Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry

To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.