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

[hegel]

"...and now I hope I can survive a defective machine that's been pouring bad air into my lungs."

Packtheknife, you don't know that for sure. I don't mean to minimize the whole thing, but at the same time, it may be that your machine is unaffected and your treatment has been normal. How old is your machine? Have you been using an ozone cleaner on the machine? etc, etc.

My point is, it's likely that not every recalled machine has been pouring bad air into people's lungs. We still don't know the extent of all all this. If you've had no obvious symptoms, and your machine isn't too old, who knows? We'll all know more as time goes on. In the meantime, assuming the worst may just result in adding a lot of unnecessary anxiety into your life.

[qwerty42]

Hi all, here's an update on my de-foamed DreamStation, for those who might be considering this (note I'm not recommending this, but if you know the risks and are confident in your abilities, and see this as the best near-term solution, I won't fault you for it!):

For the last two days, all of my machine's reported nominal leak rates (very consistent normally with my mask) and flow-based breathing parameters like tidal volume agree exactly with those parameters prior to removing the foam, when compared in OSCAR. Based on this, I think I can say with a reasonably high degree of confidence from measured data that the machine and flow sensors work just fine without the foam, as long as you seal up any cutouts used to remove the foam. If the flow measurement had been affected, it would be reporting different nominal leak rates for the same mask, which it isn't doing.

Also, I don't know yet if this is just a coincidence, but I haven't been very compliant with my DreamStation recently because every few nights, I'd wake up with my nose running like a faucet, like an allergic reaction, even though my sinuses were clear when I went to sleep. I stopped using it regularly for this reason. So far, the two nights I've used it since taking the foam out, I've had perfectly clear sinuses in the morning and great sleep. Could be coincidence; time will tell.

As for the foam itself, when I took mine out, it looked like new. My machine is 4 years old and I've never used an ozone cleaner with it. It looks just like the kind of dark foam you find on the inside of padded cases like Pelican cases, for anyone familiar with those. I put it to my nose and gave it a good sniff, for science (if I've already been breathing air directly from it for 8 hrs at a time for years, what difference will one big whiff make? ) It had a very, very faint smell, which was similar to any other foam of the same type that I've ever encountered. Nothing scientific about that, of course -- just mentioning it for anyone curious.

[paradox551]

Packtheknife, you don't know that for sure.

https://www.philips.com/c-dam/b2bhc/mast...1-06-a.pdf

and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life.

They're trying to mitigate damage in the upcoming lawsuits which is why it's downplayed as "may possibly" instead of "does occur and continue".

We all have the foam in our machines and the air goes through it. We're all getting exposed to this crap.

I'm waiting on my new resmed to arrive. Can't use my dreamstation anymore.

[WookieeInLaw]

Sorry if this has already been posted. I didn't see it. At any rate, the UK's Medicines and Healthcare products Regulatory Agency has posted the following. 

gov.uk/drug-device-alerts/national-patient-safety-alert-philips-ventilator-cpap-and-bipap-devices-potential-for-patient-harm-due-to-inhalation-of-particles-and-volatile-organic-compounds-natpsa-slash-2021-slash-005-slash-mhra?fbclid=IwAR2c9uokH3UGlYwySzo_C2kDMxkD9wTR_dZnO-NmGqzYQyIhxYmCktJAC8A

One thing that stood out to me: 

Actions to be complete by 17 December 2021

Identify whether you have any of the affected devices in your organisation, or if you have provided them to patients under your care.

Send the FSNs to all relevant departments. Ensure clinicians read and follow the manufacturer’s FSNs for each device within 2 days.

Implement and document a risk assessment process to determine the suitability of the continued use of these devices within 1 month. Refer to additional information section below for more information. Clinicians should: a) Determine whether risk assessments should be based on individual patients or patient groups and b) Contact affected patients and have a risk–benefit conversation about continued use. Advise that they can register their devices on the manufacturer’s website.

Source alternative devices where clinically appropriate. Guidance will be available through NHS Supply Chain in England (or national procurement services for Devolved Administrations).

Train staff and patients, and verify competency, in using the alternative devices. Ensure training records are updated.

I don't know if that gives anyone smarter than me any real indication of the timeline for all of this, but at least in the UK, it seems like nothing is going to happen before Christmas.


There's also this:

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.
  

[hegel]

paradox, have you never heard tv commercials for drugs? They all list a ton of possible side effects, including death, at the end. They don't say "this drug will cause liver damage' because in the vast majority of cases it doesn't. But they're required to state the warning.

You assume that the foam is off gassing from day one and it's poisonous. You don't know that for sure. I don't know that the foam isn't off gassing.

But we will learn. I wouldn't use a recalled machine either.

Telling everyone that they have been breathing crap for years and will develop cancer when that hasn't been proven just adds a lot of anxiety. It's like telling someone that their liver is about to fail because of the statin that they've been taking--you read a warning on the label and assume the worst.

[paradox551]

paradox, have you never heard tv commercials for drugs? They all list a ton of possible side effects, including death, at the end. They don't say "this drug will cause liver damage' because in the vast majority of cases it doesn't. But they're required to state the warning.

You're right - I don't know if mine is gassing or not. It's not a risk I'm willing to take though.

[hegel]

I wouldn't take the risk either.

[WakeUpTime]

Some may believe "I'm still alive so my Philips Recalled system must be fine".  Some may say, "there's dangers with everything, so I'm fine with the Philips possible dangers".

My sample analogy is this:  Let's say, hypothetically, that it's now known that the bottling plants that produce Gatorade now admit that there has accidentally been gasoline mixed in with drinks for the past 11 years.  Several varying conditions determine the amount of gasoline that you've been drinking (temperature, humidity, bottle size).  It may be that some only ingested 0.0001 ounces, while others digested 2 ounces from each bottle.  The company states:  "It's not proven that anyone has directly died or been seriously harmed from it."

Philips' recalled system users aren't sure if they've ingested 0.00001 ounces of foam, made with a cancer-causing chemical, or 12 ounces of that foam - worse if someone has been using Philips machines since 2009, later using SoClean, and/or living in a warmer humid climate.  Philips isn't giving us any of their scientific data and Philips won't analyze (or let us keep) our recalled machines so that we would be able to truly know our individual degree of ingestion.  On another note, inhaling chemical off-gases is something that we'll never be able to measure.

[btreger]

Earlier this week I mentioned that I found one DME in Europe that was selling Phillips now recalled products. It had its pricing and they shipped to a number of countries.

After reading an earlier post on what the UK was now doing, I just went back to that site. Now there is a notice you get when you click on info regarding a Philips DreamStaion. 

DreamStation Auto 
Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP, and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update.
While the site URL works with Philips Respironics to address affected inventory that may be part of this voluntary recall, we have temporarily disabled this product. If you are interested in a similar machine, please consider the AirSense 10 Autoset CPAP.

[WakeUpTime]

Earlier this week I mentioned that I found one DME in Europe that was selling Phillips now recalled products.
... Now there is a notice you get when you click on info regarding a Philips DreamStation. 

Now that all the countries in Europe are involved in the Philips defective system announcement (as well as other countries around the world), demand must be skyrocketing for immediate replacement devices (ResMed, etc.), DreamStation 2 systems, and of course the replacement foam "fix" along with creating authorized service depots around the globe.

Interesting too are the differences in wording, "recall" (U.S. only) vs. "field safety notice" (outside the U.S.).

As the old expression goes, things may get substantially worse before it gets better, for current and future PAP-required users globally, whether or not they own a Philips recalled device.  If ResMed runs out of current inventory at DMEs, only slowly increases production of new model devices, and Philips is low to increase inventory of DreamStation 2s, the industry as a whole may be faced with a serious international medical problem as a result of a significant shortage in replacement devices.

https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-letter-2021-05-a-2021-06-a.pdf

We all have the foam in our machines and the air goes through it. We're all getting exposed to this crap.

In that document, it's interesting that they put absolutely no timeline (or even an estimate) in their "corrective action".

[Philips Letter: URGENT Medical Device Recall Philips Respironics CPAP and Bi-Level PAP Devices ]

Permanent Corrective Action to be Taken by the Company: Philips is deploying a permanent corrective action to address the two (2) issues described in this Recall Notice. 

As part of the registration process above, you will be provided information on the next steps to implement the permanent solution.