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Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps.

ABSTRACT: Medical device manufacturers using computational modeling to support their device designs have traditionally been guided by internally developed modeling best practices. A lack of consensus on the evidentiary bar for model validation has hindered broader acceptance, particularly in regulatory areas. This has motivated the US Food and Drug Administration and the American Society of Mechanical Engineers (ASME), in partnership with medical device companies and software providers, to develop a structured approach for establishing the credibility of computational models for a specific use. Charged with this mission, the ASME V&V 40 Subcommittee on Verification and Validation (V&V) in Computational Modeling of Medical Devices developed a risk-informed credibility assessment framework; the main tenet of the framework is that the credibility requirements of a computational model should be commensurate with the risk associated with model use. This article provides an overview of the ASME V&V 40 standard and an example of the framework applied to a generic centrifugal blood pump, emphasizing how experimental evidence from in vitro testing can support computational modeling for device evaluation. Two different contexts of use for the same model are presented, which illustrate how model risk impacts the requirements on the V&V activities and outcomes.

SUBMITTER: Morrison TM

PROVIDER: S-EPMC6493688 | biostudies-literature | 2019 May/Jun

REPOSITORIES: biostudies-literature

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Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps.

Morrison Tina M TM Hariharan Prasanna P Funkhouser Chloe M CM Afshari Payman P Goodin Mark M Horner Marc M

ASAIO journal (American Society for Artificial Internal Organs : 1992) 20190501 4

Medical device manufacturers using computational modeling to support their device designs have traditionally been guided by internally developed modeling best practices. A lack of consensus on the evidentiary bar for model validation has hindered broader acceptance, particularly in regulatory areas. This has motivated the US Food and Drug Administration and the American Society of Mechanical Engineers (ASME), in partnership with medical device companies and software providers, to develop a struc ...[more]

PMID: 30973403

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Project description:BackgroundThe STM CP-24 I centrifugal pump is a newly developed centrifugal pump for extracorporeal membrane oxygenation equipment. This study aimed to combine hydraulic experiments, hemodynamic numerical simulations, and standard in vitro hemolysis experiments to investigate the comprehensive performance of this centrifugal pump.MethodsIn vitro experiments were first done to obtain the pressure-flow data of the centrifugal pump in its working range to evaluate its hydraulic performance. Next, the commonly used clinical working points were selected as boundary conditions, and a computational fluid dynamics method was applied to evaluate its hemodynamic performance. The blood pressure distribution, blood flow fields, and high-wall-shear-stress zones in the centrifugal pump were determined as indicators for hemodynamic evaluation. Finally, standard in vitro hemolysis experiments were performed to test the blood compatibility of this centrifugal pump (n=3 blood samples). In addition, its blood compatibility was evaluated in the form of the normalized index of hemolysis (NIH).ResultsThe pressure-flow curve of the centrifugal pump showed that the head pressure and flow of the centrifugal pump showed a mostly linear relationship within the whole working range. When the rotation speed of the centrifugal pump was 5,500 rpm, it achieved a hydraulic performance of 550 mmHg head pressure and 8 L/min output flow, which could meet the clinical needs of extracorporeal membrane oxygenation. Analysis of computational fluid dynamics data indicated that the centrifugal pump had excellent hemodynamic performance: even distribution of blood pressure in the pump, no blood flow stagnation zone or dead zone in the overall flow field, and secondary flows in the gap between the rotor and the volute that significantly reduced the volume of the low-blood-flow zone close to the impeller. There was no obvious high-shear-stress zone on the surface of the volute or the impeller, which will effectively reduce the risk of thrombosis. In vitro hemolysis experiments indicated that the centrifugal pump had excellent blood biocompatibility, with a NIH =0.0125±0.0022 g/100 L.ConclusionsThe STM CP-24 I centrifugal pump has excellent hydraulic performance, a reasonable design of the hemodynamic structure of the blood pump, and excellent blood compatibility. Therefore, it can meet clinical needs.

Dataset Information

Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps.

Publications

Assessing Computational Model Credibility Using a Risk-Based Framework: Application to Hemolysis in Centrifugal Blood Pumps.

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