title: FDA Benchmark Medical Device Flow Models for CFD Validation.
abstract: Computational fluid dynamics (CFD) is increasingly being used to develop blood-contacting medical devices. However, the lack of standardized methods for validating CFD simulations and blood damage predictions limits its use in the safety evaluation of devices. Through a U.S. Food and Drug Administration (FDA) initiative, two benchmark models of typical device flow geometries (nozzle and centrifugal blood pump) were tested in multiple laboratories to provide experimental velocities, pressures, and hemolysis data to support CFD validation. In addition, computational simulations were performed by more than 20 independent groups to assess current CFD techniques. The primary goal of this article is to summarize the FDA initiative and to report recent findings from the benchmark blood pump model study. Discrepancies between CFD predicted velocities and those measured using particle image velocimetry most often occurred in regions of flow separation (e.g., downstream of the nozzle throat, and in the pump exit diffuser). For the six pump test conditions, 57% of the CFD predictions of pressure head were within one standard deviation of the mean measured values. Notably, only 37% of all CFD submissions contained hemolysis predictions. This project aided in the development of an FDA Guidance Document on factors to consider when reporting computational studies in medical device regulatory submissions. There is an accompanying podcast available for this article. Please visit the journal's Web site (www.asaiojournal.com) to listen.
authors.affiliation: From the *Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Food and Drug Administration, Silver Spring, Maryland; †Department of Biomedical Engineering, Rochester Institute of Technology, Rochester, New York; ‡Department of Cardiovascular Engineering, RWTH Aachen University, Aachen, Germany; and §Department of Biomedical Engineering, Pennsylvania State University, University Park, Pennsylvania.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Malinauskas
authors.forename: Prasanna
authors.initials: P
authors.lastname: Hariharan
authors.forename: Steven W
authors.initials: SW
authors.lastname: Day
authors.forename: Luke H
authors.initials: LH
authors.lastname: Herbertson
authors.forename: Martin
authors.initials: M
authors.lastname: Buesen
authors.forename: Ulrich
authors.initials: U
authors.lastname: Steinseifer
authors.forename: Kenneth I
authors.initials: KI
authors.lastname: Aycock
authors.forename: Bryan C
authors.initials: BC
authors.lastname: Good
authors.forename: Steven
authors.initials: S
authors.lastname: Deutsch
authors.forename: Keefe B
authors.initials: KB
authors.lastname: Manning
authors.forename: Brent A
authors.initials: BA
authors.lastname: Craven
mesh_terms: D019985:Benchmarking; D006353:Heart-Assist Devices; D006801:Humans; D057446:Hydrodynamics; D008962:Models, Theoretical; D012212:Rheology; D014481:United States; D014486:United States Food and Drug Administration