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I have come across a press release from the U.S. Food and Drug Administration published in the US in 2020 stating that no devices that use activated oxygen to sterilize CPAP equipment are licenced for sale in the U.S. The release goes onto say that their own testing "demonstrated ozone-using disinfection devices generated ambient levels of ozone above limits considered safe for human exposure. Ozone levels were also high in CPAP machines and tubing even after waiting the amount of time recommended by the ozone-based device manufacturer after a cleaning cycle". I have been using my SoClean for several months with no ill effects but am curious if anyone knows of any independent UK testing.

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Hi Ian

Yes this has been an ongoing investigation for over a year, without many updates from the FDA, that we've been watching closely and they're also investigating the UV light cleaning system (Lumin).  I doubt the UK will be running any independent testing due to the manufacturers of the SoClean and Lumin both being in the USA.  This doesn't surprise us though because the market is now being invaded by lots of cheap chinese ozone cleaners which we fear may not have gone through all the rigorous testing that the SoClean has gone through, including the CE marking for sales here.  We always advise people not to purchase the cheap copies in case of safety issues.

We've spoken with SoClean who actually welcome this investigation to prove the safety of their product, so we shall see.... Meanwhile, all we can say is that we've had lots of people purchase the SoClean from us who have been amazed by how much their health has improved since using the SoClean - this is from people who are usually more vulnerable to repeated respiratory infections.  Some of these reviews are on the website too https://www.hope2sleep.co.uk/soclean-cpap-bipap-sanitiser-cleaner/a... and most reviews are 5 and 4 stars.  Additionally, over the past 5-6 years of selling the CPAP we have never ever come across anyone comment they have had any health issues (only positive) since using the SoClean, and I've been using one for 6 years successfully too.

It must be stressed that it's very important to follow the manufacturer's instructions and in particularly waiting for the required time before using the CPAP and accessories after sanitising.

We shall await the outcome of the FDA's findings and be very surprise if the SoClean in particular has any causes for concern.

Thanks Kath.  I've never used my CPAP without having the SoClean. I think it's a great piece of equipment and makes the cleaning regime a doddle and as mentioned I've never suffered any ill effects, indeed since using my CPAP I generally feel in much better health with more energy and now wake up in the mornings bright eyed ready to enjoy the day.


That's great to hear Ian and we suspect those cheap copies are the issue here or even if people are using the SoClean without following the proper instructions.  We'll see what the FDA say.....
Ian said:

Thanks Kath.  I've never used my CPAP without having the SoClean. I think it's a great piece of equipment and makes the cleaning regime a doddle and as mentioned I've never suffered any ill effects, indeed since using my CPAP I generally feel in much better health with more energy and now wake up in the mornings bright eyed ready to enjoy the day.

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