Kidney Week

Abstract: SA-PO387

Implausible Hemolysis with the New Chinese Standard for Testing Dialyzer Hemocompatibility

Session Information

• Hemodialysis and Frequent Dialysis - 2
  October 26, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Krieter, Detlef H., University Hospital Würzburg, Nephrology, Würzburg, Germany

Detlef H. Krieter, MD

• Rueth, Marieke, eXcorLab GmbH, Obernburg, Germany

Marieke Rueth, PhD

• Lemke, Horst-Dieter, eXcorLab GmbH, Obernburg, Germany

Horst-Dieter Lemke, PhD

• Wanner, Christoph, University Hospital Würzburg, Nephrology, Würzburg, Germany

Christoph Wanner, MD

Background

A new standard for testing dialyzer hemocompatibility (YY/T 1920-2023) has been introduced in China. With current international standards (e.g., EN ISO 10993-4 and ASTM F756) and the previous Chinese Standard (GB/T 14233.2 (2005)), certified dialyzers passed the hemolysis criteria easily (hemolysis <2%). In contrast, YY/T 1920-2023 led to aberrant results with several filters. Purpose of the present study was to analyze possible causes for these unexpected findings.

Methods

According to YY/T 1920-2023. (n=3), 0.5 g samples were cut from dialyzer membrane bundles and incubated for 30 min in saline at 37°C. Rabbit blood was added, slewed, incubated for 100 min at 37° C and then stirred with a pipette tip. Liquid was aspirated, centrifuged and the supernatant photometrically assessed at 545 nm. Hemolysis was calculated based on a positive control and two negative controls (A, saline; B, samples incubated only for 1 min). Baxter Revaclear 300 (PES; steam-sterilized), Bain DORA^® B-16HF (PS; g-radiated), and Jafron JM 16H (PUREMA^TM H; g-radiated, PET spacer yarn) were investigated. Native PUREMA^TM (PES) was also tested: with and without PET; non-sterile and g-radiated; no cutting, stirring and suction.

Results

Hemolysis rates of the Revaclear, DORA^®, and JM membranes were 5.1±1.1%, 1.1±0.1%, and 7.6±1.0%, resp. For PUREMA^TM, hemolysis for non-sterile/no PET bundles was 1.5±0.3%, γ-radiated/no PET 2.4±0.4%, non-sterile/with PET 4.3±0.7%, γ-radiated/with PET 6.3±0.1%, non-sterile/with PET/no-cutting 3.7±0.8%, non-sterile/with PET/no stirring and suction 0.9±0.4%. In the negative control B, which investigated the membrane samples with short incubation of 1 min, also hemolysis between 0.9±0.0 and 3.0±0.0% was observed.

Conclusion

Compared to current international standards, in vitro hemolysis determined with YY/T 1920-2023 can be significantly higher. Applying YY/T 1920-2023 is characterized by mechanical stress in form of compression from stirring and negative pressure from suction on blood cells which is particularly susceptible to operator influence. The outside surfaces of the dialysis membranes, which never come into contact with patient blood, also influence hemolysis as sterilization, the presence of a spacer yarn, and cut fragments have adverse effects. Consequently, the validity of the new Chinese Standard YY/T 1920-2023 must be questioned.

Funding

• Commercial Support – 3M Healthcare