FMEA for Brachytherapy

This chapter describes the techniques and tools needed to perform failure modes and effects analysis (FMEA) and other safety strategies and give examples when applied to high-dose rate (HDR) gynecological brachytherapy and low-dose rate (LDR) breast brachytherapy. While it is agreed upon that there is no perfect method to eliminate all errors, FMEA is a risk analysis tool used in many industries, including medical device manufacturing, airline travel, nuclear power, etc. Recommendations from the American Association of Physicists in Medicine (AAPM) in their Task Group 100 report describe risk analysis such as FMEA and fault tree analysis. FMEA was first developed by the US military and an early adopter of this formalism was the US National Aeronautics and Space Administration (NASA) for a large number of its programs. It was then used by the civil airline industry and adopted by the Society for Automotive Engineers (SAE). Since then, FMEA has seen widespread adoption by a variety of industries.