Regulatory Open Forum

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  • 1.  Sterilization validation adoptions for ETO

    Posted 13-Mar-2012 08:42
    I am interested in learning of the experiences of others regarding CDRH's acceptance of sterilization adoptions for medical devices sterilized by ETO.  Recently we have experienced strong challenges to adoption strategies and rejection in some cases rejection even after following the AAMI TIR 28 guidelines for adoption.  I was wondering if anyone had recently submitted an adoption strategy in a 510(k) and what your experiences have been.
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    Steven Peltier
    VP Regulatory Affairs
    Integra Lifesciences Corp
    Plainsboro NJ
    United States
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  • 2.  RE:Sterilization validation adoptions for ETO

    Posted 13-Mar-2012 14:19
    Steve:

    AAMI TIR28 is not a standard.  Assuming your device is a 510(k) device (not a PMA device) and you'd like to demonstrate your sterilization using ETO, then you need to address the issues contained in the following documents in a systematic, and integrative manner.
    • ISO 10993-7 (Part 7)
    • FDA "Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices" (1987)
    • United States Pharmacopeia (USP) <85> Bacterial Endotoxins Test
    • ANSI/AAMI ST72:2002 Bacterial endotoxins-Test methodologies, routine monitoring, and alternatives to batch testing
    David
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    www.regulatorydoctor.com
    Floyd VA
    United States
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