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PLEASE STAND BY TO HELP ME BREAK THE INTERNET

  • 1.  PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 31-Mar-2019 22:25

    I am finishing up a response to this article on "hidden" FDA reports:

    https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

    If you haven't read it, I don't recommend it. Nonetheless, I will be asking you to please forward/post my response to anyone/everywhere you can.

    Stay tuned...



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------


  • 2.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 01-Apr-2019 12:41
    There are so many regulatory consultants/people out in the industry. I never did understand why "journalists" don't ask a few for input.

    ------------------------------
    Clarisa Tate
    VP, Product Development and Regulatory Affairs
    Medical Devices Professional, RA/QA/Engineering
    Bay Area, CA
    USA
    ------------------------------



  • 3.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 01-Apr-2019 14:16
    Same reason as many startups, I would guess...they don't want to know.​

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 4.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 02-Apr-2019 15:57
    I look forward to seeing your response! Please give a heads up when it's public.

    ------------------------------
    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States
    ------------------------------



  • 5.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 02-Apr-2019 16:20
    Corey, my internet went down early this am, so I'm a bit out of touch.  I (or perhaps I should say the Regulatoty Watchcat) posted it late last night.  I later thought I should have put subject line in all caps, but was too brain dead last night and you can't edit subject lines, so nothing to be done about it now.  I trust you can find it nonetheless, now that you know it's there.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 6.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 04-Apr-2019 19:50
    Edited by Clarisa Tate 04-Apr-2019 19:51
    Pretty blunt response there, Julie! But sometimes that's the only way a person can clearly specify that their wanna-be-investigative-journalist writing isn't up to par. 

    The mistakes made by this writer is why true investigative journalists aren't lazy about handling information. True investigative journalists always question their sources' motivation, data, information, etc., critically analyzing every facet of their sources and the information given. Heck, I don't even think they trust their own eyes when they witness an event unless there is something to corroborate it did happen! They tend to be hard core looking for truth! They are also very careful with their words which this article is not. True investigative journalists fact check and re-check like you wouldn't believe. They also put their emotions (outrage) where it belongs: as a motivating factor to pursue more information, since sometimes exposes can take years in the making. They use their logic to give damning evidence after evidence and supporting documents and critical analysis (which they sometimes ask a trusted honest fellow journalist to tear down if possible to look for holes). In some cases, they let it "simmer" or "cool" so they can look at it again and critique their own investigative results and article in a new light - questioning everything, even themselves. It's very obvious that the publisher here didn't do any of this. It is unfortunate that investigative journalists are becoming a dying breed. More news articles now can pass as blogs, like KHNs, and they seem to be all opinion pieces now, editorials, rather than actual unbiased news.

    https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=81a21d0f-cccf-44a3-9bfc-a555d2af4804&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&ReturnUrl=%2fcommunities%2fcommunity-home%2fdigestviewer%3fcommunitykey%3d5af348a7-851e-4594-b467-d4d0983b6d89%26tab%3ddigestviewer

    FYI, don't even get me started with people in the entertainment industry who make so-called documentaries in our industry...


    ------------------------------
    Clarisa Tate
    VP, Product Development and Regulatory Affairs
    Medical Devices Professional, RA/QA/Engineering
    Bay Area, CA
    USA
    ------------------------------



  • 7.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 04-Apr-2019 22:25
    Clarisa, thanks so much for the feedback.

    Ah, if only you knew how much I toned it down from where I started!  When I say I have a deep, long-standing animosity towards this type of article and publication, I really mean it.

    What I have learned about the media (I normally won't even call them reporters or journalists or even "the press"), is that you can accuse them of almost anything, including being unethical and heartless and bottom-feeding parasites, and it doesn't bother them a bit.  But they do not like to be ridiculed as incompetent.  Probably because the truth hurts, and they'd prefer to be considered malicious over stupid, lol.

    So I'm reading your description of a good investigative journalist and I'm thinking, really?  You know a good investigative journalist that is still alive?  If so, I'd love to know who.  I completely share your attitude toward the so-called "documentaries."  I won't watch the Bleeding Edge, because…well, really, why would I waste my time, and also because I'm afraid that then I'd have to write about it, too.  Sometimes I can't help myself.  It's an exorcism. 

    But what really kills us is not the incompetent reporter, or the tabloid that publishes the junk they write, but the fact that all the media outlets pick up each other's stories and mindlessly repeat them.  And, like any rumor, the more people hear it, they more they think it must be true.  (One of my all-time favorite comments in a LinkedIn discussion was "And do we have any evidence to support this, other than a lot of people repeating it over and over on the internet?)

    Anyway, I need to stop thinking about this and move on to something more productive.   Thanks again for taking the time to give me your reaction.  It was a different kind of thing for me to write, so that I wasn't entirely sure I knew what to make of it myself!  But "blunt"...yeah, that part I knew, lol.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 8.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 13:38
    Edited by Vidya Jayaraman 05-Apr-2019 13:42
    Hi Julie,

    I enjoyed reading your response and you're spot-on when you say describe the writers as storytellers. It is so critical to provide an unbiased background to the issue and present facts and let the reader make a decision in these matters, simply because it concerns public health.

    With that being said, I don't quite agree with your point that the MAUDE is useless. Please correct me if I'm wrong, but doesn't FDA use the same information (on 3500 forms) to review adverse events? Given all those disclaimers FDA writes about it, yes, it is not an accurate or intuitive system but what has FDA done about making it more meaningful/relevant? One way is to actively encourage patients to file Medwatch reports and create awareness about it. MAUDE is a tool and it can only be as good as we use it.,..its better to have some data about the devices our loved ones use than completely being in the dark.

    And I do think doctors have an important role to play. They can't be innocent by-standers and let FDA and manufacturers take all the blame for 'hiding' critical risk information from patients. They are the ones talking to patients and the ones with the most influence on them. How many of them actually talk about MAUDE with their patients? Worse, how many actually report a medical device problem (or know they should) when it comes to a low risk device or home use device?

    PS: I am indeed shocked to know FDA does not review every single medwatch report. I can only hope they have a system to weed out duplicates and are not missing vital clues.

    ------------------------------
    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States
    ------------------------------



  • 9.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 13:52
    Hi Vidyalakshmi,

    I think what some folks don't understand is that just because a company filed an MDR, doesn't mean that the device has indeed malfunctioned or is responsible or the root cause of the adverse event. Hence, I do understand why Julie thinks it will be easier and better for doctors to review literature even if they don't necessarily get the full story because it's in their "language" instead of regulatory/engineer-speak.

    ------------------------------
    Clarisa Tate
    VP, Product Development and Regulatory Affairs
    Medical Devices Professional, RA/QA/Engineering
    Bay Area, CA
    USA
    ------------------------------



  • 10.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 15:47
    I triple that.  As I said in my comments, I don't have much personal direct experience with MDRs.  Even in my limited experience, I have encountered more than one report which, when investigated, turned out to be about a device other than the one listed in the report.  And more than one report where the device was not even made by the manufacturer cited in the report.

    The only reason these errors were confirmed was that the manufacturer was able to examine the device.  I would guess the success rate varies depending on the healthcare provider, the device, and the manufacturer, but my best guess is that, across all devices, physicians respond to manufacturer requests for information less than half the time, and the manufacturer gets an opportunity to evaluate the device far less often than that. It's virtually impossible to do a meaningful engineering investigation otherwise.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 11.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 15:56
    Exactly why health care providers must do more to make the system at least slightly better.

    ------------------------------
    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States
    ------------------------------



  • 12.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 14:03

    ​Ummm...did I say in some other discussion that you might not really want to know?

    FDA is in a very difficult position when it comes to device safety.  Always has been.  It has my sincerest sympathies on this point.  I am usually very outspoken (did I really need to say that), but this is one area where I tread a little lightly in what I'm willing to say publicly.  The KHN article is a perfect example of why.

    FDA is working on some stuff.  It has always been working on some stuff.  The stuff it is working on now, color me skeptical, but one thing that set me off about the KHN article (and similar junk) is that FDA really does not need the distraction. Maybe what it is working on will help, maybe it won't, but I would at least like to see it left alone to concentrate on what it is trying to do. 

    This is NOT to say I don't think anyone should "distract" FDA with informed criticism.  That's fine by me. (Which is good, because I'm soooo guilty, lol.)  It is this ignorant garbage that gets blah-blah-blahed all over the media that I think serves no interests but that of the media.




    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 13.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 15:25
    FDA doesn't review every malfunction report, though it seems like they review all, or nearly all, death and serious injury reports. They do "trend" somehow, but the two times I've been involved in a follow-up, all their "trend" seemed to do was count - I can't tell you how many times I heard "but there are XYZ# MDRS" - as if that meant anything. And there is no real identifying duplicate reports or real reports. Most smart companies try to at least flag them and tie duplicate user/manufacturer reports together so a credible searcher might at least realize they are not two different incidents, but there is nothing done to systematically identify them. The clinical sites that try to report per there legal requirements (and most don't understand they even have such an obligation), tend to report everything as a "malfunction" even if no serious injury or death could possibly occur and this is never noted in the database. The entire system is basically a mess.

    To be fair, the FDA are saddled with a hugely obsolete computer system and crazy costs to actually update anything, so it is likely incredibly hard to actually do a lot of meaningful trending.

    Then there is the fact that Drs, reporters and most of the time FDA themselves, don't seem to know that "not all MDRs are injuries" and insist on saying that # of reports in MAUDE = # adverse events. Sigh...

    g-
    ​​

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------



  • 14.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 15:59
    I think it's a virtual certainty that clinical sites reporting everything as a malfunction because of concerns over litigation.  I've never looked closely at MedSun, but I've always been inclined to think that (if CDRH is smart?) the whole thing about "working closely with healthcare providers" was an effort to find out what really happened without advertising it to the MAUDE chasers.  (But of course the media transparency police would then accuse CDRH of hiding something.)

    I agree it's a mess, and not really one of FDA's making, I don't think.  I don't know if CDRH actually thinks it can assure postmarket device safety. If anyone can do this, I think it's the manufacturers, but they don't want to, and I think there is a limit to what they can do, too.  I think mostly the FDA struggles under the weight of various constituencies that just want to believe in "safe," so, whether it believes in it or not, it has to at least pretend.  To expect otherwise is like expecting corporate leadership to nobly trash their bottom line in order to "do the right thing."  Even if they wanted to, this would just trash the company, and that wouldn't help anyone, either.  This is not to say many companies couldn't afford to do more of the right thing more often, but that there is also a limit there.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 15.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 16:43
    "To be fair, the FDA are saddled with a hugely obsolete computer system and crazy costs to actually update anything, so it is likely incredibly hard to actually do a lot of meaningful trending."

    I agree - however, that kind of rationale has never, ever worked for me as a defense :)​

    ------------------------------
    Jackie Torfin
    Vice President, Global QA and Regulatory Compliance
    Maple Grove MN
    United States
    ------------------------------



  • 16.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 17:12
    I'm not big on the offense/defense orientation.​  

    I think it's a matter of understanding the constraints under which FDA operates.  I think this is critically important. The best definition of a "regulatory" professional I ever heard was, "We are not experts in the regulations; we are experts in the regulators."

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 17.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 17:00
    Let me rephrase. MAUDE may not be useful (now) but it certainly has value and for that reason it should be made better - by FDA, manufacturers and providers. IMO the betterment should primarily be driven by FDA, the administrator of the system and health care providers, people with easy & immediate access to real-world data. Manufacturers mostly do everything they can because the legal obligations are heavier. There are some bad apples though...

    ------------------------------
    Vidyalakshmi Jayaraman
    RA Specialist
    Marlborough MA
    United States
    ------------------------------



  • 18.  RE: PLEASE STAND BY TO HELP ME BREAK THE INTERNET

    Posted 05-Apr-2019 17:17
    I don't think MAUDE is useful or has value or that it ever will.  I don't think FDA is trying to fix it, at least not any more than it is forced to by pressures created by the media. At least I hope not.  I think it has other plans.  Again, color me skeptical about those as well, but I support other plans over fixing.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------