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Abstract: SA-PO1109

Novel Dialyzer Flushing for Patient Safety

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Poppe, Clayton, Diality, Inc, I, California, United States
  • D'Alessandri-Silva, Cynthia J., Diality, Inc, I, California, United States
  • Pflager, Marie, Diality, Inc, I, California, United States
Background

Clinical practice is to prime dialyzers with saline to remove residuals such as air and chemical contaminants; improving dialysis adequacy, decreasing hypersensitivity reactions and clotting. The Standard Flow (SF) described in dialyzers routes saline through the blood compartment in a single direction. DialityTM has developed an alternative Cross Flow (CF) for flushing that routes saline from the arterial blood connection to the dialysate side-ports, purposed to more effectively clear harmful residuals. This study compared residual removal between the SF and CF methods using Total Organic Carbon (TOC) as the primary endpoint.

Methods

High-flux dialyzers were tested under two different priming configurations: SF and CF. USP-grade saline was pushed through the dialyzer to prime. Samples collected for the TOC of the priming fluid (Test Scenario 1) and samples collected for TOC in the fluid that is introduced to the patient at treatment (Test Scenario 2). The acceptance criterion was ≤500 ppb TOC, consistent with Water for Injection limits.

Results

In Scenario 1, CF removed approximately 58% more TOC during priming than SF (5,010 ppb vs. 3,165 ppb average). Scenario 2, CF reduced average patient-contact TOC by approximately 80% relative to SF (20.02 ppb vs. 97.77 ppb). All CF results <500-ppb threshold, while SF produced at least one sample above the limit. See images.

Conclusion

DialityTM's new CF priming yields meaningful improvement over SF in removing residuals from high-flux dialyzers. Early data support the hypothesis that CF priming enhances interaction between saline and membrane-bound residuals beyond what axial flushing achieves. Analysis of patient-contact fluids suggests a safety advantage in mitigating bio-incompatibility and hypersensitivity risks. These findings warrant continued evaluation across diverse dialyzer types to establish a higher standard for patient safety in dialysis.