How worried should Patients be about the BiPap and Cpap recall?

[Machine_Elf]

This whole issue first came to light in June 2021:

Philips CPAP users, heads-up: here comes a recall

Just in case you missed the news, Philips is issuing a recall on a bunch of its CPAP and ventilator devices: Foam in the intake tract (downstream of the intake particulate filters) can degrade and spew toxic particles into the air you breathe. They are advising CPAP users to stop using their machines and check in with their doc or equipment supplier for advice. Mine is only a couple of years old and has always been kept in a cool/dry environment, and does not appear to be shedding foam, so …

Philips started shipping replacement CPAP machines (the Dreamstation 2) later that year. Not sure why it has become news again, other than that Philips has halted sales in the US is negotiating with the FDA to figure out how to move forward from here.

In the case of the Philips Dreamstation CPAP machine (and probably in all the rest too), the main issue is a block of porous foam in the intake tract of the machine, intended to dampen sound from the blower that pumps air to the user. Although incoming air flows through this foam, it’s not intended to do any filtering; that happens at the very start of the intake tract, where users install coarse and fine filter inserts.

For some users, the foam has been disintegrating and spewing foam dust and toxic vapors downstream to their masks. And since the actual air filter inserts are upstream of this component, the foam particles do indeed make it all the way to the user and end up getting inhaled.

Officially, Philips has said that high ambient temperature and humidity exacerabates the problem. Unofficially, I suspect a lot of these cases are due to people cleaning their machines with ozone cleaners. Ozone is nasty, nasty shit and tears apart a lot of plastics and rubbers, and disintegrating foam is exactly the sort of symptom I would expect from pumping ozone-rich air through a CPAP machine.

If you’re handy with tools, it’s possible to remove the intake duct from the machine, cut it open, and strip the foam out:

Philips CPAP users, heads-up: here comes a recall

nearly six month after the recall was announced, it turns out there’s a safety concern with the foam being used in the proposed replacement devices: So now it’s anyone’s guess as to when acceptably safe devices will be available to replace the recalled devices currently being used by patients. I was originally planning to just wait for a replacement, but now that the timing is up in the air, I’ve decided to pull the foam from my CPAP’s plastic intake manifold. There are plenty of YouTube vi…

I was unable to make the easy fish-it-out-with-a-drain-hair-removal-snare method, so I ended up cutting into the plastic duct with a heated utility knife blade, pull the foam out, and then hot-glue that opening closed again. Worked well, no noticeable increase in noise.

The crazy thing is that there’s now a concern about the replacement machine - the Dreamstation 2 - and overheating:

https://www.fda.gov/medical-devices/safety-communications/carefully-monitor-philips-dreamstation-2-cpap-machines-signs-overheating-fda-safety-communication

No recall (yet), but it’s a weird sudden increase in reports of overheating problems in the six months. For the time being, FDA is just advising users to keep an eye on their DS2 for troubling symptoms.