Access to ICD data

All posts from Jan 1st 2011 to Dec, 31 2011

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CeeBee
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Re: Access to ICD data

Post by CeeBee » December 17th, 2011, 3:14 pm

"And no way will we ever share it with anyone because it is ours! And ours alone! Bwahahahaha!"

That was pretty darn funny, Flyingcamel. And I like the image. From now on, I think this is how I for one will always think of device makers. (only kidding. actually, it's sort of like a department meeting at my job.) I do take FC's point about motivation (or lack) of device mfgrs.

I am one of those advocates for total access to device data, partly because the only time I failed to ask for a copy of my interrogation, it ended up being misprogrammed -- at the Cleveland Clinic, no less (a doc, not the device techs). To me, it seems like there's a perspective divide. Device makers are completely uninterested in providing data to patients direct -- they say "ask your EP" -- and the EPs have no incentive to want to grant you instant access to your data, and considerable disincentive, since, for example, people who are actually on top of things might notice they're in a-fib BEFORE the EP's office does, and call up asking questions (!!). And, in my experience anyway, both device makers and EPs wonder why we're asking for it since we can't understand it anyway, which, to me, is partly understandable human nature (I'm trained to interpret this info and you're not) and also just medical/tech snobbery ("I am a fabulous Rocket Scientist and you are Too Stoopid to look up a term like "detection threshold"). Anyway, that's sort of my experience.

Now I'm off to lunch. And it's mine! ALL MINE!! BWAHAHAHAHAH
Diagnosed with HCM 2008; ICD 2009
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College professor, mystery reader; take college students abroad at least twice a year. No shocks from that -- yet.
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mrag
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Re: Access to ICD data

Post by mrag » December 17th, 2011, 6:32 pm

Let's get a grip on the real world. Does the word "priority" come into play here as far as "data" people should have?
http://abcnews.go.com/Health/orange-jui ... u0liFayDy2

OK, so no need to prosecute Wall Street bankers, no need to prosecute Bush and Cheney for war crimes, no need to give me "my" icd data, but do you think I could safely give my grand kids some juice in the morning? Either Diane Sawyer goes to jail for 'gross sensationalism' or they fire the entire FDA and start over, something is wrong here. And, oh yea . . .
Profit and helping humanity are extraordinarily intertwined in my business.
You betcha!
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Ozchrissy
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Re: Access to ICD data

Post by Ozchrissy » December 18th, 2011, 1:41 am

Personally it wouldn't be of any value if I did get all my device data. I am not knowledgeable or technically minded enough to interpret all of it anyway. BUT, I do like to know that if I did want it I could get it.

As for the companies collecting this information and using it, I think that is brilliant. I like the thought that the companies are looking at the data on my own wires, devices etc. I like the fact that through this they may improve the devices or leads, and that I or future generations will benefit as a result of what they find. I do not feel I am being used as a guinea pig, the devices and leads have gone through rigorous approval processes, before they were allowed to be put in my body, so they can only be improved with more information. After reading through this post, I get the feeling that some of us feel there is a mighty supervillain out there, collecting our data in a secret laboratory, to use it against us and to eventually place mind control over us all for monetary gain.

I think that we have the right for information, as much as we desire about our own devices, but I also feel that the relevant medical device manufacturers also need the data/knowledge for future research and design advancement.
“I am not what happened to me, I am what I choose to become.” Carl Jung

Diagnosed with cardiomyopathy in 10/99
LBBB & VT diagnosed Feb 06
Guidant Biventricular Pacer ICD inserted Feb 06: Boston Scientific Incepta CRT-D inserted May, 2012
Oesophageal Cancer, 2012, Gall Bladder & Septicemia 2014 resulting in VFib and severe heart damage
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Appropriate Shocks for Ventricular VFib.

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hugooc
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Re: Access to ICD data

Post by hugooc » December 18th, 2011, 2:13 pm

flyingcamel wrote:There were/are not people at MDT/BSX/SJM/BIO holding meetings trying to figure out "How can we get our hands on all that data?"
Sure, I'll grant you that no one is holding such meetings — BECAUSE YOU ALREADY HAVE all that data. LOL!

For those patients who prefer not to know and believe it's OK to trust the industry who's brought us Guidant Corporation, it's your prerogative to do so. (And I can't help you there.)

After having encountered hundreds of ICD patients during the last 4 years, it's clear to me that this is a generational difference. Older ICD patients tend to trust everything will be OK and younger ones would like more access and control. Given that the average age of an ICD recipient is 72.5 years, it might take a few years before every patient is given a choice to access their data online.

Of course, if I can help it, this day will come tomorrow.

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hugooc
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A bit of history:

Post by hugooc » December 18th, 2011, 2:19 pm

As a side note, there were no guidelines and no reimbursement codes when the FDA first approved Carelink, in 2002. So, Medtronic decided to charge practices $200 per patient, per year. This was subsequently changed to $30 per patient, per quarter. St. Jude followed suit with their Housecall Plus transmitter program in December of 2004. But only in 2006, Guidant (which was becoming a part of Boston Scientific) came out with their LATITUDE Active Monitoring system, and being in the midst of a messy recall, decided not to charge anyone for their home monitor. This compelled Medtronic to do the same in order to stay competitive.

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mrag
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Re: Access to ICD data

Post by mrag » December 18th, 2011, 3:43 pm

Code: Select all

Older ICD patients tend to trust everything will be OK
You're kidding right? You mean the people that know of the Korean War, the Vietnam War, The Nixon Tapes and have watched the US of A go down the toilet* "tend to trust everything will be OK?" It may be more accurate that after this period of maturity, some of us just don't give a rat's gluteus maximus, but don't think we just willingly 'trust.'

If I follow you, I believe what you are asking fine and highly ethical corporations like Guidant to do is simply provide "us"on-line access to our interrogations (or I assume, everything that is ever transmitted via the monitoring program). Is that the issue, is that the request? Because if it is, let me assure you that you will eventually get your wish because they will then be able to start sending ME quarterly charges again from Boston Scientific. What are they doing now with remote monitoring and cell phones? Aren't they now charging for those? And 99% (curious number) of us will then have access to data we don't want, don't understand, can't afford and can already get from our EP.

Really, I am all for fighting for a belief, but to convince me, I'm gonna need more justification.


* in case someone doesn't like toilets: http://www.delawareonline.com/article/2 ... ext|Home|s
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hugooc
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Re: Access to ICD data

Post by hugooc » December 29th, 2011, 11:45 pm

I've been called "crazy" by the EP nurse at my clinic for wanting access to data in my ICD. I wonder what they'd call Karen Sandler for wanting access to (not the data, but) the software in her ICD. To me, she's a shining example of things to come. Exciting times!

Watch:

Lianachan
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Re: Access to ICD data

Post by Lianachan » December 30th, 2011, 4:33 am

hugooc wrote:I've been called "crazy" by the EP nurse at my clinic for wanting access to data in my ICD. I wonder what they'd call Karen Sandler for wanting access to (not the data, but) the software in her ICD. To me, she's a shining example of things to come. Exciting times!
Excellent video, thanks for posting. I'm a software engineer myself and have the 325 page technical manual for my device too. It is far more straightforward than some of the stuff I've had to program.
I was at the cardio the other day and I asked to see my latest interrogation data. First he told me he didn't have it, 'it's in the pacemaker clinic' despite him being overall responsible for all my care, which makes me wonder whether he's even bothered to review it himself or just waits for the tech to flag any issues of concern. Then he frowned a bit and said he doubted whether I would understand it. He pressed me for specifics about what I was after but I wasn't falling for that one, I'm after the whole lot thank you.

Ulric
Boston Scientific Teligen 100 fitted Mar 2011

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mrag
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Re: Access to ICD data

Post by mrag » December 30th, 2011, 8:43 am

What about "intellectual property rights?" if I develop special software, I should make it freely available to the Chinese to copy and use? Sounds like communism or an Obama platform to me. I don't see anyone in Iowa liking that idea. I agree you should be able to have access to diagnostic results like an interrogation. Access to the company's proprietary code, that is really looney. Isn't that why we have the word proprietary?

And I am a big fan of Linux and now only use open source software.
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JoeNH
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Re: Access to ICD data

Post by JoeNH » December 30th, 2011, 9:08 am

mrag wrote:What about "intellectual property rights?" if I develop special software

This is a specious argument. Take the "Star Spangled Banner" as an example. Francis Scott Key held the intellectual property rights. That did NOT mean others were unable to sing the song or read the music. Francis Scott Key was the only person who could profit from the song.

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mrag
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Re: Access to ICD data

Post by mrag » December 30th, 2011, 12:55 pm

specious? With that I think you may have turned over Steve Jobs. But I may go along with the looney software disclosure business. How about the GPS software we use in our drones when they fly over Iran? How about software in breathalizers, radar guns? How about the encryption on MY purchased DVDs that not only hides the software, but stops me from making safety backups? How about the "secret" formulas used for coca cola or teeth whiteners? Specious, I think not :runaway:
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JoeNH
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Re: Access to ICD data

Post by JoeNH » December 30th, 2011, 2:09 pm

mrag wrote:specious? With that I think you may have turned over Steve Jobs. But I may go along with the looney software disclosure business. How about the GPS software we use in our drones when they fly over Iran? How about software in breathalizers, radar guns? How about the encryption on MY purchased DVDs that not only hides the software, but stops me from making safety backups? How about the "secret" formulas used for coca cola or teeth whiteners? Specious, I think not :runaway:
Actually, most of the stuff you've mentioned IS readily available. GPS software: No problem. Breathalyzers and Radar Guns: No problem. DVD software: No problem, burn as many as you want.

No, the Coca-Cola formula isn't publicly available. And neither is Colonel Sanders secret recipe.

What differentiates what is publicly available from what is not publicly available is the ability or inability to POLICE the improper use of the intellectual property rights.

A perfect example is Lipitor. The secret formula to Lipitor has been no secret for a long time. It's been well understood for many years. However, there is an extremely strong policing mechanism in place to assure Pfizer (who holds the patent) that they will be the ONLY folks to benefit from the patent for the duration of the patent.

There isn't honestly terribly good "policing" available to Coca-Cola or Colonel Sanders against my grandmother who had a recipe for fried chicken that's better than anything you'll get at KFC anyhow.

ICDs and all the component parts of an ICD are regulated under the Pure Food and Drug Act, in exactly the same way they regulate Lipitor and Diovan and Plavix and every other drug imaginable. ALL of these products are protected by some kind of intellectual property right throughout the world .... or at least in all parts of the world in which you'd give a damn. (I'm not sure Pfizer much cares if someone is selling "knock off Lipitor" in the "East-West Banana Republic." I doubt there is enough potential revenue there to make it worth their while.)

Honestly, I don't understand, why with such rigorous enforcement of intellectual property rights in almost all of the developed world, disclosure of the source code with respect to this particular highly regulated medical device, would represent an unreasonable burden upon it's intellectual property rights owner.

EVERYONE and their brother has the secret formula to Lipitor and it hasn't represented a problem for the folks at Pfizer. Pfizer's only complaint is NOT with the dissemination of the secret formula, but rather with the length of the patent protection (a completely different issue). Up until December 1, 2011, Pfizer is the only one to have ever made a dime off of Lipitor.

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Suzanne
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Re: Access to ICD data

Post by Suzanne » December 31st, 2011, 10:15 am

It's just easier for the Doctors and Nurses to have us not know. Todays patient is changing. They will have to adapt.
One time when I was having my ILR read, the Nurse complained that the information I wanted took too much paper. I told him he could just take a screen shot. When he asked me how I knew he could do that, I told him I read it in the manual. His reply was "you read the manual?" I replied "yes". He looked at me and said "are we obsessed"? I wanted to say, "Obsessed is the wrong word you f'ing assh@le!! I've learned to educate myself because unfortunately I learned that I need to because I can't trust people like you!!!!!!"

Anyways, I think if a patient wants to see any data, or know anything about their device, then let them!!! So many people do better knowing. For those that don't, that's okay too,
~ Suzanne ~

St Jude ICD and Lead Implanted Feb.20/09
8 Shock Storm March 21/09
Lead Dislodged, so Replaced with Medtronic Lead June 16/09
ICD and Lead Explanted Nov.23/09
Medtronic Reveal XT (Cardiac Monitor) Implanted Jan.25/10...explanted and new one reinserted on July 21/11

Cardiac Monitor explanted Sept.9/14

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TruckerRon
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Re: Access to ICD data

Post by TruckerRon » December 31st, 2011, 1:29 pm

Suzanne wrote:It's just easier for the Doctors and Nurses to have us not know. Todays patient is changing. They will have to adapt.
One time when I was having my ILR read, the Nurse complained that the information I wanted took too much paper. I told him he could just take a screen shot. When he asked me how I knew he could do that, I told him I read it in the manual. His reply was "you read the manual?" I replied "yes". He looked at me and said "are we obsessed"? I wanted to say, "Obsessed is the wrong word you f'ing assh@le!! I've learned to educate myself because unfortunately I learned that I need to because I can't trust people like you!!!!!!"
I find it interesting that when we're trying to rein in our tongues we fail to see how a simple statement like, "It's my heart," implies all of the above when said with the appropriate tone of voice and facial expression. My mother never cursed at people, but she certainly did whittle them down to size with just a look. My second oldest daughter inherited that trait.
TruckerRon -- Received Minion I on 17 Sep 2009, Minion II on 26 Jan 2015

Non-ischemic cardiomyopathy
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No shocks yet...
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JoeNH
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Re: Access to ICD data

Post by JoeNH » December 31st, 2011, 1:40 pm

TruckerRon wrote:I find it interesting that when we're trying to rein in our tongues we fail to see how a simple statement like, "It's my heart," implies all of the above when said with the appropriate tone of voice and facial expression.

Having been caught in situations similar to the one Suzanne describes on MANY occasions, with profound regret, subtle communication is all too often lost on many people. We place far too many people with relatively low IQs in positions of power, and as a result, too frequently, we are left with no alternative but to resort to the least common denominator among us in order to get the point across.

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