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New Standard for Home Healthcare Devices
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PaulaO2 Offline
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Post: #11
RE: New Standard for Home Healthcare Devices
Okay, can someone paraphrase or interpret what the article is saying? I read it twice and I am not following.

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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
12-13-2012 11:36 PM
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TheWerkz Offline

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Post: #12
RE: New Standard for Home Healthcare Devices
(12-13-2012 11:36 PM)PaulaO2 Wrote:  Okay, can someone paraphrase or interpret what the article is saying? I read it twice and I am not following.

There's a whole lot of vague references and engineer-speak about the existing standard and the newly proposed standard relating specifically to how ruggedized some medical products will need to be to meet the newly proposed standards for in-home medical devices since they're much more exposed to us end-users in a non-clinical environment, whereas hospital equipment doesn't have to meet the heightened requirements since it's mostly bigger or professional grade equipment to start with.

Bottom line, some DME products we use will probably become more expensive after all the engineers get through meddling with it, they're just trying to protect us from ourselves...

Thanks
12-14-2012 12:45 AM
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archangle Offline
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Post: #13
RE: New Standard for Home Healthcare Devices
This doesn't really sound that bad.

I used to do electrical safety design for a living. There are some serious and subtle extra risks in medical equipment of all kinds. These risks can be far above the risks for "normal" electrical equipment.

Many home medical devices are going to eventually get at least a little wet or even get a drink dumped on them. They definitely shouldn't electrocute the patient, and probably shouldn't be damaged, either. People die when their equipment stops working and they can't afford a replacement. Especially when you consider that you might not get coverage for replacement from your insurance, and will have to pay the DME "fantasy" price.

I've always thought CPAP machines should be "humidifier proof" or even "water glass proof." It's not that difficult to put all the water sensitive parts into a waterproof enclosure.

Stop and think for a moment. If someone moves your ASV machine while cleaning your house, you could end up with an $8000 bill for a new machine because the manufacturer didn't spend a few bucks properly sealing the machine against water from the humidifier. How in the world did we ever decide this is acceptable? Or the same thing if you spill a glass of water in the 20 years you have a CPAP machine sitting by your bedside.

There are also a lot more "fly by night" equipment suppliers these days selling cheap junk made in China by companies beyond the reach of lawsuits.

I'll disagree slightly with the way the "two prong" power cord requirement is worded, but a lot of homes (or users) end up without a good 3 prong ground. The equipment needs to be designed to be safe if the third prong is not connected, and also safe if the other two prongs are wired backwards.

I've done electrical equipment safety. It's NOT going to cost a lot of money per device to meet these standards. This is about protecting users lives and pocketbooks from hazards that are likely to happen to their equipment. Nothing I see in these standards is something that shouldn't have been built in to all existing machines already, especially considering how much the machines already cost.

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12-14-2012 07:53 AM
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PaulaO2 Offline
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Post: #14
RE: New Standard for Home Healthcare Devices
Ah. Okay. Got it now.

They say humans are losing their common sense. I agree but then add that it's not that we are losing it, it's that it is atrophied from lack of use. When coffee cups have to say "contents are hot", we aren't using our common sense to already know this and know not to put a cup between our legs while driving.

PaulaO2
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Breathe deeply and count to zen.

INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
12-14-2012 12:34 PM
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archangle Offline
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Post: #15
RE: New Standard for Home Healthcare Devices
(12-14-2012 12:34 PM)PaulaO2 Wrote:  Ah. Okay. Got it now.

They say humans are losing their common sense. I agree but then add that it's not that we are losing it, it's that it is atrophied from lack of use. When coffee cups have to say "contents are hot", we aren't using our common sense to already know this and know not to put a cup between our legs while driving.

A better analogy here would be they put the warning on the cup that "contents are hot," and then claimed that absolve them of responsibility if the cups are overly fragile and occasionally break open and drop the contents in your lap during normal handling.

Or if your cell phone shorts out if you go outside from an air conditioned building into a humid summer day because of moisture condensation.

Get the free SleepyHead software here.
Useful links.
Click here for information on the main alternative to CPAP.
If it's midnight and a DME tells you it's dark outside, go and check it yourself.
12-14-2012 01:21 PM
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archangle Offline
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Machine: ResMed S9 AutoSet
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Post: #16
RE: New Standard for Home Healthcare Devices
Given that we're going to be stuck with:
  • A broken patent system that makes it impossible for anyone other than the big boys to make devices anymore.
  • An oligopoly of device manufacturers. Be realistic. There are only two major manufacturers of CPAP machines today.
  • A broken insurance/medical system that goes for the lowest cost choice no matter the consequences to the patient.
  • Companies that will cut corners to save pennies, even though it costs lives.
  • A broken legal system that doesn't properly punish the big guys when they do something wrong and hurt someone. And then punishes the innocent.
  • A vast army of sheep consumers who wouldn't know a good, safe, machine from a bad one. The sheep outweigh us smart consumers and we'd simply be ignored.


We do need regulations to protect the interests of the consumer.

I'll say it again, though. The cost to comply with these regulations will be very minimal per machine and will be well worth the cost to the patient. This stuff is just not that difficult to do.

Get the free SleepyHead software here.
Useful links.
Click here for information on the main alternative to CPAP.
If it's midnight and a DME tells you it's dark outside, go and check it yourself.
12-14-2012 04:09 PM
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TheWerkz Offline

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Post: #17
RE: New Standard for Home Healthcare Devices
(12-14-2012 07:53 AM)archangle Wrote:  I've always thought CPAP machines should be "humidifier proof" or even "water glass proof." It's not that difficult to put all the water sensitive parts into a waterproof enclosure.

Stop and think for a moment. If someone moves your ASV machine while cleaning your house, you could end up with an $8000 bill for a new machine because the manufacturer didn't spend a few bucks properly sealing the machine against water from the humidifier. How in the world did we ever decide this is acceptable? Or the same thing if you spill a glass of water in the 20 years you have a CPAP machine sitting by your bedside.

Well said!

Sadly, my beloved S8 AutoSet II would be still alive today if just such a provision had been made to prevent the humidifier water from entering the blower housing.

In my case, I had just filled the humidifier an hour before going to bed and shortly afterward I accidentally bumped it with my size 14 boxcars... Four miserable days later (without CPAP) I found-out how much better the S9 AutoSet was, although I would have rather it been my decision to upgrade than to have been in an emergency situation to find a new machine that I could afford - stat!

Ren
12-14-2012 05:01 PM
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renatae Offline

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Post: #18
RE: New Standard for Home Healthcare Devices
"Regarding hardware, the standard requires the use of a two-prong (unearthed) plug"

LOL. "Unearthed??" Not "ungrounded?" This from a man who holds a B.S. in electrical engineering?

“inspection of the usability engineering file reinforces that the usability engineering process is necessary for validation of the instructions for use.” Say what?

Well, if the instructions on devices are written by the same people composing this tome, that will be a sight to see.

It will also be interesting to see what happens to devices when "parts to be applied by a patient are isolated from other parts of the device."

Okaaaaaaaaaaaaaaaaaaaaaaaaaaaay.

To sleep; perchance to dream...
[Image: resmedforher.gif]
[Image: Sleepwellpink1_zps36e39dba.gif]
(This post was last modified: 12-14-2012 05:43 PM by renatae.)
12-14-2012 05:41 PM
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renatae Offline

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Post: #19
RE: New Standard for Home Healthcare Devices
(12-12-2012 02:22 PM)trish6hundred Wrote:  Thank you genes for posting this article and thank you SuperSleeper for converting it to text as I would not be able to read a Jpeg file, as it is an image and my screen reader will only read back to me in text.
Yes we are about to be protected from ourselves and any time I see things like this, I have to wonder how badly we're gonna get "hosed?"

LOL, Trish - that's cute! Hoseheads getting "hosed!"

To sleep; perchance to dream...
[Image: resmedforher.gif]
[Image: Sleepwellpink1_zps36e39dba.gif]
12-14-2012 05:44 PM
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renatae Offline

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Machine: ResMed S9 AutoSet for Her
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Sex: Female
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Post: #20
RE: New Standard for Home Healthcare Devices
(12-14-2012 07:53 AM)archangle Wrote:  This doesn't really sound that bad.

I used to do electrical safety design for a living. There are some serious and subtle extra risks in medical equipment of all kinds. These risks can be far above the risks for "normal" electrical equipment.

Many home medical devices are going to eventually get at least a little wet or even get a drink dumped on them. They definitely shouldn't electrocute the patient, and probably shouldn't be damaged, either. People die when their equipment stops working and they can't afford a replacement. Especially when you consider that you might not get coverage for replacement from your insurance, and will have to pay the DME "fantasy" price.

I've always thought CPAP machines should be "humidifier proof" or even "water glass proof." It's not that difficult to put all the water sensitive parts into a waterproof enclosure.

Stop and think for a moment. If someone moves your ASV machine while cleaning your house, you could end up with an $8000 bill for a new machine because the manufacturer didn't spend a few bucks properly sealing the machine against water from the humidifier. How in the world did we ever decide this is acceptable? Or the same thing if you spill a glass of water in the 20 years you have a CPAP machine sitting by your bedside.

There are also a lot more "fly by night" equipment suppliers these days selling cheap junk made in China by companies beyond the reach of lawsuits.

I'll disagree slightly with the way the "two prong" power cord requirement is worded, but a lot of homes (or users) end up without a good 3 prong ground. The equipment needs to be designed to be safe if the third prong is not connected, and also safe if the other two prongs are wired backwards.

I've done electrical equipment safety. It's NOT going to cost a lot of money per device to meet these standards. This is about protecting users lives and pocketbooks from hazards that are likely to happen to their equipment. Nothing I see in these standards is something that shouldn't have been built in to all existing machines already, especially considering how much the machines already cost.

Great points, archangle. I especially agree that the device shouldn't become dangerous nor damaged if water spills on it. I cringe every time my son brings me a drink of soda and puts it on my nightstand. I tell him not to bring me drinks, but he insists. Personally, I don't put water or any such thing on my nightstand any longer, even though I'm often extremely thirsty when I wake several times a night.

To sleep; perchance to dream...
[Image: resmedforher.gif]
[Image: Sleepwellpink1_zps36e39dba.gif]
(This post was last modified: 12-14-2012 06:20 PM by renatae.)
12-14-2012 06:10 PM
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