Application of failure mode and effects analysis combined with bundled management measures in reducing ICU-acquired...

To systematically evaluate the application value and implementation effectiveness of a Failure Mode and Effects Analysis (FMEA)-based bundled management strategy in the precise prevention and control of hospital-acquired infections (HAIs) in the Intensive Care Unit (ICU) of a specialized oncology hospital.

A single-cohort study with pre-post measurements was conducted in the ICU of a tertiary Grade A specialized oncology hospital. The pre-implementation period included 2,975 patients admitted from January to December 2024, receiving conventional HAI prevention and control measures. The post-implementation period included 1,522 patients admitted from January to June 2025, who received an FMEA-driven bundled management strategy in addition to conventional measures. A multidisciplinary FMEA team identified potential failure modes using the "Man, Machine, Material, Method, Environment, Measurement" framework. Risks were quantified using the Risk Priority Number (RPN = Severity × Occurrence × Detection), and high-risk failure modes (RPN ≥ 80) were targeted with multi-dimensional bundled interventions (e.g., multi-departmental coordination, stratified training, hand hygiene improvement). Outcomes included HAI incidence, device-associated infection rates [Ventilator-Associated Pneumonia (VAP), Central Line-Associated Bloodstream Infection (CLABSI), Catheter-Associated Urinary Tract Infection (CAUTI)], hand hygiene compliance, and environmental cleaning quality.

Following the intervention, overall HAI incidence decreased significantly from 2.6% (77 infections in 2,975 patients) to 1.6% (25 infections in 1,522 patients) (χ² = 4.062, P < 0.05), a relative reduction of 36.7%. Device-associated infection rates showed notable control: CAUTI decreased from 0.57‰ to 0, VAP from 1.69‰ to 0, and CLABSI remained low (0.28-0.27‰). Hand hygiene compliance among healthcare workers increased from 72.2 to 88.9% (χ² = 4.578, P < 0.05), an improvement of 23.1%. The 24-h removal rate of fluorescent markers for environmental cleaning assessment surged from 36.1 to 76.0%. RPN values for all six high-risk failure modes decreased substantially, with reductions ranging from 28.0 to 75.0%.

The FMEA-based bundled management strategy effectively identifies and mitigates high-risk vulnerabilities in ICU HAI prevention and control. It significantly reduces HAI and device-associated infection rates while improving hand hygiene compliance and environmental disinfection quality. This model provides an evidence-based paradigm for precise HAI prevention and control in specialized oncology hospital ICUs and holds high potential for broader clinical application.