Participate in FDA Project to Predict Blood Flow in Medical Devices

By DE Editors

Round-robin 1: Conduct the first round robin test on the nozzle design (Sept. 2008 – Dec. 15, 2008).

The U.S. Food and Drug Administration (Washington, DC) invites collaboration in a project, "Standardization of Computational Fluid Dynamic (CFD) Techniques Used to Evaluate Performance and Blood Damage Safety in Medical Devices."

The purpose of this FDA Critical Path Initiative project is to determine how computational fluid dynamics (CFD) can be effectively used to characterize fluid flow and to predict blood damage in medical devices. 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.

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, 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.

Please navigate to the CFD/Blood Damage Website to find updated information (or e-mail [email protected] to collaborate in the first Round robin, now under way. In Round Robin 2, the plan is to conduct the second round robin test on the simple ventricular assist design (starting summer 2009).

To send comments or suggestions, e-mail the FDA.

Sources: Press materials received from the company and additional information gleaned from the company's website.