Phillips / Philips Respironics recent recall notice discussion thread

[JLROhio]

Just came across this FDA announcement from June 30. Nothing new really except it's FDA and not Philips, but I thought I'd throw it out here:

https://www.fda.gov/medical-devices/saf ... alth-risks?

One thing that I noted from the FDA release was this little tidbit related to bacterial filters...

Talk to your health care provider about using an inline bacterial filter, which may help to filter out particles of foam, as indicated in the Philips recall notification. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and the FDA’s evaluation is ongoing. It is important to note the following considerations:

- Filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.

- Filters may affect ventilator performance because they may increase resistance of air flow through the device.

- You should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.

Phillips basically said something similar in their letter to doctors...but one would believe the FDA would do something more about this particular statement such as try and determine rather quickly what types of VOCs are being sent directly into the patient's lungs on a continuous basis night after night. They have machines that could easily determine what chemical VOCs are being given off and the knowledge base to determine what damage long-term exposure to those chemicals could be to humans.

[Dan_McD]

Just came across this FDA announcement from June 30. Nothing new really except it's FDA and not Philips, but I thought I'd throw it out here:

https://www.fda.gov/medical-devices/saf ... alth-risks?

One thing that I noted from the FDA release was this little tidbit related to bacterial filters...

Talk to your health care provider about using an inline bacterial filter, which may help to filter out particles of foam, as indicated in the Philips recall notification. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and the FDA’s evaluation is ongoing. It is important to note the following considerations:

- Filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.

- Filters may affect ventilator performance because they may increase resistance of air flow through the device.

- You should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.

Phillips basically said something similar in their letter to doctors...but one would believe the FDA would do something more about this particular statement such as try and determine rather quickly what types of VOCs are being sent directly into the patient's lungs on a continuous basis night after night. They have machines that could easily determine what chemical VOCs are being given off and the knowledge base to determine what damage long-term exposure to those chemicals could be to humans.

This is so typical of the corporation doing the old CYA and a government agency that knows this is bad but won't tell the public how bad. These in line filters are of no use in this situation. They know users of the Philips crap should stop using these machines and want to shove the responsibility on the physician.

[nmevan]

Wondering

the foam surrounds the motor for noise reduction. It is not in the airway as far as I know.
How can the material get into the airflow?

[MotorCity]

My first post.

Iv’e been using one of the recalled cpap machines since 2014.

I had an appointment the other day with my doc to finally upgrade to a new cpap.
After meeting with her, she called me and my wife back several times, urgently…She was digging in my charts and sees that I developed a rare lung cancer in 2019, called adnoid cystic carcinoma (ACC).
Received radiation treatment for the cancer

We call her back and she confirms mine in in the recall list. Tells me to stop using it immediately, and I pick up a new cpap next day.

I don’t have lung cancer in my family.
ACC with a primary tumor in the lung(what I have) EXTREMELY rare.

something isn’t adding up…

[kbh209]

Wondering

the foam surrounds the motor for noise reduction. It is not in the airway as far as I know.
How can the material get into the airflow?

If you watch the video of the dissection of the Dream Station 1, you'll see that the foam does is in fact rest in the airway and surrounds either side of the turbine blower. The older non-dream station machines, the foam is under the casing of the turbine engine.

[ChicagoGranny]

My Dad smoked pall mall cigarettes to the ripe old age of 85.
I’m 53

I'm imagining that you were exposed to a large amount of carcinogenic smoke during your years of growing up. Secondhand smoke can be more dangerous than smoking.

Hope your cancer is gone for good!

[Dan_McD]

Wondering

the foam surrounds the motor for noise reduction. It is not in the airway as far as I know.
How can the material get into the airflow?

If you watch the video of the dissection of the Dream Station 1, you'll see that the foam does is in fact rest in the airway and surrounds either side of the turbine blower. The older non-dream station machines, the foam is under the casing of the turbine engine.

I'm not familiar with the older machines, but the Dreamstation 1, you are correct, the air does pass through the foam. That is why it gets so sticky and oily in appearance after time. The degradation of the foam magnifies the harmful results of the dangerous chemicals that pass through to your lungs.

[nmevan]

Wondering

the foam surrounds the motor for noise reduction. It is not in the airway as far as I know.
How can the material get into the airflow?

If you watch the video of the dissection of the Dream Station 1, you'll see that the foam does is in fact rest in the airway and surrounds either side of the turbine blower. The older non-dream station machines, the foam is under the casing of the turbine engine.

But mine is a system one...not a dream station. I watched a video of an australian fellow dissecting a system one and the foam did not appear to be affected by the airflow at all.

[nmevan]

will someone please watch this video by an australian fellow taking apart a Phillips system one to pull out the foam.

https://www.youtube.com/watch?v=SQnJAF3bm98

you can fast-forward to minute 7 to see the actual foam and where it resides in the machine

The foam is only in the casing and does not involve the airflow...as far as I can see.
Several people commented on the video that the issue is off gassing. But I am still at a loss to understand how any actual particles enter the airway.
Also, the main filter on the machine is a similar piece of foam.

[ChicagoGranny]

The foam is only in the casing and does not involve the airflow...as far as I can see.

I was surprised they put foam in the machine's air path. Air travels between the foam and the motor housing. The air is definitely passing over the foam.

[packitin]

This is all lunacy to me. I noticed in the website a few posts back about the FDA, and then under the heading: FDA ACTIONS in the 4th sentence it reads:

"The FDA will continue to monitor supply and demand to assess availability of the affected devices and any potential shortages."

What in the devil does that mean? And why would there be a demand for any of their machines?

Can anyone explain?

(I'm still looking for a machine as a backup - since I still haven't received my new Resmed bipap)

I'm thinking of getting my paperwork from my DME and going on my own to get a new machine, even if its in another state. Is that legal?

[tisket]

This is all lunacy to me. I noticed in the website a few posts back about the FDA, and then under the heading: FDA ACTIONS in the 4th sentence it reads:

"The FDA will continue to monitor supply and demand to assess availability of the affected devices and any potential shortages."

What in the devil does that mean? And why would there be a demand for any of their machines?

I suspect that "affected devices" is referring to the entire universe of cpap-type machines, which has certainly been affected, since even non-Philips users (and new patients) will have a hard time getting a (non-Philips) machine. This also would explain the mentions of availability and shortages.

I'm thinking of getting my paperwork from my DME and going on my own to get a new machine, even if its in another state. Is that legal?

Certainly, you don't even need any paperwork from the DME, just a copy of your doctor's prescription. Many of us here buy our own stuff online.

Now if you are getting it paid for by insurance, that's another can of worms and you have to talk to your insurer about that.

[packitin]

I just came from my sleep clinic to get my paperwork for seeing the doctor 2 wks ago.
Believe it or not, my machine hasn't been ordered as they stated. I don't know why (my doc. is part time and not in today)

So I went to see another DME that was close by.
The lady was new and didn't know anything, not even if they had a Resmed or not!

So, at my insistence (and trying to be as nice as I could) she called another DME to see if they any Resmeds. Well, you're not going to believe this.
She said they were on hold!!!. Her answer, when asked why, was that Medicare has suddenly changed the rules.

Only those with high AHI's are going to get the machines, until July 27. At that point they are going to recalculate, look at the data, and determine what the new rules will be.
So I have to submit my paperwork and wait for more information.

Can anyone verify this? I am at the point where I take anything a DME employee says with a grain of salt.

[MotorCity]

My Dad smoked pall mall cigarettes to the ripe old age of 85.
I’m 53

I'm imagining that you were exposed to a large amount of carcinogenic smoke during your years of growing up. Secondhand smoke can be more dangerous than smoking.

Hope your cancer is gone for good!

ACC doesn't come from smoking or 2nd hand smoke.

The underlying cause of ACC is not known. The disease does not run in families and therefore is not presumed to be inherited as is the case with a small portion of cancers. In addition, ACC is not associated with smoking or alcohol consumption as are some cancers of the lung and the oral cavity. The reasonable working hypothesis is that ACC, like most cancers, is the result of environmental factors that cause normal cells to acquire genetic changes, leading to uncontrolled growth. Recent research has identified a common genetic alteration in many ACC tumors: a new fused gene (MYB-NFIB) created by the fusion of two broken chromosomes (numbers 6 and 9). It is likely that this "translocation" drives the development of many cases of ACC.

[packitin]

I'm sorry for my last post. That was information that the DME gave me, but now I realize it only applies to their company, not all others or Medicare. Sorry.

But, after riding around town and looking for a machine with my prescription in hand, I had no luck.

The DME that promised me a machine, "I said goodbye, its been good to know ya". After looking at all DMEs in my city, I went with the one that was the nicest to me, which was Lincare. I know they've had some criticisms, but they have a new staff and manager, and its close to my house, and I've moved all records to them. I need no other test, or paper work.

The one I talked about in my last post told me I'd have to have another sleep test. I said: "No way Jose" and left. I've been doing this for 17 years now, and I think I know a little bit.

But, I'm on my own until January when I got the Dreamstation bipap 4.5 years ago. Apparently, Medicare rules dictate that 5 yrs. is the cutoff point for a new machine, regardless of the no. of hours.

So, if anyone hears of a good deal on a low-hour bipap, let me know. My old sys. 1 750P is just not giving me the type of therapy I need, and its too noisy.

Thanks for any help you can give me, and I'll check the suggestions that have already been given.