[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[HockeyGoon]

I'm suggesting that random people voicing opinions on the internet who brook no disagreement with their opinions are not the best sources for information on this important issue. Or other issues. I'm calling for reasonable, fact based discussion.

Couldn't agree with you more.  The bar us set very, very low for someone to think that they are an expert from a bunch of random conjecture on youtube, facebook, etc.  Fact is, we all really know very little.

I look forward to the day that this thread will be people discussing their experience with getting new or fixed machines.

[WakeUpTime]

Those of us who are continuing to use our recalled defective Philips systems each night, contrary to the manufacturer's demand not to, certainly don't want to think that we could be inhaling cancer-causing foam particles each night during our PAP therapy.  

At this stage, more (independent) laboratory analysis should immediately be performed on real-life (not laboratory simulated) recalled Philips systems and their defective sound-absorbing foam.  After using this defective foam for more than 10 years, it's clear that the company (and perhaps the industry) is unable to police themselves in consumer health protection.

[hegel]

I would certainly be using a bacteria filter. I seem to recall reading that they will capture foam particles. If true, they might also give insight into the condition of the foam in a machine--that is, no captured black flecks or some or many.

I believe that both Engish and Canadian health agencies are recommending people continue using machines until a replacement is available. That suggests that they don't find a high degree of danger exists for most users.

[btreger]

Those of us who are continuing to use our recalled defective Philips systems each night, contrary to the manufacturer's demand not to, certainly don't want to think that we could be inhaling cancer-causing foam particles each night during our PAP therapy.  

At this stage, more (independent) laboratory analysis should immediately be performed on real-life (not laboratory simulated) recalled Philips systems and their defective sound-absorbing foam.  After using this defective foam for more than 10 years, it's clear that the company (and perhaps the industry) is unable to police themselves in consumer health protection.

I could not find any labs that are offering any testing, that does not mean there aren't any, only that I could not find any.

I did find this from Salem Health if it helps.
   The short-term mitigation plan in the acute inpatient setting is to place a bacteria filter in line with the equipment to prevent particles from reaching the patient. We recognize these filters do not stop or contain any off-gassing. 

[Gideon]

An online AB filter is a common mitigation until your machine is repaired or replaced.

[WakeUpTime]

I believe that both English and Canadian health agencies are recommending people continue using machines until a replacement is available. That suggests that they don't find a high degree of danger exists for most users.

Could you please indicate where those governments have specifically stated that recalled device users should continue using their machines until a replacement is available?  

Perhaps they're referring to those that are using a ventilator in an invasive life-sustaining manor.  Otherwise, I don't think a government health agency would come out and contradict the advice of a defective product manufacturer.

Anyone that advices to continue using the recalled Philips systems is absolutely not stating that they've certified it to not represent any degree of danger.  They may simply be stating that it may be significantly more dangerous to stop without seeking medical advice, thus protecting those agencies from liability.

[hegel]

You may be right about the hospital ventilators being the subject iinstead of cpap machines, Wakeuptime.

edit: found one at least: this whole quote is from Pholynyk on page 83 I think:

From CTV news (in Canada):
In July, the Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists released a joint statement on the recall to help guide physicians, where they noted that “globally, the number of units affected is in the millions.”
The included link is https://cts-sct.ca/wp-content/uploads/20...9_2021.pdf
It's 8 pages, too long to copy in full. In brief, after discussion with their doctor, most patients should continue using the machine until it can be replaced with an unaffected machine, preferably sooner than later.

[WakeUpTime]

The included link is https://cts-sct.ca/wp-content/uploads/20...9_2021.pdf
It's 8 pages, too long to copy in full. In brief, after discussion with their doctor, most patients should continue using the machine until it can be replaced with an unaffected machine, preferably sooner than later.

That link doesn't seem valid anymore; it seems to now be:

[Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists]
CTS_CSS_CSRT-Phillips-Recall-Statement_final-07_09_21.pdf (cts-sct.ca)

It does not say "most patients should continue to use..." for standard (not life-sustaining) CPAP/BiPAP users.  

(1) For patients using affected devices that are considered life-sustaining (see above for description) physicians should discuss risks and benefits with their patients as soon as possible to determine the best course of action.  For life-sustaining devices, this would very likely involve obtaining a comparable non-recalled device or, if this is not possible, to continue the recalled device until repair/replacement.  Other experts involved in the care of these patients (such as respiratory therapists) could be helpful in these discussions, but the ultimate decision about continuing or stopping therapy remains with the physician and patient. If the device is changed to a non-recalled device or any modifications are made to the circuit (e.g., addition of a filter - see below), close follow-up and optimization of therapy (e.g., potentially changing pressures, triggering sensitivities) are necessary to ensure continued adequate ventilatory support and patient comfort. 

(2) For patients using affected CPAP or Bi-Level devices at night for obstructive sleep apnea, therapeutic decisions should be individualized. Discussion between patient and physician might also provide an opportunity to reconsider indications and effectiveness of therapy. 

[btreger]

Could you please indicate where those governments have specifically stated that recalled device users should continue using their machines until a replacement is available?  

Perhaps they're referring to those that are using a ventilator in an invasive life-sustaining manor.  Otherwise, I don't think a government health agency would come out and contradict the advice of a defective product manufacturer.

Anyone that advices to continue using the recalled Philips systems is absolutely not stating that they've certified it to not represent any degree of danger.  They may simply be stating that it may be significantly more dangerous to stop without seeking medical advice, thus protecting those agencies from liability.

This is from the FDA:

Talk to your health care provider to decide on a suitable treatment for your condition, which may include:

•         Stopping use of your device
  
  
  
  • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
    

• Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA

[WakeUpTime]

This is from the FDA:

• • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
    

Yes, I'm familiar with the FDA report.  The FDA report specifically states IF their "heath care provider determines...".  Please note the use of the word "if" and the required consultation with a health care provider.

However, the poster (hegel) had stated that the Canadian report said "most users should continue...".  That's a very different statement, which also appears to be incorrect; unless of course most users are first getting the doctor's approval to do so, and all those doctors are authorizing all those users to continue using their recalled Philips device.  

Instead, those doctors will likely first ask themselves: "Is the patient in a life-sustaining situation?", "Is the patient able to get a replacement"?, "Will the wait for a replacement cause more harm that the possible harm from using the defective device?", etc.

If I were a doctor, I'd ask the patient "how long do you think it will be for Philips to replace your device?"  Given the information we already know, if it's going to be many months AND the person is not in a life-sustaining situation, I'd advise the patient to obtain a replacement wherever and however they can.  If the person said they don't have the financial means to buy another one, or there's no inventory of a replacement product, and the person has a moderate or greater untreated AHI, I might advise to continue to use the defective product until more information is known, or a replacement is available.  Even then, if the patient is an active SoClean user, several additional months of possibly a continued daily intake of cancer-causing foam particles isn't a perfect recommendation.