Resumen en español

The use of medical devices in the home environment, originally designed for hospital use has increased. Its use is complex and uncertain because of the inexperience of the lay user and the uncontrolled environment. The objective of this study is to evaluate the safety in the use of these devices through the creation of a conceptual model that identifies the risks that could arise for a group of lay users who operate them. Through a usability study and following the Grounded Theory methodology problems and errors were identified emerging through the home use of two different medical devices in order to create a conceptual model. The conceptual model obtained is reified as an evaluation tool that allows stakeholders to identify the most suitable medical device for a specific user, detecting the weaknesses that may lead to an unsafe use. The evaluation tool created effectively allows detecting risky characteristics, considering the particular situation of use.