FDA Oversight of CPAP

Howdy,

The FDA has the impossible task of ensuring absolute safety without exerting absolute control.

There is simply too much complexity and information in our world for any one of us to understand it all. At some point we've got to trust another who has look deeply into an area we have not. Institutions spring up as a result of this need.

Laissez-faire capitalism allows snake oil salesmen to thrive just as the knowledge that at some point a population needs to trust to function leads to corruption and undue control on the part of officials. Ya'll are speaking as if one or the other was true. This makes no sense to me. I see it as a gradient and about picking the best trade offs and middle ground given that it is so.

@sleepygrumpy, you call us names for not agreeing with your initial opinion. The support of your stated position isn't fact based but emotional. That seems more of a heard animal mentality to me. You've got an MD and a PhD but we've got actual real life experience coming up against the controls the FDA does have in place. I'd say on this gradient we're more informed and our opinion more likely to be correct as we've seen deeply into this particular area. Surely your position isn't "give them the power and everything will be sunshine"?

As has been pointed out, there was a time (read "The Jungle") where capitalism had its chance to self correct and produce safe products and practices. It didn't happen.

In reaction there was a time where setting up an institution was assumed to be guarantee that the institution would produce good results. We're seeing that this doesn't happen either.

Should there be an FDA? Yeah. Will handing them more power guarantee better experiences and results? Probably not. Is it worth the risk as a result? No, unless you can tell me what specifically gets better and how accountability is ensured.

Johnny

Let's see, the FDA CPAP DEPT, no funding, no power, and like most government dept, set up for self serving wastes of money. While they may not have funding they still spend our money foolishly.

Beaucrates breed faster than Socialists, but the results are the same, like Rats, more beaucrates! Unlike Rats, methods of controlling them are even less effective. I can't imagine why anyone would think they had anything useful to bring to the XPAP table.

We seen it coming , the government wants to control thd air we breath, it won't be happy until it can control every aspect of your lives. Jim

Davidwnc wrote:

tan wrote:Exactly, fear that we will finally end up with something like EHS, a CPAP user from England recently described it and the direction our ACA with its tons of additional regulation is taking us to. You don't really want that. Government already has too much power.

What the heck is an EHS? Do you mean the NHS?

Aye, sir, NHS.

BlackSpinner wrote:The FDA was setup after people got sick from the "wonder drugs" that used radium as a base in the early 1900's. If you want to go back to that era then don't fund the FDA. If you believe in "Buyer beware" or "Free market regulates itself" just remember cancer takes a few year to happen.

Exactly -- it never ceases to amaze me the number of people who complain about the government or its regulatory agencies who have no real clue about what goes on within either, or the reasons such regulatory bodies or policies exist. Until, that is, there's an epidemic everyone wants the government to save them from, or a jet plane that everyone demands the government regulators inspect, or meat that everyone demands the government inspect every single carcass of, or approve and inspect pacemakers or contact lenses, or tens of thousands of other medical devices and drugs on the market...

But heaven forfend the FDA regulate cpaps or ventilators or, LOL, maybe in a future dystopian hell, gasp, prevent patients from playing around with their settings because the patients think they know best, being amateur doctors and all....

Sheesh bring out the teabags.

sleepygrumpy wrote:When I had an issue with a machine or two, I called the FDA to ask what they know. In speaking with them, I found that while there is a CPAP department at the FDA, they do not actually have the funding to test machines to make sure they work as intended. Nor do they have the authority to tell a manufacturer they have to change something. Nor do they even have the authority just to request a machine so they can inspect it. Sound crazy? This was told to me by the department head. She said that unless our elected representatives change the laws, they have no power to do anything besides basically collect data and file complaints. For this reason, I am urging all of you, my fellow sleep apnea patients, to call your US Senators and Congresspeople so we can get this FDA Department funded and the law updated to give them the power to oversee these machines and medical equipment properly. The department is called the Respiratory Devices Branch and is headed up by Anya Harry, MD, Ph.D

I'm thinking YOU sound "crazy".

Our problem is too much government! And, most of it isn't accountable to anybody......especially "We the people".

One prime recent example is this Ebola situation.

Not gonna call my representatives to try to get MORE government control. It's already incompetent.

Got it?


Den

.

+1 for DEN!


I'm thinking YOU sound "crazy".

Our problem is too much government! And, most of it isn't accountable to anybody......especially "We the people".

One prime recent example is this Ebola situation.

Not gonna call my representatives to try to get MORE government control. It's already incompetent.

Got it?


Den

.[/quote]

Denial Dave wrote:+1 for DEN!


I'm thinking YOU sound "crazy".

Our problem is too much government! And, most of it isn't accountable to anybody......especially "We the people".

One prime recent example is this Ebola situation.

Not gonna call my representatives to try to get MORE government control. It's already incompetent.

Got it?


Den

.

[/quote]

+2 We need to loose the Sheeple Mindset, we used to have the ability to find our own facts and use them to make your own choices.

Stop believing everything you read, the government and corporations, and almost everyone around us lie, you need to question everything you are told, ask who benefits and why from what you are told, choose the answers that make sense, and make your own choices.

If you see a group that's pulling the wool over your eyes, stop trusting them blindly, period. Think why would they tell me that I, enlighten yourself, think smarter. Jim

Wulfman... wrote:
I'm thinking YOU sound "crazy".

Our problem is too much government! And, most of it isn't accountable to anybody......especially "We the people".

One prime recent example is this Ebola situation.

Not gonna call my representatives to try to get MORE government control. It's already incompetent.

Got it?


Den

.

Hmmm if you want to control ebola tightly you first have to institute a lot of rules, enforce them with fire power, provide free health care and paid sick leave. And remember 52,000 people a year die from flu and its complications and nobody bothers to regulate that.

BlackSpinner wrote:

Wulfman... wrote:
I'm thinking YOU sound "crazy".

Our problem is too much government! And, most of it isn't accountable to anybody......especially "We the people".

One prime recent example is this Ebola situation.

Not gonna call my representatives to try to get MORE government control. It's already incompetent.

Got it?


Den

.

Hmmm if you want to control ebola tightly you first have to institute a lot of rules, enforce them with fire power, provide free health care and paid sick leave. And remember 52,000 people a year die from flu and its complications and nobody bothers to regulate that.

No, the solution is very SIMPLE......not allowing people from various parts of the world into the country.......including the southern border......where this new strain of what appears to be related to polio is coming in from......Enterovirus D68, also known as EV-D68 (which so far has been more deadly than Ebola).
The southern border needs to be closed!


Den

.

Davidwnc wrote:

tan wrote:Exactly, fear that we will finally end up with something like EHS, a CPAP user from England recently described it and the direction our ACA with its tons of additional regulation is taking us to. You don't really want that. Government already has too much power.

What the heck is an EHS? Do you mean the NHS?

*caw caw* *flap flap* I heard a rumor something is bad somewhere! *caw caw*

OLD joke, when in the Army I heard: There is three ways to do things, the right way, the wrong way and THE ARMY WAY.

I find with Government it is THE GOVERNMENT WAY....

The Government has NEVER done what is BEST...Take the highways built in the 40s and 50s, they were not done the best way they were done "Good Enough" and poorly enough to insure lots of work in the future for repairs... check Germany's own highways done at the same time..they hardly needed any reworking for decades...

Look at any thing done by the Government and you will see a screwed up mess.

They can only spend millions of stuff, like the million spent on a working space pen, one that would write in space, POOR Russia did not have that budget so had to make do with poor old lead pencils....costs .05 Cents.

It just goes on and on and on and on to the 100,000 power

Rich

I don't have a problem requesting a call to our DC representatives to change our laws.
I think we should each own and control all our medical records, have first access to our test results and decide who should be allowed access to our medical information and when.
If I want a doctor or insurance company to know something about me I can email them the info I want them to have. If I decide it's none of their business then I don't send it to them.

I certainly don't need to give more power to the FDA. The departments that have authority get their funding from fees charged to those they regulate. So just add FDA fees and testing regulations to CPAP equipment and see what happens to prices and future improvements.

racprops wrote:OLD joke, when in the Army I heard: There is three ways to do things, the right way, the wrong way and THE ARMY WAY.

I find with Government it is THE GOVERNMENT WAY....

The Government has NEVER done what is BEST...Take the highways built in the 40s and 50s, they were not done the best way they were done "Good Enough" and poorly enough to insure lots of work in the future for repairs... check Germany's own highways done at the same time..they hardly needed any reworking for decades...

Look at any thing done by the Government and you will see a screwed up mess.

They can only spend millions of stuff, like the million spent on a working space pen, one that would write in space, POOR Russia did not have that budget so had to make do with poor old lead pencils....costs .05 Cents.

It just goes on and on and on and on to the 100,000 power

Rich

I was expecting the old military saying........"If it moves, salute it.......if it doesn't, paint it".

Another example of the government run amok is the NSA.


Den

.

I'm new and have a question for sleepgrumpy. You wrote:

sleepygrumpy wrote:When I had an issue with a machine or two, I called the FDA to ask what they know.

What was the issue you had that you could not call the manufacture that made the machine and ask them? or maybe your DME provider?

racprops wrote:They can only spend millions of stuff, like the million spent on a working space pen, one that would write in space, POOR Russia did not have that budget so had to make do with poor old lead pencils....costs .05 Cents.

that's a good story, and oft repeated, but, it's totally false.