CPS: Small: A Framework for Validation and Monitoring of Robotic Surgery Systems

点击翻译按钮获取中文摘要

Complex surgical procedures in hospitals are increasingly aided by robotic surgery systems, often at the request of patients. These systems allow greatly increased precision, reach and flexibility to the surgeon. However, their powerful capabilities entail substantial system complexity in both hardware and software. The high probability of serious injuries should a malfunction occur calls for rigorous assessment and monitoring of the reliability and safety of these cyber-physical systems.In this research project, a framework for assessing and monitoring the reliability and safety of robotic surgery systems during development, field testing, and general deployment is being developed. The proposed framework complements existing techniques used in earlier phases of validation by taking into account how surgeons actually use a robotic surgery system, how it is affected by operating conditions, and how its observable behavior is related to its hardware and software dynamics.Before deployment, this framework uses accurate simulations to assess pre-clinical reliability. After deployment, the framework uses data collection through online monitoring of the system as it is being used in the field, followed by analysis to obtain assessments of operational reliability and safety. The collected data is also used to improve the simulations for future testing. The framework also aims to support post-market surveillance of these systems by providing a workable basis for reassessing reliability and safety properties after system maintenance.The developed tools and methods will also have applications in the validation of safety and reliability of other medical devices with embedded software and other cyber-physical systems in general.