基于GS1医疗器械唯一标识的医用耗材信息化管理体系建设与实践
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摘要
目的基于GS1标准的医疗器械唯一标识来构建医院医用耗材全流程信息化管理体系。方法通过改造物资管理信息系统、增加GS1条码识别模块并与供应商平台、HIS系统、LIS系统和第三方SPD配送系统对接,来打造医用耗材院内、院外唯一识别码的全流程双向追溯和临床使用监管体系。结果实现植介入、高值耗材和一对一收费低值耗材的GS1标准的医疗器械唯一标识管理,并以GS1唯一标识为桥梁实现医用耗材管理多个信息系统的互联互通。结论基于GS1医疗器械唯一标识的医用耗材信息化管理体系提高医用耗材物流管理效率和精细度,降低供应商或医院物流管理成本,为实现院外耗材追溯打下良好的标准化基础。
Objective The aim of this study was to construct a hospital-based medical consumables full-process informatization management system based on GS1 unique device identification. Methods We design and construct a medical consumables full-process and two-way traceability system both inside and outside hospital and a medical consumables regulatory system on clinical application by means of improving the material management information system, adding the GS1 barcode recognition module and interfacing Supplier information platform, HIS, LIS and Third-party SPD distribution system with medical consumables management information system. Results All of implanted or high-price or chargeable low-price medical devices have been involved in unique device identification management of GS1 standard in the hospital, moreover GS1 unique device identification has been used as the bridge to bind multiple information systems related to medical consumables management together.Conclusion The medical consumables informatization management system based on GS1 unique device identification is capable of reducing the logistics management cost of suppliers or hospitals, improving the logistics management efficiency and accuracy of medical consumables and providing a consolidated foundation of standardization for prospective traceability outside the hospital.
Objective The aim of this study was to construct a hospital-based medical consumables full-process informatization management system based on GS1 unique device identification. Methods We design and construct a medical consumables full-process and two-way traceability system both inside and outside hospital and a medical consumables regulatory system on clinical application by means of improving the material management information system, adding the GS1 barcode recognition module and interfacing Supplier information platform, HIS, LIS and Third-party SPD distribution system with medical consumables management information system. Results All of implanted or high-price or chargeable low-price medical devices have been involved in unique device identification management of GS1 standard in the hospital, moreover GS1 unique device identification has been used as the bridge to bind multiple information systems related to medical consumables management together.Conclusion The medical consumables informatization management system based on GS1 unique device identification is capable of reducing the logistics management cost of suppliers or hospitals, improving the logistics management efficiency and accuracy of medical consumables and providing a consolidated foundation of standardization for prospective traceability outside the hospital.
引文
[1]郑敏.医用耗材的规范性管理探讨[J].中国社区医师(医学专业),2012,14(35):336-337.
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[5]廖春花,曹扬,邹庆辉,等.条码技术在手术室高值医用耗材管理中的应用[J].中国医学工程,2018,26(08):33-36.
[6]林洁,张尉.医用耗材费用管理与利益相关者博弈分析[J].中国医学装备,2017,14(2):112-115.
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[8]U.S.Food and Drug Administration.Unique Device Identification System[EB/OL].(2013-09-24)[2019-02-15].https://www federalregister.gov/documents/2013/09/24/2013-23059/uniquedevice-identification-system.
[9]中国物品编码中心.国家物品编码体系/GS1系统[EB/OL].(2008-07-01)[2019-02-15].http://www.gs1cn.org/Knowledge/GS1System2.aspx.
[10]蒋昌松,刘晓华,薛昕昀,等.基于GS1扫码出入库的医院医用耗材智能物流技术研究[C].中华医学会医学工程学分会第十五次全国学术年会,2015:4.
[11]GB 12904-2008,商品条码零售商品编码与条码表示[S].
[12]GB/T 16986-2018商品条码应用标识符[S].
[13]GB/T 16830-2008,商品条码储运包装商品编码与条码表示[S].
[14]GS1 AISBL.GS1 General Specifications[EB/OL].(2019-01)[2019-02-15].https://www.gs1.org/sites/default/files/docs/barcodes/GS1_General_Specifications.pdf.
[15]韩洁,陈媛媛,王晓燕,等.细节管理在脊柱外科医用低值耗材收费中的实施效果分析[J].当代护士(上旬刊),2018,25(09):186-187.
[16]Thomas Ebel.Strength in unity:The promise of global standards in healthcare[R].McKinsey&Company,2012.
[2]伍洪,韩旭.高值医用消耗材料条码管理系统应用的再探讨[J]中国医学装备,2011,8(4):42-44.
[3]朱胜军.条码技术在高值医用耗材管理中的应用[J].中国医疗器械杂志,2012,36(02):136-139.
[4]徐鸿,向明华.医院医用试剂管理系统的开发与应用[J].中国医疗设备,2017,32(01):139-141.
[5]廖春花,曹扬,邹庆辉,等.条码技术在手术室高值医用耗材管理中的应用[J].中国医学工程,2018,26(08):33-36.
[6]林洁,张尉.医用耗材费用管理与利益相关者博弈分析[J].中国医学装备,2017,14(2):112-115.
[7]IMDRF UDI Working Group.UDI Guidance Unique Device Identification(UDI)of Medical Devices[R].International Medical Device Regulators Forum,2013.
[8]U.S.Food and Drug Administration.Unique Device Identification System[EB/OL].(2013-09-24)[2019-02-15].https://www federalregister.gov/documents/2013/09/24/2013-23059/uniquedevice-identification-system.
[9]中国物品编码中心.国家物品编码体系/GS1系统[EB/OL].(2008-07-01)[2019-02-15].http://www.gs1cn.org/Knowledge/GS1System2.aspx.
[10]蒋昌松,刘晓华,薛昕昀,等.基于GS1扫码出入库的医院医用耗材智能物流技术研究[C].中华医学会医学工程学分会第十五次全国学术年会,2015:4.
[11]GB 12904-2008,商品条码零售商品编码与条码表示[S].
[12]GB/T 16986-2018商品条码应用标识符[S].
[13]GB/T 16830-2008,商品条码储运包装商品编码与条码表示[S].
[14]GS1 AISBL.GS1 General Specifications[EB/OL].(2019-01)[2019-02-15].https://www.gs1.org/sites/default/files/docs/barcodes/GS1_General_Specifications.pdf.
[15]韩洁,陈媛媛,王晓燕,等.细节管理在脊柱外科医用低值耗材收费中的实施效果分析[J].当代护士(上旬刊),2018,25(09):186-187.
[16]Thomas Ebel.Strength in unity:The promise of global standards in healthcare[R].McKinsey&Company,2012.