A system safety approach for tomographic treatment. (October 2019)

• Record Type: Journal Article
• Authors: Yamaguchi, Shinichi; Thomas, John
• Is Part Of: Safety science. Volume 118(2019)
• Page Start: 772
• Page End: 782
• Publication Date: 2019-10
• Subjects: Tomographic treatment -- TomoTherapy -- System safety -- Hazard analysis -- FMEA -- STPA; Industrial accidents -- Periodicals; Accident Prevention -- Periodicals; Safety -- Periodicals; Travail -- Accidents -- Périodiques; 363.11
• DOI: 10.1016/j.ssci.2019.05.041
• Languages: English
• ISSNs: 0925-7535

Abstract

Highlights: A new systems approach to safety, called STPA, was demonstrated. STPA was found to holistically analyze system safety. The method highlights interactions between humans, hardware, and software. STPA identified a larger set of causal scenarios than FMEA. Abstract: 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.