"'Your mother ate my dog!'- Paquita Maria Sanchez, Dead Alive, AKA Brain Dead"
Possible Danger In Health Care Bill
Mon, 08/31/2009 - 19:08
I was talking to a couple of my liberal friends last week and they asked me how I felt about free health care. I told them I was uninsured and hoped it would work out so I could go to the doctor for the first time in 13 years. Pleased, my friends told me how much they loved the new health care bill. I commended them for taking the time to read it, admitting that I'd been too busy to do so myself. They looked at me like a couple of deer in headlights.
"Read it?" they said.
Turns out they hadn't read the damn thing they were supposedly so happy about. Typical, yet still somehow unbelievable. So I had to sit down and waste what's left of my youth slogging through this 1000-plus page, intentionally-difficult-to-read, boring as fuck document myself. And I found something kind of fucked up, but maybe I'm just worn out and I'm not thinking about it clearly, so I'd like you guys to read this part yourselves and tell me if it really says what I think it says. Okay, before I copy and paste the text, I'll tell you what I think it says. I think it says they want to put a fucking microchip in us and enter us into a database, or at least they're strongly considering it. Anyways, here it is.
H.R. 3200
pages 1000-1007
National Medical Device Registry
The Secretary shall establish a national medical device registry (in this subsection referred to as the 'registry') to facilitate analysis of postmarket safety and outcomes data on each device that is or has been used in or on a patient; and is a class III device; or a class II device that is implantable, life supporting, or life-sustaining. In this paragraph, the term 'data' refers to information respecting a device described in paragraph, including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.
OKAY! So what the fuck does that mean. I looked up "class II implantable device" and was directed to an fda document. This is what the fda says a class II device is:
This guidance document was developed as a special control guidance to support the classification of the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The device is intended to enable access to secure patient identification and corresponding health information in humans. This guidance is issued in conjunction with a Federal Register notice announcing the classification of implantable radiofrequency transponder system for patient identification and health information.
ALRIGHT THEN. Am I going crazy, am I misunderstanding this somehow? Any feedback is welcome, because I was looking forward to free health care!
Mon, 08/31/2009 - 20:50
#2
Thanks, Tristan. So what you're saying is that they're going to stick RFID chips in plastic legs, arms, etc, and enter them into a database. That's not so bad. I was afraid it meant that they were going to implant a chip in our arms with our medical history on it so it can be scanned at hospitals, and then the nurses would be able to see our entire medical history, and that would save them from having to ask us about it or have us fill out long forms. Because I know that plan is on the table... I was nervous that that would be a requirement to qualify for the new health care. Thanks for your input... I'm less paranoid about it now.
Mon, 08/31/2009 - 22:40
#3
Thanks, Tristan. So what you're saying is that they're going to stick RFID chips in plastic legs, arms, etc, and enter them into a database.
Essentially, but it might not even be a chip; it might just be a serial number so that they can track what goes where and "how did it do?".
As far as what specifically are Class III medical devices, Wiki has a pretty good summation:
Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).
http://en.wikipedia.org/wiki/Medical_device#Class_III:_General_Controls_...
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Mon, 08/31/2009 - 22:59
#4
Your take on it makes sense. When I re-read it and think about your take on it, I can see it. But what's going on with this: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/... This is what got me spooked in the first place. Maybe our links are both saying the same things but in different ways and I'm missing it...
This section of the health care bill relates to a proposal to begin tracking the history of all surgical implants (e.g., grandma's fake hip, grandpa's fake knee) in order to establish their effectiveness. I'm pretty sure something similar is already in place for prescription drugs.
http://www.medicaldevicestoday.com/2009/07/medical-devices-house-health-...