Results of FDA „Critical Path Initiative” to validate CFD
ASD Advanced Simulation & Design GmbH was one of 28 participants from 6 countries who contributed to an initiative of the U.S. Food and Drug Administration (FDA) aiming at the standardisation of Computational Fluid Dynamics (CFD) techniques used to evaluate performance and blood damage safety in medical devices:
The project goals are to
- - establish a guidance document for computational studies in device review
- - provide input into standards development for the use of computational fluid dynamics methods in medical device design and validation
- - serve as benchmarks for future research and development in this area
In a first step, a simple nozzle design was chosen to perform blood flow analysis for a sudden expansion and a conical diffuser: CFD results for velocity and pressure distributions are compared to quantitative flow visualisation measurements. Simulation-based haemolysis predictions (obtained from 11 institutions) will be compared with in-vitro blood damage experiments. A further part of this initiative will consist of the computational analysis of a ventricular assist device.
First results were published at the 2009 Annual Meeting of the American Society of Artifical Internal Organs in Dallas, USA.
A current survey about the improvement of flow modeling were summarized in a further poster.

