Integrated application of FMEA and PDCA cycle in prevention and control strategies for maternity ward infections
医疗质量工具耦合视角下的产房感染防控策略研究——FMEA与PDCA的交互效应分析

摘要

目的 探讨失效模式与效应分析（FMEA）联合PDCA循环法在产房感染防控中的实施效果。方法选取衢州市某基层专科医院2023年1月-2024年2月（对照组）与2024年5月-2025年4月（干预组）收治的产妇为研究对象，通过FMEA识别28项潜在失效模式并计算风险优先值（RPN），针对RPN≥400的6项高风险环节（手卫生依从性差、终末消毒遗漏等）制定PDCA循环改进方案，对比干预前后感染率及防控指标变化。结果 实施联合管理模式后，产妇医院感染率由4.2%降至0.9%（P<0.05）；手卫生依从率从83.4%提升至98.0%，消毒合格率由95.5%升至99.5%，产妇满意度提高4.5个百分点。结论 FMEA-PDCA联合模式通过量化风险识别与动态闭环管理，显著降低产房感染发生率，为产科感染防控提供了可复制的系统化解决方案。

Abstract

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.