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  • 1.  Domestic reprocessing surgical instrument requirements

    Posted 13-Jun-2023 09:34

    Hi the community,

    I am wondering if one of you is aware about some specific European Domestic surgical instrument requirements related to reprocessing and where we can find the regulations.



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    Quang Tran
    VP QARA
    Antony
    France
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  • 2.  RE: Domestic reprocessing surgical instrument requirements

    Posted 14-Jun-2023 04:53

    Quang,

    There is the Common Specification which was published back in 2020 the implementing regulation for reprocessing of single-use devices 2020/1207, but there is nothing specific Europe-wide for reprocessing of surgical instruments.  There are the requirements specific in the EU MR 2017/745 (Annex I, Annex II, etc.) which has been changed from the Directive where these devices now require a Notified Body intervention.  There may be country specific regulations for reprocessing of instruments, but I am not aware of any of these.  There is also a standard ISO 17664 which might be helpful in what you are looking for regarding reprocessing of devices.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Domestic reprocessing surgical instrument requirements

    Posted 15-Jun-2023 11:45

    Not directly related, but note that the European Commission also posts a list of Member States who do not allow reprocessing of single-use devices: https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices/national-rules-reprocessing-single-use-devices_en



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    Corey Jaseph RAC
    Senior Research Analyst
    Morongo Valley CA
    United States
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    Original Message


  • 4.  RE: Domestic reprocessing surgical instrument requirements

    Posted 15-Jun-2023 11:50
    Thank you. The question is not related to single use device but re-usable devices like surgical instruments.

    Best,

    Quang


    Original Message


  • 5.  RE: Domestic reprocessing surgical instrument requirements

    Posted 15-Jun-2023 21:56

    Hi Quang

    There's some guidance and accreditation norms directed to hospital sterile processing departments, rather than manufacturers, if that may be relevant. Some examples:

    https://www.gov.uk/government/collections/decontamination-and-infection-control

    https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing---maintenance/reprocessing.html

    https://www.sf2s-sterilisation.fr/category/textes-officiels/normes/

    https://www.has-sante.fr/jcms/c_272424/fr/sterilisation-des-dispositifs-medicaux-la-conduite-des-cycles-de-sterilisation



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    Anne LeBlanc
    United States
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    Original Message


  • 6.  RE: Domestic reprocessing surgical instrument requirements

    Posted 16-Jun-2023 01:07
    Thank you Anne.

    Best,

    Quang



    Original Message


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