title: A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing.
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.
authors.affiliation: McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA, USA.|Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA.|Artificial Heart Program, University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Salim E
authors.initials: SE
authors.lastname: Olia
authors.affiliation: Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Luke H
authors.initials: LH
authors.lastname: Herbertson
authors.affiliation: Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Malinauskas
authors.affiliation: McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA, USA.|Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, USA.|Department of Surgery, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Marina V
authors.initials: MV
authors.lastname: Kameneva
mesh_terms: D001243:Assisted Circulation / Q000009:adverse effects* / Q000295:instrumentation; D002315:Cardiopulmonary Bypass / Q000009:adverse effects* / Q000295:instrumentation; D004867:Equipment Design; D004912:Erythrocytes / Q000473:pathology*; D006403:Hematologic Tests / Q000295:instrumentation; D006461:Hemolysis; D006801:Humans; D057446:Hydrodynamics
keywords: Blood reservoir; Cardiopulmonary bypass; In vitro hemolysis testing; Mechanical circulatory support devices