Abstract
Purpose This study explores the application effects of medical failure mode and the analysis of device packaging quality defects. Methods In this study, a total of 183,642 equipment kits were assembled in our hospital from January to June 2020. Using medical failure mode and effect analysis methods, we retrospectively analyzed and evaluated the device packaging process. Besides, we used a decision tree model to determine the strategies that need to be acted upon and formulate improvement plans. We also selected a total of 1,90,231 assembly equipment packages in our hospital from July to December 2020, implemented the improved plan for packaging quality control, and compared medical failure modes, including the incidence of equipment packaging defects before and after the application of effective analysis. Results Before implementing medical failure mode and effect analysis, 1,83,642 equipment packages were assembled, 98 defects occurred, with a defect rate of 0.053%. However, after implementing medical failure mode and effect analysis to improve the packaging process, 1,90,231 device packages were assembled, 22 defects occurred, and the defect rate was 0.012%. The results showed that the packaging quality defects of the disinfection supply center were significantly reduced (χ2=50.822, P=0.001). Conclusion Using the medical failure mode and effect analysis method to control device packaging defects can effectively reduce the rate of device packaging quality defects, ensuring patient safety.