International Journal of Clinical Research

Objective To explore the implementation effectiveness of integrating Failure Mode and Effects Analysis (FMEA) with the PDCA cycle in infection prevention and control within maternity wards. Methods This study enrolled parturients admitted to A Community-Based Specialized Hospital in Quzhou from January 2023 to February 2024 (control group) and May 2024 to April 2025 (intervention group). Through FMEA, 28 potential failure modes were identified, and Risk Priority Numbers (RPNs) were calculated. Six high-risk processes (e.g., poor hand hygiene compliance and incomplete terminal disinfection) with RPN ≥ 400 were targeted for PDCA-driven improvement plans. Changes in infection rates and prevention indicators before and after the intervention were compared. Results After implementing the integrated management model, the maternal hospital-acquired infection rate decreased from 4.2% to 0.9% (P< 0.05). Hand hygiene compliance improved from 83.4% to 98.0%, disinfection qualification rate increased from 95.5% to 99.5%, and maternal satisfaction rose by 4.5 percentage points. Conclusion The FMEA-PDCA integrated model significantly reduces infection incidence in maternity wards through quantitative risk identification and dynamic closed-loop management, providing a replicable, systematic solution for obstetric infection prevention and control.

Failure mode and effects analysis (FMEA); PDCA cycle; Maternity ward infection; Risk priority number (RPN); Closed-loop management