FDA Oversight of CPAP

49er wrote:
Exactly DD. By the way, what is it with folks who have sleepy as part of their ID? I was attacked by sleepy1235 in another thread because I had the nerve to politely disagree with him on an issue and now this dude does the same thing to other folks who did nothing to deserve that type of response from him.

49er

Oh dear 49er, did you ever think the nature of your many posts attracts attacks? You post a lot on here and much of it is about things that are subject to varying opinions if not downright controversy.

This is the internet after all and I don't think you have any desire to change your habits, so just keep a tough skin.

Sheffey wrote:

49er wrote:
Exactly DD. By the way, what is it with folks who have sleepy as part of their ID? I was attacked by sleepy1235 in another thread because I had the nerve to politely disagree with him on an issue and now this dude does the same thing to other folks who did nothing to deserve that type of response from him.

49er

Oh dear 49er, did you ever think the nature of your many posts attracts attacks? You post a lot on here and much of it is about things that are subject to varying opinions if not downright controversy.

This is the internet after all and I don't think you have any desire to change your habits, so just keep a tough skin.

Interesting response Sheffey I didn't know that politely disagreeing with someone was considered to be controversial and warranted attacks which is what happened in that thread. And in this thread, the only thing I did was agree with cathyF which was pretty tame. Hmm, I stayed the heck away the political posts on government vs. no govenment so sheehs, give me credit for that.

By the way Sheffey, I am long over the attack. But I did think it was interesting that two people with sleepy in their ID pretty much operated in the same manner when people disagreed with them.

49er

49er wrote: I stayed the heck away the political posts on government vs. no govenment so sheehs, give me credit for that.

No, you get no credit from me. I much prefer someone who has read, listened, watched, discussed and honed their thought process through debate ... over some, as Goofproof would say, sheeple, who are part of the uninformed electorate who go in the voting booth and put down D or R.

Both D and R make it so easy to put them down.
They both support excessive, stupid spending on pet projects and over regulations.
When freshmen arrive they are immediately indoctrinated into the go along to get along way of doing things.

End of rant.

Judge Nap wrote:

Wulfman... wrote:The problem here is that most of the politicians are "bought and paid for" by special interest groups.

You have it backwards. The problem is not that lobbyists "buy" elected officials. The problem is that elected officials "sell" themselves to lobbyists and other special interests.

If you go further, the real problem is that the people elect these politicians and keep electing them - 90+% of incumbents are reelected.

There is an alternative, but apparently the people want to keep electing the same sorry-ass Republicans and Democrats.

That's kind of "splitting hairs". They can only be bought if they're "for sale"......but if they're "not for sale", they can't be bought. Newly elected politicians may get elected with the best of intentions, but are soon corrupted by "the system". On the other hand, some may go into politics with the intentions of getting rich.

About 40 years ago, someone (a wise person.....a local game warden) once told me that "EVERYONE has their price".
Meaning that you can buy anybody (for whatever reason) if you offer them enough money. Over the years, I've noticed that that seems to be true in just about all areas......and especially politics.

The biggest problem when you go into the voting booth is that you basically have two options......"Dumb" and "Dumber". You just don't know which one is which until after they've been elected. Unfortunately, there aren't very many of the "3rd party" candidates to choose from either. With the way the established party machinery (both of them) goes after the challengers, it's keeping some potentially decent people from getting on the ballot or getting elected.
So, saying "throw the bums out" is pretty easy to say.......but achieving that goal is pretty tough in reality.


Den

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Maybe that's the point of elections. Some can be bought, some are Rent to Own, some are leased by the term. The object is to vote and hope to get some of what you pay for, we seldom do! Jim

Orgionally politics was a part time job, a service, then you went back to your job. Now it's a place for people that have never worked or created anything to carve out a fortune, from bartering power, and selling their souls to the highest bidder. And the Sheeple keep putting them back in power, and collecting their unearned benefits.

I was attacked first in this thread; but I have been called worse.
--- I attended public school with troglodytes, so it's nothing new.
---"you can call me anything but late for supper."

I forgot to mention one other thing about the politicians.......
Once they DO "retire" from their political offices, many of them become lobbyists. And, that's where they get even richer.

http://en.wikipedia.org/wiki/K_Street_% ... n,_D.C.%29

http://en.wikipedia.org/wiki/Lobbying_i ... ted_States

That's enough to make you sick!


Den

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chunkyfrog wrote:Unfortunately, a good agency has over the years taken on a great deal of bloat,
and now serves the businesses at least as much as the patients.
I would recommend a complete overhaul of the FDA so we can get it right.

As a person working in an industry that is FDA-regulated (medical devices --blood monitoring instruments) and who has written submissions to FDA for clearance of devices and has dealt with them from a manufacturer's compliance perspective, I totally agree that an overhaul of the Agency is required, as is some redirection in the legislation of what they regulate by Congress. The classification of medical devices is also flawed, as we know, evidenced by the prescription requirements for devices and masks. The pre-market clearance/approval process could stand some significant improvement. And contrary to what the OP quoted, the FDA has plenty of muscle post market as well with quality audits of manufacturers and oversight of customer complaints. The comment about not having the authority to ask for a device for testing is kind of ridiculous. FDA is not equipped, either from a facility standpoint or from a staffing/knowledge standpoint, to test equipment. That's not what they do and not the kind of agency it is, at least on the medical devices side.

FDA regulation (both pre- and post-market) costs manufacturers LOTS of money, eventually driving up the costs of regulated products. BTW, the FDA already charges fees and has "regulations" for CPAP manufacturers so is already to some degree funded by the industry it is regulating, as somebody alluded to. Campaigning to give more power to the FDA? I'm way against that!

palerider wrote:the fda is the reason that we have to have a freaking *prescription* to be able to buy *masks*, much less machines.

Yeah, that and the insurance industry!

Snowleopard28 wrote: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?

+1

Irene, I love your gorgeous kitty.

49er wrote: By the way, what is it with folks who have sleepy as part of their ID?

49er

Well, exactly! It's the sleep disordered thinking!

chunkyfrog wrote:Irene, I love your gorgeous kitty.

Thanks! I agree she's a cutie... And I love your froggie!!!

Wulfman... wrote:I forgot to mention one other thing about the politicians.......
Once they DO "retire" from their political offices, many of them become lobbyists. And, that's where they get even richer.

http://en.wikipedia.org/wiki/K_Street_% ... n,_D.C.%29

http://en.wikipedia.org/wiki/Lobbying_i ... ted_States

That's enough to make you sick!


Den

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So true Den.