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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"Who cares, this is the real information provided by the FDA:"

You missed the point entirely. I hope not willingly.

The point is that Canadian authorities are not on the same page as PR and US authorities regarding the seriousness of the same recall - OUR recall.

Not the ventilator recall, which I agree is not relevant to us.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-04-2021, 11:17 AM)SingingSam Wrote: The point is that Canadian authorities are not on the same page as PR and US authorities regarding the seriousness of the same recall - OUR recall.

This is a "Position Statement from the Canadian Thoracic Society, Canadian Sleep Society, and the Canadian Society of Respiratory Therapists Philips Respironics Device Recall"

As far as I can tell this document replicates the same set of facts that have been discussed in numerous other documents. There is nothing new, or any disagreements with other reported agencies.

Position Statement from the Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists Philips Respironics Device Recall - Canadian Sleep Society (CSS) (css-scs.ca)
 
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-04-2021, 11:17 AM)SingingSam Wrote: The point is that Canadian authorities are not on the same page as PR and US authorities regarding the seriousness ...

As I re-read that Canadian document, I'm trying to find significant differences from what's being advised in the U.S.  Could you please point the significant differences.

They do allow an exception for "mild to moderate" patients, but even then they say that they should be closely monitored by a doctor:

Quote:For patients with mild to moderate OSA without substantial comorbidities and symptoms, interruption of therapy until the repaired/replacement machine is available may be reasonable. Patients in whom therapy is interrupted or discontinued should be followed closely for possible adverse effects. 

We should remember that this started out as only a U.S. recall, but rapidly expanded globally.  Other countries recognize that they're rather stuck in a difficult situation which they're all taking a practical approach to.  Continuing or stopping therapy still requires a doctor's approval.  I like the non-government Canadian document as a discussion paper, but I think we're giving it too much of a spotlight now.  The groups that put out the paper haven't stated that they know anything more that leads them to any different conclusions.  ApneaBoard has given them more reads than they likely would have received otherwise.

There likely will be Canadian Philips Recalled Device Users who continue to use their defective devices for more than a year without having their faulty foam replaced - with or without the approval of a doctor.  Their Canadian Philips class action lawsuit may begin to see results before then.

The Canadian Respiratory Therapists likely cannot handle 500,000 urgent visits and 500,000 replacement device orders - along with the complexities of medical insurance and setup/training those new machines.  (I actually don't know the exact number, but found one article that says: "5.4 million adults in Canada were diagnosed with sleep apnea".)  They may not all qualify for prepaid replacement devices there.  The industry, globally, seems to be in chaos at the moment.  The easiest solution for many will be to continue doing what they've been doing, without alteration.

Philips is right in that no one has immediately become sick or died as a result of ingesting its faulty foam.  Regrettably, some groups are interpreting that to mean that there are no health consequences to continuing to use the defective devices. 

I've never known anyone who has died from smoking cigarettes within a year or two of starting.  But groups should not consider that to mean that smoking is "safe".  Cigarette manufacturers might be able to state that there are no reports of anyone dying immediately after smoking a cigarette.  Philips is using the same strategy, so again it will be up to investigative lawyers to prove that prolonged use of their faulty-foam devices has negatively impacted the health of some/many users - especially those using internal ozone cleaning products.  Others may never get a corresponding illness, but they've still likely ingested some (possibly minute) quantities of disintegrating foam particles made with cancer-causing chemical components.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
AASM

Sleep medicine in America: 

Millions of people in the U.S. are struggling to sleep well at night and stay awake during the day. Our nation’s sleep problem is so widespread that the CDC has called insufficient sleep “a public health epidemic.”

The need for high-quality sleep care has never been greater. The good news is that sleep medicine expertise is available all across America.


About 7,500 doctors in the U.S. are board-certified in sleep medicine. There also are more than 2,500 sleep centers that are accredited by the American Academy of Sleep Medicine.


I have e-mailed the AASM and asked if they keep records on the specific CPAP machines used in their accredited sleep centers. 
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"As far as I can tell this document replicates the same set of facts that have been discussed in numerous other documents. There is nothing new, or any disagreements with other reported agencies."

"As I re-read that Canadian document, I'm trying to find significant differences from what's being advised in the U.S. Could you please point the significant differences."

It helps to read what they wrote.

PR's Recall letter (note the last sentence):
"Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s the air  pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam  may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during initial operation and may possibly continue throughout the device’s useful life. These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment." (emphasis mine)

PR's Supplemental Clinical Information for Physicians:
"According to analysis performed by Philips, the majority of particulates are of a size (>8 µm) that are unlikely to penetrate into the deep lung tissue. Smaller particulates (<1-3 µm) are capable of diffusing into deep lung tissue and deposit into the alveoli. During testing performed by an outside laboratory on lab degraded foam, the smallest particulate size identified was 2.69 µm."
"Based on the available information to date on estimated particulate size range, the bacteria filter is expected to effectively filter out some foam particulate that could make its way up the patient circuit." (emphasis mine. "Some" does not mean "all". The smallest are the most dangerous and the least likely to be stopped by an AB filter. Just to be clear, PR suggests AB filters in the context of recalled ventilators, not for recalled xPAP devices.)

FDA's FAQ About the Recall:
"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." (emphasis mine)

Position Statment of several Canadian Medical Societies:
"On June 23, 2021 Health Canada posted a medical device recall for the same products.  The hazard classification is type II, defined as a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote." (emphasis mine)

Health Canada's type II recall classification is not aligned with either the FDA's Class I recall or the clear language of the PR recall and subsequent PR communication to physicians and DMEs.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The initial paragraph from PR's recall letter used "may" and "can" to qualify all of its statements. Drug companies do this too in their advisories to FDA approved drugs: "statins may cause muscle weakness in some patients" etc. "Benadryl may cause drowsiness". etc. They also will write of "serious possibly life threatening allergic reactions" to drugs which, again, have been FDA approved. If you were to highlight SERIOUS LIFE THREATENING REACTIONS to a huge number of drugs that are approved and in wide use, you could scare a lot of people for whom these drugs pose no risks.

I understand that you're highlighting this to underscore the difference with the Canadian statement, which claims that the "probability of serious health consequences is remote". You're asking why is there this difference in statements between PR and the Canucks.

If you take my example about how commonly safe drugs will carry a list of warnings that sound dire, but have been deemed remote enough to justify approval, the discrepancy may be explained. There is a remote risk that one may have an allergic reaction to peanuts. That reaction can be serious and life threatening. Whether or not you call peanuts safe depends on which aspect you want to emphasize, doesn't it?

part of the confusion is that it's unclear if PR is issuing a medical alert or a legal disclaimer, as those that are buried in the fine print of almost all drugs.

We shouldn't tell people that they're going to die because they've been eating peanuts. The situation is more nuanced.
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NEWS REPORTS OF UPSET PHILIPS PAP USERS
"After recall, CPAP users still waiting on machines"
NBC News WI - August 2, 2021

For some CPAP users that means a decision between a better night’s sleep or the fear of ingesting potentially dangerous foam.  In her 20 years working with sleep disorders, this is the first recall she’s ever seen.  It’s impacting many people like Benson.  Since his machine’s been recalled, he hasn’t been using it.  His daughter has been working to find a solution for him, but said she is getting nowhere.

“I called the company we got his from, and they directed me to Philips, the brand name, so I called them and they had no answers,” said Dana Benson, Lyman’s daughter.  She said it’s been months, and they still don’t know when a new machine will be on its way.  If they want to buy a new machine right now, Dana said they’d have to pay $800 to $900 out of pocket.  “They got us a new one, but we have to pay for it 100%,” Dana said. “The insurance won’t cover it because Respironics Philips should be sending us a new one.”


"CPAP recall leaves truck drivers with sleep apnea between a rock and a hard place"
Overdrive - August 3, 2021

In the wake of the recall, an Oregon-based truck driver has filed a class action lawsuit due to not being able to work while not being treated for sleep apnea.

The U.S. Food & Drug Administration has classified the recall at its most serious, Class I level given potential injury risk. FDA flags a long list of potential ill effects of  “black debris from the foam or certain chemicals released into the device’s air pathway" and inhaled or swallowed, from irritation to "inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (such as kidneys and liver) and toxic carcinogenic effects.”

This presents a critical decision for truckers with sleep apnea using affected Philips devices and their treating physicians. Such haulers can stop using the device and wait for the recall to play out to have the device repaired or replaced, or try to purchase a new device. Alternatively, they might continue using an affected device and take a chance with the potential health risks that prompted the recall.

The degradation of the foam is exacerbated by the use of unapproved cleaning methods, such as ozone, according to Philips, as well as environments subject to high heat and humidity like those of parked, un-air-conditioned vehicles.

Gerry Shelton, a truck driver based in Boring, Oregon, filed a class action lawsuit on June 29 against Philips seeking a refund, replacement with a non-defective device, costs for ongoing medical monitoring, and all other appropriate damages for all the injuries he has suffered as a result of his defective device.

The lawsuit alleges that Philips knew about the risks associated with the foam in its devices well before the recall was issued. It also claims that “Philips timed its recall of the recalled breathing machines to coincide with the launch of its next generation of products, which purportedly do not suffer from the same PE-PUR foam issues. Thus, the only safe option that Philips offers to its customers – many of whom need and rely on the recalled breathing machines – is to purchase Philips’s newer model, thus profiting Philips further.”

ResMed also said its devices use a different material for sound abatement that doesn’t break down.


"Knoxville woman can’t afford new CPAP machine after FDA issued recall on current machine"
ABC News TN - August 3, 2021

The device that Karen Sparkes uses was paid by for Medicare. She’s been told not to use the machine but has also been told she is not eligible for another one unless she pays for it out of her own pocket. She’s also on a fixed income.

“He said it’s a defective machine,” Sparkes said. “You need to have a machine where you are breathing right and it’s working right. And he said, ‘we’ll get this filter, we’ll test for that.'”  But according to Karen, that filter doesn’t help. She says it makes the machine heat up.

“I’ve only had the machine for two years, since June of 2019,” Sparkes said. “Then there is a rule in Medicare that says you have to have a machine for five years in order to get it replaced. But this is a defective machine. That means I’d have to wait another three years or pay 3,000 dollars to get a new machine.”

Medicare says if a device is less than five years old, like Karen’s, the supplier is required by federal regulations to accept, return and replace it at no charge to the beneficiary.  The Medicare spokesperson also said that as a result of the number of patients and devices affected by the recall, there may be a delay in getting a new device.


...And, for our Canadian followers:

"Northern Respiratory Centre fielding 125 calls a day regarding CPAP recall"
CBC News - July 30, 2021

"Our location alone has a list of 4,000 people," he said, adding that the centre is averaging about 125 calls a day regarding the recall.  "It's taking up a huge amount of our time," he said.

"If somebody has not had a current prescription, so anything that's inside of a year, they have to get a new prescription and it takes time to see the doctors and get that all done."  McKay says the big problem is that some of these other options are on backorder "because the whole world is scrambling to do the same thing."

Philips has said anyone with an affected unit should discontinue using it immediately and register the device on the company website. It will then be replaced eventually.  "Most people need to continue using these machines. The sleep apnea is going to be back immediately if they don't use them," said McKay.  McKay says many physicians around the North Bay area are recommending that users of these devices speak with their doctor or specialist to decide what to do based on their individual circumstance. 

"The tough part is: people need these things, but are very concerned about the bad side effects of this foam," McKay said.  "There really aren't a lot of options for people right now
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(08-04-2021, 06:51 PM)hegel Wrote: The initial paragraph from PR's recall letter used "may" and "can" to qualify all of its statements. Drug companies do this too in their advisories to FDA approved drugs…

…part of the confusion is that it's unclear if PR is issuing a medical alert or a legal disclaimer, as those that are buried in the fine print of almost all drugs.

There are real differences between a warning label on a drug and Philips’ recall language. The warning label is to be read and considered by a patient MAKING A CHOICE that has not yet been made.  The Philips recall letter is entirely different—information that was never given to the patient and that is now TOO LATE to be helpful; it is a statement of what harm has been done and it expresses the degree to which the patient was misinformed from the start of treatment.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
In post 994 AASM I stated the following:

I have e-mailed the AASM and asked if they keep records on the specific CPAP machines used in their accredited sleep centers. 

This is their response:

Thank you for contacting the American Academy of Sleep Medicine with your question.

The AASM Accreditation Department does not collect data from sleep programs on the manufacturer of the CPAP device they are utilizing (i.e. Philips, ResMed, etc.). Unfortunately, I am unable to assist further.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Some facts about Philips:

Only for those interested

"We are a diverse team made up of some 80,000 individuals across over 100 countries, all with different backgrounds, perspectives, and experiences"

A list of Subsidiaries:

List of Subsidiaries. (sec.gov)
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