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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-02-2021, 12:57 PM)WakeUpTime Wrote: Unless I'm mistaken, the UK (and Canada) have NOT done any extensive testing of their own.  They're simply going with the data released by Philips.  We would not want to give the false impression that other countries have done any additional significant testing of Philips recalled PAP systems.  Since those countries haven't, I'm not sure why people are quoting them as "additional evidence of safe use".  Instead, we could just quote Philips original source documents regarding it's laboratory findings. 

Who has claimed that the UK (or Canada) has done extensive testing?

You're the one taking a position, and you're claiming they haven't. I don't know. 

The context of their statement suggests it is a summary and explanation of many source documents, probably a lot provided by Philips. Unfortunately, we don't have access to the documents. But, it does claim it is evidence based.


Quote:Biological safety risk assessment (based on the currently available data) The available evidence suggests:
  • Volatile organic chemicals of concern (Dimethyl Diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1- methylpropyl) are not detectable 24 hours after the first ‘out of box’ use of the device.
  • Levels of diethylene glycol detected were within an acceptable margin of safety.
  • The degradation by-products Toluene Diamine and Toluene Diisocyanate are classified by IARC as Group 2B carcinogens. This category is used for chemicals where there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals.
  • Laboratory analysis found that as the foam degraded it tended to stick to nearby surfaces as well as itself. This reduces the risk of respirable particles entering the breathing circuit.
  • Degradation of the polyurethane foam can be accelerated by off-label use of ozone decontamination or use in environments with high humidity and temperature, neither of which apply in the UK.
  • Available evidence suggests that most degraded foam particles are too big to be inhaled.
  • Diisocyanate is associated with isocyanate-induced asthma in a very small number of patients. For sensitised patients even low concentrations can cause adverse effects.

The available evidence suggests that the risks to patients of ceasing to use these devices significantly outweigh the biological safety risks if patients do not have ready access to an alternative.



https://assets.publishing.service.gov.uk...NatPSA.pdf
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: < above >

Correct, then we all agree.  The U.K. and Canadian documents provide no "new" information whatsoever.  It all falls back to Philips' original advice, and advice Philips (and others) continues to give:  stop using their faulty-foam product and obtain another product solution.  Until you're able to obtain another non-recalled PAP device, and if your doctor advises you to do so, continue to use your recalled Philips device - reducing your health risk through the use of an inline filter.

There may be individual country medical authorities that advise their citizens differently, contrary to the instructions given by the manufacturer in its recall.  Their citizens will have to choose their own course of action, based on their country's unique advice.  To date, however, I'm not aware of any particular country which has received unique information directly from Philips which other countries have not also received.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-02-2021, 05:52 PM)WakeUpTime Wrote: RE: < above >

Correct, then we all agree.  The U.K. and Canadian documents provide no "new" information whatsoever.  It all falls back to Philips' original advice, and advice they continue to give:  stop using their faulty-foam product and obtain another product solution.  Until you're able to obtain another non-recalled PAP device, and if you're doctor advises you to do so, continue to use your recalled Philips device.

No, we don't agree. 

I don't know if they are providing new information or not. You don't either. 

But the difference between us is,  I readily admit, I don't know. You keep claiming you do know. 

The last pdf I provided contains much more information than what has been provided to the to the general public, or at least readily accessible. 

But let's assume for a second the UK and Canadian government have not discovered new information. They most certainly have come to different conclusion than does Philips. You have been blasting Philips (and rightfully so) on their inadequate testing, and methods. 

But now, you are taking the position that it is Philips advice that is to be followed. Given the choice between Philips whose motivation is not just health oriented, who has been negligent for years, and who is currently in litigation protection mode. You are now advocating on their behalf. That doesn't make sense.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-02-2021, 06:25 PM)Dog Slobber Wrote: ...I don't know if they are providing new information or not. You don't either.  But the difference between us is,  I readily admit, I don't know. You keep claiming you do know. 

I've made no such claim of what the U.K. (or Canada) may uniquely have heard directly from Philips - but not publicly disclosed.  I simply asserted that those countries have not disclosed specific details of any new details that they uniquely received from Philips.  If you wish to argue the point that they "may" have received special information, but won't disclose it, of course, anything's possible.  They "may" also have individual storage facilities housing green three-eyed aliens.

So, again, it seems we all agree.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Yes, government regulatory agencies will have access to data that isn't readily available to the public. When Merck wants to release a new drug they submit all sorts of test results to these agencies, that go over them with a fine tooth comb, and/or perform their own tests. There are penalties for failing to disclose adverse health info. Regulatory agencies review data and come to a decision. They don't just take the manufacturers word for it.

The foam was doubtless tested and reviewed years ago. When an agency says, "Levels of diethylene glycol detected were within an acceptable margin of safety", and all the rest, this is based on testing. They're not just shooting off at the mouth.

Wakeuptime, again, if you have access to credible studies that contradict the British and Canadian reports, we're all ears. Quoting some guy with a video on the internet doesn't count. You seem to want to push the idea that you know as much as the regulatory agencies and others in the field. I question that.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-02-2021, 07:19 PM)hegel Wrote: if you have access to credible studies that contradict the British and Canadian reports, ...

Nothing in the British and Canadian reports contradict existing known facts in other countries.  I'm not sure why you continue to insist that they've made special assertions otherwise.  Therefore, how am I contradicting the same information that is known in the U.S. and elsewhere?  As an analogy, you're asking me to disapprove the possibility that the British and Canadian governments have information about aliens that they haven't disclosed.  

It's a bizarre argument that provides no insightful information to PAP users truly impacted by the Philips recall.  I'd recommend that we focus on providing information that might truly benefit all those affected by the Philips recall.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-02-2021, 07:53 PM)WakeUpTime Wrote: I'd recommend that we focus on providing information that might truly benefit all those affected by the Philips recall.

Then we agree.

For some, the the best course of action is to continue using their device, as per the Canadian and British Medical  advisory boards.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
AASM is maintaining current official information and professional guidance at this link:

https://aasm.org/clinical-resources/guid...ap-devices

They include information and guidance from Philips, government organizations and medical societies. 

One detail that remains unclear to me is whether Philips is waiting for the FDA to approve the foam that Philips wants to provide for System One devices. Or, is the FDA waiting for Philips to make a submission? Regardless, System One owners are in for a long wait.

There is no one-size-fits-all interim solution. The key is to remain calm, informed and flexible as this discussion evolves toward a set of interim good practices.

We're caught in the same predicament. I take the FDA's assigning the recall Class 1 status as confirmation that PE-PUR particles smaller than 8 microns can cause serious harm. The good news is that we remain sovereign over our machines and our bodies.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I appreciate the willingness of the posters to continue this argument, because it's the most important question -- should you stop using the affected units or not?

I don't have a serious condition.  CPAP reduced my index from 17 to well below 5 and has kept it there the last three years, ending snoring, etc.

The Philips recall notice is clear for people in my situation -- STOP USING the machine.  The choices in the Philips notice about continuing, seeing your doctor, weighing risks, etc. are ONLY for people with serious conditions.  That is how their "decision tree" works.

The government notices have a different recommendation --  EVERYONE continues to use the machines, sees their doctor, weighs risks and THEN decides what to do.

So we are left in the strangest position I have ever seen in a product recall -- the product manufacturer has made a stronger recommendation not to use their product than the health authorities are making.

It is incredibly odd for the regulator in England to be presenting side evidence that contradicts the manufacturer's recommendation and tries to put the recalled machine in a better light.

Are the agencies worried about having their original approvals of the machines second-guessed?  Are the national health services worried about their own sponsorship of these machines in their treatment programs?  In a country like the UK, is the National Health Service effectively the equivalent of our DMEs, sleep clinics and doctors, all rolled into one?  For US patients, those are all the folks that are going to be the defendants in the coming lawsuits.

So I worry.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
One possibility is that Phillips is looking at lawsuits, for sure. So they put out the strongest warning.


It may be that the new foam will begin to become available sooner than a million new machines.
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