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

[btreger]

This is from The DutchNews.nl

Uncertainty

In the Netherlands, where some 50,000 people use the devices, doctors are calling on Philips to provide more information about the risks.

‘There is still a lot of uncertainty and this has been a huge surprise for us as a profession,’ lung specialist Monique Klaaver told broadcaster RTL Nieuws. She hopes Philips will soon provide more clarity and come up with an action plan.

Philips, she says, has not yet shared information about the health implications with doctors. ‘So we can’t really assess the risks,’ she said.

Philips has set aside €500m in total to fund the recall but said it does not expect any impact on 2021 earnings. 

[SuperSleeper]

Some folks have gotten better with this, but we still have a few who just don't seem to get it, so I'm going to post this 5 times so that no one can say "I didn't see it""

DO NOT USE THE "REPLY WITH QUOTE" function unless you absolutely have to!

See here:

http://www.apneaboard.com/forums/Thread-...-T-HAVE-TO

[SuperSleeper]

As an example on how to make things less annoying for other forum members...

If you're replying to user SamSmith393, please don't quote his entire post.

Instead, simply say something like "I agree with SamSmith393 mostly about the foam off-gassing, but also I'd like to caution against blah, blah, blah".  That way, folks know you're responding to SamSmith393's post without quoting the ENTIRE post or large portions of it.

Or, you can simply quote SamSmith393's post PARTIALLY, (not quoting the entire post or several paragraphs of it).  If you must use the Quote with Reply button, then PLEASE only quote the portions of SamSmith393's post that are absolutely necessary for folks to know what you're replying about.  Cut it down to one or two short sentences, in other words if you must use the quote function.

Remember, PEOPLE HERE have ALREADY read SamSmith393's post.  You don't need to quote the entire thing again.

 

PS - I've edited some previous posts in this thread to edit out huge quotes of entire posts.

[ruthcatrin]

This is from The DutchNews.nl

…….

Philips, she says, has not yet shared information about the health implications with doctors. ‘So we can’t really assess the risks,’ she said.

This is what both my doctor and my DME told me.  That Philips isn't giving them any info on the actual risks beyond the same press releases I saw, and so they honestly have no way to assess what is or isn't a better choice.  My DME also told me they are running VERY short on the bacterial filters.  I ordered a 10 pack from Supplier #1 so I can try them and see if/how they affect my machine function.

[LookingForward]

I have a Dreamstation BiPap AVAPS that is part of the recall.

Does anyone know if a ResMed ST-A is completely compatible and will assure the volume I need? 

I didn’t know about this recall until a week ago and just sent a message to my doctor this morning asking for advice. 

I don’t have the option to go even one night without the machine because of muscular dystrophy. 

If I bought a ResMed ST-A, I don’t know how to set it up to match my current settings on the AVAPS but don’t feel comfortable getting a Philips at this point.

[btreger]

Statement of the European Respiratory Society (ERS)


ERS has issued a statement on this which is summarised below:

1 – It is important to balance the risks for each individual patient. This includes:

• The known and the possible risks of inhaling the foam from the machine and the likelihood of this happening,
  
  
• The risks of what might happen if you suddenly stop using the PAP machine.
  

2 – The decision to stop or continue using your PAP machine should be made on an individual basis.
3 – There is no evidence of sudden life-threatening events happening with patients who have used the faulty machines. There have been a small number of reports, that have described cough, headache, and sinus infection in users.
4 – Therefore, you should not stop or change your treatment, even if you receive notification from the manufacturer.
5 – You should contact your physician/sleep team for advice and discussion.
6 – Their medical recommendation should consider how coming off treatment would affect you, for example:

• Your levels of daytime sleepiness and how this affects you, risks of accidents at work and when driving, and other related health risks.
  
  
• How severe your disease is, based on how affected you are in daily life, the Apnoea–Hypopnea Index (AHI), hypoxic load, and hypercapnia (the amount of carbon dioxide in the blood).
  

7 – Your doctor will help you decide on the best action for you. Some examples may include:

• Continuing to use the PAP machine if your condition is severe and you would be at risk if you stopped using it.
  
  
• Swapping to a different treatment if your symptoms are mild to moderate.
  
  
• Considering pausing treatment if your symptoms are very mild and it is safe for you to do so.
  
  
  

Any changes to your treatment should be made under medical supervision and you should be regularly monitored by your doctor.  
8 – If you continue using your device, you may be advised to use an in-line bacterial filter.

Questions asked to Philips from the ELF Sleep PAG

How many devices in Europe are part of the recall including CPAP /APAP/Bilevel and presso-volumetric, and specifically how many units are in each country of the 27 member states?
This figure is not known at present and will need to come from the regulators.

Can you confirm that the German regulatory body coordinating the regulatory bodies will give some plans for the EU by the beginning of next week?
We do not have information yet on how the process of the national regulatory boards will be and how it will be organized on the EU level. We may get information this week.
When do you expect to replace all the devices covered by the recall, with the new dream station 2 models and with the new noise abatement (reduction) object?
At the moment it is not clear how long this process could take. However, it could realistically take 12 months or more.
What material was the turbine noise abatement (reducer) made of?
The current material is Polyester polyurethane. We do not have information about the material on other devices yet.
Will System One and Dreamstation 1 machines older than 5 years be replaced?
All affected machines will be replaced or refitted.
Does Philips plan to support and promote research studies to assess the health impact this carcinogenic (cancer-causing) material may have on patients in the medium to long term?
Studies have already started and will be ongoing.

[WakeUpTime]

Although this started as a U.S. recall, where Philips may have an existing 60%+ xPAP market share, it's quickly becoming a complex international recall as many countries are now investigating Philips and demanding actions. Of course, no one could blame them at all as they should all receive an equitable response from Philips.  I'm only pointing out that Philips' production "supply constraints" could become a lot more restrictive as they try to meet their production estimates - something they've already said may impact their response to the recall even more.

However, let's all keep in mind that Philips continually states that the recall will not significantly impact their financial earnings this year.  Philips has balanced and minimized their response accordingly to protect its stock owners.  As Philips' CEO recently stated, Philips has received a significant financial boost as a result of the international COVID-19 pandemic.  Put another way, Philips' good fortunes, brought on by the global pandemic, and their light and lengthy response, won't cause Philips to even "break a sweat".  So much for the CEO recently stating that Philips puts patients first, before everything else ("at the heart of everything we do").  Perhaps he meant to say "stock owners first".

[btreger]

  As Philips' CEO recently stated, Philips has received a significant financial boost as a result of the international COVID-19 pandemic.

Is it just me or does anyone else see this as being a totally disgusting statement?

While millions of people have already died, and more are dying daily from COVID, not counting the millions of people who have been impacted by their recalled defective CPAP machines, Philips is sitting back and telling the world how well they are doing financially.

[Shulamet]

Did Phillips indicate if you did not use Ozone and  cleaned only with Respisoak, Dawn Baby Shampoo, etc....can you continue to use  it your  recalled CPAP et al? Is there any conventional wisdom/ best practices/ work around? Doctors and DMEs are not helpful.
 Car companys deal with this and advise you accordingly. Thank you for the update.

[Gideon]

Not from Philips.
BUT.....
Many medical organizations around the world have IMHO put together a reasonable approach.
Recognizing that many xPAP users rely on their devices they suggest continued use and to consult your doctor asap and discus options. Basically to replace your system asap but continue use, possibly with an online AB filter to catch any particles. Note: these filters are sensitive to humidity because it is a very fine filter and the humidity will 'clog' the filter so use without humidity ( no water in humidifier). Also your pressure settings may need to be adjusted because of the added resistance. Many devices have an AB filter setting to help. If black flecks show on your filter your machine is demonstrating failure and see your doctor about an urgent replacements.

I've seen news articles projecting that PR's replacement repair cycle will take up to a year. Don't count on the timeframe yet.