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The refurbished pulse generator.

H Mond, S Tartaglia, A Cole

    Pacing and Clinical Electrophysiology : PACE
    |May 1, 1980
    PubMed
    Summary
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    Refurbishing long-life lithium pulse generators for re-implantation is a safe and economical procedure. This practice, involving thorough cleaning and sterilization, proved effective in reducing waste and costs associated with pacemakers.

    Area of Science:

    • Biomedical Engineering
    • Medical Device Reprocessing
    • Cardiology

    Background:

    • Long-life lithium pulse generators, functional for over five years, are often removed from patients.
    • Pulse generator refurbishing is common globally but not widely adopted in the United States.
    • Reprocessing reusable medical devices is crucial for cost-effectiveness and sustainability.

    Purpose of the Study:

    • To evaluate the safety and economic viability of refurbishing explanted lithium pulse generators for re-implantation.
    • To assess the complication rates and overall success of refurbished pulse generators.
    • To determine the feasibility of implementing a standardized refurbishing protocol.

    Main Methods:

    • Explanted lithium pulse generators were cleaned with a quaternary ammonium compound and formaldehyde.

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  • Generators underwent electronic testing; functional units were sterilized using distilled water and ethylene oxide gas.
  • A cohort of 600 pulse generators were implanted, with 93 removed and 83 (89%) refurbished over 48 months.

    • Main Results:

    • Eighty-three percent of removed pulse generators were successfully refurbished and made available for re-implantation.
    • Only two complications were reported in patients receiving refurbished devices: one instance of infection spread and one removal due to power depletion.
    • No primary infections or unusual tissue reactions were observed, indicating the sterilization process was effective.

    Conclusions:

    • The described pulse generator refurbishing protocol is a safe and economical procedure.
    • Reprocessing functional explanted pulse generators can significantly reduce medical device waste and healthcare costs.
    • This practice offers a viable alternative to discarding fully functional, long-life pulse generators.