New Medical Technology Failure Mode and Effect Analysis Risk Assessment Implementation Rate FMEA
目的：应用失效模式与效应分析方法开展风险评估，持续改善新技术管理运行机制。方法：成立FMEA改善小组，梳理新技术管理流程中的关键环节，运用FMEA评估其高风险因素，制定集束化的改善措施。比较此流程改善前后风险系数（Risk Priority Number，RPN）值和新技术申报开展率。结果：应用FMEA管理后，新技术管理潜在失效模式的RPN值显著下降，新技术申报开展率由70.54%上升至82.05%，差异有统计学意义。结论：失效模式与效应分析方法能及时帮助医务管理部门对其识别出的风险问题做出提前干预，防范风险。
Objective：Using Failure Mode and Effects Analysis（FMEA）to carry out risk assessment and continuouslyimprove the operation mechanism of newtechnology management. Methods：FMEA quality improvement team was established to sort outthe key links of each sub process in thenew technologymanagement process，and to evaluate high-risk factors and formulate a cluster improvement plan. The risk priority number（RPN）value，implementation rate of new technology declarationwere compared. Results：After the application of FMEA to consumables management，the RPN value of failure modes was significantly decreased，the implementation rate of new technology application increased from 70.54% to 82.05%，and the difference was statistically significant. Conclusion：Using FMEA method can timely help medical managers intervene and control the identified risk in advance，prevent therisk in process management.