FDA Oversight of CPAP

[sleepygrumpy]

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

[chunkyfrog]

Not surprising. Departments like these are often only called "regulatory",
but they are merely paper shufflers and pencil pushers.
If they do nothing, perhaps they should be dissolved altogether--
or maybe that's why they have no funds or power?
(pork barrel employment?)

[sleepygrumpy]

Yes, but this is a serious issue for all of us and its fixable. Please call your US representatives.

[cathyf]

I would be extremely cautious about doing this -- what if a newly-muscular FDA department decided that it was against the law for patients to have access to the data from their machines? What if they decide that nasal masks should be outlawed because some people breathe through their mouths? Or they decide that chin straps are a strangulation hazard? What if they decide that cpap.com is practicing medicine without a license and shut it down?

The "medical mafia" clearly thinks about sleep apnea differently than we do. I like that I can get information and talk to my doctor and she can write a prescription and get what we think I need. And I can find a new doctor if she starts being an idiot. Fighting with insurance companies is bad enough -- I don't need to add the federal government to my problems!

[49er]

I would be extremely cautious about doing this -- what if a newly-muscular FDA department decided that it was against the law for patients to have access to the data from their machines? What if they decide that nasal masks should be outlawed because some people breathe through their mouths? Or they decide that chin straps are a strangulation hazard? What if they decide that cpap.com is practicing medicine without a license and shut it down?

The "medical mafia" clearly thinks about sleep apnea differently than we do. I like that I can get information and talk to my doctor and she can write a prescription and get what we think I need. And I can find a new doctor if she starts being an idiot. Fighting with insurance companies is bad enough -- I don't need to add the federal government to my problems!

I definitely agree with this cathyf. Be careful what you wish for as they say.

49er

[tan]

aint gonna call my senator... it may be a good thing that FDA has less power than it "thinks" it is necessary.

[chunkyfrog]

I, for one am not about to give Uncle Fatso more money to do anything he can't/won't understand.
I feel that an independent consumer organization is in a better position to evaluate the quality
of any consumer product. We have already seen how good the government has been
about protecting our health. I only wish CR was inclined to do this, but they do not appear to care.

[sleepygrumpy]

You are running on fear and superstition. How sad. I assume you think astrology is running our lives too. The FDA is set up for these issues. They need more power to make them right. Hopefully others wont be as scared as you are.

[tan]

You are running on fear and superstition. How sad. I assume you think astrology is running our lives too. The FDA is set up for these issues. They need more power to make them right. Hopefully others wont be as scared as you are.

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.

[sleepygrumpy]

Wow, you people are like antelope. They have horns but prefer to run away from the lions.

[BlackSpinner]

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.

[chunkyfrog]

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.

[TangledHose]

Keep the Government Buracrats out of it -- all they do is screw things up for the end user and incure more wasteful spending!

"Government is not the solution, it is the problem"

[palerider]

Wow, you people are like antelope. They have horns but prefer to run away from the lions.

listen, troll, the FDA is the reason that cpap is such a big pain in the ass now... the fda is the reason that we have to have a freaking *prescription* to be able to buy *masks*, much less machines.

there needs to be *less* regulation, not more.

I'd rather have the CPSC in charge of cpaps instead of the FDA... let them spend their time trying to keep the FOOD and DRUGS safe.

[Davidwnc]

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?