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Updated: May 9, 2026

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
Clinical risk assessment in intensive care unit
Saeed Asefzadeh1, Mohammad H Yarmohammadian, Ahmad Nikpey
1Qazvin Research Center for Social Determinants of Health, Qazvin University of Medical Sciences, Qazvin, Iran.
This study used Failure Mode and Effect Analysis (FMEA) to identify 48 clinical risks in an ICU. Ventilator alarm malfunction was the highest risk, highlighting the need for effective clinical risk management.
Area of Science:
- Healthcare Quality Improvement
- Patient Safety Research
- Clinical Risk Management
Background:
- Clinical risk management is crucial for enhancing healthcare quality and patient safety.
- It involves identifying and mitigating risks that could lead to patient harm.
- This study aimed to apply Failure Mode and Effect Analysis (FMEA) in an Intensive Care Unit (ICU).
Purpose of the Study:
- To identify and assess potential failure modes within the ICU of Razi Hospital.
- To evaluate risks using the Failure Mode and Effect Analysis (FMEA) methodology.
- To improve patient safety through proactive risk identification and management.
Main Methods:
- A qualitative-quantitative research approach was employed.
- Focus Discussion Groups (FDGs) were conducted with knowledgeable individuals familiar with ICU processes.
- Data was systematically analyzed using the FMEA technique.
Main Results:
- Forty-eight distinct clinical errors and failure modes were identified.
- The highest Risk Probability Number (RPN) was associated with "Ventilator's alarm malfunction (no alarm)" (RPN=288).
- The lowest RPN was for "not washing the NG-Tube" (RPN=8), indicating a lower-priority risk.
Conclusions:
- Many identified clinical errors are preventable through collaborative efforts.
- Effective clinical risk assessment and management are fundamental to delivering high-quality healthcare.
- Proactive identification and mitigation of failure modes can significantly enhance patient safety in ICUs.
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