Reengineering of surgical inventory counting process based on HFMEA and effect evaluation
基于HFMEA的手术物品清点流程再造与效果评价

摘要

目的 借助医疗失效模式与效应分析（HFMEA）工具对手术室物品清点环节开展系统性风险识别，并对原有流程进行优化与再造，评估改进后流程在降低清点失误、提升手术运行效率与患者安全保障方面的实际应用效果。方法 成立HFMEA专项管理小组，梳理手术物品清点全流程，识别各环节潜在失效模式并计算风险优先指数（RPN），筛选高风险点并制定针对性改进策略；选取2025年1-6月采用传统清点流程的手术病例为对照组，2025年7-12月采用再造后流程的病例为观察组，对比两组RPN数值、清点差错发生率、操作耗时、流程执行合格率及不良事件发生情况。结果 观察组高风险失效模式RPN平均值由（301.6±24.3）下降至（48.5±8.7），清点差错率由0.82%降至0.09%，单次清点用时由（7.8±1.6）min缩短至（4.2±1.1）min，流程规范执行率由82.3%提升至98.7%，器械缺失、异物残留等手术清点物品清点不符发生率明显降低（均P<0.05）。结论 将HFMEA应用于手术物品清点流程再造，能够有效预判并降低安全风险，提高清点工作的准确性与规范性，对保障手术安全具有显著价值，适宜在手术室临床管理中推广使用。

Abstract

Objective To conduct systematic risk identification for the item counting process in the operating room using the Healthcare Failure Mode and Effect Analysis (HFMEA) tool, optimize and redesign the original process, and evaluate the practical application effect of the improvement in reducing counting errors, enhancing surgical operation efficiency, and ensuring patient safety.
Methods A special management team for HFMEA was established to review the entire process of surgical instrument counting, identify potential failure modes in each stage, calculate the Risk Priority Number (RPN), select high-risk points and formulate targeted improvement strategies; 2025 surgical cases using the traditional counting process were selected as the control group, and cases using the re-engineered process from July to December 2025 were selected as the observation group. The RPN values, error occurrence rate of counting, operation time, process execution qualification rate, and adverse event occurrence of the two groups were compared.
Results The average RPN value of high-risk failure modes in the observation group decreased from (301.6 ± 24.3) to (48.5 ± 8.7), the error rate of counting decreased from 0.82% to 0.09%, the single counting time was shortened from (7.8 ± 1.6) min to (4.2 ± 1.1) min, the execution rate of process standardization increased from 82.3% to 98.7%, and the occurrence rates of surgical item counting discrepancies such as missing items and residual foreign objects decreased significantly (all P < 0.05).
Conclusion   Applying HFMEA to the re-engineering of the surgical item counting process can effectively predict and reduce safety risks, improve the accuracy and standardization of the counting work, and has significant value in ensuring surgical safety. It is suitable for promotion and application in clinical management of the operating room.