Application of failure modes and effects analysis combined with the PDCA cycle in infection prevention and control in the operating room

Abstract

Objective: To evaluate the impact of integrating failure modes and effects analysis (FMEA) with the Plan-Do-Check-Act (PDCA) cycle on infection prevention and control (IPC) in the operating room (OR) and to establish a structured risk surveillance and management framework.

Methodology: This was a retrospective study. It was conducted in the laminar air flow(LAF) OR of The 82nd Army Group Hospital of the PLA from January 2025 to January 2026, which performs more than 7,000 surgical procedures annually across multiple surgical specialties. The study employed a comprehensive approach incorporating literature review, structured surveys, and brainstorming. Through FMEA, potential nosocomial infection risks in the OR were systematically identified, quantitatively analyzed, and prioritized using risk priority numbers(RPNs). Targeted interventions were then formulated and implemented using the PDCA cycle.

Results: Thirty-eight potential failure modes were identified. Six high-risk failure modes with RPN values >125 were selected for prioritized risk mitigation. Through effective risk control, the RPN values for all six high-risk failure modes decreased to <125. Compliance with standardized surgical hand antisepsis increased from 62.5% to 87.5%. The success rate of adenosine triphosphate testing after surgical hand antisepsis rose from 64.29% to 89.29%. Hand hygiene compliance improved from 44% to 78%. Adherence to aseptic operations increased from 62.5% to 87.5%. All observed differences were statistically significant(all P< 0.05).

Conclusion: The integration of FMEA with the PDCA cycle can facilitate IPC in the OR via a pertinent infection risk surveillance and management system and improve the quality of IPC in the OR.