A system safety approach for tomographic treatment

摘要

In recent years, technology in the medical industry has been advancing to provide safe and systematic medical care. However, medical technologies and treatments have also become more complicated, presenting new challenges for the traditional approaches used to engineer safety-critical systems. This research compares one of the most popular approaches in the medical device industry, Failure Mode and Effect Analysis (FMEA), with a relatively new method, System-Theoretic Process Analysis (STPA), in the context of a tomographic treatment system. STPA is found to be an effective means to ensure the quality of TomoTherapy and to conduct a holistic hazard analysis including both human and technical factors. A comparison of STPA and FMEA results found that STPA can identify a larger set of causal scenarios. The interactions of humans, hardware, and software were highlighted through the new STPA approach.