Malinauskas Richard A, Hariharan Prasanna, Day Steven W, Herbertson Luke H, Buesen Martin, Steinseifer Ulrich, Aycock Kenneth I, Good Bryan C, Deutsch Steven, Manning Keefe B, Craven Brent A
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.
ASAIO J. 2017 Mar/Apr;63(2):150-160. doi: 10.1097/MAT.0000000000000499.
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.
计算流体动力学（CFD）越来越多地用于开发与血液接触的医疗设备。然而，缺乏用于验证CFD模拟和血液损伤预测的标准化方法限制了其在设备安全评估中的应用。通过美国食品药品监督管理局（FDA）的一项倡议，在多个实验室对两种典型设备流动几何形状（喷嘴和离心血泵）的基准模型进行了测试，以提供实验速度、压力和溶血数据，以支持CFD验证。此外，20多个独立团队进行了计算模拟，以评估当前的CFD技术。本文的主要目的是总结FDA的倡议，并报告基准血泵模型研究的最新发现。CFD预测速度与使用粒子图像测速法测量的速度之间的差异最常出现在流动分离区域（例如，喷嘴喉部下游和泵出口扩散器中）。对于六种泵测试条件，57%的CFD压头预测值在平均测量值的一个标准差范围内。值得注意的是，所有CFD提交内容中只有37%包含溶血预测。该项目有助于制定FDA关于在医疗器械监管提交文件中报告计算研究时应考虑因素的指导文件。本文配有播客。请访问该期刊的网站（www.asaiojournal.com）收听。
