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Blood Studies for Cardiovascular System I: Cardiac Biomarkers01:20

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Microfluidics in Assessing Platelet Function
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Blood trauma testing for mechanical circulatory support devices.

Guruprasad A Giridharan1, Michael A Sobieski, Mickey Ising

  • 1Department of Bioengineering, University of Louisville, Louisville, KY, USA.

Biomedical Instrumentation & Technology
|August 5, 2011
PubMed
Summary

Standardizing preclinical hemolysis testing for mechanical circulatory support devices (MCSD) ensures consistent safety evaluations. This protocol aids FDA 510(k) approval by reducing variability in blood trauma assessment.

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Area of Science:

  • Biomedical Engineering
  • Medical Device Testing
  • Hematology

Background:

  • Preclinical hemolysis testing is crucial for FDA 510(k) approval of mechanical circulatory support devices (MCSD).
  • Existing guidelines from FDA and ASTM allow for significant variability in testing, hindering device comparison.
  • This variability complicates the assessment of blood trauma caused by test and predicate devices.

Purpose of the Study:

  • To present a standardized hemolysis testing protocol for MCSD.
  • To ensure adherence to FDA and ASTM guidelines while minimizing experimental variability.
  • To facilitate consistent and transparent blood trauma characterization for regulatory submissions.

Main Methods:

  • Utilized static mock flow loops with bovine blood (600 mL, Hct 27±5%, ACT >300 sec).
  • Maintained MCSD differential pressure at 80 mmHg and temperature at 25°±2° C.
  • Collected blood samples over 360 minutes to measure complete blood count (CBC) and plasma free hemoglobin.

Main Results:

  • The standardized protocol was successfully applied to two adult MCSD, leading to 510(k) approval.
  • The protocol has also been used for testing novel cannulae and a pediatric MCSD.
  • Demonstrated feasibility of consistent hemolysis testing across different device types.

Conclusions:

  • Standardized hemolysis testing procedures improve the characterization of blood trauma from MCS devices.
  • Transparent reporting of hemolysis data facilitates FDA 510(k) and PMA submissions.
  • Improved blood trauma assessment can lead to enhanced clinical outcomes for patients using MCSD.