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  • 1.  Usability engineering IEC 62366 for reagent kits

    Posted 14-Jun-2017 04:25
    Hi,

    Did anybody use IEC 62366-1:2015 Part 1 : Application of usability engineering to medical devices for diagnostic assay kits and how did you adapt it?
    I have used it for instruments and equipment. It's the first time that during an audit I got an observation for not using it for an assay. 

    Thanks and kind regards,
    Patrick


    Patrick Manouvriez
    MP.QRA Services sprl
    rue de Sondeville 20
    7600 Péruwelz, Belgium
    Tel. +32 497 43 15 10
    VAT BE 502.515.230
    RPM Mons division Tournai



  • 2.  RE: Usability engineering IEC 62366 for reagent kits

    Posted 15-Jun-2017 03:40
    Hi Patrick,

    While I am sorry you received this finding during your audit, I can certainly understand the point. One thing to remember is that this standard (IEC 62366-1) is aimed at preventing user errors. Using your product risk assessment, you have likely identified several potential user errors that could cause issues with the assay (contamination of the sample, insufficient sample size, etc.). The standard is aimed at identification of the user groups, the potential errors, mitigation of those errors (through user interface design) and testing (formative and summative evaluation) to make sure your mitigation is effective.

    You may have already done much of this if you have an effective risk management process, so make sure it is not just blind application (an auditor didn't see a reference to this standard in you design history, so they wrote it up). I would recommend a review of your risk management file and the associated mitigations to see how you have addressed potential user error first to determine the need for correction/corrective action. It may be just an updated to your design and development processes to reference the standard. Unfortunately, there are too many auditors out there that are simply looking for a reference to that standard and not looking to see if you might meet the requirements (even though you might not formally reference it). Good luck and let us know if you need any help.

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
    Becker MN
    United States
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    Original Message


  • 3.  RE: Usability engineering IEC 62366 for reagent kits

    Posted 15-Jun-2017 08:23
    Patrick,

    Thanks for sharing your experience.  I would think that the CE mark auditor was a great one from my perspective.

    Mark,

    Thank you for sharing your valid points.  

    Patrick and Mark,

    For IVD design validation to be effective, usability including assays (e.g., system level) should be documented.  

    I would recommend that firms include a flow diagram for design validation including usability (system level including assays). 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 4.  RE: Usability engineering IEC 62366 for reagent kits

    Posted 15-Jun-2017 11:20

    A well-written audit nonconformance includes three parts: A statement of the requirement, a description of the how the requirement failed to be satisfied, and the evidence to support the failure to satisfy the requirement.

     

    Could you provide the wording of the audit conformance? I'm particularly interested in the requirement cited, but belive the whole non-conformance statement would be of value.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 5.  RE: Usability engineering IEC 62366 for reagent kits

    Posted 20-Jun-2017 02:43
    Dear all,
    Thank you for your feedback. The auditor only pointed out that there is no reference to the standard. Usability has also not been a formal part of the development process.  All assays of the company are very similar in their kit configuration what is very standard for the kind of assays. The whole post market surveillance is very active at watching usability.
    Mark in his response confirms what I am planning to do.
    Thank you all for your very useful comments,

    Patrick

    ------------------------------
    Patrick Manouvriez
    MP.QRA Services Sprl
    Peruwelz
    Belgium
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    Original Message


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