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Medical Device R&D

Blood Handling Safety & Performance

The safety and performance of many blood handling devices – such as dialysis machines or artificial hearts – are typically evaluated by measuring the damage they inflict upon red blood cells (RBC).  The chief indicator of this damage is the amount of hemolysis (cell rupture and hemoglobin release) induced by a device as it interacts with the blood. Free hemoglobin can induce toxic effects to organs, so designing devices with materials and configurations to minimize hemolysis is of paramount concern.

However, such hemocompatibility evaluations are hampered by two major problems: 1) variability in the fragility (susceptibility to hemolysis) of blood used for testing, even when multiple sources are pooled, owing to a wide range of factors; and 2) inability to ascertain sub-hemolytic damage that is not cell-lethal, but is nevertheless important to consider for precise and comprehensive evaluation.  Regarding the former, calibration of blood samples or sources thereof can facilitate “apples to apples” comparisons. And regarding the latter, both implantable and ex vivo medical devices can induce a range of effects associated with blood damage – long term hemolysis, bleeding, thrombosis – which immediate hemolysis alone cannot fully reflect. RBC mechanical fragility profiling of respective samples can both provide calibration for ordinary hemolysis testing plus offer more thorough reporting of RBC health.

Blaze’s technologies for RBC hemolysis measurement and mechanical fragility profiling can, respectively, improve the efficiency and the sensitivity of hemocompatibility assessments. This in turn can reduce post-market safety issues and shorten product development cycles for bringing safe devices to market.