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Expiration dating not needed on commercially sterilized items.

G B Phillips

    Hospitals
    |April 16, 1981
    PubMed
    Summary

    Commercial sterilization ensures medical device sterility is event-related, not time-based. This aligns with healthcare infection control standards, allowing device use without expiration dates.

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    Area of Science:

    • Healthcare infection control
    • Sterilization and aseptic processing

    Background:

    • Commercially sterilized medical devices are often assumed to have a limited shelf life.
    • Expiration dating is a common practice for managing medical device inventory.

    Purpose of the Study:

    • To clarify the principles of sterility maintenance for commercially sterilized medical devices.
    • To explain how the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) infection control standards address the use of devices without expiration dates.

    Main Methods:

    • Review of JCAHO standards and guidelines related to medical device sterility.
    • Analysis of the scientific basis for event-related sterility maintenance.

    Main Results:

    • Sterility of commercially sterilized medical devices is dependent on maintaining the integrity of the packaging and is event-related, not time-related.
    • JCAHO's infection control standards support the use of these devices without expiration dating when sterility is maintained.

    Conclusions:

    • Expiration dating is not a scientifically valid method for ensuring the sterility of commercially sterilized medical devices.
    • Healthcare facilities can confidently use commercially sterilized medical devices without expiration dates, adhering to JCAHO standards for infection control.

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