Abstract: Objective: To analyze the application of Healthcare Failure Mode and Effect Analysis (HFMEA) in the process management of surgical emergency instruments, in order to further improve the management quality of medical devices in the operating room. Methods: A workflow chart for surgical emergency instruments was created, potential failure modes in the management process were identified, root causes were analyzed, action plans were developed and implemented, and outcomes were evaluated. Results: After the implementation of HFMEA, the accuracy rate of notifications for surgical emergency instruments improved from 91.44% to 99.04%; the completion rate of face-to-face handovers increased from 91.58% to 99.18%; and the on-time delivery rate rose from 90.82% to 99.49%. All these differences were statistically significant (P<0.001). Additionally, the turnover time between consecutive surgeries was reduced from (20.02 ± 2.06) min to (12.68 ± 2.02) min, a change that was also statistically significant (P<0.001). Conclusion: The application of HFMEA in the process management of surgical emergency instruments helps to standardize the handover and management between the operating room and central sterile service department. It effectively improves the turnover efficiency of surgical emergency instruments, shortens surgical table turnover time, and enhances the overall quality of operating room management.

Key words: Healthcare Failure Mode and Effect Analysis; surgical emergency instrument; process management