Abstract
The application of medical devices is often combined with some risk. This risk needs to be evaluated and compared with the benefits: based on this, evaluation of the device needs to fulfil a certain safety integrity level.
On the basis of examples of failures of medical systems, some measures to overcome repetitive failures and to diminish their negative effects will be described. The use of a reporting procedure and a reporting system should help early recognition and removal of faults. Learning from incidents must be organized and users, producers and licensing bodies need to be involved. The design of medical devices needs to take careful consideration of the possible risks involved with the use of the devices, especially in the case of sophisticated devices and their use by inexperienced laypersons. The identification of user requirements, relevant application contexts and the associated assignment of the appropriate risk category are discussed.