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

[Gideon]

IMHO you are the proud owner of a $400 door stop (It's too big for a paperweight).
Do note that ozone "cleaners" do NOT clean. Instructions say to clean per manufacturers steps PRIOR to using the ozone device. There is a biofilm that forms and the ozone will not break down and thus never even touch the bugs in that film. The required prior cleaning sufficiently takes care of that and the 'bugs" too.

[StratCat48]

I have never used an ozone cleaner per advice from the RT that set up my CPAP (the RT's DME does sell them). Regardless if a SoClean 'might' sanitize, but not 'clean' a CPAP machine, it generates ozone which is released into the room it's in. Ozone is not healthy to inhale and conceivably could cause health issues.

I don't obsess about cleaning. My cleaning routine is pretty simple. In the morning when I refill the humidifier chamber I wipe down the mask with a baby wipe inside and out. Pretty quick and takes little time. Once a month usually about the time I change the fine filter I wash the mask and headgear. I have a large plastic nut container with a lid that I put the mask and headgear in with a couple drops of Dawn dish liquid and then 3/4 fill with hot water. Shake the container a bit and let set for a short while and then empty and fill a few times with cold water to rinse out. Sparkly clean when it comes out. Water chamber is also cleaned monthly at this time with hot water and Dawn.
The heated hose gets a drop or two of Dawn, filled with hot water, and sloshed back and forth for a couple minutes followed by running hot water through it.
All items then are placed outside in the sun to dry if the weather is good. I did this routine this morning and it may have taken all of 20 minutes.

[upsman]

First, you absolutely DO NOT need any type of "cleaning device" to keep your equipment clean and sanitized. They're completely unnecessary. Soap and water will take care of that.

Next, the use of ozone cleaning devices only exacerbated the breakdown of the foam insulation. It was breaking down without the introduction of ozone. The ozone didn't cause the foam issue.

[hegel]

I use a Respify ozone cleaner. The ozone generator, humidifier tub, hose and mask go into a sealed bag; bag goes into the bathroom with windows open. Done. When the process is over I remove the articles from the bag to air out.

ozone doesn't run through the machine. It doesn't enter the bedroom.

yes, one doesn't NEED to do this. I still have to wipe down the mask with baby wipes to remove oils and such. Some have reported the ozone discolors their tube or what not. I've never found that to be the case. I also hand wash my mask and tube about every month.

Mine is not a popular opinion hereabouts. Oh well!

[Sean B]

Thanks for the replies. The SoClean unit was a gift from family as I wasn't likely to ever purchase one if it was up to me.

I've found that hand washing like others have mentioned has always been enough. Also, in addition to soaking everything in dish soap and hot water, I run a piece of solid 12 gauge copper wire through the hose, attach a small piece of t-shirt to it and pull it through so that the inside of the hose is getting more than a rinse.

[btreger]

I just came across a new Facebook group, or a least new to me called, "CPA Machine Marketplace - USA".

It seems its intent is to buy and sell equipment. Some used and some new. This is not a DME site.

[SuperSleeper]

The posts that dealt with the CPAP Mask supply issues was moved into it's own thread, now located here:

http://www.apneaboard.com/forums/Thread-...ply-Issues

Also, some contentious posts were removed from that thread.

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Feel free to continue the discussion of the Mask Supply Issues in that split-off thread and we should all try to keep this huge Recall thread focused upon the actual Philips recall issues.  I realize that many of us (me included) participated in the thread-drift.  So let's get back on track here in this thread.

Thanks.

[chasmm]

The posts that dealt with the CPAP Mask supply issues was moved into it's own thread, now located here:

http://www.apneaboard.com/forums/Thread-...ply-Issues

Also, some contentious posts were removed from that thread.

Thank you!

[btreger]

This is an e-mail sent by Tom Wilson, Admin for The Philips CPAP Recall Support Group


Below is an email I sent to Jeff Shuren, MD who is Director of the Center for Devices and Radiological Health at the Food and Drug Administration, responsible for the Philips recall.

I encourage you to send him an email as well so he is clear on how you feel the FDA is protecting consumers.  
jeff.shuren@fda.hhs.gov

Dear Dr. Shuren,
 
My understanding is that you are the lead interface between the FDA and Philips regarding the current CPAP recall. 
I represent over 3,700 patients throughout the U.S. who are members of Philips CPAP Recall Support Group.  I have asked each of them to contact you and share their personal history.  Needless to say, this recall is large (2 million in the U.S.) and very serious recall (Class I Medical Device) affecting the health of millions of at-risk patients.
  
Many of our members feel like they have been ignored for the past 10 months by Philips.  Like myself, they never received any communication about the recall from Philips even though they owned a registered machine.  Since filing, they have received little to no communication from Philips.  Patients who had new machines are receiving old machines used for years by another party.  That simply is not fair.

Many of our members have been severely disappointed in the slow and ineffective response by the FDA on this widespread, serious recall.  Certainly, we were happy on March 11 to see you  'encourage' Philips to improve their communication.... only after receiving a great deal of feedback from patients.

We encourage you to leverage the power of the FDA to convince Philips to do the following:

Reimburse any patient who has a recalled machine and purchased a replacement machine (upon submission of a valid receipt).  I purchased a ResMed AirSense 10 for about $1,000.  Philips would not need to send patients old, previously used, reconditioned machines.  As patients, we can not be without our equipment -- especially for what is now expected to take up to 18 months to resolve.

Do not allow Philips to replace patients' equipment with refurbished, old equipment.  This is simply not fair.  I am sure you, yourself, would not find this acceptable.
 
Send monthly communication to all patients with an expected arrival date of their new, replacement equipment.  We realize this may be subject to change.
 
Please respond and let me know your thinking and I will pass it along to our Philips CPAP Recall Support Group.

[WakeUpTime]

I encourage you to send him an email as well so he is clear on how you feel the FDA is protecting consumers.  
jeff.shuren@fda.hhs.gov

You sure can write great letters.  You hit many important issues without it being too lengthy, making it easier for him to come up with any kind of action plan.  Thanks for doing that as it helps everyone.

I will indeed send him an e-mail too, to address outstanding issues.  I'll be sure to focus on efforts that the FDA indeed could assist with now, otherwise it might become a 20-page letter.  Philips has really failed to deliver their intended solution responsibly.  

Since news first broke in April 2021 (or earlier), a September 2022 or year-end fix/replacement will be 17-20 months of waiting, with many continuing to inhale/ingest faulty carcenagenic foam particles.  It's my prediction that many will still fall out of the system and not be provided with a fix/replacement by year-end - yet Philips will likely state that the vast majority of issues have been resolved.