Has FDA ‘Dumbed-Down’ MAUDE Accident Database?

I like to keep my finger on the pulse of MRI accidents and safety issues. One consequence of this is that I frequent the FDA’s MAUDE database (MAUDE is a tortured acronym for medical device user-reported mishaps). I have long criticized the FDA for their half-hearted efforts at collecting MRI accident data (which, in fairness, appears to be as much a product of congressional limitations on the FDA’s power as anything else), but MAUDE has been the only national database for these accidents that is publicly accessible.

Every so often there is an MRI accident description that is so stunning that it sends a jolt through me, reminding me why I do what I do. This is the entry that I came across just two weeks ago…

“Event Type Injury   Patient Outcome Life Threatening; Hospitalization Required Intervention”

‘Wait a minute… that may border on interesting (and I’m being very generous there), but that’s hardly a ‘jolt.’ What gives?’

Well, two weeks ago that exact same incident report described an accident in which an MR technologist had to be rushed to surgery to extract the pair of scissors from their forehead! Turns out that the tech was between the magnet and another staff person who had brought a pair of ferromagnetic scissors into the magnet room. The magnet ‘grabbed’ the scissors and started drawing them into the bore, but for the fact that the technologist’s head was in the way!

My longstanding complaint with the FDA and their MAUDE data has been that they seem completely disinterested in actually collecting it with regard to MRI accidents. The overwhelming majority of MRI accidents are a product of the inherent risks, and not a result of equipment malfunction and it seems to me as if the very existence of the MAUDE database is NOT as a patient safety tool, but as a CYA tool to validate that the approval of a medical device was warranted.

Now the hobbled MAUDE data (built on the FDA’s Medwatch program) has gone mute and the actual substance of an accident report is no longer there. Today there’s more information about the postal address of the company that manufactured the MRI than there is about the accident that is being reported, at least that’s the contemporary reality via the online database.

So I implore the FDA to please restore the narratives associated with MRI accidents. Removing this information does a grave disservice to patients and those who advocate for MRI patient safety.

Tobias Gilk, President & MRI Safety Director
Mednovus, Inc.
Tobias.Gilk@Mednovus.com
www.MEDNOVUS.com

18 thoughts on “Has FDA ‘Dumbed-Down’ MAUDE Accident Database?

  1. Tobias Gilk Post author

    On Twitter, the FDA announced that they are having technical difficulties with the MAUDE database…

    “FDAcdrhIndustryMaude database having technical difficulties. To get an available adverse event report go to http://bit.ly/Qa8yn #fda #medicaldevice”

    If you’re on Twitter, you can follow the FDA’s CDRH tweets (updates). For more information, or to follow my updates, visit http://twitter.com/tobiasgilk

  2. Bruce Rosenberg

    I monitor Hernia mesh injuries, and have requested explanation from CDRH staff as to why the removal of the summaries. Completely ignoring me, which indicates coverup/fraud with absolute problem regarding FDA failure to acknowledge product complications. They are endangering the public. When will this stop?…

  3. Suzanne McClain

    I have noticed exactly the same thing Bruce. Documents that I was able to access less than a year ago has disappeared. Luckily, I had the insight to print them, and therefore these particular documents are not completely gone, at least not to me. Unfortunately, they are gone to anyone who is just now beginning their search for information through the MAUDE database. This most certainly is a sad state of affairs.

    Anyone with any intelligence could only come to one conclusion, and you hit the nail on the head; this most certainly is an FDA coverup, yet the only people who are privy to this information are those of us that started our search prior to a few months ago. A newbie would have no clue that these docs were available in the first place.

    Furthermore, the MAUDE database has never, (as long as I have been researching anyway) been a uniform database, and one must enter criteria in regards to adverse events numerous ways to maximize the number of actual events to be found. Then one must question as to if the search that netted the lower amount of adverse events is actually an independent number, which means the number should be added to the larger number of events, or are these events already incorporated into the larger number? It is a confusing animal.

    The FDA and the doctors, in my opinion are in the pharmaceutical companies pockets. This is only an opinion/observation on my part, but one I felt important to share. People are so unaware of this government entity and the power they wield over peoples lives. It is a scary time we live in.

    Something must be done, but what? We, the whistle blowers of the world are ignored by the FDA, our Government Officials, and the media. I have tried to expose the dangers of surgical mesh repeatedly. Our local newspaper (in Starkville, Mississippi) who in the past has printed all of the articles I have written refuses to print the one I wrote exposing the dangers of mesh. In fact, despite repeated attempts to speak to the editor, I have been totally ignored. This is a disgrace and constitutes selective journalism. I can only assume this is because pharmaceutical companies and/or doctors advertise with them, and opposed to conducting responsible journalism and risking future revenue ventures from these sources, they choose to tuck tail and run.

    “When is it going to end?” You ask a very good question. I am fairly certain it will be long after hundreds of thousands of new people have been victimized. After all, the standard form letter we all seem to receive says the FDA will review products more stringently after only one or two well-documented cases have been received, yet there were 664 adverse events on file at the time of my surgery in June of 2004, and as of last month the number had skyrocketed to 1332. As of today when I checked, the FDA had reduced the number of adverse events in regards to the mesh implanted in me to 26. What happened to the other thirteen hundred plus adverse events that were previously on file?

    Coverups/Fraud you say, Absolutely!

  4. Suzanne McClain

    I must amend the statement in my earlier submission, “…1332. As of today when I checked, the FDA had reduced the number of adverse events in regards to the mesh implanted in me to 26. What happened to the other thirteen hundred plus adverse events that were previously on file?”

    I inadvertently had entered an incorrect date, and upon checking again, found that the actual figure to date is 1323.

    Respectfully yours,

  5. Patrick L O'Meley

    MAUDE Summaries missing for all sorts of devices.

    We are conducting similar research into adverse events for a wide variety of device (defibs, monitors, ventilators etc) and have used the summaries to classify types of failures and alert ourselves to the means by which devices injury staff and patients. It is not just a national tragedy it is a world-wide tragedy as there is no other database with such a wide funnel to capture events. In Australia, where I am based, for example, our regulator only produces summary stats – not even individual events are searchable! We rely/relied on MAUDE to get the details and help us manage our risk intelligently.

    The lack of summaries is perplexing and disappointing.

    Alas, MAUDE is becoming a fraud!

  6. Tobias Gilk Post author

    I followed the advice of the FDA twitter post and submitted a Freedom of Information request for the MAUDE data. Got a call from the FoI rep today to tell me that they were collecting the info.

    Strikes me as a genuine mistake, dropping the narratives.

    What I find astounding is that they’ve been unable to make the narratives accessible with nearly a month of time.

  7. Brian Todt

    I monitor MAUDE on a monthly basis. I found that the text description of events was missing for July and August 2009 data (published about 14 days into the following month). It was missing both in the online search on FDA’s web site and in the ZIP archives for download. Then on October 11, when I pulled down the September data, the text was there for the last 3 months. However, the manufacturer that they populate switched from one place to another (they have 3 manufacturer fields + a distributor field). It smells to me like they have had personel turnover, and the new staff is having trouble outputting the data.

  8. Brian Todt

    On the FDA MAUDE search page, if you click on “Download Files” you will now see a last change date of 10/27/2009 at the bottom. This is interesting, because today their online search comes up with no event description for events that have FOITEXT in the files I downloaded a couple weeks ago. This implies that they might indeed be purging the event descriptions intentionally. One example (out of thousands) is report number MW5011960, which had an event description 2 weeks ago, and is now null.

  9. Nancy E. Bowling

    I have a question. Does anybody who has the authority to do anything about all these serious injuries and deaths that consumers and physicians are reporting ever actually do anything about them? Does either the FDA or the CDRH ever reconsider any of the approvals based on what is being reported? My sister had a VNS manufactured by Cyberonics implanted to control her seizures and it almost cost her her life, so I logged onto the Maude Data Base to see if this was just a fluke or if anyone else had any trouble with it. I could not believe the deaths and serious injuries that were listed going back 10 years for this device. So I did a little more research on its approval and found they have not even met the FDA’s conditions of approval yet. This device was approved in 1997 for seizures and in 2005 for depression, but with conditions. Two of these conditions were a 1,000 patient 5-year outcome registry and a 450-patient postmarketing dosing study, and yet in a F1Q10 [Qtr End 07/24/09] Earnings Call Transcript, Daniel Moore is talking about his request to the FDA to reduce the amount of people they had to test. Are you kidding me? My sister was a registered nurse for Pete’s sake making very good money and now she will be on social security for the rest of her life, and she’s only 45. Every week I log onto the Maude Data Base and the death toll goes up along with the injury count. So like I said, does anybody in the FDA ever actually read these?

  10. Brian Todt

    In response to Nancy, you can rest assured that the FDA most assuredly does look carefully at all the reports of serious injury and death. They routinely challenge manufacturers for additional information, and persist until they are satisfied. This correspondence is mostly outside of the MDR reports that are captured in MAUDE. Also, an initial report often contains assumptions that are disproved upon investigation. But if a device malfunction occurs and causes patient harm, and it is likely to reoccur, you can bet the FDA will be all over it.

    On a related note, the FDA now posts on their web site “Please note: due to technical difficulties all fields may not currently be available…” Indeed we already had concluded that.

  11. Nancy E. Bowling

    Brian, I’m not sure you understand. Her VNS device did NOT malfunction. It was working exactly as it was suppossed to. This was the device that the FDA approved. What I don’t understand is that the FDA was formed to regulate these devices and pharmaceuticals to assure us that they are safe for the public, right? I read Cyberonics “Conditions of Approval” document which very clearly stated that FAILURE TO COMPLY WITH ANY POST-APPROVAL REQUIREMENT CONSTITUTES FOR WITHDRAWAL OF APPROVAL OF PMA. When the FDA granted Cyberonics approval, two of the conditions were a 460-patient Post Market Dosing Study and a 1,000 patient Out-Come Registry. In November of 2008 the company submitted a proposal to the FDA to change the enrollment from 460 down to 330. These conditions are in P970003 doc# 98M-0140. They were given to a Class III medical device which MUST undergo an approval process that includes special controls, eg performance standards and general controls required of all devices, and, in addition to that, the device or product must meet a rigorous premarketing approval standard, which may delay the release of the product for months, even years. Since these conditions were given to them in 2005 they should have been near completion, not still discussing how to get out of them. Then in Master File No. H-05-2121 of the UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF TEXAS on page 14 [c] Defendants were well aware of the shortcomings of their own clinical studies, including the fact that a randomized & blinded study of the Vns system as therapy for TRD failed to yield statiscally significant results [page 44] when [CWI] checking on the study sites to see they followed protocol, only 3 of 26 sites did. Pages 80 & 81- failure to document death data properly and Report INV 01-0006, dated January 8, 2002 and Febuary 19, 2003, talks about prior knowledge of high lead impedance [which, by the way, has caused deaths] Every week I log onto the Maude Data Base and the death count and serious life-threatining injury count goes up, and yet, it seems to me that the FDA really doesn’t have much authority over the situation. And Cyberonics knows that!

  12. Pingback: Can We Still Call Them ‘Never Events’ When Accidents Happen So Frequently In MRI? « MRI Metal Detector Blog

  13. Lisa C

    I think all of you should email the whitehouse.gov and report the FDA MAUDE website as negligent. It’s obvious the FDA is not addressing these problems! Of course…why would they??? Their the ones that approved it! Really makes sense…they have the fox guarding the hen house?!?

  14. Brian Todt

    The FDA MAUDE database online search is lagging many months behind in publishing reports. An example is the following 6mo old report:

    Report Number: MW5016338
    Date of Event: 6/5/2010
    Mfr: SIEMENS MEDICAL
    FOIText: RESEARCHERS CONDUCTING CARDIAC IMAGING ON SWINE MODEL, INADVERTENTLY WHEELED A TRANSPORT CART INTO A 1.5T MRI SCANNER. A FERROUS IV PUMP ON THE CART BECAME A PROJECTILE AND WAS PULLED TO THE MAGNET HOUSING. AN ATTENDANT’S HAND WAS PINCHED BADLY WHEN TRYING TO REMOVE THE PUMP. NO BROKEN BONES. MAGNET HOUSING REQUIRED REPLACEMENT. TWO MINUTES PRIOR TO THE INCIDENT, ALL PRESENT WERE INSTRUCTED NOT TO ALLOW SAID PUMP INTO THE SCAN ROOM.

  15. Tobias Gilk Post author

    MAUDE is a mess. Yes, some events appear in MAUDE a L-O-N-G time after they’re reported. Generally speaking, I allow 6 months to elapse before I try and perform any year-over-year comparisons of reports. This means that I won’t start to aggregate the 2010 data on MRI accidents until we’re half way through 2011!

    The FDA works on its own clock. I’ve got a FOI request that just passed it’s 1-year anniversary!

    Tobias

  16. Nancy E. Bowling

    I was just reading on ClinicalTrials.gov, where they keep information on clinical trials, and I looked up Cyberonics’ depression studies and there were quite a few, but NCT00305565 says 330 people were enrolled and NCT00533832, which was the Pivotal Trial [D02] of VNS for TRD had an enrollment of 266. Right there is almost 600 people, so why couldn’t this company come up with the 460 people required in their ‘Conditions of Approval’ studies? Then at: http://dynamic.cyberonics.com/depression/hcp/AboutVNSandTRD/clinicalstudy.aspx it is discussing the Pivotal study acute phase-12 wk double blind, randomized study. It says ‘all of the 235 patients were implanted’ for this depression study, and then goes on to say the ages were 18-80. 80 years old? Are they serious? My sister had this surgery and she was in good health and half that age, and it almost killed her. Why in heavens name would they implant an 80-year old? Was this person even in full control of his mental facillities?

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