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

[Guilhermedico]

I suspect the following question will be answered with certainty during a "discovery" phase of the Philips Respironics class action, should that move forward. And, to be clear, I am NOT a plaintiff's attorney, just an end-user like most of you. But, out of curiosity, does anyone know precisely when Philips Respironics added the "Do NOT Use Ozone!" warning to its DreamStation line? I purchased my PR DreamStation Auto BiPAP machine at the end of February 2021 and the admonition was already part of the accompanying booklet. But others have mentioned that the DreamStation line has been around for 5 or more years.

Did Philips Respironics include the "no ozone" warning in the patient documentation from the very beginning, i.e., 5+ years ago, or was it added later? If the latter, exactly when did PR add this advisory to the package insert? That date might provide a clue as to when PR became aware that there was a problem with use of ozone-generators in its DreamStation devices. 

I am also curious to know the following: Did the appearance of the "no ozone" notification in the patient brochure coincide with the timeframe in which the PR R&D team began to design the DreamStation 2, which reportedly does not contain the degenerating foam with outgassing of toxins?

[WakeUpTime]

It may take a legal case (or orders from a government agency) before Philips will eventually be instructed:

Users may expect the performance of their systems to degrade over time, whether that's the manufacturer recommended replacement time of 5 years, or 20 years - but there should never be a reasonable time when their systems might cause long-lasting harm.

If such a time does exist when actual harm may come to a user, then Philips should label and/or hard-code into each Philips ventilator system an absolute expiration date.

Some harm did in fact occur with Philips system users, to a degree determined by their machine type, age, cleaning method, environmental humidity, etc.  The harmful affects of ingesting the Philips composition of foam particulates will vary significantly by system usage, the existing health condition of the system user, etc.

Therefore it is vitally important that Philips recalled system users individually become aware of the degree to which they themselves have ingested foam materials from their Philips recalled systems.  

Recalled Philips system users should be allowed to keep their recalled machine as a record of any degree of potential harm, so the foam inside those devices could later be inspected internally, should they wish to do so.

- or -

Philips should setup an independent service company that, as part of the refurbishment of their recalled system (or replacement) will make a record of the foam condition in the returned recalled systems.  That record will then be made available to the Philips recalled system user, or a federal health agency, stored by serial number.

[Ratchick]

I never wrote that ozone "breaks down in minutes"

What I've read is that ozone in air converts back to oxygen in 30 minutes to four hours

... ozone converts to oxygen in 30 minutes to at most four hours. I don't think pockets of it somehow remain trapped in nooks and crannies of the machine for 14 hours.

Um. Okay? It's still not accurate, though.

In any case, we're not talking about the breakdown rate of ozone in water.

No. And the point is that the half-life of ozone isn't 30 minutes in air at room temperature. It is, roughly, however, in water and most of the references on Google are related to water treatment. In fact, even the link above showing the info about half-life times at different temperatures is from a company that makes water treatment devices.

Perhaps you mean in absolute terms that ozone is breaking those things down--just not enough to show in the normal life of such items. In that case, what does it matter?

Because it does show (for many people) within those lifecycles for a not-insignificant number of people. This is why Resmed say that using SoClean or similar products even one time invalidates the warranty, and they have done for at least eighteen months. And because a person may not even realise that it's causing damage (considering in the case of the foam, people generally weren't looking into the innards of the machine to see what was going on. And because even if you can't SEE the damage, it doesn't mean that it's not going to affect the quality of it. Especially when we're talking about devices that cost hundreds or thousands of dollars.

Well, ozone is widely used in hospitals and labs and other places. What can I say? I simply don't think it's the dangerous poison that eats through tubes and tubs that you make it out to be.

That's your prerogative. Unfortunately, the chemistry and safety data isn't just my opinion. I could post the FDA advice, the safety data sheets, the research demonstrating the damage even low levels of ozone cause to mucous membranes and respiratory tissues, but I don't think that you would be interested. You can choose to disagree. But there are a lot of things used in laboratories and hospitals that are phenomenally dangerous when not used properly. X-rays. Most medications. Bleach. Harmful, toxic, corrosive, oxidising chemicals. Ultraviolet radiation. Other radioactive sources.

It's bad form to put false words in my mouth, but maybe you were getting even for my 'hedging' remark, which I admit was poorly made.

I wasn't "putting words into your mouth" nor was I trying to "get even". Explaining why I believe something to be wrong isn't about attacking you, it's about discussing the facts. There's no intent on my part to attack the messenger - I don't even know you, so I have no reason to do so. You have a good day.

[Ratchick]

But, out of curiosity, does anyone know precisely when Philips Respironics added the "Do NOT Use Ozone!" warning to its DreamStation line? 

I don't know exactly, but I do know that it's been at least 18 months on the Resmeds. I think at first it was just that they felt that ozone would cause the machines to potentially malfunction mechanically quicker because of the effects of ozone when the machine wasn't designed with ozone use in mind, but I don't know for sure that they were aware of the toxicity. Just to be clear, the issues CAN still happen without using ozone in the PR machines - but ozone is likely to hasten the process if used in the machines and the FDA (as well as the manufacturers) have been talking about the risks since February 2020, and so the awareness (and concerns) must have been raised before that. That said, the fact that ozone is harmful to human health and can degrade all kinds of substances has been known for years. Many, many years.

[SarcasticDave94]

Go back to the Sullivan type. Good day.

[Ratchick]

Pfft... These new-fangled machines are just too fancy for me. Let's just have one of these, the original non-invasive ventilator...



Of course they do have new, modern day, new-fangled versions too...

[btreger]

Advice For Philips:

Stop the recall, and instead offer all affected users a 65% discount on the newest version of their existing machines. with the assurance and proof that you are now using a safe product for noise suppression.

This would help to restore some of your now-disgraced reputations.

This would reduce the number of units you would need to send for refurbishment. Most people don't trust that process.

This would allow you to start up the production line on your new products, and reduce the backup of new products because the vast majority of your customers are totally avoiding you. 


  

[milesarcher]

I just talked with my Sleep DR's office.  They said to disconnect the humidifier and it should be OK.  Does that make sense to anyone?  I thought that the humidifier came after the foam.  

Another thought.  Why wasn't there a message on the Dreammapper app?

Thanks.

[Phaleronic]

I just talked with my Sleep DR's office.  They said to disconnect the humidifier and it should be OK.  Does that make sense to anyone?  I thought that the humidifier came after the foam.  

Another thought.  Why wasn't there a message on the Dreammapper app?

Thanks.

They don't know what they're talking about.  The humidifier is downstream of the foam and I would use it as it has a chance to trap some of the foam particles...

[WakeUpTime]

Advice For Philips:
... instead offer all affected users a 65% discount on the newest version of their existing machines

I also think that solution, or something similar that included a credit based on machine type and aged depreciation, would have been a good idea for users and the company.  (Several mobile phone manufacturers have used similar programs.)  

For users, I would additionally argue that the credit compensation should be usable towards ANY Philips Respironics product, not merely a equivalent replacement to their recalled machine.  That way, users who have already purchased a replacement product from another manufacturer could use the Philips credit towards another Philips system such as a portable system, or on masks and other accessories.


Philips, like all corporations, likely discussed all possibilities; and like all corporations, chose the solution that would maximize their subsequent financial quarterly results and ultimately their stock price.  

Instead, Philips has allocated a mere $170 per user (average) corporate cost for each recalled device user (total €500 Million).  That may be the cost for users to have the replacement foam service done by a Philips-appointed 3rd party service company, including all courier costs, and possibly a DME coordination fee for their time.

That credit concept is still quite viable, but it would take a legal judgement (or government department directive) for it to be enforced.