Has anyone had their Dreamstation replaced due to the recall? (UK)

[Skraggy]

No. Philips need to wait for the new foam to be approved for use in medical devices by the UK regulator.

As for the details:

The VOCs are only an issue within the first 24 hours of out-of-box use. After 24 hours, they could no longer be detected, so only a concern for brand new machines.

The only other danger is if the foam breaks down. This requires both hot AND humid environment. MHRA say the UK doesn’t have the climate.

If the foam degrades, it will create diethylene glycol, toluene diamine and toluene diisocyante.

Diethylene glycol is in the margin of safety.

The toluene compounds, however, don’t have a ton of data. They are classed as IARC group 2b carcinogens. (Limited evidence of carcinogenicity)

Toluene diamine, a colourless to brown, needle-shaped crystals or powder. It is not classifiable as to the carcinogenicity to humans. You’ve most likely come into contact before if you’ve used products like hair dyes.

Toluene diisocyanate is a colourless to pale yellow flammable liquid with a sharp pungent odour. It is not classifiable as to the carcinogenicity to humans. It does not persist in the environment and is rapidly broken down in air and water. You’ve most likely been exposed to this compound before when using adhesives or varnishes. Some people maybe sensitive to toluene diisocyanate even in very small quantities and may aggravate or trigger asthma. In such a situation, it would be wise to find a replacement machine as a matter of urgency.

These chemicals are sticky particles, not gases. It is very unlikely they would break away, make it’s way down a tube and into your mask for you to inhale. However toluene diisocyanate can trigger asthma in even trace amounts.

Philips have not released publicly the amounts of toluene found, so it is hard to advise how safe of dangerous it may be. What we do know is the symptoms of dangerous exposure to these chemicals are not listed in full by Philips or by the regulators, so exposure seems to be very low.

I’ll let you decide for yourself if it’s risky or not, but at present I’m unconcerned by these chemicals, especially since I’m in the UK.

No permanent harm has ever been caused by these machines and the complaint rate is 0.03% worldwide in 2020 and no reported cases in the UK. (Which makes sense based on the climate)

- Reno

"The only other danger is if the foam breaks down. This requires both hot AND humid environment. MHRA say the UK doesn’t have the climate"

That's not entirely true. Research has shown that Pe-Pur foam that was being used can breakdown when used for long periods of time, circa 3+ years regardless of climate. Hot and humid conditions will speed up and exacerbate the breakdown of the foam but it's certainly not the only factor. Incidentally the UK does actually have a humid climate. There are legal claims against Philips for causing cancer from around the world including Germany for example who have a similar climate to us.

On a personal level I am in the UK and have a barrister looking into bringing a claim against Philips. I am 55 and have terminal bladder cancer that my consultant thinks may well have been caused by my using Philips Resperonics machines since 2011. The type of cancer I have normally affects men in their mid 70s+ so my consultant has always been confused as to what caused it. My hospital sleep physiologist has confirmed that all the serial numbers of every machine I've ever used was affected by the foam recall issue. I used my first machine, a system one for 5 years and another system one for 4 years.

See below for information:

Source: https://ankinlaw.com/why-are-cpap-ma...ting-recalled/

Why are CPAP machines getting recalled? Philips Respironics recently recalled millions of the company’s continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines because of the tendency for the devices’ sound abatement foam to degrade, potentially leading to serious health issues.

Which CPAP Machines Were Recalled?

In June 2021, Philips recalled a line of CPAP, BiPAP, and ventilator products due to the potential health risks associated with them. Specifically, polyester-based polyurethane (PE-PUR) sound abatement foam in these devices degrades, generating particles and toxic gasses that can cause illnesses and injuries to develop. The Food and Drug Administration (FDA) labeled this a Class I recall, which means that these devices can lead to serious injury or even death.

So, how can a CPAP machine cause cancer, exactly? Users may inhale or swallow the toxic gasses and particles, which contain various types of carcinogenic and toxic chemicals. The most affected devices include CPAP and BiPAP machines that are three years old or vulnerable to humidity and heat.

[Reno]

If you’re seeing particles, you could ask your clinic for an inline bacteria filter, like these. Tests have shown they block the particles. However, it may provide some resistance so it’s possible a pressure increase may be needed.

If you your clinic won’t supply you a filter, although you don’t seem to be in any immediate danger, you may need to press for a replacement machine.

[Kelly @ Intus]

Good Morning

Thank you for your post.

Here is the link to the Philips Medical Device Field Safety Notice (outside of U.S.) - https://www.philips.co.uk/healthcare...ons/src-update

If you have any concerns then please call the support number on the above link.

Kelly

[Grahamuk]

I am visiting this forum for the first time as i was also looking for information on the recall being based in the UK. I had information from my NHS trust that my machine would be replaced early 2022 - in March the update was "we are expecting a delivery of replacement devices from Philips imminently. We are hoping that the replacement of devices will be a drop-in clinic based in community settings and therefore closer to home and easy to access." and still waiting in June.

I worry about my device as I spotted black flecks in my ait outlet today - i attach some images - and there are also in there and couple visible either side my hose. I dont know if its just black dust that got into the system, i couldnt spot anything on the filter this morning when i washed it (though it was coated in white stuff as normal??) so of course am worrying that my foam is degrading and i have breathed in this toxic stuff. i have ocd so struggle to filter out worry signals.

Have attached images of:
1. zoomed in airout let - you can see a couple black areas
2. general area around the air hose out showing black build up under
3. another ghenreal view show.


I have my cpap attached to the humidifer module but have heating turned off (and no water in tank) as it tends to quieten down the machine a little and there are this black flecks in there too. Im just hoping its duet - though as i said i didnt spot any black on the filter or around the intake air area.


Graham

[Reno]

Here is a link to the Philips Medical Device Field Safety Notice (Outside of U.S.) - https://www.philips.co.uk/healthcare...ons/src-update

Please read the section titled - Immediate Actions to be taken by You, the User.

Although Philips do rightly say you should contact your physician (and you really should) their advice is still for you to stop using it, which is the complete opposite of the regulators. As such, I would go so far to say it is BAD advice. At the very minimum it’s misleading. Not to mention the disproportionate fear it causes.

As the health consequences of stopping therapy vastly outweigh the minimal risk of using the devices. Only in very niche situations would a medical professional recommend to stop therapy.

Simply put: You SHOULD contact your clinic to make sure you don’t have any medical conditions that would require you to stop using it.

You DO NOT need to be worried at present as the health consequence are trivial, VOCs aren’t relevant after 24 hours, and no reported cases in UK because we don’t have the climate to cause the chemical reaction.

I have not factored use of ozone into this, so if you use ozone, you need to take this with a pinch of salt.

- Reno


Sources:
MHRA Risk assessment details
National Patient Safety Alert

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.

and

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.

[Kelly @ Intus]

Good Afternoon

Thank you for your posts.

Here is a link to the Philips Medical Device Field Safety Notice (Outside of U.S.) - https://www.philips.co.uk/healthcare...ons/src-update

Please read the section titled - Immediate Actions to be taken by You, the User.

If you have ant concerns, the please call Philips directly on the number on the above link.

Kelly

[Reno]

I think there may be a misunderstanding with your clinic. (I know I’ve had to correct mine a few times, but NHS is understaffed and they do naturally overlook or miss things)

The only advice I’ve seen from NHS England is to keep using them. They have advised clinics to register the device as part of Philips replacement plan. However Philips cannot give us the replacements yet until MHRA (UK regulator) approve the use of the new foam. Looking at the American folks, it looks like Philips intend to replace affected devices with the DreamStation 2, since the DS2 uses the new foam.

I do know some clinics are in the midst of a change from Philips to ResMed, however this change was planned before the problems discovered with certain Philips devices.

- Reno

[Cidwill]

Just to add to this that my lung clinic have been instructed by NHS England to replace all devices but they aren't doing so just yet due to severely limited availability of new cpap devices in the UK.

[Reno]

No. Philips need to wait for the new foam to be approved for use in medical devices by the UK regulator.

As for the details:

The VOCs are only an issue within the first 24 hours of out-of-box use. After 24 hours, they could no longer be detected, so only a concern for brand new machines.

The only other danger is if the foam breaks down. This requires both hot AND humid environment. MHRA say the UK doesn’t have the climate.

If the foam degrades, it will create diethylene glycol, toluene diamine and toluene diisocyante.

Diethylene glycol is in the margin of safety.

The toluene compounds, however, don’t have a ton of data. They are classed as IARC group 2b carcinogens. (Limited evidence of carcinogenicity)

Toluene diamine, a colourless to brown, needle-shaped crystals or powder. It is not classifiable as to the carcinogenicity to humans. You’ve most likely come into contact before if you’ve used products like hair dyes.

Toluene diisocyanate is a colourless to pale yellow flammable liquid with a sharp pungent odour. It is not classifiable as to the carcinogenicity to humans. It does not persist in the environment and is rapidly broken down in air and water. You’ve most likely been exposed to this compound before when using adhesives or varnishes. Some people maybe sensitive to toluene diisocyanate even in very small quantities and may aggravate or trigger asthma. In such a situation, it would be wise to find a replacement machine as a matter of urgency.

These chemicals are sticky particles, not gases. It is very unlikely they would break away, make it’s way down a tube and into your mask for you to inhale. However toluene diisocyanate can trigger asthma in even trace amounts.

Philips have not released publicly the amounts of toluene found, so it is hard to advise how safe of dangerous it may be. What we do know is the symptoms of dangerous exposure to these chemicals are not listed in full by Philips or by the regulators, so exposure seems to be very low.

I’ll let you decide for yourself if it’s risky or not, but at present I’m unconcerned by these chemicals, especially since I’m in the UK.

No permanent harm has ever been caused by these machines and the complaint rate is 0.03% worldwide in 2020 and no reported cases in the UK. (Which makes sense based on the climate)

- Reno

[Cidwill]

I've been trying to get information on the process but so far there has been no movement. I've spoken with my lung clinic about the issue and they say that they've been informed there is no risk unless Ozone was used for cleaning. From what I've read in official philips documents and factsheets published by other medical providers that isn't true though and the foam can degrade anyway? I've also read that carcinogenic gas is only an issue for the first 24 hours of use?