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Novel online infusate-assisted dialysis system performs microbiologically safely.
C Weber1, W Groetsch, S Schlotter
1Fresenius Medical Care, Bad Homburg, Germany.
Artificial Organs
|June 10, 2000
Summary
The ONLINEplus system provides safe, cost-effective online infusate for hemodiafiltration, reducing labor and costs. Laboratory tests confirmed its microbiological safety even with contaminated dialysis fluid.
Area of Science:
- Nephrology
- Biotechnology
- Medical Device Engineering
Background:
- Convective dialysis therapies like hemodiafiltration require large infusate volumes, making commercial fluids labor-intensive and costly.
- Online preparation of infusate from dialysis fluid offers a cost-effective alternative to commercial infusion fluids.
- Novel online systems aim to enhance hygiene, user-friendliness, and operational flexibility for dialysis fluid preparation.
Purpose of the Study:
- To evaluate the safety and efficacy of the novel ONLINEplus system for preparing microbiologically safe infusate.
- To assess the system's ability to produce large quantities of infusate for various dialysis applications.
- To determine if the ONLINEplus system can overcome concerns regarding endotoxins and pyrogens in dialysis fluid.
Main Methods:
- The ONLINEplus system was challenged with microbially contaminated dialysis fluid over a 5-week laboratory testing period.
- Infusate samples were analyzed for microbial counts, endotoxin concentration, and cytokine-inducing activity.
- Compliance with the European Pharmacopeia test for sterility was assessed for all infusate samples.
Main Results:
- Despite high levels of microbial contamination and endotoxins in the source dialysis fluid, no contaminants were detected in the final infusate.
- Infusate samples consistently met the European Pharmacopeia standards for sterility throughout the testing period.
- The ONLINEplus system demonstrated its capability to produce large volumes of microbiologically safe infusate.
Conclusions:
- The ONLINEplus system provides a comprehensive, user-friendly solution for producing large quantities of microbiologically safe infusate online.
- This system enhances convective dialysis therapy, reduces labor burden for dialysis staff, and makes treatments more cost-effective.
- The ONLINEplus system effectively addresses safety concerns associated with using dialysis fluid for infusate preparation.