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  • 1.  AE reporting of reports seen on social media?

    This message was posted by a user wishing to remain anonymous
    Posted 07-Feb-2018 15:36
    This message was posted by a user wishing to remain anonymous

    hello all, 
    my question is related to what is a company's responsibility for reporting an AE that is seen on twitter, or on a blog? If a Regulatory or  PV employee happens to see a tweet related to AE from our product in a general public forum, are we required to report it? Especially if we do not have an identified reporter or time frame, etc? For example, a tweet stating "I hate my new [medicine name], it gives me a headache". or "taking care of my boyfriend today, he got a  [vaccine name] and it made him nauseous."
    I would love to hear your thoughts. 
    thank you!


  • 2.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 04:23
    The only comment that I can make is that regulatory agencies do consider and look at Social Media as an avenue for customer feedback and/or customer complaints.  How much they actually look at this, is probably fairly minimal at the moment, but gaining momentum on a tweet-by-tweet basis, no pun intended.  Whether sometime tweeted, posted on a blog, or other social media avenue should be reported ... the minimum is that a medical device manufacturer should assess, determine reportability, monitor occurrences, and consider impact of incident.  There have been presentations on this, some experiences, but should consider this because regulatory agencies are more and more.

    At a minimum if you are a medical device manufacturer certified to ISO 13485:2016, social media in all its entirety could be considered customer feedback.  This allows an organisation to understand what is happening with their product in the field, whether it is good, bad, or even on social media.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 3.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 09:38

    In my experience, an event discovered in social media is still considered a complaint if it alleges deficiencies.  I would document it as a complaint/customer feedback and go through the exercise of determining if it is reportable, based on the information you can gather.  If you report to FDA, they usually expect some due diligence on trying to obtain additional information so I would also document any attempts to contact the complainant, if possible.



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    Angela Nunez RAC, CQA, ex-CQE
    Quality Assurance/Compliance
    ainunez@comcast.net
    (954) 643-8598
    Pembroke Pines, FL
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    Original Message


  • 4.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 10:23
    Under 21 CFR 820 (b), a complaint means any written, electronic or oral communication that alleges deficiencies related to the identify, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. Under ISO 13485:2016, a complaint is a written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization's control or related to a service that affects the performance of a medical device. Once it is determined that a complaint has been received, then you determine if it is an adverse event and whether that AE needs to be reported.

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    Soonie Wilson McDavid
    Quality Leader
    Flagstaff AZ
    United States
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    Original Message


  • 5.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 12:22
    Companies are obligated to investigate any (adverse) claims made by anyone, via any format. Word of mouth, social media, etc. It may only need to be recorded in the company's complaint database, but it should be captured, regardless of whether or not you are able to obtain any further information. Remember, companies are not admitting "guilt" by reporting adverse events to any agency.

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    Melissa Abbott
    Regulatory Compliance Manager
    United States
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    Original Message


  • 6.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 13:08
    ​So, how is a company to apply resources to this daunting task? Is every employee asked to monitor their own Twitter account (if they even use one) to see if a product their employer makes is mentioned? What about the dozens of other social media platforms on which people might create and transmit statements/graphics that mention your products, e.g., Instagram, LinkedIn, Pinterest, Snapchat, Facebook, Tumblr, Baidu Tieba, QZone, WeChat, Houseparty, Lisa, MetaShort, Station, etc., plus an uncountable number of blogs, some open to public viewing and others quite private, where people can complain (or cheer) about anything or anyone. I suspect even the resources of the NSA cannot monitor "all" social media communications that might be of interest to them, so unless the apparent complaint is somehow directed to the company from an identifiable source, how would useful follow-up be obtained in order to judge the veracity and reportability of the "report"? Really, do you want to believe all of what you see on the Internet?

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    Jan S. Peterson, MS, RAC
    Senior Regulatory Affairs Manager
    The Emmes Corp
    Rockville MD
    United States
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    Original Message


  • 7.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 20:12
    It would largely depend on the social media presence of the company. If the company maintains a Facebook page to talk about its products, it should be actively monitored for reports of device events. 

    To the question if everythig else, good success with the right Boolean terms can be achieved with a simple Google Alerts or RSS feed that lets you know when new material on the web appears that matches your search criteria. If the company has a clinical group that routinely updates CERs for compiliance with the EU MDD, these search terms are likely already defined by that team's research.  By no means perfect (I don't believe it searches images), but for a more proactive approach that doesn't require an army of social media miners, Google's tools are a step in a better direction.

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    Michael Petrini RAC
    Manager, Regulatory Affairs
    Lakewood CO
    United States
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    Original Message


  • 8.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 13:09
    ​Hi,

    I agree with all previous comments that AEs found in Social Media should be processed as you would any complaint from more "traditional" sources. The FDA has yet to require external Social Media sites be mined for potential AEs, but if your company becomes aware of an AE through Social Media, there is definitely an expectation that it will be processed as a complaint. You should also make sure you know who at your company is responsible for monitoring your company's Social Media sites to ensure that there is a process in place for forwarding AEs to the appropriate department.

    Sharon

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    Sharon Perez PhD
    Director Global Medical Device Safety
    Novocure
    Portsmouth NH
    United States
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    Original Message


  • 9.  RE: AE reporting of reports seen on social media?

    Posted 08-Feb-2018 16:14
    Related to this question, it is prudent for companies to post externally-facing social media policies on each social media platform.

    Here are a couple examples of external policies, typically called Social Media Guidelines:  BSCI    JNJ 

    Within those policies you will find the following:

    • BSCI

      Comments That May Involve a Potential Product Complaint - As a medical device manufacturer, we strive to design products that are safe and benefit patients and <g class="gr_ gr_415 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling ins-del" id="415" data-gr-id="415">health care</g> providers. If a comment infers that there may be a problem with our product, we may contact you to investigate the nature of the complaint according to our company's policies.

    • JNJ
      Statements about side-effects, whether expected or not, from any of our <g class="gr_ gr_139 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-del replaceWithoutSep" id="139" data-gr-id="139">products,</g> or product quality complaints, are discouraged, inasmuch as it is important to report this type of information appropriately. Please report any side effects from any of our products or product quality complaints to our Customer Care Center at 1-866 565-2229 between <g class="gr_ gr_141 gr-alert gr_gramm gr_inline_cards gr_run_anim Style multiReplace" id="141" data-gr-id="141">8AM</g> to <g class="gr_ gr_142 gr-alert gr_gramm gr_inline_cards gr_run_anim Style multiReplace" id="142" data-gr-id="142">8PM</g> EST Monday-Friday. We reserve the right to contact you if such information is posted in this public forum.


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    Sam Lazzara
    https://mdqc.blog/
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    Original Message


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