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

[btreger]

One of the DME's, that is currently selling Philips products, is the one that I bought my DreamStation Go from. They also notified me via email on the 16th of the recall. So they know.

Let's go back to standards that Philips says it is and has always followed.

NEW ISO STANDARDS FOR MEDICAL DEVICES

Click on this link to get there:

 https://www.iso.org/news/ref2534.html

[sawinglogz]

Is it possible that PR is simply unaware that when they oh so carefully curate and protect this data, that virtually the only people who are willing to look at it are the patients -- the exact people that they are "protecting" the data from!

Or is it really the case that they know that they are hiding the data from the only people who will look at it, and they are deliberately doing this because they have something to hide?

I think they simply don't care. The patients aren't their customers.

And they may think that taking steps to prevent patient access shields them from some liability if a patient gets hurt after adjusting their own settings based on their data.

And yes, I know my doctor is unusual. I specifically sought him out.

[WakeUpTime]

DMEs and sleep labs are now reporting that, over the past few months, they had "clues" from Philips that a significant issue was developing that was significantly disrupting existing Philips PAP systems backorders (except DreamStation 2 orders).  It appears that Philips had known about the coming recall for several months and began withholding deliveries of Philips PAP systems to DMEs and sleep labs of all models (except the DreamStation 2).

Sleep solution equipment suppliers, sleep labs, etc., are all scrambling right now to find replacement systems anywhere they can find them.  Failing that, they are asking patients to sign a legal release form regarding any use of Philips recalled systems.

As one of the sleep professionals in the article noted, the last thing we'd want is for PAP users to stop using their PAP system altogether, or any resulting events such as a motor vehicle accident could lead to serious legal consequences. By Philips' statement to immediately stop using their recalled breathing systems, without an immediate replacement, they've presented a significant problem to the industry.

This article shows some of the impact on the daily operations at sleep labs.
(Note that none of the direct quotes within the article are from Philips themselves, but rather from DMEs or sleep labs.)

"Sleep Professionals Scramble to Find Solutions for Sleep Apnea Patients Amidst Philips Device Recall"

Last week’s announcement that Philips is recalling millions of its CPAPs, bilevel PAPs, and ventilators sent shock waves throughout the sleep medicine subspecialty, leading to a frenzy of sleep lab administrators and sleep clinicians looking for alternative sleep apnea therapies for their patients.

Without enough devices, and with questions of how long it will take to replenish the supply, sleep professionals have had to quickly find solutions to handle the ongoing situation.  Even the smallest sleep facilities have been impacted. Prior to the recall, the center was leasing Philips machines, but the lab is now working to get new devices from an alternative supplier.  

“There are very tangible risks to patients stopping CPAP or biPAP abruptly and especially since, I feel that it is going to take months, if not longer to get replacement machines from Philips,” says Ayas. “The last thing you want to happen is someone getting into a motor vehicle crash. So I think that we have to be more nuanced and say ‘what is the best thing for our patients.’”

During this time, many providers have turned to another major CPAP manufacturer, ResMed, to order new devices. Machines made by ResMed have not been affected by the recall and use a different material for noise abatement, says Jayme Rubenstein, public relations director at ResMed, via an email interview.

Still, aside from the disruption in care, there will be a significant financial cost to shoulder and it remains unclear if patients will be supplied with alternative therapy devices in the interim.

Patients who have devices that are less than five years old, will not be able to get a new device covered by insurance under current policies. So if it is going to take months or up to a year to get a device through Philips registration process, that is going to become a problem.  “They can’t be without treatment for that long,” he said. “So we are really petitioning the payors to add some flexibility.”

[buddy0329]

"Sleep Professionals Scramble to Find Solutions for Sleep Apnea Patients Amidst Philips Device Recall"


Patients who have devices that are less than five years old, will not be able to get a new device covered by insurance under current policies. So if it is going to take months or up to a year to get a device through Philips registration process, that is going to become a problem.  “They can’t be without treatment for that long,” he said. “So we are really petitioning the payors to add some flexibility.”

[url=http://www.apneaboard.com/forums/private.php?action=send&uid=19187][/url]
Ever since this recall fiasco started I had been calling Aetna to put pressure on them.  Aetna called me this afternoon to tell me that they were going to waive the 5 year coverage rule.  It had been escalated to a policy team for more than a week.  Of course I paid out of pocket for a (heavily discounted) AS10 last night, but that means I still have benefits to use on an AS11 whenever it comes out.

Point of the above....if you need coverage to help pay for a new CPAP/APAP, call your insurer.  Tell them they need to waive the 5-year rule:

1. Philips' device recall statement indicates to discontinue use of affected machines
   
   
2. Philips has no plan / timelines / expectations yet for remedies set with customers, payers, or DMEs.
   

Those two points made over and over again were key in getting Aetna to back-off on their 5-year rule.

[Lazer1234]

I wonder if Philips' recall of machines is really about getting their new encrypted machines into use by patients. Then they get into their new patient management system, Care Orchestra? I guess it will mean much more profit than the recall of the old machines costs.
Almost everything that concerns our health should go through this platform, right?
HDSP

[WakeUpTime]

^^^
I fear that adding this posted link might cause this thread to now become the Philips DreamStation 2 data encryption thread, but here's the link for those interested in Philips' new cloud-based architecture:

Philips Health Suite Digital Platform (HSDP) brochure
https://cf-s3-9b8a2d91-c007-4d01-985a-ef...ochure.pdf

(I'm hoping that someone will start a separate thread, related to Philips data encryption and its cloud architecture, so this thread can focus on the issues related to the Philips Recall.)

[Lazer1234]

^^^  
I fear that adding this posted link might cause this thread to now become the Philips DreamStation 2 data encryption thread, but here's the link for those interested in Philips' new cloud-based architecture:

Philips Health Suite Digital Platform (HSDP) brochure
https://cf-s3-9b8a2d91-c007-4d01-985a-ef...ochure.pdf

(I'm hoping that a separate thread will begin to further that discussion, so as not to detract too much from the issues related to the Philips Recall.)

I mean the recall is just a cover to get started all over the world faster with HDSP?

[SarcasticDave94]

In case you're interested, comparing the 2 charts racprops posted, the ResMed reports events it encountered. If it didn't encounter a certain event, there's no events to report. The Philips maybe is doing the same, but I know for certain the ResMed acts this way.

His ResMed comparison has some other differences. The ResMed Min EPAP pressure was 10, Respironics min EPAP 12. ResMed AHI 0 Respironics AHI .39

ResMed PS 6-15 Respironics PS 6-11.5

ResMed didn't allow Hypopnea or Obstructive but Respironics did have a bit of both.

[SuperSleeper]

WakeUpTime, I'd suggest you start a new thread about the encryption info, rather than mix it all up in this recall thread.

Once you create the new thread, come back  here and post the link to the new thread so folks can continue to talk about the encryption stuff there.

Thanks.  

[cathyf]

Another question -- does anybody know how the worldwide chip shortage is going to affect the ability of any and all manufacturers to produce more machines than anyone was planning on needing?