Proceedings of the
The 33rd European Safety and Reliability Conference (ESREL 2023)
3 – 8 September 2023, Southampton, UK
Optimizing Performance and Safety for a Particle Therapy Accelerator
EBG MedAustron GmbH, Wiener Neustadt, Austria.
ABSTRACT
Performance and safety are two key attributes of a medical device. Likewise in other sectors, the two attributes are generally inversely interdependent: the higher the performance, the lower the safety and vice versa. Because of that setting the two attributes is a matter of optimization. Performance and safety are analyzed and evaluated before the certification of the medical device respectively as benefits and risks. This is also performed for every design development by comparing the benefit-risk ratios, which must ideally increase or remain acceptable. This paper presents the methods for evaluating and optimizing benefits and risks that have been applied at MedAustron, including some results from selected performance increase projects.
Keywords: Medical device, Benefits-risks analysis, Risk management, Safety, Benefit/risk ratio, Optimization.
