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

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

    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?

  • #2
    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