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

Abstract

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.