About FDA
Improving the Use of Computational Fluid Dynamic (CFD) Techniques to Evaluate Performance and Blood Damage Safety in Medical Devices
Description: The Office of Science and Engineering Laboratories’ Division of Solid and Fluid Mechanics (OSEL/DSFM) is leading an international effort to develop guidelines and provide a publicly-accessible repository of experimental data to make computational fluid dynamic (CFD) more effective for evaluating the safety of medical products by industry and FDA. CFD methods for describing flow patterns and fluid forces are increasingly being used in the development and premarket and postmarket evaluations of blood-contacting medical devices. However, this technology has limited usefulness due to the lack of reliable standardized techniques for assessing the validity and limitations of CFD simulations, and their predictions of blood damage. This project will make the necessary data and standards available for the use of this important tool.
Briefing Status: DELAYED
Prior Briefing Status: DELAYED
| Milestone Description | Milestone Date | Milestone Status | Milestone Completion Date |
|---|---|---|---|
| A. Update publicly-accessible data repository ( https://fdacfd.nci.nih.gov) with publications and reports on benchmark fluid flow patterns for future computational fluid dynamic (CFD) studies that will be submitted to CDRH |
4/30/2012 |
Completed | 4/5/2012 |
| B. Provide technical input to the draft American Society of Mechanical Engineers (ASME) standard “Verification and validation for computational modeling of medical devices” |
5/30/2012 |
Completed | 5/5/2012 |
| C. Complete study of Blood Pump Model |
11/30/2012 |
Delayed | |
| 1. Complete blood damage protocol for inter-laboratory testing |
4/30/2012 |
Completed | 4/30/2012 |
| 2. Complete quantitative flow visualization protocol for inter-laboratory testing |
5/30/2012 |
Completed | 5/29/2012 |
| 3. Complete blood damage inter-laboratory testing |
11/30/2012 |
Delayed | |
| 4. Complete quantitative flow visualization inter-laboratory testing |
11/30/2012 |
Delayed | |
| D. Complete study of Nozzle Model |
12/31/2012 |
Delayed | |
| 1. Complete assessment of CFD performance in simulations of FDA’s first computational inter-laboratory study |
3/31/2012 |
Completed | 3/30/2012 |
| 2. Complete analysis of inter-laboratory blood damage testing |
8/31/2012 |
Completed | 8/31/2012 |
| 3. Submit journal article on inter-laboratory CFD studies with sudden contraction at inlet |
12/31/2012 |
Delayed |
Key Projects Legend
| Milestone Status | Definition |
|---|---|
| Not Yet Started | Work for specific milestone has not yet been started. |
| Completed | Milestone and/or overall project is completed. |
| On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
| On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
| Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |
