Incident reports to BfArM support the importance of usability for patient safety

Due to various international regulations and standards medical devices are generally safe as far as mechanical or electrical characteristics are concerned. On the other hand the correct use of many medical devices is often a daily challenge for the operators and use errors caused by inadequate medical device usability have become an increasing cause for concern. As healthcare evolves, both less skilled users including patient themselves are now using medical devices as well as medical devices becoming more complicated [1]. Many of the medical devices developed without applying a usability engineering process are non-intuitive, difficult to learn and to use. In simpler times, the user of a medical device might be able to cope with an ambiguous, difficult-to-use user interface. Furthermore, in most of the complex work systems 70 to 80% of all failures are caused by human errors [2]. Several studies arrive to the conclusion that 50 to 80% of human errors are a result of a non adequate product design or complex working conditions [3]. Use errors are often supported or provoked by technology or working conditions. Since functionality and complexity of the medical devices increased during the last decades and safety mechanisms of the devices are not able to protect against use error the usability of medical devices has become a main issue for patient safety. The importance of usability is reflected by the facts that the FDA has started a human factors program, the Essential Requirements of the European Directive [4] a are amended as far as usability and ergonomics are concerned, and international standard organizations developed usability standards IEC 60601-1-6 [5] and IEC 62366. Analysis of the reports to BfArM demonstrates that incidents are caused at least partially by errors of device handling.