Work

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

Year: 2016

Type: article

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.

Source: Artificial Organs

DOI: 10.1111/aor.12724

Authors: Salim E. Olia, Luke H. Herbertson, Richard A. Malinauskas, Marina V. Kameneva

Institutions: University of Pittsburgh, University of Pittsburgh Medical Center, McGowan Institute for Regenerative Medicine, United States Food and Drug Administration, Center for Devices and Radiological Health

Language: English

Topic: Mechanical Circulatory Support Devices

Subfield: Biomedical Engineering

Field: Engineering

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funder: National Heart, Lung, and Blood Institute