Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool presents a lab method designed for a blood reservoir that can be easily integrated into the in vitro hemolysis testing of many medical devices. Please see appendix.
Technical Description
The three-piece reservoir consists of a 3D-printed base, a plastic clamp set, and a hemocompatible blood bag. This simple, reusable, and cost-effective design was successfully used in the hemolysis assessment of FDA benchmark nozzles and prototype rotary blood pumps, and it may be useful as an integral component to any in vitro blood circulation loop.
Bench-top in vitro hemolysis testing is a fundamental tool used during the design and regulatory safety evaluation of blood-contacting medical devices. While a number of experimental mechanical hemolysis test protocols have been published, for example ASTM F1841-19e1, descriptions of the test loop reservoir often remain ambiguous. Despite being a critical fixture within the test circuit, there was previously no readily available blood reservoir that ensures thorough mixing and complete air evacuation—two major factors which can affect results.
A full description of the reservoir design and manufacturing details is described in the instructions below. More details about the design are described in A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing - Olia - 2017 - Artificial Organs - Wiley Online Library.
Intended Purpose
The regulatory science tool, the small volume blood reservoir, is intended to be used as a key flow loop component for in vitro dynamic hemolysis testing such as the testing described in ASTM F1841-19e1 for evaluating the blood damage potential of medical devices.
Testing
This tool was successfully used as part of different flow loops in the hemolysis assessment of FDA benchmark nozzles and rotary blood pumps by the following laboratories:
- U.S. Food and Drug Administration
- University of Pittsburgh
- Rochester Institute of Technology
- Cleveland Clinic
The reusable, compliant, small volume blood reservoir was optimized to effectively help eliminate issues pertaining to inadequate mixing, air bubble entrainment, inlet collapse, and test sensitivity during in vitro dynamic hemolysis testing of medical devices. The use of this reservoir during hemolysis testing led to improved test reproducibility and blood mixing. Details about the quality of the hemolysis test data collected while using the blood reservoir can be found in FDA Benchmark Medical Device Flow Models for CFD Validation and Multilaboratory Study of Flow-Induced Hemolysis Using the FDA Benchmark Nozzle Model.
Limitations
Since the blood reservoir is only a single component within a typical in vitro hemolysis test set-up, the validity of the entire flow loop in evaluation of blood-contacting medical devices is beyond the scope of this tool.
Supporting Documentation
A full description of the reservoir design and manufacturing details are in the instructions below. A SolidWorks (.STL) file is also included to aid in 3D printing the reservoir base. More details about the design are available online: A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing - Olia - 2017 - Artificial Organs - Wiley Online Library.
Contact
Tool Reference
- In addition to citing relevant publications please reference the use of this tool using RST24CV09.01