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Symbol to show reuse times or cycles of a reusable MD

  • 1.  Symbol to show reuse times or cycles of a reusable MD

    Posted 17-Sep-2021 11:26
    Dear RAPS community

    Could you advise me on how to provide the user the information on how many times of reuse or cycles are established by the manufacturer for a medical device?

    I have been searching for a symbol to provide the user this information but I haven't found anything so far.

    Thank you!

    ------------------------------
    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
    ------------------------------


  • 2.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 18-Sep-2021 03:23
      |   view attached

     

    You've not specified the type of device Carolina – can you share more details?

     

    That said- below US FDA Guidance might help to render some clues.

     

     

    Search was performed not with US FDA website search but eSTARHelper -go compare

    US FDA website search - https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

    eSTARHelper search -see attachment.

     

    ========================

    eSTARHelper- Microsoft TEAMs

      Turbo-charge your US FDA 510(k)

      Cphi North America eSTAR Article:

       https://tinyurl.com/2wkxp69y

      

      Ram Balani

      CEO – FDASmart Inc.

     

      Phone: 201-913-0558 (Mobile)

     

      Email: rbalani@fdamart.com

     

      7 Barlow Court

      Amawalk, NY 10501

     

      www.fdasmart.com

     

          Title: LinkedIn - Description: image of LinkedIn icon         Title: Twitter - Description: image of Twitter icon 

     

     

     




    Attachment(s)

    pdf
    Response to Carolina Reuse Cycles.pdf   67 KB 1 version
    Original Message


  • 3.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 19-Sep-2021 07:49
    Hello Carolina,

    Hope you are doing well.  The symbol you could use is the maximum number with the cross through it.  If you look at ISO 15223-1 there is the "single-use only" symbol which is the "2" in a circle with a line through it.  We had devices which had 5 uses or 10 uses, where we had "6" or "11" in the circle with a line through it.  There is also the new Single Patient - Multiple Use symbol which could be used depending on number of uses.  When we had a device which could be used say more than 10 times - we did not really put an indicator.  However, in all cases in the Instructions for Use (IFU) would include the number of expected uses, number of maximum uses, length of time for use, or the usable life of the product.  This is actually expected under the EU MDR now.  Also read Annex B of ISO 15223-1 which discusses General Prohibition and Negation use of symbols.  This should be clearly described (like in the IFU) so there is no misunderstanding and also make sure to include as part of your risk management file.​

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 19-Sep-2021 08:26
    Hi,
    I agree with the solution proposed by Richard.
    Best

    ------------------------------
    Michael Maier
    Senior Partner - Medidee Services AG
    Switzerland
    michael.maier@medidee.com
    ------------------------------

    Original Message


  • 5.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 21-Oct-2021 17:54
    Thank you Mr. Maier.

    Best Regards,

    ------------------------------
    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
    ------------------------------

    Original Message


  • 6.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 21-Oct-2021 17:53
    Hello Richard

    I hope you are doing well too.

    Thank you for your answer, very helpful. I will discuss with the team this suggestion of using the circle with the maximum number with the cross through it. We are including the maximum of reuses permitted in the IFU, but when looking for symbols or something other than text to communicate that information on the label, we did not find anything.

    Best regards,

    ------------------------------
    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
    ------------------------------

    Original Message


  • 7.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 21-Oct-2021 17:34

    Mr. Balani, thank you for your answer. 


    Unfortunately, I cannot share details, just that it is a reusable surgical instrument as per MDR terminology.

    I really appreciate your answer and will review this link and documents you provided.

    Best regards,




    ------------------------------
    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
    ------------------------------

    Original Message


  • 8.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 18-Sep-2021 23:17
    Dear Carolina,

    I am not aware of one.  Good spots to look are ANSI/AAMI/ISO 15223 and EN 980.  If its not in either of those (and I suspect its not), then there is no symbol for communicating the max number of reuses (except of course where the no reuses are permitted) and you will just have to use text.  

    Good Luck!

    Brandon Martin
    Martin Regulatory Consulting & Legal Services
    www.martinregulatory.com
    https://www.linkedin.com/in/brandon-c-martin/

    ------------------------------
    Brandon Martin
    San Francisco CA
    United States
    ------------------------------

    Original Message


  • 9.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 21-Sep-2021 10:09
    A symbol that means "do not reuse" (i.e. the crossed out "2") can be useful at the time of use​, letting you know to discard it. A "limited reuse" symbol, if we had one, might be useful at the time of reprocessing, as a reminder to pull out the serial number log and record another reprocessing cycle. I'm not sure if it would be useful enough to justify the space it takes up. Depending on the risk associated with an excess number of uses, I'd hope for a robust enough process to control that.

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    Anne LeBlanc
    United States
    ------------------------------

    Original Message


  • 10.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 21-Oct-2021 18:05
    Thank you for your answer Mrs. LeBlank.

    I agree with you that the process has to be robust enough to address related risks to the reuse. That´s why it is included in the risk documentation and also communicated through the IFU.  Having a symbol to communicate this information on the label should be only an additional risk control. 

    Best regards,



    ------------------------------
    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
    ------------------------------

    Original Message


  • 11.  RE: Symbol to show reuse times or cycles of a reusable MD

    Posted 21-Oct-2021 17:37
    Mr. Martin, thank you for your answer. O already reviewed those standards your mention. I agree, maybe using text will be the option. 

    Best Regards,

    ------------------------------
    C.Oviedo
    Sr. RA Specialist
    linkedin.com/in/carolina-oviedo-5251a4b7
    ------------------------------

    Original Message


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