Regulatory Open Forum

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  • 1.  Social Media Help

    Posted 11-Sep-2019 16:56
    Hello,
    If there is anyone that specializes in Medical Device Social Media processes and can provide consultation services, please message me. We are getting more into promoting products on social media sites and need a robust yet risk-based and flexible process for controlling communications. 
    Thank you,
    Maddi

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    Maddi Myers
    Regulatory and Quality Project Manager
    Carver MN
    United States
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  • 2.  RE: Social Media Help

    Posted 13-Sep-2019 05:48
    Maddi,

    I would not presume to have expertise in this specific area, though in honesty just treat as any other post market surveillance source.  The challenge with social media, i.e. Facebook, twitter, these can have large amounts of data you need to sort through.  Working tangently with this area so far, we have been developing procedures where we triage the information coming out of social media sites because not all of the information may be correct or even accurate.  Sorting through the noise as we have liked to start calling it haha.  However, your process for this review/sorting/scanning/filtering should have a trigger or methodology for when something is truly considered patient safety or performance impacting.  The challenge with social media is then getting the actual source of information because someone can post anonymously on a Facebook site and so would not have ability to further inquire into the event or issue.  This is an important area to look at not only from a medical device complaint reporting or adverse event reporting perspective, but just a company perspective.  Negative reviews, comments, or experiences with a product that is posted on a social media site should also be evaluated and investigated, because this can have a big impact on products sold.  Imagine someone posting on twitter they got hurt or your device "failed horrible" (as people like to use strong words) ... how many followers do they have that see this post?  Awareness of social media content is not only safety related, but goes well beyond into the overall business.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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