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

Abstract

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.

• Medical robotics
• surgical manipulator
• risk analysis
• interventional radiology
• image guided surgery
• surgical robotics
• technology challenges
• man‐machine interaction