Risk analysis and safety assessment in surgical robotics: a case study on a biopsy robot.

One of the most important issues in medical robotics is safety and integration into the clinical workflow. If a robot is not safe and its use is complicated by difficult handling and complex user interfaces physicians would not use a robotic system during clinical patient trials, whatever the other advantages are. However, there are only few publications on this topic, in particular on risk management in developing a robotic prototype (for clinical trials). In this paper risk management and the safety of using robot-assisted surgery equipment are discussed and demonstrated exemplarily in the process of developing a prototype biopsy robot.