失效模式与效应分析在手术患者围术期安全核查中的应用

Application of Failure Mode and Effect Analysis in Perioperative Safety Check of Surgical Patients

摘要: 目的：评价失效模式与效应分析(Failure Mode and Effect Analysis, FMEA)在手术患者围术期安全核查中的应用效果。方法：根据FMEA方法，选取2020年1~6月的540例手术患者为对照组，2021年1~6月的540例手术患者为观察组，通过分析手术患者围术期安全核查流程的失效模式，确定13项失效模式为改善重点并制定整改措施，进一步比较失效模式与效应分析管理前后的风险优先指数(Risk Priority Number, RPN)及手术安全核查正确率、手术标识正确率，并评估整改的成效。结果：FMEA管理实施前后比较，RPN平均值从184下降至48.5；手术安全核查正确率从95.45%上升到99.42%，差异有统计学意义(P < 0.01)；手术标识正确率从98.84上升到99.90%，但差异无统计学意义(P ˃ 0.05)。结论：FMEA用于手术患者的围术期安全核查，有助于发现流程改进中的潜在缺陷，显著降低RPN指数并提高手术安全核查率。

Abstract: Objective: To evaluate the application effect of Failure Mode and Effect Analysis (FMEA) in perioperative safety check of surgical patients. Methods: Based on FMEA, 540 surgical patients from January to June 2020 were selected as the control group, and 540 surgical patients from January to June 2021 were served as the observation group. By analyzing the failure modes of the perioperative safety verification process of surgical patients, 13 failure modes were identified as the key points for improvement and corrective measures were developed. The Risk Priority Num-ber (RPN) before and after failure mode and effect analysis was compared, as well as the accuracy rate of surgical safety verification and surgical identification, and the effectiveness of recti-fication was evaluated. Results: The mean RPN value before and after FMEA management decreased from 184 to 48.5; the accuracy of surgical safety check increased from 95.45% to 99.42% with a statistical difference (P < 0.01); the correct rate of surgical identification increased from 98.84% to 99.90%, but no statistical difference was observed (P ˃ 0.05). Conclusion: As used for perioperative safety verification of surgical patients, FMEA is very helpful in identifying potential defects in process improvement, significantly reduces the risk priority index and increases the accuracy of surgical safety check.