First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics.

Abstract

Computational fluid dynamics (CFD) is increasingly important in biomedical engineering; however, its use in medical device design remains constrained by regulatory requirements for model validation and verification. To address this, the Food and Drug Administration (FDA) proposed a benchmark nozzle geometry for standardized validation. This study employs a turbulence-based hemolysis model-the Ozturk-Papavassiliou-O'Rear (OPO) model-to investigate the FDA nozzle and identify red blood cell (RBC)