FMECA and HFMEA of indoor air quality management in home mechanical ventilation

Risk analysis (RA) plays an important role in the development of safety-critical healthcare systems and numerous methods have been specifically designed for the risk analysis. As a matter of fact, these processes are complex, composed by many sub-processes and characterized by the presence of sophisticated technologies used in diagnoses and therapies. According to these considerations, the Clinical RA (CRA) techniques derive from those used in other complex industrial systems, adapted on concepts and settings typical of healthcare. Often the industrial risk analysis methods combine more risk analysis methods with the advantage of obtaining multi-views analysis exploiting the different focus points of each method. In this work, a particular critical aspect of home care service with high level of assistance has been analysed using the combination of Failure Mode Effects and Criticality Analysis (FMECA) and Healthcare Failure Mode Effects Analysis (HFMEA^TM). The results show that the use of both methods increases the efficiency of analysis because it highlights a more complete and effective set of criticalities and vulnerabilities.