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Inter-Laboratory Characterization of the Velocity Field in the FDA Blood Pump Model Using Particle Image Velocimetry (PIV)

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Abstract

Purpose

A credible computational fluid dynamics (CFD) model can play a meaningful role in evaluating the safety and performance of medical devices. A key step towards establishing model credibility is to first validate CFD models with benchmark experimental datasets to minimize model-form errors before applying the credibility assessment process to more complex medical devices. However, validation studies to establish benchmark datasets can be cost prohibitive and difficult to perform. The goal of this initiative sponsored by the U.S. Food and Drug Administration is to generate validation data for a simplified centrifugal pump that mimics blood flow characteristics commonly observed in ventricular assist devices.

Methods

The centrifugal blood pump model was made from clear acrylic and included an impeller, with four equally spaced, straight blades, supported by mechanical bearings. Particle Image Velocimetry (PIV) measurements were performed at several locations throughout the pump by three independent laboratories. A standard protocol was developed for the experiments to ensure that the flow conditions were comparable and to minimize systematic errors during PIV image acquisition and processing. Velocity fields were extracted at the pump entrance, blade passage area, back gap region, and at the outlet diffuser regions. A Newtonian blood analog fluid composed of sodium iodide, glycerin, and water was used as the working fluid. Velocity measurements were made for six different pump flow conditions, with the blood-equivalent flow rate ranging between 2.5 and 7 L/min for pump speeds of 2500 and 3500 rpm.

Results

Mean intra- and inter-laboratory variabilities in velocity were ~ 10% at the majority of the measurement locations inside the pump. However, the inter-laboratory variability increased to more than ~ 30% in the exit diffuser region. The variability between the three laboratories for the peak velocity magnitude in the diffuser region ranged from 5 to 25%. The bulk velocity field near the impeller changed proportionally with the rotational speed but was relatively unaffected by the pump flow rate. In contrast, flow in the exit diffuser region was sensitive to both the flow rate and the rotational speed. Specifically, at 3500 rpm, the exit jet tilted toward the inner wall of the diffuser at a flow rate of 2.5 L/min, but the jet tilted towards the outer wall when the flow rate was 7 L/min.

Conclusions

Inter-laboratory experimental mean velocity data (and the corresponding variance) were obtained for the FDA pump model and are available for download at https://nciphub.org/wiki/FDA_CFD. Experimental datasets from the inter-laboratory characterization of benchmark flow models, including the blood pump model presented herein and our previous nozzle model, can be used for validating future CFD studies and to collaboratively develop guidelines on best practices for verification, validation, uncertainty quantification, and credibility assessment of CFD simulations in the evaluation of medical devices (e.g. ASME V&V 40 standards working group).

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Acknowledgments

Our thanks to Dr. Tina Morrison at the FDA/Center for Devices and Radiological Health for review of the manuscript and helpful comments. Matthew Giarra (Rochester Institute of Technology) was the principal design engineer for the blood pump model, under the direction of Dr. Steven W. Day and in collaboration with Dr. Richard A. Malinauskas.

Conflict of Interest

All authors declare that they have no conflicts of interest.

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors.

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Authors and Affiliations

  1. Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, USA

    Prasanna Hariharan, Kenneth I. Aycock, Luke H. Herbertson, Brent A. Craven & Richard A. Malinauskas

  2. Pennsylvania State University, University Park, PA, USA

    Kenneth I. Aycock, Bryan C. Good & Keefe B. Manning

  3. RWTH Aachen University, Aachen, Germany

    Martin Buesen & Ulrich Steinseifer

  4. Rochester Institute of Technology, Rochester, NY, USA

    Steven W. Day

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  1. Prasanna Hariharan
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  2. Kenneth I. Aycock
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Correspondence to Prasanna Hariharan.

Additional information

Associate Editors David A. Steinman, Francesco Migliavacca, and Ajit P. Yoganathan oversaw the review of this article.

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Hariharan, P., Aycock, K.I., Buesen, M. et al. Inter-Laboratory Characterization of the Velocity Field in the FDA Blood Pump Model Using Particle Image Velocimetry (PIV). Cardiovasc Eng Tech 9, 623–640 (2018). https://doi.org/10.1007/s13239-018-00378-y

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