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  • 1.  Loaner Instrument Sets

    Posted 26-Jul-2016 10:59

    Hello, I work in the orthopedic device industry and we have some instrument sets that are designated as loaner sets and taken from facility to facility.  I know that this is somewhat common, especially in orthopedics, but I'm wondering how others have addressed labeling and tray content issues.  Thanks in advance for your insight.

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    Paul Vagts
    United States
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  • 2.  RE: Loaner Instrument Sets

    Posted 26-Jul-2016 11:28
    Paul,

    I suppose these devices ("instrument sets"; aka "loaner sets") are reusable devices.

    These devices need to be sterilized before each use. 

    Correct? 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



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  • 3.  RE: Loaner Instrument Sets

    Posted 26-Jul-2016 11:53

    Yes, these are all reusable devices that require sterilization prior to use.

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    Paul Vagts
    United States

    Original Message


  • 4.  RE: Loaner Instrument Sets

    Posted 26-Jul-2016 12:19

    Relevant resources include, but are not limited to:

    • AAMI TIR63: 2014 - Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection

    • AAMI / ANSI ST81:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

    • ISO 11607-1:2006 - Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

    • AAMI TIR12:2010 - Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

    • FDA guidance document: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff
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    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com

    Original Message