Hazard analysis of EUCLIDIAN: an image-guided robotic brachytherapy system.

Robotic assistance can help clinicians to improve the flexibility of needle insertion and accuracy of seed deposition. However, the robotic platform is a safety critical system for its automated operational mode. Thus, it is important to perform Hazard Identification & Safety Insurance Control (HISIC) for securing the safety of a medical robotic system. In this paper, we have performed HISIC for our robotic platform, called Endo-Uro Computer Lattice for Intratumoral Delivery, Implementation, and Ablation with Nanosensing (ECLIDIAN). The definition and requirements of the system are described by Unified Modeling Language (UML). Failure Mode and Effect Analysis (FMEA) are executed for the principles of HISIC, such as hazard identification, safety insurance control, safety critical limit, monitoring and control. FMEA combined with UML can also be implemented to ensure reliability of the human operation. On the basis of safety control index and fuzzy mathematics, safety effective value is outlined to assess the validity of safety insurance control for robotic system. The above principles and methods are feasible and effective for hazard analysis during the development of the robotic system.