Application of healthcare failure mode and effect analysis in controlling surgical instrument packaging defects.

ABSTRACT

Surgical instrument packaging defects may affect the safety of medical care and patients and waste the hospital workforce, material resources, and financial resources. This study explored the application of healthcare failure mode and effect analysis in controlling surgical instrument packaging defects. We retrospectively evaluated the packaging process of 183,642 surgical instruments packaged in our hospital during January-June 2020 using the healthcare failure mode and effect analysis. Besides, we used a decision tree model to determine the steps requiring improvement and formulate the improvement measures. We applied the improvement measures to 190,231 surgical instrument packs packaged in our hospital during July-December 2020. Based on the healthcare failure mode and effect analysis, we compared the packaging defect rates before and after adopting the improvement measures. Of the 183,642 packs selected before adopting the improvement measures, 98 defects occurred, with a defect rate of 0.053%. However, of the 190,231 packs selected after adopting the improvement measures, 22 defects occurred, with a defect rate of 0.012%. The defect rate of surgical instrument packaging handled by the central sterile supply department staff was significantly reduced (χ2 = 50.822, P = 0.001) after adopting the improvement measures. Using the medical failure mode and effect analysis method to control the defects in surgical instrument packaging can effectively reduce the packaging defect rate, ensuring patient safety.