失效模式和效应分析在种植手术高值耗材追溯管理中的应用  

The application of failure mode and effect analysis in the retrospective management of high-value consumables in implant operation

作　　者：周革霞 占莉琳[2] 章爱群[3] 应玉瑛[4] 黄静[1] 聂沁 

机构地区：[1]南昌大学护理学院,330006 [2]江西省口腔生物医学重点实验室南昌大学附属口腔医院修复科,330006 [3]南昌大学附属口腔医院门诊手术室,330006 [4]南昌大学附属口腔医院院感科,330006 [5]南昌大学附属口腔医院财务科,330006

出　　处：《中国实用护理杂志》2017年第31期2405-2409,共5页Chinese Journal of Practical Nursing

基　　金：江西省卫生和计划生育委员会科技计划项目（20171097）;南昌大学研究生创新专项资金项目（cx2016345）

摘　　要：目的 通过失效模式和效应分析（FMEA）对种植手术高值耗材管理流程进行追踪监测,建立种植手术高值耗材的可追溯管理流程.方法 应用FMEA对流程进行风险评估,制订具体改进措施,比较实施此流程管理前后风险优先指数（RPN）值、种植手术高值耗材管理指标合格率、患者满意度、不良事件上报例数.结果 应用FMEA进行种植手术高值耗材管理之后,追溯困难、信息记录问题、管理制度不完善等失效模式的RPN值显著下降,差异有统计学意义（t=16.655、10.664、9.321,P〈0.01）;管理后耗材准入符合规定率、质量管理指标信息记录完整率、库存耗材质量合格率、条码粘贴规范率、收费准确率、按时回访并记录率、耗材可追溯率、患者满意度等合格率分别为99.2%（373/376）、96.7%（363/376）、99.5%（374/376）、95.6%（361/376）、98.6%（371/376）、95.7%（360/376）、100.0%（376/376）、97.1%（365/376）,高于管理前的90.9%（355/390）、81.8%（319/390）、94.2%（367/390）、91.3%（356/390）、84.7%（330/390）、87.3%（341/390）、87.5%（342/390）、91.8%（358/390）,差异有统计学意义（χ2=7.149~49.371,P〈0.01）;耗材不良事件上报由0起上升到了5起.结论 应用FMEA模式对种植手术高值耗材进行前瞻性管理,对于提高医院管理水平和保障患者医疗安全是有效可行的.Objective The failure mode and effect analysis （FMEA） were used to monitor the managerial process of high-value consumables in the implantation surgery, and establish the traceable management process for high-value consumables of the implantation surgery. Methods FMEA was used to carry out risk assessment process, formulate specific measures for improvement. The risk priority number（RPN）,the qualified rate of the management index of implant surgical consumables,the patients satisfaction, and the number of adverse events reported were compared before and after the implementation of this process management. Results After FMEA was used to conduct management over implant surgery consumables,the RPN value decreased dramatically due to difficulty of traceability, information recording, and imperfect management system, thereby showing that the difference was statistically significant （t=16.655, 10.664, 9.321, P〈0.01）. Quality management measures： the access to consumables meets the requirements,complete information record,quality of stock consumables,paste bar code standard, charge accurate, return visits and records on time, consumables traceability, patient satisfaction rate were 99.2%（373/376）,96.7%（363/376）,99.5%（374/376）,95.6%（361/376）,98.6%（371/376）, 95.7% （360/376）, 100.0% （376/376）, 97.1% （365/376）, respectively after the implementation of this process management, which were higher than 90.9% （355/390）, 81.8% （319/390）, 94.2% （367/390）, 91.3% （356/390）,84.7%（330/390）,87.3%（341/390）,87.5%（342/390）,91.8%（358/390）before the implementation of this process management, thereby showing that the difference was statistically significant （χ2=7.149-49.371, P〈0.01）.The number of adverse consumables event reports increased from 0 up to 5. Conclusions It was feasible and effective to improve the level of hospital management and ensure the safety of patients by using the FMEA model in the implantation surgical high-value consumables.

关 键 词：失效模式与效应分析 手术耗材 手术室 

分 类 号：R47[医药卫生—护理学]