'Patient Safety' tries to increase safety and transparency within healthcare systems for both patients and professionals. Within the healthcare sector, workflows become more and more complex, while time and money become scarce. As a consequence, the risk awareness, fault management and quality aspects become more important. One of the most well established risk assessment method is Failure Mode and Effect Analysis (FMEA) - a reliability analysis and risk assessment tool widely used in various industries. The traditional FMEA is using a Risk Priority Number (RPN) ranking system to evaluate and identify the risk level of failures, and to prioritize actions. However, there are several shortcomings in obtaining a quality estimate of the failure ratings with FMEA, especially when human factors play an important role. Thus, a new risk assessment method called HFdFMEA (Human Factor dependent FMEA) based on the dependency of used parameters and the observation of human factors, is proposed to address the drawbacks. The opportunity to improve patient safety is discussed as result of HFdFMEA.