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August 24, 2025

Preventing Operating Room Errors in Healthcare: A Risk-Based and Data-Driven Framework Using FMEA and Fault Tree Analysis

Key Points

Implementing a two-pronged framework effectively reduced surgical errors in operating rooms, improving overall safety.
Analysis of 120 surgical procedures identified instrument delays and medication mislabeling as key errors, with high Risk Priority Numbers.
Utilizing Failure Mode and Effects Analysis and Fault Tree Analysis provided a structured method to assess and address surgical errors.
Increasing compliance to checklists by 25% further highlights the importance of systematic safety measures in healthcare.

Abstract

Operation rooms (ORs) are characterized with high risks healthcare settings in which errors that can be avoided such as wrong-site surgeries as well as medication errors continue to occur even amid this safety procedures that are put in place. The presented study adopts a hybrid approach that combines the Failure Mode and Effects Analysis (FMEA) method with the Fault tree analysis (FTA) method to systematically analyze 120 surgical procedures to find out instrument-delays (24.2 percent) and medication-mislabeling (17.5 percent) as the most common surgical errors with Risk Priority Numbers (RPNs) of 192 and 189 respectively. Interventions aimed at the source of the errors were piloted in 30 cases, leading to the decrease in errors by 37.5 percent, RPNs by 24.1 percent, and an increase in checklists compliance by 25 percent. These results promote the idea that this two-pronged framework should be adopted by the institution, and instill psychological security and accountability in employees.

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