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Evaluation of fluid warmer safety using hemorheologic analysis with outdated human blood
Hee Jung Kim1, Sung Mook Yoo2, Jae Ho Chung1
1Department of Thoracic and Cardiovascular Surgery, College of Medicine, Korea University, Seoul, South Korea.
Clinical Hemorheology and Microcirculation
|January 31, 2015
Summary
The ThermoSens® fluid warmer showed no significant red blood cell injury or negative rheology effects during laboratory testing. Hemorheologic analysis is a valuable tool for evaluating the safety of blood-contacting medical devices.
Area of Science:
- Biomedical Engineering
- Hematology
- Medical Device Safety
Background:
- Fluid warmers are essential for maintaining blood product temperature during transfusion.
- Direct blood warming plates, like in the ThermoSens®, may pose a risk of hemolysis or red blood cell (RBC) injury.
- Evaluating RBC rheology is crucial for assessing blood product viability after warming.
Purpose of the Study:
- To assess the safety of the ThermoSens® fluid warmer by evaluating its impact on hemolysis and erythrocyte rheology.
- To determine if direct blood warming causes significant RBC damage or alters blood flow properties.
- To investigate the utility of hemorheologic analysis in medical device safety evaluations.
Main Methods:
- Outdated human blood was used, with packed RBCs mixed with saline passed through the ThermoSens® warmer under gravity and 300 mmHg pressure.
- Blood samples were analyzed pre- and post-heating for hemolysis markers (hemoglobin, hematocrit, LDH, plasma free hemoglobin).
- Erythrocyte rheology parameters, including deformability, disaggregating shear stress, and aggregation index, were measured.
Main Results:
- Outlet temperatures exceeded 38°C under both gravity and pressure conditions.
- No significant differences were observed in most hemolysis markers or erythrocyte rheology parameters post-heating (p > 0.05).
- Lactate dehydrogenase (LDH) showed a significant increase at gravity flow (p = 0.0001), but other markers and rheology remained unaffected.
Conclusions:
- The ThermoSens® fluid warmer demonstrated safety, causing no significant erythrocyte injury or adverse rheological effects.
- Hemorheologic analysis provides a valuable method for assessing the safety of temperature-modulating medical devices that contact blood.
- Further research may explore the clinical implications of minor LDH changes in specific transfusion scenarios.