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EtO Sterilisation Validation

Discussion in 'Medical Devices (21 CFR Part 820)' started by Jo Campbell, Jan 5, 2016.

  1. Jo Campbell

    Jo Campbell Member

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    Hi All,

    We manufacture a device used in laporoscopic surgery which is sterilised by EtO. For the validation of the EtO sterilisation we chose the adoption method into a mixed cycle that has been fully validated by the sterilisation provider to ISO 11135 Method C, and AAMI/ISO TIR 28 – Product adoption and process equivalence for ethylene oxide sterilization.

    This validation has been accepted by the Notified Body in the EU and by HealthCanada, but the FDA are putting up some resistance.

    The device is novel, but basic in design, so could anybody tell me why the FDA will not accept this method of validation, or have I just answered my own question?

    Jo
     
    Jo Campbell, Jan 5, 2016
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  2. Ronen E

    Ronen E Well-Known Member

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    It is a little difficult to relate without reading what the FDA response is saying...
     
    Ronen E, Jan 5, 2016
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