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Performance Qualification Testing Improves Processing of Lumened Surgical Instruments in Ultrasonic Cleaners.

Kevin Anderson, Mary Ann Drosnock, Stephen M Kovach

    AORN Journal
    |July 26, 2023
    PubMed
    Summary
    This summary is machine-generated.

    Implementing performance qualification (PQ) tests for ultrasonic cleaners enhances surgical instrument reprocessing. This quality management practice reduces the risk of soiled instruments, thereby lowering patient infection rates and adverse events in healthcare facilities.

    Keywords:
    lumen cleaningoperational qualificationperformance qualification (PQ) testquality management systemultrasonic cleaner

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    Area of Science:

    • Healthcare Quality Improvement
    • Medical Device Reprocessing
    • Sterile Processing Technology

    Background:

    • National standards mandate quality management systems for medical device reprocessing.
    • Effective mechanical cleaning of surgical instruments is critical for patient safety.
    • Ultrasonic cleaners require validation to ensure proper function (cavitation, soil removal, lumen perfusion).

    Purpose of the Study:

    • To assess current practices in ultrasonic cleaner usage and performance qualification (PQ) in healthcare facilities.
    • To provide guidance on installation, operational, and PQ for ultrasonic cleaning equipment.
    • To highlight the benefits of PQ testing in improving the quality of surgical instrument reprocessing.

    Main Methods:

    • A survey was conducted among sterile processing personnel regarding their use of ultrasonic cleaning units.
    • Analysis of survey responses to audit current practices.
    • Development of guidance for assessing ultrasonic cleaner installation, operation, and PQ.

    Main Results:

    • Survey data provided insights into the current state of ultrasonic cleaner use and PQ implementation.
    • Identified variations in practices related to the testing of ultrasonic cleaning units.
    • Highlighted the need for standardized PQ testing protocols.

    Conclusions:

    • Performance qualification testing of ultrasonic cleaners is essential for effective reprocessing of lumened surgical instruments.
    • Implementing PQ testing decreases the risk of contaminated surgical instruments reaching the Operating Room (OR).
    • Reduced risk of soiled instrumentation directly correlates with a lower incidence of patient infections and adverse events.