ABSTRACT
Missing or false device alarms pose a risk in clinical practice. Publications from the United States suggest that alarm errors are not only caused by technical issues but to a considerable degree result from user-device interaction problems. To safely operate a medical device, users have to thoroughly understand both device behavior and device functioning. They also need to foresee the exact consequences of their interactions with the device. This can be challenging, especially if a device has multiple functions, is applied in various use contexts or networked with other devices - as is often the case with patient monitors. In this case, human error in operating a device may not necessarily be detected, but is experienced as device failure. If medical device failures occur in German hospitals that are associated with a risk to the patient, the user, or other persons, they have to be reported to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). In the present study, we analyzed reports to the BfArM (received between 01/2009 and 12/2015) about loss or failure of the alarm function of patient monitors. It was found that the perceived 'faulty' behavior of the device was the device's intended behavior in almost half of these reports. Hence, the person who detected this fault was not sufficiently acquainted with the device and/or its configuration. Examples of knowledge deficits related to various aspects of device knowledge. Further studies are needed to find out whether these findings are suggestive of more general knowledge deficits among clinical staff and to explore the underlying reasons.
