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

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The FDA

Regarding the two news stories, we reported on regarding Philips and starting the recall.

Everything we have been told before was that the FDA would be the ones releasing all that information once they were satisfied with the documentation provided by Philips.

Since we have as yet to see that, I decided to call the FDA directly. I finally got to a Chief Security Officer (CSO). I did get his name but I promised not to use it, at least for now. He is working on the Philips recall project.

When I asked about the news articles he had no idea what I was talking about. I e-mailed him the two links associated with the news stories. I asked if he could e-mail me back with any new information. His answer was a maybe if he could.

Your guess is as good as mine, what the fudge is really going on.......

[Gideon]

This is such a volatile topic I'd be hesitant to release incomplete info as both sides would stretch it to suit their interests. Better to get the full story than bits and pieces.

[WakeUpTime]

The FDA...

Well done.  Outstanding effort.  You're that one in a million (likely one in two million) that had the persistence to reach that FDA contact, and well-armed with the right background knowledge.  That FDA contact will always keep in mind that, with every word he uses in communications with you, his job is on the line; so he'll likely be extremely cautious about responding with anything other than what's been already publicly disclosed.  However, he won't be able to completely ignore your findings (internally, anyway) and you'll always be able to say "I informed the FDA and the failed to take action regarding...".

So, it's September and the FDA approval has come in - 2 weeks off Philips' estimate of mid-August.  There must have been significant political pressure on the FDA to act fast, with Philips continually blaming them for the delay.  I suppose the "up to 12 months" estimate now starts and recalled device users should anticipate a fix/replacement by September 1, 2022.

Philips' phone lines should start to get extremely busy as upwards of 2M (in the U.S.) begin to demand their fix/replacement device.

There's a paragraph in the recent news story that I'm puzzled by:

"The vast majority (>80%) of the registered affected devices in the US to date
are in thefirst-generation DreamStation product family."

That seems to imply that <20% of recalled device registrations are in the System One and other device categories.  That doesn't seem accurate to me, but it could be because more-recent Philips xPAP devices purchasers have been the most active with registrations.  In addition to myself, I personally know many current (until recently anyway) System One device owners (individuals, sleep labs, etc.).  Perhaps they're just choosing to discard their device entirely, rather than registering for a fix/replacement.  That'll save Philips a huge number of fixes.  That way, in the U.S., Philips won't have anywhere near 2M devices to fix/replace.

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RE: >Above<

Thank you WakeUpTime

I really hate to say this, but I think Gideon is right. Something about this just doesn't feel like the final story.

This could be a first strike by Philips to push the FDA to approve whatever they wind up summiting for review.

Or the FDA did grant permission, but you would think that with all the light currently shining on this, they would want to put the news out first like they all said they would.

I think it may be more complicated than we think.

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Another news story just came out, so I guess I need to post it:

FIERCE BIOTECH

Philips gets the green light to begin repairing millions of recalled sleep apnea machines

by Conor Hale | Sep 1, 2021 11:48am

Philips is preparing to launch what it expects to be a year-long process of repairing and replacing the recalled components within millions of its sleep apnea and respiratory care devices sold internationally.

The company has now received a green light from the FDA to start replacing the sound abatement foam with a new material and plans to begin the work over the month of September. 

Philips gets green light to begin repairing millions of recalled sleep apnea machines | FierceBiotech

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NEWS STORIES
RECALL

We have now had three different reports that Philips has received the ok to start its repair, replace procedures.

Millions of people have been waiting for this. We have been posting about it for three months.

Something feels off. There have been no fireworks, no celebrations. We are still posting as if nothing has happened.

It took a few hours before it hit me. Philips can't do anything without FDA approval.

The big news so far is that neither the FDA nor Philips has issued a direct statement.

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Let's Go For Four

HME NEWS

PHILIPS BEGINS REMEDIATION

HME News Staff

Updated 1:36 PM CDT, Wed September 1, 2021


AMSTERDAM, the Netherlands – Royal Philips has received authorization from the U.S. Food and Drug Administration to begin replacing the sound abatement foam with new material in certain sleep and respiratory care devices starting this month. 

The company has also started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices, which aren’t affected by the recall.

Philips begins remediation | HME News

Note: All of these stories all read and sound the same. The same lead paragraph, but no real facts.

This whole day reminds me of this:

Abbott and Costello

 "Who's on First?"

Abbott: You throw the ball to first base.
Costello: Then who gets it?
Abbott: Naturally.
Costello: Naturally.
Abbott: Now you've got it.
Costello: I throw the ball too Naturally.
Abbott: You don't! You throw it to Who!
Costello: Naturally.
Abbott: Well, that's it—say it that way.
Costello: That's what I said.
Abbott: You did not.
Costello: I said I throw the ball too Naturally.
Abbott: You don't! You throw it to Who!
Costello: Naturally.

[WakeUpTime]

It's all over the news now.  You'd think we'll be getting fixes/replacements next week.  It's great that Philips can't blame the FDA anymore and the pressure is back on Philips, and no one else.  Here's some more Philips advertizing:

CPAP Recall: Philips to Start Replacing Millions of Devices
SLEEP REVIEW - Sep 1, 2021

Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. The company intends to complete the repair and replacement programs within approximately 12 months.

“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” says Frans van Houten, CEO of Royal Philips, in a release. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website.”

‘Bacteria Filters Should Not Be Used on CPAP/Bilevel Devices as a Means of Mitigating Risk of PE-PUR Foam’
SLEEP REVIEW - Sep 1, 2021

Philips states: “Philips does not recommend using bacteria filters outside of their normal intended use. Therefore, these bacteria filters should not be used on CPAP/BiLevel devices as a means of mitigating risk of PE-PUR foam chemical
emission or particulate matter for the following reasons:

• Bacteria filters do not provide protection from the chemical emissions resulting from manufacturing or continued foam degradation. Furthermore, possible gas emission of the degraded foam has not been fully characterized yet throughout the life of the CPAP/BiLevel device.
  
• In-line bacteria filters are not intended to be used under the current affected CPAP/BiLevel devices use cases.
  
• Federal law (USA) restricts bacterial filters for sale under the order of a physician.
  
• In-line bacteria filters are specified to be used where they can be monitored by a medical professional.
  
• Bacteria filters need to be replaced frequently as referenced in the bacteria filter manuals, or as deemed necessary upon inspection by a medical professional.
  
• Bacteria filters increase the resistance to airflow and will impact device performance of CPAP/BiLevel devices. Filters alter device performance by negatively impacting the maximum airflow, dynamic pressure and static pressure delivered by the CPAP/BiLevel devices. The extent of performance degradation will vary dependent upon prescribed therapy settings and air leakage which are different for each patient. Because of this, device performance may not meet the approved device’s specifications.
  
• When an inline bacteria filter is used with a CPAP/BiLevel device the pressure reported by the device may be different than the prescribed pressure as well as the pressure received by the patient.
  
• Certain circuits are unable to be used with bacteria filters due to an increased airway resistance that can affect device performance: 12mm circuit or heated humidifier circuit.
  
• Bacteria filters may alter algorithms that govern therapy on many CPAP/BiLevel devices. Different modes (AutoCPAP, ASV, AVAPS, AVAPS-AE, Flex) require airflow sensing and demonstrate varying degrees of performance impact. Individual patients may experience varying degrees of performance impact.
  
• Therapy device performance reporting in Care Orchestrator may be impacted. There may be an impact on event detection, and the prescribed pressure may not accurately reflect the pressure received by the patient.
  
• Use of humidification, common to CPAP/BiLevel devices, will negatively impact the bacterial filter performance.
  
• Fixed mode humidification cannot be used with bacteria filters as the humidification may increase condensation within the filter.
  
• In-line bacteria filters specifications vary by manufacturer and the filters should be with accordance with the manufacturer’s labeling.”
  

[WakeUpTime]

"CPAP Machine Recall"
ABC News Boston - Sept. 2, 2021

The company says it’s working on a “repair and replacement program.”  But John just got an email from Philips saying it will take about 12 months for his repair or replacement.  That leaves him and millions of others with a difficult decision. “Do you take the chance on using the machine? Or do you stop and live life like you used to, in a zombie state of not having great sleep?” John says.

John’s doctor is telling him to buy a new device that’s not part of the recall. But that could cost more than a thousand dollars and may not be covered by insurance.  “They are really left with no options,” Makenna Cox, an attorney with the law firm Girard Sharp says.  

Lawyers have filed more than a dozen lawsuits in federal court in Boston against Philips. The company’s North American headquarters is in Cambridge.  One suit wants the company to pay for ongoing medical monitoring and give patients a refund, or replacement with a non-defective device.  “We want them to be reimbursed for the trouble, the headache they’ve gone through, the anxiety that this is causing,” Makenna says.

For now, John is struggling.  He can’t find a new machine in stock.  And the one he’s using could be harming him.  “It’s a rock and a hard place,” John says.


(Canada) 

"St. John’s Lawyer Launches Class Action Against Philips Canada on CPAP Recall"
Canada - Sep 2, 2021

The impact on those affected by the recall is “profound and troublesome” says Buckingham, noting that the three lead plaintiffs have separately identified “individual and unique serious consequences and harms likely arising from the recalled respiratory devices.”


(Australia)

"Philips Respironics recall puts patients in a bind"
Australia - Sept. 2, 2021

• Clinical information for people with sleep apnoea and other conditions has been confusing and conflicting 
  
• Philips is focusing on repairs rather than refunds, but that process could take many months
  
• Patients now face a ‘horrible decision’, says one sleep researcher
  

The July recall of 14 sleep and respiratory care devices by Philips Electronics Australia has left patients uncertain about when their machines will be fixed and unclear about whether they should keep using them.  The product defect is a polyurethane foam component that can degrade into particles and be ingested or inhaled by the user. Whether or not it degrades, the foam emits potentially dangerous chemicals with no known tolerance levels.

"There have been no reports of deaths or long-term harmful effects, but because there's a chemical compound involved there's always a risk of toxic or carcinogenic effects longer term," Young says, stressing that there's no current data to support this concern.

We asked Philips if it was offering refunds, but a company spokesperson stressed that "our priority is to replace the foam with the new material in all the affected devices either by repairing or replacing with like devices" – although the spokesperson did add that "consumers' rights under the Australian Consumer Law will always be in addition to any remedy that Philips may provide".

One of the compounds, diethylene glycol (DEG), is used in a wide range of industrial products including antifreeze and brake fluid, and has been linked to fatal poisonings.  Another chemical compound in the foam, toluene diisocyanate, is classified as toxic by inhalation and potentially fatal if breathed in.

"Philips says no-one had died from this issue," he says. "Well that's very nice of them. But no-one knows about the cumulative effect of these volatiles [chemical compounds] going up my respiratory tract. The inline filters do not stop the volatiles."

Continued...  https://www.choice.com.au/health-and-bod...pap-recall

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HME NEWS

2 Articles

1st

PHILIPS RECALL: QUESTIONS CONTINUE MORE THAN TWO MONTHS LATER
‘I HAVE NO IDEA WHAT MACHINES WILL GET JUST THE FOAM AND WHICH WILL GET REPLACED’


Theresa Flaherty, Managing Editor

Updated 10:21 AM CDT, Fri September 3, 2021

YARMOUTH, Maine – Philips’ announcement last week that it will begin repairing and replacing CPAP devices affected by a recall was welcome news to providers, but they still have more questions than answers. 

The company announced on Sept. 1 that it had received authorization from the U.S. Food and Drug Administration to begin replacing the sound abatement foam with new material in certain sleep and respiratory care devices starting this month. 

“The question I have is, are they going to allow companies like myself to, in fact, put the screwdriver to the machine to do the repair or will patients have to send the machine (to be repaired),” said Woody O’Neal, vice president of O2 Neal Medical in Pelham, Ala. 

Philips also announced that it has started shipping DreamStation 2 CPAP devices to replace certain affected first-generation DreamStation CPAP devices in the U.S. 

“I talked to Philips this morning and they told me 1,500 (replacement) machines are being shipped out every day,” said Richard Spafford, president of USA Medical Supply in Springfield, Mass. “I have no idea what machines will get just the foam switched out and which will get replaced.” 

https://www.hmenews.com/article/philips-...nths-later


2nd 

STAKEHOLDERS: RECALL ALERT IS MISLEADING


WASHINGTON – Industry stakeholders are pushing back on a CMS alert that, they say, makes it seem like patients can get CPAP devices and ventilators affected by a recent Philips recall replaced or repaired right away. 

The alert states: “If you would like to replace or repair your equipment, the supplier you bought the equipment from is responsible for replacing or repairing rental equipment at no cost to you when the equipment is less than five years old. If the equipment is more than five years old, Medicare will help pay for a replacement.” 

https://www.hmenews.com/article/stakehol...misleading