Medical Devices with RFID Technology: Informed Consent?

I have several implanted medical devices which manage my chronic pain. The first is an RF-spinal cord stimulator (manufactured by ANS) and the second is an intrathecal pump (manufactured by Medtronic). Both devices communicate with programmers by radio waves.

[atsimg]http://files.abovetopsecret.com/images/member/89163b07a858.jpg[/atsimg]

Now, I realize that incorporating a certain degree of "smart" technology is necessary for them to work properly. However, these implants also contain other types of information that are not necessary for them to work. I wouldn't have known just how much if I hadn't changed pain clinics (I no longer go to the same doctor who implanted the pump and the stimulator was implanted by still another doctor).

[atsimg]http://files.abovetopsecret.com/images/member/d316b81ab560.jpg[/atsimg] Spinal Cord Stimulator (programmer & implantable leads & pulse generator)

During my first doctor's appt at the new clinic, an antenna was placed over my pump as it is at every refill (to access information about how much medication is left in the reservoir, what medication it is, when it will run out, etc.). In addition, the programmer also displayed my name, age, date/location, the doctor who did the implant, alarm dates, other medical information, etc. The sheer amount of data was really shocking! Then, my new doctor turns to me and asks, "Are you (Firstname Lastname) of such-and-such, etc., ..." to confirm the data!

[atsimg]http://files.abovetopsecret.com/images/member/a01cf1deabd9.jpg[/atsimg] Intrathecal Pump The pump itself is usually implanted in the lower abdomen on the right or left side and is attached to a catheter that delivers small amounts of opioid medication to the epidural space of the spinal column.

At the time, I thought he was kidding... Refills can be a bit scary for people who aren't used to having needles poked in their bellies so it isn't uncommon for someone to try cracking a joke. But, I saw the display on the programmer myself and the data was really quite extensive!

I am completely dependent on my implants. When my pump needs it's battery changed in another 2 years, I just can't say, "Not now. Let me know when they come out with an RFID-free version." So, the question is, did I have the opportunity for informed consent and if not, what could I do about it? There have been various debates on ATS over the years about how RFID chip technology may constitute an invasion of privacy and could ultimately become the newest plaything for identity thieves but I never had the chance to say "no" to this (although I did consent to the devices). Is it already too late? Should patients be advised of the data that will be stored in their medical devices and be asked to consent to that as well?

FYI: Other ATS threads that mention incorporation of RFID technology in medical implants include:

RFID in hospitals could pose risks!
Me RFID Chipped-Without inforned consent
SCI/TECH: "Intelligent" Implants In The Human Body
Microchip implants cause malignant tumors in lab animals
"Intelligent" Implants In The Human Body
RFID chip: would you say yes?

[edit on 20-4-2009 by X-tal_Phusion]

There has to be a certain level of fail safe and identification for implanted devices.

if you were rendered incapacatated, it is a resonable expectation that a health care profession would need to access data from an implanted device if you cannot provide such identification, function etc.

The implanted serial numbers also prevent such devices from being recycled by less than ethical people.

In fact in terms of pacmakers the virtual alphabet soup of acronyms like PEVARP, Ma, pacer modes like DDD, AAI, VVI etc is alot for a person to remember and get correct so it helps.

I will check but my recollection is that these devices DO not transmit unless interrogated by the correct device. Now thats not to say someone coould get ahold of one and use it, but the odds are pretty long. They would have to know you, know what device and get the specific device to do so.



I do not know your case but when a kids gets a pacemaker, as part of the pre operative education they get time with the Cardiology Nurse pract. Who goes over the risks, benifits, and shows them the device she uses to tune the pacemaker etc. They also Always get a copy of the data generated.

In your case, im guessing its a nessesary evil as the data is needed to tune, modify, and service your implants. Im betting you will not get a version with the changes you mention.

I agree that some information should be stored in medical devices and I agree that having a database for serial numbers is a good idea (to prevent inappropriate recycling). I've heard of engraving serial numbers on artificial joints, for instance and I see nothing wrong with that. I also wear a medical bracelet so that in the event I am incapacitated, medical personnel would immediately know that I have implanted medical devices and, in the case of the pump, what medication is in the reservoir.

Medtronic is the main supplier of pumps, and to a lesser extent, spinal cord stimulators as well so the readers are commonly housed by clinics and hospitals across the country. If someone really wanted to get a hold of one and use it to interrogate my pump, for instance that would not be difficult to do. Furthermore, in cases where readers are not available, Medtronic is only too happy to fly in their reps with the requisite equipment at the drop of a hat.

Programmer antennae, in their most commonly-employed form, must be placed directly over the implants in order to read them but this is not to say that it would be technologically impossible to create one that is capable of reading from a distance. I admit that most of us would not know how to do this, but there are people out there who could, if sufficiently motivated. Just because the protocol isn't common knowledge, doesn't mean it's an impossibility.

Keeping certain kinds of data in the implants is necessary for them to function. The issue here isn't whether or not data should be stored but what kinds of data and the purpose behind storing that data. For instance, does the pump need to store my name, date of birth and address in order to function? Why isn't a serial number sufficient?

Unfortunately, I don't think it is possible for the patient to control what kind of information is stored. The only information that changes each time I get a refill is the date of the refill and dosage. Everything else, is there as long as I have the pump. Reading my device's serial number from a distance isn't going to mean anything to someone who isn't employed by Medtronic. Serial numbers don't contain any personal information. In order for them to have any sort of meaning, they must be looked up in Medtronic's database.

The same goes for the MedicAlert bracelet I wear. The number on the bracelet is useless to an identity thief without the database. Anyone who finds me unconscious would have to call the 1-800 number on the tag and provide their own ID as medical personnel to access anything more (as it should be!).

[edit on 20-4-2009 by X-tal_Phusion]

I have to give you kudos for a very interesting thread The info you provided on your pumps and the technology behind them is stunning. Thanks for sharing



Ive thought about this and I have a simple (I hope) solution for you.

Call medtronic or thier website and see if they have a HIPPA compliance office or department and pose your questions to them. Certianly unauthorized reading of your data would be a major HIPPA violation. See what they say. Its worth a shot and its interesting to see how they intend to stay HIPPA compliant.

Unfortunately, I don't think it is possible for the patient to control what kind of information is stored.

I dont think so either and they have to be standard accross the board for anybody who has it I think.

[edit on 4/20/09 by FredT]

I just did a search on the US Department of Health and Human Services' website to see what they had on medical devices. Here's what I found:

PERSONAL HEALTH RECORDS AND THE HIPAA PRIVACY RULE
THE HIPAA PRIVACY RULE’S RIGHT OF ACCESS AND HEALTH INFORMATION TECHNOLOGY

I haven't had a chance to read them yet, but here they are for anyone else who's interested.

I just found a few other items of interest:

HIPAA's Influence on Medical Device Technology
What are the Benefits and Risks of Fitting Patients With Radiofrequency Identification Devices
Biomedical Devices and Systems see pg 9-14
Networking Implanted Medical Devices: Ensuring effectiveness and security
HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations