resperonics sleep machines

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magna 6882

magna 6882

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I know this has nothing to do with boating but i wanted to get this info out.
For all those with sleep apnia equipment resperonics has anounced a recall and immediate discontinuing of most of there machines do to cancer causing problems. My wife didnt discover this until she went to make a waranty claim on one of her machines. This is a world wide recall with no solution. I can not believe this has not been made public. If you use a resperonics machine you need to register on there site and consult your doctor. My wifes doctor said to discontinue use and buy a new machine,out of pocket, since her machine is less then 5 years old. This is only resperonics. I am really disappointed that no notice or news coverage on a medical device that effects thousand of people is out there. she still has gotten no notice from the manufacture and the cpap company she bought the machine from is no longer answering there phone.
Thoughts?:banghead:
 
Fortunately we had a new res-med machine so she was able to have a solution. In my head this is such a big deal. If anyone gets lung cancer that used a machine there is going to be hell to pay. What really surprises me is i see recall an car seats and cribs and such that seem to be more parenting then manufacturing all the time on the news but nothing on this. I hope this blows up on Philips. They were supposed to send a filter to put in line to catch the larger partials but nothing after a month.
 
I have a degree in sleep medicine so have interest in this subject although now retired. The recall is being handled poorly in the USA in my humble opinion.
Medicare still requires a 5 year interval between replacement of C and Auto PAP machines. Phillips has a registration mechanism on the internet but makes no promises about when a replacement will be available. Cost of a new machine is ~$1000.
Mitigating this some what is risks maybe not be that high from available information but it seems clear risk is presence. Resmed apparently is not having similar issues.
Would suggest if you have a Phillips machine go to their web site now and register it. Call your provider. Find out if you can get a Resmed, or other brand covered by insurance. If not then you have a difficult decision. I called the durable medical device vendor we’d mostly dealt with. They say at present they are unaware of any reimbursement protocol should you buy an alternative out of pocket while this sorts out.
Do think it’s important you continue therapy so it’s worth the effort to figure out a plan.
 
Magna thank you for the post. Hippocampus thank you for sharing your knowlege.
A buddy who never could use a machine claims no if no snoring no breathing stoppage so he just tapes his lips shut! Cancer is too scary, I am tempted to temorarly try it.
 
Resperonics isn't putting the word out? Maybe I've just discovered an avenue for augmenting my retirement funds, eh?
 
Moby Nick said:
Resperonics isn't putting the word out? Maybe I've just discovered an avenue for augmenting my retirement funds, eh?
Click to expand...
You got that right. This is really a simple class action. A durable medical device approved by the fda producing known cancer carcinogens.

I just want to get the word out to those who need to know.
 
I just went to the companies web site, and registered my wife's device.
We were not aware of the recall.

THANKS EVERYONE!
 
I too have a recalled Phillips CPAP. I knew of the recall...from news reports, registered, received letter from Phillips; I also received a letter and phone call from my medical equip supplier. Supplier advises difficult to impossible to get new machine at this time- supply shortages for obvious reasons. Supplier and sleep doc both confirmed there is no way to know when/if Philips will be repairing, replacing existing machines. Sleep doc advised that risk "extremely low" and for many people the risk of not using CPAP far outweighs the risk of using the recalled machine. I guess it will be up to individuals working with their docs to make a decision. I do know there are resmed machines out there and some people I know of seem to have an "in" to get one. Medicare does only replace after 5 years but again, supply shortages will impact the ability to even do a scheduled replacement.

Oh, and as one would expect, there are already numerous law firms seeking "clients" for a potential law suit. Just need to Google it.
 
Relative going through this.

The newest Philip’s machines, like the Dreamstation 2, apparently not affected. Go to their website to check.
 
Thanks for mentioning this.

I have a friend with a CPAP (we happened to be traveling in tandem when he first got going with it so it was a topic of conversation then).

I gave him a call but he has a ResMed (whew). He bought a spare last year (same model; Craigslist) which now sounds like a good thing since they will probably be unobtanium for awhile.

Looked at the recall and it sounds like the culprit is some sound-attenuating foam in the machine. It either breaks down or deteriorates in some deleterious way. Ugh.

Maybe I'm too much of a DIY-er (probably a no-no on medical devices), but I'd be tempted to try to get that foam out of there. Especially if there is a shortage on replacement machines. (Not that I've looked into the details.)

Buddy mentioned above has the machine in a bedside cabinet with just the hose coming out, so a bit louder would not (have been) a problem.
 
my wife had to do a new sleep study to get a new machine. She is there tonight. I am surprised they are working on a weekend over the holiday. With the new study she can get a new resmed if available. Fortunately she is able to use my spare ,which was on the boat, while she waits.
I am just hopeful to get the word out.
 
I know this has to be nerve-wracking for the OP and his family. We had a scary, frustrating experience with sleep disorder treatment that I hope is on topic here.

After my wife had a sleep study, we received an urgent call from her doc telling us to cut short our vacation and see her immediately. The study showed that my wife had central apnea—a more serious, neurologically based form of apnea which can stress the heart. She was put on a CPAP machine but could never adjust to it. A second study by a different hospital confirmed the first—central apnea—and she was put on a biPAP machine. Same problems with adjusting and going without sleep.

I decided enough was enough and took her to the sleep center at the Mayo Clinic. After having the “gold standard” sleep study, she was told she had garden-variety, moderate, obstructive sleep apnea. She bought a $400 dental device to extend her jaw and now sleeps like a baby. After many thousands of dollars and countless nights of lost sleep—both hers and mine as I worried about her—she’s fine. Mayo was great, but i found myself wondering if sleep studies are inherently inaccurate or whether this branch of medicine is still in its infancy?
 
As one board certified in sleep medicine can reassure you the field is not in its infancy. Unfortunately just like plumbers there’s good ones and not so much. Confounding the field further there’s ENT, pulmonary medicine and neurologists who have gotten boarded in this field so come from different backgrounds
I trained in a Harvard affiliated program, kept up on the literature so felt confident in my skill set.
General advice. Although home testing is adequate for the most common form that being simple obstructive sleep apnea testing in lab in a ASA lab with a certified tech and read by a sleep boarded physician remains the gold standard. Unfortunately due to insurance issues it may take extra effort on the part of physician to get it done.
As with any physician bedside manner doesn’t speak to fundamental skill set. Pay attention to where they trained, what other boards they hold, is the lab certified, and who is the reader. Also as a broad generalization looking at the organization of the lab may be of interest. Is it part of a hospital or private, is the hospital a primary or tertiary center.
Currently there are multiple different devices used for home testing. This adds some degree of variability. Patients may have different levels of compliance to the testing protocol or sufficient fragmented sleep or other issues making the study non diagnosic or incorrect. Generally doing two nights of home testing is more reliable. Fortunately usually (in my area at least) can usually get 2 nights covered by insurance.
As regards interventions some form PAP usually is best. Current machines allow recording the AHI (how many apneas per unit time) during therapy. The fine points of using a fixed pressure setting or an AutoPAP device is beyond the scope of this discussion. However, if any intervention other than a PAP device (which allows a reliable way to judge efficacy) is employed would suggest beyond clinical response a repeat study after institution of that intervention be done. I believe this is particularly important for anything beyond very mild sleep apnea.
 
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I've been using two of the affected machines for years. One of them is nearly ten years old now. This is the first I've heard of any of this. Thanks for posting.
 
Hippocampus said:
As one board certified in sleep medicine can reassure you the field is not in its infancy. Unfortunately just like plumbers there’s good ones and not so much. Confounding the field further there’s ENT, pulmonary medicine and neurologists who have gotten boarded in this field so come from different backgrounds
I trained in a Harvard affiliated program, kept up on the literature so felt confident in my skill set.
General advice. Although home testing is adequate for the most common form that being simple obstructive sleep apnea testing in lab in a ASA lab with a certified tech and read by a sleep boarded physician remains the gold standard. Unfortunately due to insurance issues it may take extra effort on the part of physician to get it done.
As with any physician bedside manner doesn’t speak to fundamental skill set. Pay attention to where they trained, what other boards they hold, is the lab certified, and who is the reader. Also as a broad generalization looking at the organization of the lab may be of interest. Is it part of a hospital or private, is the hospital a primary or tertiary center.
Currently there are multiple different devices used for home testing. This adds some degree of variability. Patients may have different levels of compliance to the testing protocol or sufficient fragmented sleep or other issues making the study non diagnosic or incorrect. Generally doing two nights of home testing is more reliable. Fortunately usually (in my area at least) can usually get 2 nights covered by insurance.
As regards interventions some form PAP usually is best. Current machines allow recording the AHI (how many apneas per unit time) during therapy. The fine points of using a fixed pressure setting or an AutoPAP device is beyond the scope of this discussion. However, if any intervention other than a PAP device (which allows a reliable way to judge efficacy) is employed would suggest beyond clinical response a repeat study after institution of that intervention be done. I believe this is particularly important for anything beyond very mild sleep apnea.
Click to expand...

Brilliant! Thanks very much for clarifying this.
 
i was diagnosed with apnia several years ago and ended up with resmed and have went thru 4 or 5 generations of machines. Since i cant sleep without one ,likely psychological,i have allways kept new spars bought out of pocket. She started with resperonics and never got a choice of machines . she had her original machine and i got her a spare she could keep on the boat. The spare was not working correctly and under warranty so that is how i discovered the recall. I gave her the spare resmed and she registered in her name. Its the newest model and she loves it and will not be going back to her previous design. The dealer contacted me today regarding her machine and told me all resmed inventory was now back ordered and they doubled there price. He was good enough to tell me he would jump me in line and reduce the cost since i have bought all my machines from him but at this point just glad i had new machines as spares just never thought i would need on for this type of situation.
I just really want to get the word out so people can make there own choices regarding there health.I have no cause to bitch about how respironics has handled this i just wish the media would help get the word out so folks can decide what they wasnt to do. I have ran into at least a dozen cpap users who were un aware. This should not be.
 
Think at least in part this is the responsibility of the proscribing physician to get out notification.
Don’t know the legalities of this so can’t speak to that. Several ways to handle this. A global notification of all patients. This should not be cumbersome for those with access to email. This is doable if your EMR includes that field. Or through asking your DME (durable medical equipment) to do so. Or a string search inside your EMR (electronic medical records) to ascertain which machines your patients are using if you have a field for that in your EMR. In short, both the electronic billing records of the DME and your practice EMR should make this doable without excessive labor or expense for the vast majority of patients. Have run into a few elderly or neurologically compromised individuals without email. Then ask for contact information for a first order relative (spouse, offspring) or guardian in order to deal with such issues. However, can see how this may not work in select populations (rural, indigent, incarcerated etc.).
 
I have two Phillips machines and both are under recall- crap. But my understanding of the reason is that the sound deadening foam breaks down over time and that the break down is primarily caused by those ionizing or chemical cleaning machines. The reports included evident foam pieces in tubing.

Directly from Phillips:

"Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions."


My machine cleaning directions were to soak mask, tubing and humidifier chamber in warm water and distilled vinegar. Never have cleaned with anything else. I continue to use both machines, the old one being 10+ years old w/ no evident foam breakdown. Not advocating continued use by any means! Check with your doctor! Especially if you are using an alternate cleaning method than what the manufacturer recommends. Certainly boat life is high humidity which can contribute to break down. But I believe the safe cleaning I perform makes my machines much lower risk than if I used chemical or ozone cleaning machines.
 
I was surprised to see comments saying how poorly this was publicized until I saw how few were aware of it. I had seen it and just thought it was widely known. Clearly a lousy job was done.

Now, what annoys me most about Respironics is the lack of a solution. I know they don't want to send you to Resmed, but they should pay for one if they can't fix yours. Medicare and insurers should also ignore any five year rules. I think Phillips should have been required to refund all monies paid but unfortunately that would be to insurers, not patients. Getting actual help to patients is more complicated but should have happened.

Then to prescribing physicians. They absolutely should have notified every patient. No excuse for not doing so.

I feel for all of you caught in this.

There are brands like Luna for $600-700 but Resmed is $900+. However, one thing I would try with my supplier is to get them to honor their insured or Medicare price on a Resmed unit. They typically only pay something in the range of $400-600. The provider would still get paid what they would get if the insurer was paying and at least you wouldn't have to pay full price.

As to sleep doctors, huge differences. Also differences in those who come from neurology vs. allergy and respiratory. Many tend to only notice their area of specialty. And huge differences in facilities. A lot of poorly done sleep studies, especially the half night ones, where instead of evaluation one night and using CPAP another, they switch you in the middle of the night and short change both parts. Fairly easy to see an apnea problem quickly but takes more time to evaluate it and to look for any other issues. I've seen sleep centers determine a level of apnea but too little to recommend CPAP. Meanwhile they failed to note the oxygen levels and subsequently the patient was found to have interstitial lung disease. Sleep center should have seen the issue 3 years earlier. I've also seen sleep centers selling services so recommending CPAP to nearly everyone.

I don't know the level of risk. Would be easy to say it's relatively low but it I was the one exposed to potential cancer, I'd consider any risk to be outrageously high and more than I could tolerate. It's like surgery. Minor when it's you, major when it's me, and if it was me, I'd consider this major.
 
I'm not a doctor and maybe I am too much of a DIY-er at times, but just went to youtube and put "remove sound abatement foam respironics" in the search box.

Sure enough, there are quite a few videos on it.

(Of course they say DO NOT TRY; VOIDS WARRANTY.)

If I had sleep apnea and didn't have another machine available to me..... I'd certainly watch the videos and consider removing the foam. Especially if it's as it sounds, just for sound abatement (vs. actual respiration). I can't imagine just breathing in carcinogenic foam while they spend weeks or months sorting it out (or going without if I had bad apnea). If nothing else, it would keep me awake worrying :nonono:

Obviously not saying people should actually do this. And even for me, I'd have to research it and see what I thought.
 
B agree with much you say but yours one statement about split nights. Not infrequently someone comes into the lab with very severe apnea. Very prolonged episodes with no air movement not just hyponeas. They desat severely and 02 levels fall enough to place them at significant risk of a cardiac event. You may even see arrhythmias associated with these events. The national sleep association which board certified physicians follow and their recommendations which certified labs follow stipulate how long you must record before you intervene with therapy during an in lab study. Given the constraints insurance payment places on many patients it is overwhelming better you institute therapy and have an opportunity to see it works ASAP. On occasion you discover mixed apnea (central and obstructive) , Cheyne Stokes respiration (periodic breathing) or other confounding abnormalities which will impact on therapy in a meaningful way. There’s a huge difference between an in lab and in home study. As you say any study is only as good as the tech performing it and the physician reading it. We’ve had patients where we interrupted an in lab study and had them immediately admitted to hospital. We’ve had in home studies (usually done else where) which were misleading. Either sorted out by the protocol of two consecutive nights of in home or a in lab study.
Problem here is the vast majority of sleep apnea is simple obstructive apnea. Risk increased by male sex, neck circumference, BMI and simple look at the back of throat with a tongue depressor. The expense of a careful in lab study isn’t necessary so insurance coverage reflects that in many places. This allows decrease cost of identification and treatment. Like so many things in current medical practice you raise the floor but lower the ceiling imho.
I summarized my advice concerning choosing a physician and lab above. In the current environment feel constrained from saying more. As a neurologist I love neurology but there are highly skilled pulmonologists and those who from internship who wanted to specialize in sleep medicine among others who practice excellent medicine and run excellent labs. Similarly some community sites are as good as tertiary settings. Unfortunately the internet will disclose more about bedside manner than skill set in some instances. Look at the credentials of the physician and lab. Look at certification as well.
 
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