-ceous deposits[J].J Clin Microbiol,2006,44(10):3728-3733.
[14]Rutala WA,Gergen MF,Jones JF,et al.Levels of microbial contamination on surgical instruments[J].Am J Infect Control,1998,26(2):143-145.
[15]Huys J.The sterile supply cycle:cleaning,sterilisation of medical devices by steam:general theory[M].Heart Consultancy,Renkum,The Netherlands,2006.
[16]刘卫红,周万丹.手术室外来器械的使用与管理现状调查[J].中国感染控制杂志,2008,7(4):264-265,271.
[17]张宇,冯秀兰,任伍爱,等.医院消毒供应中心落实三项标准的调查[J].中国感染控制杂志,2014,13(4):193-197.
[18]Association for the Advancement of Medical Instrumentation.ANSI/AAMI ST79:2006-Comprehensive guide to steam sterilization and sterility assurance in health care facilities[S].Arlington,VA:Association for the Advancement of Medical Instrumentation,2006,60.
[19]Graybill-D’Ercole P.Implementing AORN recommended practices for sterilization[J].AORN J,2013,97(5):521-533.
[20]Canadian Standards Association.CAN/CSA-Z314.3-09 Effective sterilization in health care facilities by the steam process[S].Rexdale,Ont.:Canadian Standards Association,2009.
[21]The Project Group Loaner Instrumentation.Professional standard for loaner instrumentation-Standard for loaning or renting of surgical instruments[S].Netherlands:The Project Group Loaner Instrumentation,2010.
[22]巩玉秀,冯秀兰,付强,等.医院消毒供应中心第1部分:管理规范WS310.1-2016[J].中国感染控制杂志,2017,16(9):887-892.
[23]黄浩,周晓丽,陈慧.超重器械包装及灭菌效果的实验研究[J].中国消毒学杂志,2013,30(6):577-578.
[24]Basu D.Reason behind wet pack after steam sterilization and its consequences:An overview from central sterile supply department of a cancer center in eastern India[J].J Infect Public Health,2017,10(2):235-239.
[25]王凤勤.外来骨科医疗器械接管中存在的问题与对策[J].护理实践与研究,2012,9(20):97-98.
[26]Association for the Advancement of Medical Instrumentation.AAMI TIR31:2008 Process challenge devices/test packs for use in health care facilities[R].AAMI,2008.
[27]Donlan RM.Biofilm formation:a clinically relevant microbiological process[J].Clin Infect Dis,2001,33(8):1387-1392.
[28]Edmiston CE,McBain AJ,Kiernan M,et al.A narrative review of microbial biofilm in postoperative surgical site infections:clinical presentation and treatment[J].J Wound Care,2016,25(12):693-702.
[29]Roberts CG.The role of biofilms in reprocessing medical devices[J].Am J Infect Control,2013,41(Suppl 5):S77-S80.
[30]Mittelman MW.Bacterial biofilms in pharmaceutical water systems[J].Drugs Pharmaceut Sci,2008,174:699.
[31]杨风,赵自云,杨杰书,等.外来手术器械使用后规范化处理探讨[J].中华医院感染学杂志,2015,25(15):3583-3585.
[32]Burns J.Loaner inventory management system and method:U.S.Patent Application 10/100,007[P].2003-9-25.
[33]黄玉华,李焕平,陈雯玮,等.医院外来手术器械管理现状及清洗质量调查[J].护理研究,2013,27(6):1815-1817.
[2]Huter-Kunish GG.Processing loaner instruments in an ambulatory surgery center[J].AORNJ,2009,89(5):861-870.
[3]张宇,冯秀兰,任伍爱,等.中国9省市医院消毒供应中心3项标准执行现状与分析[J].中华医院感染学杂志,2014,24(10):2549-2551.
[4]陆蕾,董卫红,黄明芬.医院外来医疗器械管理存在的问题与对策[J].中华医院管理杂志,2014,30(5):370-371.
[5]周彬,巩玉秀,张宇,等.外来医疗器械与植入物处理现况分析[J].中国医院,2014,18(11):3-4.
[6]俞桂珍,叶旭琴,汤秋芳,等.外来医疗器械管理现状及管理对策研究[J].中华医院感染学杂志,2017,27(10):2393-2396.
[7]Seavey R.Reducing the risks associated with loaner instrumentation and implants[J].AORN J,2010,92(3):322-331.
[8]Nestman C,Mckinley M.Loaner instrument tray management:A shared responsibility[EB/OL].(2010-1)[2018-5].https://www.hpnonline.com/.
[9]Winthrop TG,Sion BA,Gaines C.Loaner instrumentation:processing the unknown[J].AORN J,2007,85(3):566-573.
[10]Young M.Putting teeth in your loaner set policy[J].ORManager,2011,27(9):22-23,26.
[11]Chobin N.Effective management of loaner instrumentation[J].Perioperative Nurs Clin,2010,5(3):393-396.
[12]Tosh PK,Disbot M,Duffy JM,et al.Outbreak of Pseudomonas aeruginosa surgical site infections after arthroscopic procedures:Texas,2009[J].Infect Control Hosp Epidemiol,2011,32(12):1179-1186.
[13]Lipscomb IP,Sihota AK,Keevil CW.Comparative study of surgical instruments from sterile-service departments for presence of residual gram-negative endotoxin and proteina-ceous deposits[J].J Clin Microbiol,2006,44(10):3728-3733.
[14]Rutala WA,Gergen MF,Jones JF,et al.Levels of microbial contamination on surgical instruments[J].Am J Infect Control,1998,26(2):143-145.
[15]Huys J.The sterile supply cycle:cleaning,sterilisation of medical devices by steam:general theory[M].Heart Consultancy,Renkum,The Netherlands,2006.
[16]刘卫红,周万丹.手术室外来器械的使用与管理现状调查[J].中国感染控制杂志,2008,7(4):264-265,271.
[17]张宇,冯秀兰,任伍爱,等.医院消毒供应中心落实三项标准的调查[J].中国感染控制杂志,2014,13(4):193-197.
[18]Association for the Advancement of Medical Instrumentation.ANSI/AAMI ST79:2006-Comprehensive guide to steam sterilization and sterility assurance in health care facilities[S].Arlington,VA:Association for the Advancement of Medical Instrumentation,2006,60.
[19]Graybill-D’Ercole P.Implementing AORN recommended practices for sterilization[J].AORN J,2013,97(5):521-533.
[20]Canadian Standards Association.CAN/CSA-Z314.3-09 Effective sterilization in health care facilities by the steam process[S].Rexdale,Ont.:Canadian Standards Association,2009.
[21]The Project Group Loaner Instrumentation.Professional standard for loaner instrumentation-Standard for loaning or renting of surgical instruments[S].Netherlands:The Project Group Loaner Instrumentation,2010.
[22]巩玉秀,冯秀兰,付强,等.医院消毒供应中心第1部分:管理规范WS310.1-2016[J].中国感染控制杂志,2017,16(9):887-892.
[23]黄浩,周晓丽,陈慧.超重器械包装及灭菌效果的实验研究[J].中国消毒学杂志,2013,30(6):577-578.
[24]Basu D.Reason behind wet pack after steam sterilization and its consequences:An overview from central sterile supply department of a cancer center in eastern India[J].J Infect Public Health,2017,10(2):235-239.
[25]王凤勤.外来骨科医疗器械接管中存在的问题与对策[J].护理实践与研究,2012,9(20):97-98.
[26]Association for the Advancement of Medical Instrumentation.AAMI TIR31:2008 Process challenge devices/test packs for use in health care facilities[R].AAMI,2008.
[27]Donlan RM.Biofilm formation:a clinically relevant microbiological process[J].Clin Infect Dis,2001,33(8):1387-1392.
[28]Edmiston CE,McBain AJ,Kiernan M,et al.A narrative review of microbial biofilm in postoperative surgical site infections:clinical presentation and treatment[J].J Wound Care,2016,25(12):693-702.
[29]Roberts CG.The role of biofilms in reprocessing medical devices[J].Am J Infect Control,2013,41(Suppl 5):S77-S80.
[30]Mittelman MW.Bacterial biofilms in pharmaceutical water systems[J].Drugs Pharmaceut Sci,2008,174:699.
[31]杨风,赵自云,杨杰书,等.外来手术器械使用后规范化处理探讨[J].中华医院感染学杂志,2015,25(15):3583-3585.
[32]Burns J.Loaner inventory management system and method:U.S.Patent Application 10/100,007[P].2003-9-25.
[33]黄玉华,李焕平,陈雯玮,等.医院外来手术器械管理现状及清洗质量调查[J].护理研究,2013,27(6):1815-1817.