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  • 1.  Single patient multiple use device

    Posted 04-Sep-2022 11:10
    Do i need to mention how many times to reuse a single patient multiple use device for EU and US market?

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    Bedwuine Senatus
    QA/RA Director
    Springfield NJ
    United States
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  • 2.  RE: Single patient multiple use device

    Posted 04-Sep-2022 19:14
    Yes, if there is a limit to the number of times it can be safely reused.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Single patient multiple use device

    Posted 05-Sep-2022 01:33
    Hello Bedwuine,

    Simple answer yes.  You will not necessarily find this specific requirement listed anywhere, but it is expected to have not only number of uses, maximum number of uses, or recommended number of uses, but also how a user can discriminate when device can still be used.  Depending on the device type the number of uses might be straight-forward or able to determine; in other cases it might not be.  Also this needs to be part of the Technical Documentation (for EU) in the "life of the device" describing how long a device can be used.  It is quite common today also in 510(k) submissions under "shelf life" for multiple use devices having supportive evidence.  This should all be supported by validation testing performed on the useable life of the device (lifetime of the device).

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


  • 4.  RE: Single patient multiple use device

    Posted 05-Sep-2022 01:54
    Edited by Erik Vollebregt 05-Sep-2022 02:01
    Annex I, 23.4 (n) MDR: "if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses; "
    So … it depends. The requirement is provision of information enabling the user to determine when the device should no longer be re-used. Risk management will determine how that is done and design needs to be amended for this if needed, e.g. via a maximum number of uses or by means of a method to identify when the device has been degraded too much to be re-used (a design measure could be material changing color if it cannot be reconditioned another time). In practice I see manufacturers often provide only warnings (disclaimer, e.g. do no not reuse if visibly degraded) without telling the user how to establish whether the device is in the state that is warned against (e.g. visibly degraded how, to what extent, how to measure?), whereas the MDR requires provision meaningful actionable information for the user (proclaimer: this is how you determine when the device should no longer be used).
    Good point by Richard that the overall life time always needs to be specified too.

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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


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