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Artif Organs. 2017 Feb;41(2):175-178. doi: 10.1111/aor.12724. Epub 2016 Apr 18.

A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing.

Author information

1
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
2
Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA.
3
Artificial Heart Program, University of Pittsburgh Medical Center, Pittsburgh, PA.
4
Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
5
Department of Surgery, University of Pittsburgh, Pittsburgh, PA, USA.

Abstract

Bench-top in vitro hemolysis testing is a fundamental tool during the design and regulatory safety evaluation of blood-contacting medical devices. While multiple published experimental protocols exist, descriptions of the test loop reservoir remain ambiguous. A critical fixture within the circuit, there is no readily available blood reservoir that ensures thorough mixing and complete air evacuation: two major factors which can affect results. As part of the Food and Drug Administration (FDA) Critical Path Initiative, we developed a three-piece reservoir consisting of a 3D-printed base, a plastic clamp set, and a medical-grade blood bag. This simple, reusable, and cost-effective design was used successfully in the hemolysis assessment of FDA benchmark nozzles and prototype rotary blood pumps, and may be useful as an integral component to any in vitro blood circulation loop.

KEYWORDS:

Blood reservoir; Cardiopulmonary bypass; In vitro hemolysis testing; Mechanical circulatory support devices

PMID:
27087363
PMCID:
PMC5069150
DOI:
10.1111/aor.12724
[Indexed for MEDLINE]
Free PMC Article

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