Improving Pressure Steam Sterilization Quality Through Healthcare Failure Mode and Effects Analysis: A Pre-Post Intervention Study in Central Sterile Supply Departments.

OBJECTIVE

To evaluate the effectiveness of Healthcare Failure Mode and Effects Analysis (HFMEA) in reducing quality defects during pressure steam sterilization in the Central Sterile Supply Department (CSSD).

METHODS

The study followed a structured HFMEA framework: (1) A multidisciplinary team (n=7) with CSSD expertise was established to analyze sterilization workflows, including instrument scanning, sterilization verification, and post-sterilization cooling. (2) Process mapping and risk prioritization were conducted using a 4-level severity/occurrence matrix (adapted from Australian clinical risk criteria) to calculate Risk Priority Numbers (RPN=Severity×Occurrence). High-risk failure modes (RPN≥8 or severity=4) were identified, including unlabeled "non-sterilized" packages (due to incomplete scanning), wet packages (from insufficient cooling<30 minutes), and unverified sterilization information. (3) Root causes were analyzed via fishbone diagrams (human, machine, material, environment, method). Targeted interventions included: optimizing the traceability system with department-specific alerts, standardizing scanning protocols, staff retraining on verification procedures, increasing instrument inventory and sterilizer racks, and implementing performance monitoring with 5W1H checklists.

RESULTS

Pre-intervention, 87 defects were identified among 185,382 sterilization packages (32 unlabeled "non-sterilized", 10 wet packages). Post-intervention, defects decreased to 11/189,531 packages (χ²=115.556, P<0.001), including 4 unlabeled (χ²=374.951, P<0.001) and 2 wet packages (χ²=8.889, P=0.003).

CONCLUSION

Systematic HFMEA application reduced sterilization defects by addressing critical workflow gaps, demonstrating its value in enhancing CSSD quality control and patient safety.