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Related Experiment Videos

Clinical experience with heat sterilization for reprocessing dialyzers.

A M Kaufman1, S Frinak, R O Godmere

  • 1Department of Medicine, Beth Israel Medical Center, New York, New York 10128.

ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|July 1, 1992
PubMed
Summary

Heat sterilization is a safe and effective method for reprocessing dialyzers, offering advantages over chemical germicides. This method demonstrated no significant decrease in dialyzer performance or increase in adverse patient events during clinical trials.

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Area of Science:

  • Nephrology
  • Biomedical Engineering
  • Sterilization Technologies

Background:

  • Chemical germicides are commonly used for dialysis reprocessing.
  • Heat sterilization presents potential advantages over chemical methods for dialyzer reprocessing.

Purpose of the Study:

  • To evaluate the safety and efficacy of heat sterilization for reprocessing polysulfone dialyzers.
  • To compare the performance and clinical outcomes of heat-sterilized dialyzers with those sterilized by chemical methods.

Main Methods:

  • Polysulfone dialyzers (Fresenius 60M or 80M) were heat sterilized at 105°C for 20 hours.
  • Clinical trials involved 180 patients undergoing 9,000 treatments with heat-sterilized dialyzers.
  • In vitro and in vivo performance metrics (clearances, KoA, Kt/V) were assessed at baseline and after multiple uses.

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  • Dialyzer integrity and clinical blood leak incidence were monitored.

    • Main Results:

    • No pyrogenic reactions, sepsis, or subjective symptoms were reported.
    • In vitro clearances and in vivo KoA values showed no significant decrease after multiple uses.
    • Kt/V for urea remained comparable to baseline formaldehyde-sterilized dialyzers.
    • Dialyzer failure modes included integrity test failures (70%), blood leaks (8%), and reaching maximum usage limit (12%).
    • Clinical blood leaks occurred in less than 0.5% of treatments.

    Conclusions:

    • Heat sterilization is a safe and effective method for reprocessing polysulfone dialyzers.
    • Quality control is essential for the heat sterilization process.
    • Heat sterilization offers a promising alternative to chemical disinfection for dialysis reprocessing.