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.

IntraROB—a programmable targeting device for interventional radiology

“…The system is easy-to-use and does not considerably interfere to the clinical workflow. A first risk analysis of the complete system [7] did not come up with particular risks. A series of quantitative evaluation studies-for both US-and CT-guided biopsies-for different system setups (no/mechanical/optical tracker, remote controlled operation) is currently in process.…”

Role of robotic arm assistance in computed tomography guided bone biopsy

“…Examples include working in hazardous environments such as imaging rooms where radiation is used. 8 During fluoroscopic or CT guided procedures the operator frequently advances the cannula with the imaging beam off and then acquires additional images to identify the current position of the tip. Options to overcome the limitation of intermittent imaging include stand-off devices to keep the operator 's hands out of the direct xray beam.…”

Hazard analysis of an industrial upper‐body humanoid

“…In the area of hazard analysis of robots, some productive studies have been conducted. Korb et al (2003, 2005) reported the result of a hazard analysis for a prototypical surgical robot. They utilized such standard techniques as fault tree analysis (FTA), event tree analysis (ETA) and failure mode and effect analysis (FMEA).…”