Abstract: PUB055
Achieving Substitution Fluid Quality in Moda-Flx Gen 2 Novel Hemodiafiltration Device
Session Information
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- D'Alessandri-Silva, Cynthia J., Diality, Inc, Irvine, California, United States
- Pflager, Marie, Diality, Inc, Irvine, California, United States
- Heine, Christina, Diality, Inc, Irvine, California, United States
- Petersen, Eliza, Diality, Inc, Irvine, California, United States
- Poppe, Clayton, Diality, Inc, Irvine, California, United States
Background
Hemodiafiltration (HDF) is increasing given the association with lower mortality and better fluid control. The fluid must be purified and involves introducing online substitution fluid (SF). Standard dialysate permits limits of 100 CFU/mL and 0.5 EU/mL, but SF must be sterile and pyrogen free. Achieving this is paramount for patient safety. HDF devices prioritize patient safety by integrating advanced endotoxin filtration, system redundancy, and superior disinfection into a streamlined design.
Methods
With limitations of analytical techniques and external contamination during sample collection, analysis tested endotoxins in the SF. Samples were collected post first ultrafilter; in clinical use, this fluid then passes through a second ultrafilter before delivery to the patient. Acceptance criterion for pyrogen-free SF is an endotoxin level below 0.03 EU/mL.
A dialysis machine that had been idle for 72 hours was sampled for endotoxins to establish a pre-disinfection baseline. The device was then disinfected, and SF samples were collected and tested at the timepoints: immediately after disinfection, post-disinfection rinse and 24-hour hold, after 48 hours (+/- pre-sample flush), and after 72 hours (+/- pre-sample flush).
Results
Pre-disinfection samples confirmed endotoxin when machines idle (0 - 2.3 EU/mL). Sample immediately post disinfection 0.0473 EU/mL, meeting and exceeding the 0.03 EU/mL acceptance criterion. This sample was taken before any post-disinfection rinsing, which is required in clinical practice. Once rinsed, all samples, 24 hours post-disinfection, passed the acceptance criterion. Shown in Figure 1.
Conclusion
Disinfection of Moda-Flx Gen 2 is effective at reducing endotoxin in SF meeting guidelines. These results confirm the importance of a post-disinfection rinse step. Overall, the system design can support and maintain pyrogen-free substitution fluid for HDF. The redundant second ultrafilter in the fluid path provides an additional margin of safety beyond what was demonstrated at the sampling point.