Yanrong Zhang,1,2 Ruixue Hu,1,2 Yanhua Chen,1,2 Xiaoxiao Liu,1,2 Jin Wu,1,2 Liangying Yi1,2 

1Department of Sterile Processing Nursing, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, People’s Republic of China; 2Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, Sichuan, People’s Republic of China

Correspondence: Liangying Yi, Department of Sterile Processing Nursing, West China Second University Hospital, Sichuan University, No. 20 Section 3, South Renmin Road, Chengdu, Sichuan, 610041, People’s Republic of China, Email yiliangying88@163.com

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.

Keywords: healthcare failure mode and effects analysis, central sterile supply department, pressure steam sterilization, quality defects