Abstract：Objective To explore the effect of failure mode and effect analysis (FMEA) in the management of precision ophthalmic
surgical instruments. Methods 1358 pieces of ophthalmic precision surgical instruments before the implementation of FMEA
management from July to September 2020 were taken as the control group and 1905 pieces of ophthalmic precision surgical
instruments after the implementation of FMEA management from October to December 2020 were taken as the experimental group.
FMEA method was used to analyze the causes of faults in the reuse process of ophthalmic precision surgical instruments, formulate
the corresponding improvement scheme, and further supervise the implementation. Results Compared with the control group,
the experimental group were significantly improved (P<0.05). The failure rate of the experimental group was 0.73%, which was
significantly lower than that of the control group (1.91%). The difference was statistically significant (P<0.05). The equipment failure
of the experimental group was mainly caused by natural wear and tear, accounting for 71.43%, while that of the control group was
mainly caused by external forces, accounting for 73.08%. Conclusion The implementation of FMEA method can effectively find the
failure cause in the reuse process of ophthalmic precision surgical instruments. The targeted improvement measures can reduce the
failure rate of ophthalmic instruments ensure the smooth progress of ophthalmic surgery and the safety of medical care.
刘训俭a，颜繁诚b，王菲a. 基于失效模式和效应分析的眼科精密手术器械管理实践[J]. 中国医疗设备, 2022, 37(7): 111-115.
LIU Xunjiana, YAN Fanchengb, WANG Feia. Management Practice of Ophthalmic Precision Surgical Instruments Based on
Failure Mode and Effect Analysis. China Medical Devices, 2022, 37(7): 111-115.
