Issues in the implementation of the EN 62366-2007 standard for medical devices' usability and safety: A case study

Better systems of care are linked to the integration of increasingly innovative medical devices in healthcare environments. Since the ‘90s, the medical devices market has exploded (Feldman, Petersen, Karliner & Tice, 2007) and thus brought new opportunities for care. The quality of care, the patient safety and the overall healthcare systems have greatly improved. But although the benefits are undeniable, many systems have been accused of facilitating or generating medical errors that endanger patient safety. Incidents related to the integration of new medical devices in healthcare environments are regularly listed. The problem is that innovative and promising technologies can be ineffective, useless, costly and even dangerous when installed in real work situations. Problems of interactions between the users and the medical devices are said to cause most of these medical errors (IOM, 1999; Guiochet et al., 2007). In other words, the listed incidents would be due to usability problems of the device, for at least one third of them (Gupta, 2010).