At least some people seem to believe the garbage coming from here, so lets go through it and see how much crap it is.
Let's start with what is fueling this panic. In HR 4872 (our friend is looking at an older HR 3200) Subsection C is titled "National Medical Device Registry". Here is the full bill, subsection C starts on page 1013. So what is the national medical device registry?
(g)(1) 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—
(A) is or has been used in or on a patient; and
(B) is—
(i) a class III device; or
(ii) a class II device that is implantable, life-supporting, or life-sustaining.
So far we're on the same page. So what is in this registry? Well here is the text of the bill:
(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each device described in paragraph (1) by type, model, and serial number or other unique identifier;
(B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A)
I've read the entire subsection C as it is in HR 4872 (the bill that has passed so far). It lists potential locations to gather data on medical devices, talks to tracking safety rates, and even mandates that the data be made publicly available. So where does it mandate that we all get implanted RFID chips? Nowhere. Not one mention of making anybody use any type of any device.
So where did our other blog find such an assertion? Well he basically made it up, but I'll try and follow the leaps and jumps he went through in order to start his own personal little panic.
If we go back to the beginning we see that this subsection covers class III devices and class II devices that are implantable, life-supporting, or life-sustaining. As you can read here medical devices are split into three classes. Class I includes things like bandages, tongue depressors, and bedpans. Class II gets into needles, wheelchairs, x-ray machines, and such. Finally class III devices are things like heart valves and pacemakers.
Because the bill mentions class II devices that are implantable our friend in the other blog insists that this covers RFID tags (which is true) and that means everybody will be required to get an RFID tag (which is just a valid as saying this bill will require everybody to get a pacemaker). Nowhere in the bill does the word radio or RFID exist.
Now our friend in the other blog does a couple of nice tricks to amp up the scare tactics. First he links to a fda.gov document that shows RFID chips are class II devices, which is true but really doesn't have anything to do with his argument that this new bill requires us to get them. Then there is my favorite. He drops in these quotes from the (older version) bill.
Pages 1001-1008 “National Medical Device Registry” section.
Page 1006 “to be enacted within 36 months upon passage”
Page 503 “… medical device surveillance”
And we all collectively scream "Oh no, surveillance!". Except if you take a second look at the page numbers he listed you'll notice the "... medical device surveillance" bit comes from a completely difference section of the bill no where near subsection C. The surveillance quote comes from a section about supporting a 2003 bill aimed at improving medical research.
So to wrap things up this part of the bill basically sets up a system to track the safety and performance of medical devices (kind of how the transportation department tracks the safety of cars). A couple people seem to have jumped on this to make up a bunch of crap and try to make themselves feel more important. And now hopefully none of my friends and family will fall for it.
I'm sure there are serious problems with this bill, but this isn't one of them, and focusing on things like this help nobody.
Friday, March 26, 2010
Subscribe to:
Posts (Atom)

