The FDA Generic Centrifugal Blood Pump Model as a Benchmark for CFD Validation*

Computational fluid dynamics (CFD) is widely used in the design and assessment of medical devices. To be relied upon to inform regulatory decisions, however, CFD credibility must be established by performing verification and validation. Toward this end, FDA and academic collaborators established a benchmark centrifugal blood pump model for CFD validation. Interlaboratory validation experiments were conducted with the pump across a wide range of operating conditions to measure the pressure head and the velocity field using particle image velocimetry. Hemolysis experiments were also performed in a single laboratory to quantify the damage to red blood cells caused by the pump. Additionally, an open interlaboratory CFD study was conducted in which blinded participants from around the world submitted CFD simulation results of the pump for comparison with the experimental measurements. In this presentation, we provide an overview of the benchmark blood pump validation case and we summarize the results of the interlaboratory CFD study. The blood pump model and the experimental data are publicly available for use as a benchmark data set for CFD validation. This study also provides insight into the accuracy of CFD simulations of mechanical circulatory support devices from a wide range of users in the medical device community.