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Abstract Patient Safety (PS) is becoming a global concern since the past decade and a fundamental element of health care quality. It aims to prevent or reduce harm that might occur to patients while receiving health care services. Patient harm owed to adverse events (AEs) is one of the top ten reasons of mortality and incapacity globally. Creating safe patient care environment has placed a spotlight on preventable medical errors within healthcare organizations especially in complex health care settings such as critical care units (CCUs). Such settings represent high risk areas for AEs because of the nature of health care services, the large number of interventions performed, long clinical stays and the patients’ characteristics. Assessing the existing Patient Safety Culture (PSC) is essential for providing a ground for improving PS and quality of health care and to evaluate the impact of improvement interventions applied. Shifting PSC from blaming/ shaming one to a positive PSC is highly needed. This might be enhanced by using proactive risk assessment tools such as Failure Mode and Effect Analysis (FMEA). FMEA in the medical field is used to analyze health care processes to determine potential risks, assess their relative harmful effects and identify contributing factors to effectively deal with them hence improving healthcare quality. FMEA has been applied in several health care processes such as blood transfusion, IV drug administration and hemodialysis. |