Abstract

National and international efforts under the initiative ‘patient safety’ aim for more 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 the consequence, the risk awareness, fault management and quality aspects in general become more important. One of the most established risk assessment methods 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 shortcomings in obtaining a quality estimate of the failure ratings with FMEA, especially when human factors play a role, as it is in healthcare. Thus, a new risk assessment method named HFdFMEA (Human Factor dependent FMEA) based on dependency of used parameters and observation of human factors, is proposed to address these drawbacks. The results of this paper show that the HFdFMEA does not only increase risk level of failures based on the inclusion of human-factors but also gives the possibility to reduce the risk level of failures through means of addressing human-factors via trainings, motivation, etc. Finally, we discuss the opportunity to improve patient safety as result of the proposed HFdFMEA, used as technique for Human-Factor-based Risk Management (RiDeM).

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