The hazard identification and safety insurance control (HISIC) for medical robot

摘要

A novel systematic methodology for the enhancement of safety of medical robot, in terms of hazard identification and safety insurance control (HISIC), is put forward in this paper. HISIC is to identify, evaluate, and control medical safety hazards based on 7 principles: definitions and requirements, hazard identification, safety insurance control, safety critical limits, monitoring and control, verification and validation, system log and documentation. HISIC tries to provide a standard for the safety of medical robots. Its initial implementation in a robot for urological application named URObot was successful. URObot in the authors' lab is a universal platform for 3D ultrasound image-guided interstitial laser coagulation (ILC), radiation seed implantation (RSI) and laser resection (LR) to treat the benign prostate hyperplasia (BPH) and prostate cancer. URObot is currently undergoing safety tests. HISIC improves URObot safety.