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To address this complex issue, FDA has partnered with academia and industry under the Critical Path Initiative program to advance the application of CFD technology in the development and evaluation of medical devices. This project is open to anyone who wishes to collaborate (in part or in full), comment, or provide suggestions.
In order to better understand the current state of the art of how CFD is applied to medical devices, a practical evaluation will be conducted of two different flow models, which were developed by the project’s Technical Steering Committee. Collaborators on the project may perform computational simulations of the two models using the parameters described in the detailed project plan; this is essentially a Round Robin investigation of virtual models. For comparison and validation of the computational simulations, three select laboratories will perform quantitative flow visualization measurements on physical models. The FDA will collect the data, analyze the results in a blinded fashion (i.e. the identification of the person who provides the data will be removed and replaced with a unique identifier), and then compare and present the collective results. The results will be available in a public database. Hence, the two models will also serve as benchmarks for future CFD evaluations.
Participants will also be invited to predict the amount of blood damage (i.e. hemolysis) which might occur in the models under different flow conditions. For comparison to the computational predictions, in vitro blood damage experiments will be performed on the models at three different laboratories. This important comparison will help to correlate computational predictions to actual biological results and safety assessments.
One goal of the project is to develop an FDA Guidance Document (and provide information for standard’s organizations) on the valid use of CFD in the evaluation of medical devices. This will be based on the techniques utilized, the results obtained, and the suggestions made by researchers in the performance of the CFD, flow visualization, and blood damage experiments for this project.
Please navigate to the CFD/Blood Damage Website to find updated information. We value your participation and suggestions, so please email us at cpi-cfd@fda.hhs.gov to find out more information on how to collaborate in the first Round robin, now underway.
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