Precautionary Recommendation System in Risk Management: A FMEA-Based Approach

Area of Science:

• Healthcare Risk Management
• Medical Device Safety
• Clinical Engineering

Background:

• Failure Mode and Effects Analysis (FMEA) is a common risk management tool.
• Current FMEA methods, like Risk Priority Number (RPN), lack systematic guidance for selecting appropriate precautions.
• This gap hinders effective risk mitigation in critical healthcare settings.

Purpose of the Study:

• To introduce a novel rule-based FMEA model for systematic precaution selection.
• To address the limitations of traditional FMEA in guiding specific risk control measures.
• To enhance decision-making in healthcare risk management.

Main Methods:

• Developed a multi-dimensional rule-based FMEA model incorporating numerical parameters (probability, severity, detectability, RPN) and contextual variables.
• Structured the model based on the Occupational Health and Safety precaution hierarchy, defining six precaution classes.
• Validated the model's consistency, sensitivity, and applicability in a Neonatal Intensive Care Unit (NICU) setting.

Main Results:

• The FMEA identified 24 infection-related failure modes in the NICU.
• Contextual variables significantly impacted recommended precautions, with administrative and training measures being most frequent.
• Personal Protective Equipment (PPE) was consistently advised for exposure risks, and expert evaluation showed 95.8% agreement.

Conclusions:

• A rule-based system provides a repeatable and explainable decision-support tool for FMEA.
• This approach is particularly valuable in high-risk environments like healthcare.
• The study contributes a novel method for enhancing FMEA's practical application in patient safety.