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

[btreger]

FDA

Frequently Asked Questions:


Q: I use one of the affected devices daily. I can’t wait for a new device. What can I do now?
A: The FDA has provided recommendations for people who use an affected device in its safety communication, Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks, including that you may continue to use your affected device if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
You may also read the FDA’s consumer update, Always Tired? You May Have Sleep Apnea, which includes updates on obstructive sleep apnea treatments.
Additionally, the FDA is engaging professional societies and patient advocacy groups to help connect sleep and dental professionals and patients with information regarding alternative treatment options for obstructive sleep apnea.

Q: When a medical device is recalled, what is the FDA’s role?
A: When the FDA learns of a company’s correction or removal action, it reviews the strategy the company proposes to address the problem, assesses the health hazard presented by the product, determines if the problem is in violation of the Federal Food, Drug, and Cosmetic Act or otherwise fails to comply with FDA requirements, and, if appropriate, assigns the recall a classification (I, II, or III) to indicate the relative degree of risk. After the recall is classified, the FDA monitors the recall to ensure that the recall strategy has been effective.
For the Philips Respironics recall, the FDA has identified this as a Class I recall, the most serious type of recall, and is continuing to work with the company to assure it has sufficient evidence to support the Philips Respironics recall strategy, including its corrective actions. The FDA will continue to monitor the company’s recall.

Q: Philips Respironics has stated they “will replace the current sound abatement foam with a new material and has already begun the preparations, which include obtaining the relevant regulatory clearances.” Is the FDA reviewing Philips Respironics' submission for clearance of the new foam?
A: As the medical device manufacturer, Philips Respironics has a responsibility not only to ensure the manufacture of safe and effective devices but also to establish an appropriate mitigation strategy to reduce public harm in the event of device failure or defect.
The FDA is reviewing the information Philips Respironics has provided regarding replacement devices while continuing to work with Philips Respironics on their corrective actions for existing devices. As the FDA reviews this information, the FDA will determine whether the proposed replacement devices pose any additional risk to people who use these devices.

Q: I understand the sound abatement foam may be causing the problems related to the recall. Should I try and remove the foam from my device?
A: No. The FDA recommends that you do not remove the sound abatement foam, as it may impact device performance and possibly introduce foam debris into the device.

Q: Who is responsible for correcting the issue with the affected Philips Respironics devices?
A: The recalling firm, Philips Respironics, is responsible for correcting the issue and developing a recall strategy that takes into account the following factors as they apply to this particular recall:

• Results of health hazard evaluation.
  
  
• Ease in identifying the product.
  
  
• Degree to which the product's deficiency is obvious to the consumer or user.
  
  
• Degree to which the product remains unused in the marketplace.
  
  
• Continued availability of essential products.
  

The FDA is reviewing the adequacy of Philips Respironics’ proposed recall strategy as it becomes available from Philips and is recommending changes as appropriate.

Q: What else can the FDA require Philips Respironics to do to correct the affected devices?
A: The FDA can use advisory actions, administrative actions, and enforcement actions when a firm’s voluntary action is not rapid or complete, or when the firm is uncooperative.

Q: Should I expect any notification from Philips Respironics?
A: The FDA recommends you register your device on Philips Respironics’ recall websiteExternal Link Disclaimer to stay informed of updates from Philips Respironics about any new instructions or other corrective actions required by the FDA.

Q: I have registered my recalled device on Philips’ website. What should I expect now?
A: The FDA is working with Philips Respironics to assure the company sufficiently evaluates the device problems, the scope of the recall, and the most appropriate mitigation strategies, including adequate corrective actions by the company. The FDA will continue to share updates with the public as new information becomes available.

Q: What should I do if I am unable to register my device on Philip’s website?
A: For more information or help with the registrationExternal Link Disclaimer process, please call Philips Respironics at 877-907-7508, as indicated on their website. The website provides you the instructions on how to locate your device Serial Number for the registration.

Q: Can I be reimbursed for the cost of a replacement device?
A: Please contact Philips RespironicsExternal Link Disclaimer as indicated on their website.

Q: If I obtain a new CPAP machine, what should I do with my recalled device?
A: Contact Philips RespironicsExternal Link Disclaimer or your health care provider for information on your local Philips Respironics representative to receive instructions and directions on how to return your recalled device(s). Do not discard or recycle the recalled device.




 

[WakeUpTime]

RE: <above>

The FDA's FAQ is an interesting way of giving answers without offering solutions - likely a result of Philips marketing-oriented responses.

"you may continue to use your affected device if your health care provider determines that the benefits outweigh the risks identified in the recall notification"

Our heath care providers know as much as we do, and no more.  There has been no extensive independent laboratory results on the release of the decomposing faulty cancer-causing foam under various conditions (pressures, humidities, temperatures, age of device, cleaning methods, etc.).  Philips has no desire to bring in extensive real life examples from customers to be analyzed.  Therefore, how can a health care provider truly advise a patient as to their 'real risk'.  They can't; they're merely making a best guess based on need and available negative health effects from Philips.  

Most device users truly need to use their xPAP machine, and Philips is providing very little real-life end-user impacts as it's counter to Philips own best interests.  Therefore, knowing that there is a risk of further digestion of toxic particles, health care providers would be negligent if they didn't first advise their patients to get a replacement system.  Some aren't doing that, such as the U.S. VA, and I believe that they are being negligent in an effort to save costs.

Q: Can I be reimbursed for the cost of a replacement device?
A: Please contact Philips Respironics External Link as indicated on their website.

<< Philips' Answer: "No."  Your new xPAP purchase is your own expense.  >>

Q: If I obtain a new CPAP machine, what should I do with my recalled device?
A: Contact Philips Respironics External Link or your health care provider for information on your local Philips Respironics representative to receive instructions and directions on how to return your recalled device(s). 

<< Philips' Answer: When you eventually receive your fixed/replaced system, you'll then have a second system. >>

[btreger]

RE >above<

I think there is a real fear among doctors to give advice concerning what to do or not do. Insurance issues and lawsuits would be a major concern of theirs. This is an issue they never had to deal with before and puts them in a tight spot.

I have a real example that just happened to me. I had a mild form of skin cancer diagnosed on my noise. My dermatologist gave me two options for removal. When I asked for her recommendation she said I had to make that decision on my own. After spending a few days going over all the pros and cons of both procedures, it was very clear which would be best for me. When I went in to have it done, I asked her if this was the one she would have recommended she looked at me and said yep.

[Zalagar]

My doctor told me to just keep using my CPAP for the meantime as I have to do a New Sleep Study and everything before I can get a new machine. He basically said you've already been using it for 5 years, what's another month? For me, it has been over 5 years, so I qualify for a new machine. The sleep lab just called me like 5 minutes ago, they are about a month out on scheduling. So my appointment isn't until the end of August. I ended up just deciding to remove the dumb foam. I personally removed the foam from my Dreamstation One machine without cutting or modifying anything and I think that's the best way to do it. I found a YouTube video showing how to remove the foam with a metal coat hanger and that's what I did. No cutting, gluing, modifying, no damage, or anything else. Removed the foam and then rinsed and soaked it multiple times to make sure it was thoroughly clean. The foam in my machine was pristine, no dust, no damage, no flaking, nothing, it came out looking brand new, but I have also never used any type of Ozone devices and have always sworn against them. I live in California, High Heat, but not very high humidity. I will say this, it's not super easy or fast, it took me about an hour to get the foam out and was frustrated at least once, but I got it all out. Been using my machine for almost 2 weeks now with no worries or issues. I can't provide a link here because I'm still new and don't have a total of 5 posts yet, but the video is called "No Cutting CPAP Foam removal" on YouTube. I have pictures of mine, but can't post those yet either.

[SuperSleeper]

Moderator Note:

If anyone wants to discuss the how-to part of de-foaming any Philips machine, please discuss that topic at one of these two threads:'



DreamStation Foam Removal:
http://www.apneaboard.com/forums/Thread-...val-Thread

System One Foam Removal:
http://www.apneaboard.com/forums/Thread-...System-One


We'd like to keep this thread focused upon the recall issues.

And yes, I realize that the topic of how to de-foam a machine is related to the recall.  But for our purposes here, it's a separate topic, so that this recall thread is not over-burdened with side-issues and rabbit trails.

[WakeUpTime]

"Wrestling With a Recall"
HomeCare News
July 30, 2021

Up to a year.  That’s how long it could take to repair and replace the entire inventory of Philips Respironics PAP devices and ventilators that the company recalled this summer, according to the American Association for Homecare.  And while patients might be able to switch to replacement models or even other brands if they’re concerned about using the affected devices, pre-existing supply chain issues had deliveries of new devices from multiple brands in the sleep and respiratory arena delayed well before Philips announced the recall June 14, limiting options for both replacement devices and new starts—and creating a perfect storm situation for the respiratory and sleep industry.

“We’ll be out of business well before that,” said Nick Blythe, director of operations for Southeast Idaho Sleep in Idaho Falls, Idaho. The independent home medical equipment (HME) provider specializes in CPAP and BiPAP machines and other sleep therapies—he says about 90% of their business comes from Respironics devices—and is trying to reassure distraught customers, including some who “are referring to their PAP machine as their cancer machine,” he said.

“We are working to address this issue as expeditiously as possible,” Mario Fante, Philips Global’s senior press officer, told HomeCare. “However, given the number of devices currently in use ... and that important elements of the repair and replacement program require regulatory clearances, we are not able to provide an immediate solution at this time.”

That led to the American Academy of Sleep Medicine (AASM) expressing concern that the recall would disrupt obstructive sleep apnea treatment and also lead patients to fail to meet the Centers for Medicare & Medicaid Services’ adherence requirements while waiting for machines to be fixed.  “(We) believe that it is both reasonable and necessary to allow (durable medical equipment) suppliers to repair or replace the recalled equipment without requiring documentation of a new clinical evaluation, sleep test or trial period, and do not think patients should be responsible for the repair or replacement costs,” said AASM in a letter.

Then, on June 30, the Food and Drug Administration (FDA) issued a safety communication that softened the initial recommendation to cease sleep apnea therapy, urging users instead to “talk to your health care provider to decide on a suitable treatment for your condition.”  The FDA also suggested talking to doctors about using an inline bacterial filter to try to block particles of foam—while also warning that it has no evidence that would be safe or effective in mitigating foam risks, and in fact, that it could possibly impact ventilator performance.  Either way, the FDA said, “you should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.”

Some HME providers who provide repair services, like Blythe, have said they have opened up clients’ machines to check the status of the foam and reassure them it has not degraded, or, in some cases, to pull out the foam altogether.  Fante [Philips] said that “units subject to the recall must be repaired or replaced by Philips service teams or Philips-authorized service partners.”

Fante indicated that Philips is still working out the details of the repair or replacement process, which depends in part on the FDA approving use of a new foam to replace the old one. Philips also announced it is increasing production of DreamStation 2 CPAPs, which aren’t affected by the recall.  “Philips is currently exploring the possibility of potential loaner devices for certain affected products, in accordance with local compliance or regulatory requirements,” Fante wrote in an email.

Meanwhile, AAHomecare wrote a letter to durable medical equipment Medicare administrative contractors (DME MACs) asking about the affects the recall will have on new Medicare patients, what to do if users refuse temporary replacement devices or warranties, and more.

They also said that the responsibility to replace recalled equipment depends on who originally paid for the device; if the patient owns the equipment and it wasn’t paid for by Medicare, HME providers are not obligated to repair or replace it—but if it was a Medicare-bought device, the original supplier is responsible.

One other concern providers had is whether they might be vulnerable to lawsuits from patients on the unlikely chance they do become ill. Philips has already been hit with multiple class action lawsuits in the United States—including one filed by a professional truck driver claiming the recall interrupted his work—and Canada.

[*POSTER'S NOTE:  Philips is continuing to produce significant quantities of DreamStation 2s that are unaffected by the recall.  Philips seems to be storing that inventory at the moment to be used in the future as possible DreamStation 1 replacements (or "loaner units"), but they're waiting until the official recall process begins, which is likely September once FDA approvals are received at the end of August.]

[btreger]

RE >above<

Philips is continuing to produce significant quantities of DreamStation 2s that are unaffected by the recall.  Philips seems to be storing that inventory at the moment to be used in the future as possible DreamStation 1

Philips has gone for 12 years manufacturing a product line containing medically dangerous materials. How can anyone trust that the foam in the DreamStation 2 is safe, just because Philips says so, and everyone just repeats their statements?

We need the FDA to actually do their own testing and report those findings. They should also test the hosses and the nasal pillows to see what they are made of.

Now is the time to do this, not 12 years from now after more problems are found.

[btreger]

This is pretty scary:

On March 25, 2020, "The FDA Recommends CPAP As A Considered Alternative Combatant For Coronavirus Due To Ventilator Shortage"

COVID-19, also known informally as Coronavirus, is taking the world by storm and hitting the United States hard with over 9,000,000 cases as of November 2nd, 2020, according to Johns Hopkins Coronavirus Resource Center.

The virus is inflicting tremendous strain on U.S. hospitals and the healthcare system at large resulting in a shortage of medical supplies including ventilators.

A ventilator is a medical device that helps patients who cannot properly breathe on their own by pumping air into their lungs and is literally a lifesaver when it comes to combating COVID-19.  

Unfortunately, the U.S. is in short supply of ventilators with a total estimated supply of approximately 170,000 according to Johns Hopkins researchers.  

To put it in perspective, New York City alone is estimating a need of 35,000 ventilators to treat its Coronavirus stricken patients and currently only has around 3,500, a tenth of what is estimated will be needed.  

As a result of this shortage, the U.S. Food & Drug Administration (FDA) recommends “that health care providers and facilities consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring such ventilatory support” including Continuous Positive Airway Pressure (CPAP), auto-CPAP (APAP), and bilevel positive airway pressure (BiPAP or BiLevel) machines that are typically used for the treatment of sleep apnea.

The two largest PAP manufacturers are ResMed and Philips Respironics. 

[Mustang 85]

I am not sure what is so scary.  This is ancient news from over a year ago. With increased production by Ventec (Vocsn ventilator), Ford Motor, and other producers there really is no shortage of ventilators now in the US. We have even sent ventilators to India to help with their crisis in cases.  Most hospitals never had to resort to using home PAP machines, if any did at all.  In the hospital I work at in a small rural community there are plenty of ventilators sitting on standby.

[btreger]

RE >above<

Exactly one year and one month before Philips issued their warning concerning the potential health concerns for the DreamStation, the FDA was recommending it in place of hard-to-get ventilators. Then roughly a month later came the official recall. 

Do you think any Hospital or ICU doctor would voluntarily come forward today and admit they had used or of these now recalled products?

Lawers now have not only us users to work with, but potentially major hospital chains, doctors, Philips, and maybe even the FDA to go after. And if they can prove some of the recalled products were used that way, they can add those families to their class-action lawsuits. 

This could be the reason the US medical community has been reluctant to make any formal comments concerning the recall,