基于UDI的医疗器械信息化管理系统的开发与应用  

Development and Application of Medical Device Information System Based on Unique Device Identification

作　　者：陈经涛 朱大伟[1] 袁海尚 CHEN Jingtao;ZHU Dawei;YUAN Haishang(Information Statistics Center,Huai’an Second People’s Hospital,Huai’an Jiangsu 223001,China)

机构地区：[1]淮安市第二人民医院信息统计中心,江苏淮安223001

出　　处：《中国医疗设备》2024年第5期66-72,98,共8页China Medical Devices

摘　　要：目的设计一种基于医疗器械唯一标识(Unique Device Identification,UDI)的医疗器械信息化管理系统,并探讨其在临床应用中的价值。方法基于国家药品监督管理局《医疗器械唯一标识系统规则》,使用C#语言结合SQL Server数据库开发基于C/S架构的医疗器械信息化管理系统,实现档案管理、资质管理、订单管理、库存管理、风险控制管理、溯源管理、使用管理和统计分析等功能,并探讨系统的应用效果。结果应用医疗器械信息化管理系统后,医疗器械库存周转率、使用率分别增加了11.37%、14.52%,医疗器械损耗率、产品不合格率以及产品退货率分别降低了3.18%、3.44%以及4.31%,且差异均有统计学意义(P<0.001);医疗器械库房人力投入下降效果显著,临床满意度增加了24.09%,且差异均有统计学意义(P<0.05)。结论UDI编码的实施可加速医疗器械信息化建设的发展,实现全生命周期管理,具有一定的借鉴和推广价值。Objective To design a medical device information management system based on unique device identification(UDI),and to discuss its value in clinical application.Methods Based on the Medical Device Unique Identification System Rules of the National Medical Products Administration,C#language combined with SQL Server database was used to develop a medical device information management system based on C/S architecture to achieve file management,qualification management,order management,inventory management,risk control management,traceability management,use management and statistical analysis.And the application effect of the system was discussed.Results After the implementation of the information management system,the inventory turnover rate,device utilization rate increased by 11.37%and 14.52%,respectively,the device loss rate,product unqualified rate and product return rate decreased by 3.18%,3.44%and 4.31%,respectively,and the differences were statistically significant(P<0.001).The decrease of manpower input in medical device warehouse was significant,and the clinical satisfaction increased by 24.09%,and the differences were statistically significant(P<0.05).Conclusion The implementation of UDI coding can accelerate the development of medical device informatization construction and achieve life cycle management,which has certain reference and promotion value.

关 键 词：医疗器械唯一标识 编码技术 资质管理 风险管控 库存周转率 

分 类 号：R197.32[医药卫生—卫生事业管理] TP311.5[医药卫生—公共卫生与预防医学]