Device Database for the Public?

I'm assuming that this information is already available to professionals..............so the answer is NO!

If a layman goes to get an xray or an MRI, there is no need for them to understand the intricate and complex workings of these machines. If they feel the need, they can google it on their own.

Yet another bloated government agency desperately attempting to justify their existence/budget/size/importance.

Re: I'm assuming that this information is already available to professionals..............so the answer is NO!

I strongly disagree. (I do agree with your next example, you don't need to understand the intricate working of these machines.)

And it doesn't necessarily have to be in a database, but I think some in a database is a good idea.

You already agree, btw--if the information can be googled, well then it is available to the layman.

I could offer a range of examples that I think would be useful in a database. (BTW, google is a (fairly large, free-format, well-indexed database).

How about expected life of various models of pacemakers?

How about a simple explanation of the difference between what MRIs, X-Rays, bone scans, CAT scans are good for? (I went through some things with a close relative where doctors often prescribed anything but an MRI, but the MRI was the only thing that could reliably detect the problem being looked for. Had I known that earlier, I would have (gently) questioned (but probably rarely tried to overrule) the doctor.

Re: My "NO" answer wasn't about whether the information should be available, (I think a lot of it is), but whether we need government intervention to compile it and put it into a data base. I think not.

I agree, and I figured that's what you meant. But I felt I couldn't let your big (bold?) NO stand without more qualification (by egotistical me) ;-)

Moving OT, this is somewhat similar to what I think about the money wasted by the FBI (or their contractors)--was it close to a billion for some sort of computerized criminal tracking system. They could have started with an encrypted wiki, at much lower cost.

(BTW, to me, that billion was another billion in makework and corporate welfare.)

Even a mock up using a wiki would have saved a lot of mistakes, false starts, and taxpayer money. (I say mock up to further decrease the possibility of information in such a system falling into the wrong hands. It never will (fall into the wrong hands) in a professionally developed commercial criminal database, right ;-)

Not marked OT because (I think) only half of it is OT. ;-)

I have to differ with the view that the government agency in question should not share their professional database with the public.

As to a waste of money, I will assume that the database is already necessary for the purpose of regulating devices. Someone has to know what devices are available and what the spec is, yes? Presumably this agency.

As for the industry that wants such information to be kept out of the public domain, what do they have to hide?

They don't have a database................at this point it's a proposal. Considering it's the US government, I'm sure it's a very laborious and expensive one.

The companies don't have anything to hide, (that I know of). Proprietary information, (which would not be disclosed anyway), would relate to something specific to a particular company's product, that makes it work better, or in a different manner, from those of their competitors. They would want this information hidden, (which is legal), to maintain market share, a competitive edge, or both.

You make a good point though. Since all medical devices have to be reviewed and approved by one agency or another, (usually the FDA), such a database could have been started and maintained decades ago, at very little cost.

Obviously, that was not done. It's a shame. At one point or another they had their hands on all of this information. I seriously doubt that they have anything that resembles a coherent database at this point.

Those are not reassuring words... The equivalent regulatory body in Canada (or regulations at least, possibly lacking an actual "body" with capacity or responsibility to take an action) stipulates that a device that has already been approved in the US can be imported into Canada without so much as filing a description of the product and what it is for.

If there's not even a handy database on your side of the border, then I guess devices can just float around our country for this or that purpose without any clear record of what, why, or to whom - and plenty hard work to trace em if you needed to do so.

(As for our civil service, I imagine a dutiful Federal employee who is not to ask questions, with a large, Kafka-esque ledger in which an X is marked to indicate that an unknown (but US approved) piece of gear has entered the country.)

One big problem with "medical device" is that the term encompasses such a diverse range of stuff, everything from bandaids to CT scanners. The idea that a database is needed to explain 'labeling' is no joke! And why should these labels be unintelligible to the lay person - we are the ones, ultimately, being bandaided or scanned... Do the police have any idea what is coming in the country under this industry.

As for the motive to hide, well, in my bitter and twisted opinion, wherever it is convenient to hide, there you will find organized crime conveniently hidden. Jack-Hornered with their thumbs in the pie.

Don't get me wrong. The FDA, and others, are extremely meticulous in the screening/testing of any medical procedure, device, drug etc. Some would say too much so. It takes years to get anything approved in the US.

Since the blog is just a sneak peak, and provides no link to the actual proposal, all we can do is speculate as to what it entails. Given the current economic/financial condition of the US, anything that sounds like it's going to cost a lot of money, that we don't have, raises my hackles.

Kudos to Canada for allowing us to spend the time and money required to get this stuff approved. ( If it's good enough for them, it's good enough for us, eh). I'm sure it's saving your country a boat load of money. I've got to give your government credit for not insisting that all studies, tests, trials, etc., be repeated up there.......good thinking.

I was going to mention that 'slumming humpty' effect of our government dependency, sort of guessed you might bring it up.

But do bear in mind that not all of the devices in question have been thoroughly tested in humans down south. Canada has a beast of a medical research system, with opportunities to test stuff on Canadians - even without their informed consent. They quietly neglected to update with Helsinki and close those loopholes in 2004. The research industry is tightly bound to the public health monopoly, although the jurisdiction is split - again, making it easy to hide who is being served and who paid off and who exploited and what's the gear in that brown paper package from the USA. The federal research regulatory environment, taxation setup etcetera was all tweaked by a very infamous Canadian prime Minister, Brian "envelopes-of-cash" Mulrooney, decades ago. They actually gave Brian the industry's highest award - the same award they gave to Alexander Fleming, that's how much he contributed to their bottom line. But I digress....

It's too bad the article isn't clear about an existing database, but surely if the information is documented it would not be a giant megaproject to organize and make it available in a publicly readable form. This is what our democracies are about, it is a way of giving back something for the tax dollars already spent, and a way of opening that expenditure of your dollars to public scrutiny. The fact that other readers on the internet also benefit and have opportunity to learn is not a bad thing, it is consistent with the higher ethics of democracy, for which I am personally very grateful. (Kudos, USA, and thanks! When I'm elected Prime Minister I'll try to return the favor )

with opportunities to test stuff on Canadians - even without their informed consent.

That sounds scary!

I wasn't knocking Canada for utilizing the work done down here. I wouldn't call that slumming, I'd call it smart policy.

As far as the blog goes, I have no idea what, " a repository for medical device labeling", would be..................it could range from completely useless, to somewhat helpful.

One thing I do wish they would do, is before spending a bunch of time and money on things that they have determined that the public needs, is to find out for sure if it is something the public really does need.............or want.

They do all of these wonderful things for us, but never bother to ask us what we want.......................well, maybe during an election cycle, but that doesn't count.

Some background info.

Good find. It's interesting how the entire write up only mentions what it, "could do", or, "might do".

It shows no confidence in what it, "will do".

In a classic example of government run amok, the toothbrush is considered a medical device and falls within the scope of the FDA.

I don't think creating an online repository for medical device labeling will accomplish a thing...................busy work.................years of it.

Re: It's interesting how the entire write up only mentions what it, "could do", or, "might do".

Although the meeting has occurred (on April 7, 2011), the document doesn't read like meeting notes / results so much as a meeting notice. Furthermore, those "could do's" are in a section named "Background".

Furthermore, the entire thing is still speculative--the document includes a section of "Draft Questions for Panel Discussion" which presumably will be held on or after May 10, 2011.

I'm a little reluctant to place too much emphasis on the uses of "could do" vs "will do" in that document.

(Of course, maybe I spent too much time in a corporate bureaucracy in which I had to avoid making promises that I would not be able to keep (because they were not totally in my control).) ;-)

They're still talking about labeling and package inserts though. A bunch of technical mumbo jumbo that no one is going to be interested in...........at least not any patients. The people that use these devices already have the documentation that came with them.

As far as patients go, it's important for a patient to research whatever condition they may have, as well as treatment options. None of this would be included, and I believe very little help would be garnered by reading the various labels from medical devices.

In a worst case scenario, a patient would read some device labeling on the web, and attempt to tell his doctor what he thought should be used, based on his very limited understanding of the various devices. This already happens, (and drives doctors nuts), when people see television ads for prescription drugs, and proceed to tell the doctor what they need. The clever marketers even instruct the patients to suggest XYZ drug to their doctors.....................and it works.

I just spent a few minutes googling on a few different medical devices..........there's plenty of information available...........labeling and everything else.

Call me a kook, but in a very worst case scenario, I could see this as a first step toward making all information that could be construed as pertaining to public health and safety, only available through the government........................which would essentially give them control of the internet. No Thanks!

Problem is............whenever the government hatches a scheme to keep us safer, it ends up chipping away at our freedom...............every time.

At least in India, the patient rarely gets to see the instruction manual or the label on the unit carton of medical devices used for his treatment. Since the proposed database is about labeling info and not the technicasl details, it does not seem inappropriate to set it up.

It may be worthwhile to have various mandatory cautionary info regarding the device be accessible to the patient from an impartial source.

Bioramani