Risk Assessment in Hospitals Using the FMEA Method: A Data-Driven Analysis for Patient Safety Improvement

This study applies Failure Mode and Effects Analysis (FMEA) to assess and mitigate risks in key hospital departments, aiming to enhance patient safety and process reliability. Conducted in a ۴۰۰-bed tertiary hospital over a six-month period, the research focused on three high-risk units: the Intensive Care Unit (ICU), Operating Room (OR), and Pharmacy. Data were collected through incident reports, structured interviews, and process observations. For each failure mode, the Risk Priority Number (RPN) was calculated based on severity, occurrence, and detectability scores. In the ICU, alarm fatigue had the highest RPN (۳۳۶), signaling a critical need for smarter alarm systems. In the OR, incomplete time-out procedures posed the greatest risk (RPN: ۳۱۵), highlighting communication gaps. In the Pharmacy, look-alike/sound-alike (LASA) medications were the most dangerous (RPN: ۳۳۶), indicating the importance of system-based labeling and verification strategies. The study concludes that FMEA is a practical, data-driven approach for identifying latent hazards in hospital systems. Targeted interventions such as staff training, digital checklists, and barcode medication administration systems are recommended. Integrating FMEA with hospital information systems and routine quality audits can significantly improve patient safety outcomes and organizational resilience.

کلیدواژه ها:

Failure Mode and Effects Analysis (FMEA) ، Hospital Risk Management ، patient safety ، Risk Priority Number (RPN) ، Intensive Care Unit (ICU(