Medical Devices: Another take on “We want Access to our Damm Data”

Another potent guest post by SPM member Alexandra Albin, @MsAxolotl. If this doesn’t give you a sense of who is “the ultimate stakeholder” in health matters, nothing will.

Remember, “patient” is not a third person word. Your time will come.

A conversation on the SPM listserve was started by Joleen Chambers, @JjrkCh, a patient advocate for patients with failed medical devices. Here’s her Failed Implant Device Blog. She made a plea to have our members support a petition on the ConsumersUnion site that would enable medical devices to be more heavily scrutinized by the FDA, and outlined the needs for a better tracking system of medical devices than which currently exists. This includes the ability to contact patients in the event of a device’s recall.

These are all critically important things to have in place. I have a vested interest because I happen to have a failed medical device.

The conversation broke out when Joleen’s reference’s were put to the test….in her email she mentioned “millions of medical devices” and at the recall rate of 700 per year. A list member shared a link from the FDA listing medical device recalls, whose numbers differed from Joleen’s, and there was much discussion of her assertion. I made the point that we, as patient advocates, need to be clear on our data to support our argument. Dubious data, with the correct intention or not, undermines our credibility as patient advocates. Others chimed in, producing a really engaging dialogue.

In a parallel universe, Hugo Campos, @HugoOC, a patient advocate, poses the question: Who owns the data from his implanted heart defibrillator, (an ICD)? because he has been struggling to get access to the raw data from his heart monitor, that collects a large number of data points around the heart and the clinical status of his body. Hear the podcast here, from on NPRs media.org, and his TEDx presentation. The manufacturers argue that he would not be able to understand the data. Hugo is a selfquantifier at heart (no pun intended). Through his own self monitoring activities, he learned that coffee and scotch whiskey were triggers for cardiac arrhythmias.

Joleen’s argument that we need to support an independent registry and better monitoring of medical devices is important for patients, as is my argument, that we should have the right to know what is implanted in us. (I have requested from my doctor the information on my hip implant parts without luck, so far. I have my operation report and associated medical records, and nowhere is there information on what parts were installed. Someone has to have this information somewhere…no?) This aligns with Hugo’s assertion that he (or any patient) should have access to the data that his implanted medical device is collecting and transmitting about him to some place somewhere. All these should be our patient rights.

The real underbelly of this issue, for me, is who has responsibility for when something goes wrong?

When there is an implant that has been recalled, what happens to us, patients? Who pays to fix it?

What if it is a critical function device, like a heart defibrillator? Who’s liable is hard to determine unless really obvious (as is in my case). What happens, as in my case, when 90% of my femoral bone has grown into a hip implant except the tip, (mind you it is quite an uncomfortable pain…like my leg is snapped at that point) and doctors are throwing around words like, “We will throw in someone else’s femur and wire bind it to yours”, or “We could try a controlled fracture of the femur and dig out the titanium stem and hope for the best.”

That is when I think “#WTF, what a mess!” I am the one living in pain, and no good solution, and I will be paying for the surgery, not the doctor (at least that is not how the system currently works as far as I know), and what is really irritating for me is that the reason why I am having an early hip replacement in the first place is because of a medication that I was given for a misdiagnosis. How’s that for a double whammy. (That’s a whole other story.)

The question remains: how is the medical machine positioned to manage these types of complications? What I do know is that recently in 2009, for orthopedic devices at least, the AAOS (the American Academy of Orthopedic Surgeons) has sponsored a implant registry to track devices. I have no idea how to access it, and I would really like to know if my problem is being tracked. I cannot even get the info from my doctor, which I am working on. Although, the AAOS does not list patients directly as a stakeholder, it does list patient advocates, and it does indicate that the registry should be transparent. I would really like to get some ortho’s response about the registry. With this post I will put out a tweet to my Ortho twitter list including: Howard Luks @HjLuks, Katherine Burns @KburnsMD, and Steve Mora, @myorthodoc among others.

I also think we as advocates need to reach out and partner, in the hopes of transparency, with groups like the AAOS to have at least ortho implants information available to the patient. Patients should be able to add their own experience of their device.

I think there is a fine line between what a doctor considers a failure and what a patient does. I think I would technically not be considered a failure, although I cannot walk very far without pain. I also think we need to support more stringent rules on how devices get to market and are monitored. As such I support Joleen’s legislative efforts and will add my name to her petition for better management of these devices.

Also, I think patients have an inalienable right to their own data. Ultimately, this is all about the same thing, which is being educated empowered engaged patients partnering to make healthcare better for each/all of us and more transparent.

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Posted in: hc's problem list | medical records | reforming hc

 

 

Comments

5 Responses to “Medical Devices: Another take on “We want Access to our Damm Data””

  1. Katherine Burns says:

    The joint registry for the US is not up and running yet, to my knowledge. The legislation passed in 2009 requires that data begin collection within 3-5 yrs of passage. Safety and quality in healthcare will require increased transparency and cooperation among the different stakeholders in medicine. I agree that the ultimate stakeholder is the patient, and we would be wise to remember that we will all, every one of us, be patients one day.

    • Katherine, first thanks for the comment, and re: failed ortho implants, it would be great if we can get some insight into how is the information currently captured if at all? If the FDA the only repository? Thanks in advance. i will also ping you on Twitter.

      • Katherine Burns says:

        I am unsure if the FDA collects data. The manufacturers rely on data from other countries’ registries, and will voluntarily recall products if and when they believe it is indicated.

  2. Zakkiyya Asad says:

    These problems are faced by every patient that has had a medical device implanted in them. There are failures at every step in the process- First the operating physicians do not always track the specific product numbers of the devices implanted through the patient medical records. However in order for them to be billed these numbers must be present on the billing that goes to the insurance carrier (not the pateint statement you see) You have a right to request that document. The larger issue is how do we efficiently track defective medical devices and get them removed from the market once a problem is found. This could be done simply by tracking medical devices appropriately throughout the 510K approval and aftermarket process. Simply described the 510K approval process allows a manufacturer to stipulate that their product operates essentially like another product that has already passed FDA scrutiny, therefore it does not need further safety testing prior to release. Transvaginal mesh is a recent highly reported example that has led to mass tort litigation and hundreds of law firms nationwide filing on behalf of claimants in class action litigation against the manufacturers of Surgical Mesh used in the treatment of Pelvic Organ Prolapse and Stress Urinary Incontinence. Attached is a link to one of the many attorney sites filing on behalf of injured parties. http://www.womenshealthattorney.com. Based on the authors description of what his personal issues are it is quite likely that his hip implant is also being litigated nationwide.

    The Transvaginal Mesh Case became front page news in part because so many manufacturers were involved. I believe the reason this occurred is because most received clearance for their mesh devices based on the fact that it was very similar to another company’s product that had already received approval.

    This well intended method of fast tracking new medical products has several disturbing flaws. First, not unlike the children’s game of whispering a secret from person to person, the story becomes less cohesive the more times the story is passed on, resulting in products that are no longer like the original entering the marketplace with little or no testing prior to release.

    Secondly, when a 510 K is submitted for approval we are relying on the manufacturer to fairly evaluate the device as essentially the same as a predecessor device and presumes their assessment is being presented without other motivating factors influencing their decisions. This is a reckless assumption since millions of dollars are at stake if the product is not released timely in terms of lost opportunity cost, as well as the significant cost associated with conducting viable safety studies. Remember, poor safety results could prevent the product from coming to market at all and all of their R&D costs as well as the cost of testing are a total loss.

    Finally, there is no mechanism by which all products that are essentially the same are pulled from the market when the original product or sister products safety comes into question or is proven to be defective. In the case of Transvaginal Mesh the original product which cleared the way for many of the other mesh products to gain entrance into the market was pulled from the market in a recall after it was shown to have been unsafe for patient use, yet the similar products that claimed acceptance based on their similarity to the withdrawn product and all other sister products remained on the market and their next generation products now receive 510K clearance based on being essentially similar to the faulty progenitor.

    As recently as July 2011, even with all of the media attention and FDA warnings surrounding the efficacy and safety of these products new 510K’s were approved on vaginal mesh using the progenitor’s devices to gain approval.

    This process is circumventing the purpose of the FDA to protect consumers from defective medical products and brings into question the wisdom of allowing manufacturers to self govern. Having used the 510K process to gain access to the market by stipulating their product was essentially the same as a product that was later found to be defective one would assume that manufacturers would not wait for further patient injuries before pulling their own products from the market. Yet this type of industry self governance does not occur, because regulators are not able to enforce it.

    An application that could track all products that were essentially the same would give regulators enormous clout to pull dangerous products from the market when needed or standardize labeling practices when black box warnings are issued for a product that is proven to be dangerous in the aftermarket period. Standard software that immediately correlated these kinds of records coupled with native language analysis that could be applied to archived 510K filing records make the goal of normalizing this kind of record keeping possible and could prevent tens of thousands of debilitating patient complications and deaths over time.

    While its heartening that the FDA is ordering more safety tests on these devices just as they have the hip implants described by the author- it is very unfortunate that thousands of patients have suffered life altering consequences due to this failed process that could be made infinitely better with the application of solid technology.

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