Regulatory Open Forum

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  • 1.  Orthopedic Implants

    Posted 26-Oct-2017 15:27
    I have not had many questions but I am running in a issue.  If Orthopedic implants shelf life is expired can the manufacturer just repack and re-sterilize the expired implants?  

    I know that is not possible with disposables.

    A answer with rational is highly appreciated.

    Thanks in advance,

    Armin

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    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armingbeck@aol.com
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  • 2.  RE: Orthopedic Implants

    Posted 27-Oct-2017 09:47
    It depends.  Do you have a validation for resterilization for the implant(s)?  Is the shelf life expiration for the implant itself or just the packaging?  We were going to run into this and had started the process for validating resterilization of some of our parts but then our extended shelf life validation came through so we are just re-labeling.  Some of our plastics cannot go through sterilization a second time but our metals can so it just depends on materials and what validations you have in place.

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    Bobbi Siddoway
    Regulatory Specialist
    Salt Lake City UT
    United States
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    Original Message


  • 3.  RE: Orthopedic Implants

    This message was posted by a user wishing to remain anonymous
    Posted 30-Oct-2017 09:24
    This message was posted by a user wishing to remain anonymous

    You also need to make sure device functionality is not impacted by the additional sterilization processing.
    Original Message


  • 4.  RE: Orthopedic Implants

    Posted 27-Oct-2017 20:21
    I would normally expect the shelf life data to reflect the shelf life of the entire product, not just the packaging and/or the sterilization.  In that case, I don't see how repackaging and re-sterilizing would be sufficient, as the device itself is still past its shelf life.

    I'd be interested to hear the rationale for why repackaging and re-sterilizing ARE sufficient.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 5.  RE: Orthopedic Implants

    Posted 28-Oct-2017 11:38
    I agree with Bobbi.  It depends on the material and type of sterilization.  I have seen metal implants repackaged and resterilized with a rationale that it is solely the packaging that limits the shelf life.  ETO may leave residuals on plastic and silicone parts.  Plastic and silicone parts may also be affected by the heat and moisture during preconditioning or heat/cold due to the storage conditions during the initial shelf time period.  Repeating gamma radiation sterilization may effect UHMWPe making it more brittle and also may have material characteristic degradation during the initial shelf time period.

    If you do repackage and resterilize, remember to devise a method of traceability so that all device history remains documented.

    Regards,

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    John Minier, RAC
    Consultant, Principal
    Minier Medical Device Consulting
    john@johnminier.com
    1(914)850-4432
    Highland Mills, NY
    United States
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    Original Message


  • 6.  RE: Orthopedic Implants

    Posted 30-Oct-2017 10:53
    This is an excellent example of a situation where a robust product and process risk-assessment can help you. Others in the discussion thread have already asked very good questions, but the risk assessment needs to be more comprehensive. In addition, you may have to review your stability studies. If you believe your product can last longer than the labeled "expiration date", then why not consider updating the expiration date itself? Of course, this may have other implications both from QA and RA perspective.

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    Naveen Agarwal
    Creative Analytics Solutions, LLC
    Jacksonville FL
    United States
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    Original Message


  • 7.  RE: Orthopedic Implants

    Posted 30-Oct-2017 11:56
    Thanks to all of your input.  It looks for me that a justification that re sterilization could be a option using metal on metal implants as we all know that surgical instruments are sterilized many times using the autoclave validation.  Orthopedic implants have typically a useful life from 10 to 15 years what is kind different than the shelf--life.   

    However within  that case and considering the current issue with broken implants and revision surgery would the FDA accept just a justification or would it be better to be very conservative conducting a additional accelerate aging and rel-time aging study.

    Thanks again,

    Armin

    ------------------------------
    Armin Beck
    CEO
    SunTrixConsulting LLC
    El Dorado Hills, CA
    1-925-212-7683
    armingbeck@aol.com
    ------------------------------

    Original Message


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