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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