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Anyone in the medical equipment field?


sassnetguy50

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I had to go check mine. It’s a Philips Respironics System One. 

 

Edit:
Sonofa….make sure you look at the list on page 3 as well…mine is on the list…

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I know all about it. I work at a Sleep Lab. 

 

Philips started getting complaints rare(1 thousand out of millions) of machines where particles of foam were entering the pathway of air which Philips thought would impossible because the foam was incased in plastic around the blower. Much to their surprise when they opened these machines everything was horribly corroded. The plastic case around the foam had turned brittle and fell apart and the foam also fell apart and could now enter the pathway of air.  They discovered that the common denominator on all these damaged machines was the owners had been using a non-FDA approved CPAP cleaner that uses Ozone called the SoClean.  Philips met with the FDA to report their findings asking if they could do anything to stop SoClean. FDA can't do much about the SoClean since it's not the medical equipment but since Philips had just reported a safety issue with their machine they could do something about that. FDA instructed them to recall ALL of their machines. 

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I'm surprised they have not yet come up with a Hookah-like water filtration device for CPAPs.
This would effectively filter out particles, pollen, dust, etc.

I bought a lab double neck flask to experiment with this, but am having trouble locating the necessary stoppers and fitting.
I also use a CPVC street ell to have a more straight line hose run, instead of bending the hose 90 degrees.  Works great.

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6 hours ago, Chili Pepper Kid, SASS #60463 said:

Philips met with the FDA to report their findings asking if they could do anything to stop SoClean. FDA can't do much about the SoClean since it's not the medical equipment but since Philips had just reported a safety issue with their machine they could do something about that. FDA instructed them to recall ALL of their machines. 

 

So... because of a problem caused by a third-party product, Phillips has to recall all their machines??  :huh:

 

That bites for Phillips.  :(

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@sassnetguy50

Thank you very much for posting this thread, otherwise I may not have known about this issue. 
 

@Chili Pepper Kid, SASS #60463

Thank you for providing some details on the reason for this. 
 

Curious, I went looking for this “So Clean” CPAP cleaning system.  It appears you can still buy them online. But the word “ozone” isn’t mentioned so perhaps I am mistaken that these are the correct “SoClean” products. 
 

I have never used any other cleaning processes other than the ones I learned from my doctors and the folks that inspected my machine at the medical equipment supplier’s office. 
Why? Because I do not trust after market products that aren’t recommended by my pulmonologist or equipment reps. Perhaps my suspicions have paid off in this case. 
 

2 hours ago, Hardpan Curmudgeon SASS #8967 said:

 

So... because of a problem caused by a third-party product, Phillips has to recall all their machines??  :huh:

 

That bites for Phillips.  :(

Yeah, how chicken sh** is that?

 

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1 hour ago, Pat Riot, SASS #13748 said:

@sassnetguy50

Thank you very much for posting this thread, otherwise I may not have known about this issue. 
 

@Chili Pepper Kid, SASS #60463

Thank you for providing some details on the reason for this. 
 

Curious, I went looking for this “So Clean” CPAP cleaning system.  It appears you can still buy them online. But the word “ozone” isn’t mentioned so perhaps I am mistaken that these are the correct “SoClean” products. 
 

I have never used any other cleaning processes other than the ones I learned from my doctors and the folks that inspected my machine at the medical equipment supplier’s office. 
Why? Because I do not trust after market products that aren’t recommended by my pulmonologist or equipment reps. Perhaps my suspicions have paid off in this case. 
 

Yeah, how chicken sh** is that?

 

Their commercials and ads never do mention Ozone, they usually mention "Activated Oxygen" which is the same thing. O3, trioxygen, activated oxygen & Ozone all same thing. For years their infomercials were all over TV with William Shatner as the spokes person. We told all of our patients of the risks but that infomercial was too strong. Pat your System One has to be an old machine which also can contribute to the foam falling apart. That's one of the reasons it's recommended machines be replaced every 5 yrs. 

 

Here is what the FDA released on the SoClean after Philips brought it to their attention.

Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication | FDA

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1 hour ago, Chili Pepper Kid, SASS #60463 said:

Their commercials and ads never do mention Ozone, they usually mention "Activated Oxygen" which is the same thing. O3, trioxygen, activated oxygen & Ozone all same thing. For years their infomercials were all over TV with William Shatner as the spokes person. We told all of our patients of the risks but that infomercial was too strong. Pat your System One has to be an old machine which also can contribute to the foam falling apart. That's one of the reasons it's recommended machines be replaced every 5 yrs. 

 

Here is what the FDA released on the SoClean after Philips brought it to their attention.

Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication | FDA

Interesting. My doctor tells me that insurance companies won't authorize replacement until 7 years.

I have had mine 7 years. Calling to set up a replacement appt today. Thank you.

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33 minutes ago, Pat Riot, SASS #13748 said:

Interesting. My doctor tells me that insurance companies won't authorize replacement until 7 years.

I have had mine 7 years. Calling to set up a replacement appt today. Thank you.

Every 5 years here.  May check with your insurance provider on what your policy covers.

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Every insurance I've ever came across it's been 5 yrs. If you register for the recall you will eventually get a new machine.

 

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9 minutes ago, Chili Pepper Kid, SASS #60463 said:

Every insurance I've ever came across it's been 5 yrs. If you register for the recall you will eventually get a new machine.

 

I did register. I am just wondering if I would give my current machine up. Could be evidence later on...

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Wow... every five years...
That would get steep every 5 years.

I have a Cash Guarantee Card that I used to buy mine... about $900 if I remember correctly.
Kaiser wanted me to buy some crappy little thing, so I got an Rx and bought from cpap.com
Not disappointed at all.

I keep the filter clean, and replace the mask and hose every now and then... it runs like a Timex.

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  • 1 month later...

I have not heard a thing from Philips or anyone else. To be fair I have seen no evidence of the foam insulation breakdown that is the reason for the recall. I have never used the cleaning system that set all this off in the first place. 

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My stepson is a Respiratory Therapist and in the durable medical goods business. All his customers have been given a HEPA filter to go inline between the machine and face apparatus to ensure that no foam or plastic particles are inhaled. 
 

 As Pat eluded to, almost all the people having trouble have been using devices like So Clean. 

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  • 2 months later...

My sister works in a private clinic and, as she says, they buy new medical equipment like Philips breathers every 3 years.  In addition, the clinic constantly purchases medical gloves at an appropriate price, as they are a necessary consumable.  In total, according to my sister, three things affect the quality of the patient's treatment. These are the qualifications and experience of a doctor, high-quality medical equipment and, of course, the use of high-quality consumables such as medical gloves and cotton wool.

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On 8/24/2021 at 6:24 AM, Sedalia Dave said:

My stepson is a Respiratory Therapist and in the durable medical goods business. All his customers have been given a HEPA filter to go inline between the machine and face apparatus to ensure that no foam or plastic particles are inhaled. 
 

 As Pat eluded to, almost all the people having trouble have been using devices like So Clean. 

I somehow missed this when you posted it.
 

Interesting. I actually wondered if something like this would be or could be a fix. I also find it interesting that I heard about here and not from Philips, the online respirator company I have been corresponding with or my pulmonologist. To be fair my pulmonologist hasn’t been working with me on my BiPap. 
 

I see Amazon has a bunch of suppliers providing inline filters for this particular problem but none say “HEPA” on their ads. 

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  • 4 weeks later...

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