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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(Yesterday, 09:30 PM)RayBee Wrote: Good to know. Thank you hegel.

From the UK - Alerts, recalls and safety information


Quote:Release of volatile organic compounds (VOC) including Dimethyl diazene and Phenol. Evidence suggests these gases dissipate after 24 hours from first ‘out of box’ use. There is a risk of short-term effects such as: headache/dizziness; irritation of the eyes, nose, respiratory tract and skin; hypersensitivity; nausea and vomiting. There have not been any reports of this to date. Patients with known allergies or sensitivities to these VOCs should be prioritised for an alternative device if available. There is currently no definitive data showing long-term harm to patients, but VOCs and degradation of the foam are associated with possible long-term effects such as: genotoxicity; mutagenic and carcinogenic effects; hepatotoxicity; nephrotoxicity; neurotoxicity.


And more importantly:

Quote:Note: Do not advise patients to stop using the devices unless a risk assessment has concluded that the risks outweigh the benefits.

https://www.gov.uk/drug-device-alerts/na...slash-mhra
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Sleep Review:

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

  I am going to post only a few highlights from this link, you can read the full article at 
Sleep Professionals Scramble to Find Solutions for Sleep Apnea Patients Amidst Philips Device Recall | Sleep Review (sleepreviewmag.com)

According to clinicians interviewed by Sleep Review, recall has become a major obstacle to providing care. Akhil Raghuram, MD, medical director of the Vancouver Sleep Center in Portland, Ore, says about 50% of his sleep apnea patients use Philips machines, and his team has launched an email campaign to alert them of the problem. For the new patients, the recall means delaying care because there are not enough machines to go around.

How big of a problem is the recall? “It’s huge,” says Raghuram in a phone interview.

Even the smallest sleep facilities have been impacted. In Kentucky, a two-bed sleep lab has had to reschedule their upcoming titrations. Prior to the recall, the center was leasing Philips machines, but the lab is now working to get new devices from an alternative supplier, says Candace Martin, RRT, the cardiopulmonary manager at Caldwell Medical Center in Princeton, Ky.  

At Vanderbilt Medical Center, a risk management team is working to get a letter out via the patient portal to patients who were seen in the last 5 years, according to Beth Ann Malow, MD, professor of neurology and pediatrics and director of the Vanderbilt Sleep Division. Malow shared this information during an American Academy of Sleep Medicine (AASM) virtual event last week entitled “Impact of the Philips PAP Recall on Patient Care and Sleep Center Operations.”

Sara Elizabeth Benjamin, MD, a neurologist and sleep specialist at Johns Hopkins Center for Sleep, says she is giving her patients the option to carry on with in-lab titrations. All patients who wish to proceed must sign a consent form making them aware of any potential harm.

“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.’”

“I feel like the ground is shifting a lot as well, so I am hoping that over the next few weeks there may be more information available in terms of longer-term cancer risk.”
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(5 hours ago)Dog Slobber Wrote: From the UK - Alerts, recalls and safety information

A few have quoted the UK and Canadian paper that suggested the off-gassing is limited to the first day, and that patients should just continue to use their machines, while first consulting with their doctor.  

Unless I'm mistaken, the UK (and Canada) have NOT done any extensive testing of their own.  They're simply going with the data released by Philips.  We would not want to give the false impression that other countries have done any additional significant testing of Philips recalled PAP systems.  Since those countries haven't, I'm not sure why people are quoting them as "additional evidence of safe use".  Instead, we could just quote Philips original source documents regarding it's laboratory findings.  

Doctors don't have any additional information beyond what the patient, or Philips, or their country's medical advisory board, has provided them with.  Doctors have no additional risk details as a result of any new extensive test data on the longer term use of recalled Philips devices under various situations.  So doctors will all likely advise patients to obtain a replacement system if they can while continuing to use their PAP system.  Would anyone expect a doctor to say anything different?  Doctors are fully aware that the risk for liability and malpractice exists for advising their patients to halt the use of their medically necessary devices.  So anyone that says "my doctor said to keep using, so it's fine" isn't living in the realistic world or not fully understanding all the details of their doctor's advice.

Here are the facts of the situation:
Quote:
For people who are using one of the recalled bi-level PAP or CPAP machines,
Philips says they should stop using the device and
contact their medical equipment provider or doctor about an alternative.

Patients who don’t have an alternative are advised to talk with their doctor about whether the benefits of
continuing to use the machine would outweigh the risk associated with the foam.

Lastly, we should all be reminded that Philips has done minimal limited testing on the foam degradation, off-gassing, toxicity and health impacts of real life recalled Philips PAP devices, outside of its laboratory pre-defined conditions.  Since 2007, the onset of its defective foam use, it's never been in their "best interests" to do so.  Philips hasn't tested end-user installations under a variety of conditions:

- all Philips various systems families and device models
- all ranges of real-life device use (one month to 15 years)
- various methods of cleaning (SoClean, other, nothing)
- various climates with varying temperatures, humidity, climate pressures, device stored in direct sunlight
- various user conditions (e.g. 8 hours/day, IPAP pressure 20, start/stopped 3 times each evening, etc.)

Looking at those original Philips source documents, their testing was absolutely minimal, under very limited laboratory conditions.  Even so, after 15 years, Philips went public with its disclosures - likely because of the accelerating number of users who used extensive ozone cleaning products.

Lastly, Philips states that it only received a small number of "complaints".  Anyone try to register an official complaint with Philips?  They likely bounced users back to their DME (Philips' actual "customer").  Up until recently, if Philips recalled device users had later developed lung cancer, asthma, etc., would there have been any possibility in their minds that it could have been remotely related to their PAP device?  No.  Likely users who repeatedly had flakes of foam in tier mask (etc.) were successful in getting a complaint officially registered with Philips.  That's likely to change now.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Wake up time, where did you get your info on any testing. or lack of testing, performed by PR and the UK and Canadian agencies?
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