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Projects Medical Devices

Wolfgang Lauer, Kathrin Lange, Klaus Liebl, Robin Seidel

Aims:
Research topics are closely connected with the “Medical Devices“ unit of BfArM. Any research activities focus on those scientific problems that result from the regulatory tasks in connection with medical devices. Beside the development and publication of scientific findings, the research group will concentrate on the utilisation of research findings in the regulatory work of the “Medical Devices“ unit. The research group under development is mainly concerned with two scientific topics:

I Data base supported risk identification and risk assessment for medical devices
Among other tasks the Medical Devices unit at BfArM is concerned with the approval of applications for conducting clinical studies with mostly new, innovative medical devices, and with the central registration, analysis and assessment of risk reports on devices being on the market. Timely and reliable identification and assessment of potential risks for patients, users, or third parties, requires the analysis of extensive complex and extremely heterogeneous data sets for potentially risk relevant patterns. Research is focussed on the development of intelligent, adaptive analytical algorithms and the efficient support of human risk assessment by tailored data analysis and supply of the results.

II Reduction of risks caused by application errors
Apart from the purely technical performance of a device, success or failure of device application depends largely on the ergonomic quality and usability of the device in the specified setting. The increasing technical complexity of medical devices and their application in clinical as well as domestic settings bring about new risks for errors in operation and application with potentially grave consequences. Therefore, minimisation of risks in the medical device area should also include the human factor, i.e. consider organisational and other elements influencing and limiting the human performance. Scientific topics in this area include the development of methods to identify and assess those factors that tend to provoke certain errors in device application and to prevent undesired incidents in the medical device work systems.