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

[WakeUpTime]

It's truly amazing that a company feels that it's adequately addressing issues related to its faulty carcenogenic medical device, required by dependent patients, more than one year later, by continuing to remind them they're still working on resolving the issue for most.  And this is commonly tolerated and accepted.

I'm trying to imagine some hypothetical equivalents:
- We understand that it’s been a year since we realized our insulin solutions were determined to be potentially cancer-causing, and that you still require them, but we’re working on it.
- We understand that your pace-maker is faulty and could malfunction at any time, but we haven’t forgotten about you even though we've known about the issue for well over one year.
- etc.

PHILIPS

In this month’s update, we’re sharing the latest device allocation update, as well as a reminder about the features of our Patient Portal.  
Our progress
To date globally*, Philips Respironics has produced 2.4 million repair kits and replacement devices. We aim to complete our repair and replacement program by the end of 2022 for most registered patients.

Common questions around the Patient Portal
We wanted to remind you about our Patient Portal, how it should be used, and how you can access it.
Here are some frequently asked questions:

Q. What is the Patient Portal?
A. We created the Patient Portal to allow you to check the status of your order until you receive your replacement device. The content is tailored around you and the information you have given us. You can find the Patient Portal here.

Q. What can I use the Patient Portal for?
A. You can use the Patient Portal to check on the status of your device and to check if you are matched with your DME. You can also input your patient prioritization information which ensures that we have the information we need to get your replacement device to you as soon as possible. Please note that you cannot change or update information once it has been inputted.

[tjb1013]

It's truly amazing that a company feels that it's adequately addressing issues related to its faulty carcenogenic medical device, required by dependent patients, more than one year later, by continuing to remind them they're still working on resolving the issue for most.  And this is commonly tolerated and accepted

I suspect the company is just impotently responding to FDA (and other agencies') pressure about its lack of communication.

For example:

https://www.fda.gov/news-events/press-an...assistance

They are struggling to respond, but they must believe they can assuage the regulators with logorrheic versions of "Update: Nothing New".

[btreger]

yahoo/finance


Philips says tests on recalled ventilators are' very encouraging'

AMSTERDAM (Reuters) -Independent tests on ventilators that Dutch health technology company Philips recalled last year because of possible health risks showed the problems were almost exclusively caused by unauthorized cleaning products, the company said on Tuesday.

"Inspection of over 60,000 machines in the U.S. has shown foam degradation in less than 0.5% of the users of the machines said had not been cleaned with ozone," Van Houten told Reuters in a telephone interview.

"With the use of ozone products, this goes up to 7% or 14 times higher. The correlation between the use of ozone and foam degradation that we assumed last year has been proven."

Philips says tests on recalled ventilators 'very encouraging' (yahoo.com)

[WakeUpTime]

It's a newsworthy day indeed, with Philips providing their carefully scripted global statement to their latest "independent" lab results.  It goes without saying that this may be Philips' most important press release since June 14, 2021.  This release is just now making its way throughout the world press and it may take several days for independent critical analyses to be published.  At the moment, the press is merely re-publishing Philips' official press release, along with details on the history of the Recall.  

"Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program"
PHILIPS GLOBAL OPERATIONS - June 28, 2022
https://www.philips.com/a-w/about/news/a...ogram.html
 
Steve Klink | Philips Global Press Office | Tel: +31 6 10888824 | steve.klink@philips.com
Ben Zwirs | Philips Global Press Office | Tel: +31 6 1521 3446 | ben.zwirs@philips.com

< includes video presentations > 

Not surprisingly, Philips has carefully selected which devices that would go through more extensive testing.  If I'm not mistaken, the "independent" testing was conducted on select Dreamstation models that Philips (it's assumed) had received back from customers early in the Recall.  

60,847 devices were supposingly studied, although the Recall covers millions of devices.  Independent investigations need to take place to see what the sampling categories included.  At the beginning of the Recall, no BiPAP, ASV or other Philips xPAP systems were being returned.  These were likely more recent purchases that may not have had extensive uses.  Device usage histories should have been recorded as a device used for 6 months would show different results than a device used for 5 years - with or without ozone cleaning.  

Since Philips was completely in control of the order of Recalled device return schedule, Philips was allowed to extensively limit the sample set by the "independent" laboratory study.  For all we know, Philips could have included the existing inventory of existing new, samples, or lightly used inventory returns from DMEs in the initial batch of returned and later-analyzed devices.  Those machines would produce significantly different lab results from devices used in sleep labs for years that required daily cleaning.  Which devices were "invited" early on by Philips to be returned?  Those devices, whichever and wherever they came from, were studied at the "independent" lab.

This indeed was not a random pull from all DreamStation models, other Philips xPAP Recalled devices, usage categories (individuals/labs/hospitals), etc.  A 5-year-old DreamStation ASV may show much different results from their 6-month-old DreamStation CPAPs/APAPs that were selected.  An extensively used 8-year-old System One ASV from Florida, or an active sleep lab, would also show significantly different results.  High humidity regions (Florida, Hawaii, etc.) would also produce different results.  

Regrettably, Philips did not allow those devices to be returned in the early part of the Recall.  The mainstream press won’t be aware of that.  They’ll simply report on Philips’ findings as reported by the “independent” lab results.  The FDA, or the lawyers in the class-action lawsuits, would do a more representational selection of random sampling from commonly used devices.

If one manipulates the sample data set, one effectively manipulates the results.  This was not a random analysis taken from randomly selected devices pulled into the lab directly from the field.  These were devices that Philips has selected in the first phase of the Recall.  Those who received early invitations were a very select group.  Indeed, there were many that refused to return their extensively used devices - choosing to keep their Recalled device as a backup or future evidence.  

Did Philips selectively "invite" only more recent carefully selected purchasers (those early in their warranty period), perhaps only DreamStation CPAP model owners, of a certain type, from only select regions in the first part of the product returns?  It's unlikely that hospitals and sleep labs that used older devices, that were cleaned daily, were initially or ever returned to be studied.  Those devices would unlikely have any foam particles remaining.  

That careful decisive strategic planning by Philips executives early in the Recall, that would selectively limit the selection of devices for "independent" lab study, may have saved Philips a significant amount of money down the road - if it goes unnoticed without oversight.  The question is, will the FDA, other agencies, and courtrooms, accept the conditions surrounding the results as "good enough" in order to move on?

[btreger]

RE>Above<

Philips provides an update on Philips Respironics’ PE-PUR sound abatement foam test and research program

Other devices under the recall notification/field safety notice

Other devices that are being tested include DreamStation Go (1% of the registered devices) and SystemOne (26% of the registered devices). These devices each have a different air path design/configuration compared to the first-generation DreamStation devices but contain the same PE-PUR foam.

New DreamStation Go and SystemOne devices passed VOC and PM testing based on standards available prior to ISO 18562 i.e., Indoor Air Quality Evaluation (as previously disclosed on April 25, 2022, update). Further ISO 18562 VOC and PM testing is ongoing. The results of ISO 10993 biocompatibility testing of degraded PE-PUR foam for the first-generation DreamStation devices, which is ongoing, will also apply to DreamStation Go and SystemOne devices.

Per the FDA, Philips does not even have the FDA approval completed for the remediation process for the DreamStation Go.

I verified this with Dr. Jeff Shuren and this is accurate. This means no Go machines were ever returned to Philips. If no machines were returned what the hell were they testing?

If they lie about this, how can we accept anything they just released. 

[WakeUpTime]

This means no Go machines were ever returned to Philips. If no machines were returned what the hell were they testing?  

So very true.  As expected, these flawlessly prepared Philips responses appear to resolve all concerns when their simulated testing dataset is so far removed from realistic typical patient usage.  Hopefully those in any legal case will have saved their Recalled devices.  For an accurate testing, I'd want to see results for each series, model-type, ranges of usage hours (after 1 avg year, 3 avg years, 5 avg years), etc.  They'd also have to check humid vs. non-humid regions, ozone vs. non-ozone cleaned, etc.  It should be an extensive testing matrix with results that are extremely important.  

Just going with samples of whichever Philips device categories that are being serviced (or returned) at any particular time, isn't going to do it.  The media, health agencies, and lawyers need to become aware of the flaws in the Philips device-selected testing.  Philips strict control of the process is allowing it to steer towards more favorable results.  I can understand Philips approach though.  Perhaps several hundred million in lawsuits and stock losses are riding on every action that Philips takes in response to the Recall.  There are no penalties for its attempts to more positively shape the results.  It's not as though they're doing the testing, so they can't be accused of wrong doing.  They're merely shaping the funnel of machines that are being tested.  

To use an anaolgy, it is vitally important to protect a crime scene before analyzing clues and making conclusions.  Otherwise, the data can't be of high integrity.  In this situation, Philips has been allowed to be in control of the evidence.  Philips alone determined which device series, model category, age of machine and therefore likely usage, geographic region, etc., that would be initially processed for the Recall.  No one forced them to not exercise that power so they did everything in their own 'best interests'.

[pholynyk]

I notice that it said 1% of registered devices, not 1% of returned devices.

If the Go sales are 1% of total sales, it's going to be a pretty low priority. I would guess.

[btreger]

More info that sticks out in the Philips news release:

Silicone foam testing:

"In November 2021, the FDA requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by silicone-based foam. Philips Respironics engaged independent testing laboratories to perform additional VOC testing. Based on the draft reports, Philips Respironics has not identified any safety issues. The assessment is being completed, and the final reports are subject to FDA review, which is expected in the coming months".

Note: Nine months later we are right back where this started, nowhere. They keep referring to VOC testing, but nothing has been added concerning the new silicone-based foam. 

"Philips Respironics remains fully committed to addressing all devices affected by the recall notification/field safety notice* and continues to work with the relevant competent authorities to further optimize the remediation plan. To date, approximately 2.7 million replacement devices and repair kits have been produced".

They do not mention who they think are relevant competent authorities. My guess is only ones that they have vetted and will provide Philips only the results they want to see. 

[btreger]

FIERCE Biotech


Philips attributes foam breakdowns in recalled CPAP ventilators to ozone-based cleaners

While the company seemed to place much of the blame for the recall on ozone cleaners in its report, the FDA has made a specific point of discounting that idea. In a letter (PDF) sent to Philips at the beginning of May, the regulator said, “although the use of ozone cleaners by device users may have exacerbated degradation of the PE-PUR foam, evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”

Instead, both the FDA and Philips itself have previously concluded that the foam’s degradation can actually be primarily attributed to “long-term exposure to environmental conditions of high temperature combined with high humidity,” according to the letter.


'This is not a good situation': Philips engineer flagged ventilator foam issues years before recall, court docs show
Documents unsealed earlier this month in a class-action lawsuit against Philips confirmed that the device-maker knew about those potential effects on the foam several years before beginning to formally investigate the issue in early 2021.

In a statement sent to Fierce Medtech regarding Philips’ latest report, the lead attorneys for the plaintiffs in the class-action case said, “Philips knew as far back as 2015 that the foam is used in the recalled devices would degrade, creating an unreasonable health hazard to patients, but waited until June 2021 to issue a recall.”

They continued, “Philips’ actions have forced millions of sleep apnea patients to choose between using an unsafe product or going without needed treatment. Rather than taking ownership of its mistakes, the company continues to deflect blame and attempt to cover up the full extent of the risks to users. We look forward to holding Philips fully accountable for its misconduct.”

Philips attributes foam breakdowns in recalled CPAP ventilators to ozone-based cleaners (fiercebiotech.com)


FDA U.S. FOOD & DRUG

ADMINISTRATION

1. The recalled devices contain a PE-PUR foam that may degrade and/or emit harmful 
chemicals, potentially resulting in toxic and carcinogenic effects and other significant 
harms to device users, and therefore present an unreasonable risk of substantial harm 
to the public health.

2. There are reasonable grounds to believe that the devices were not properly 
manufactured with reference to the state of the art as it existed at the time of their 
manufacture.

3. Although the use of ozone to clean the recalled devices might exacerbate degradation 
of the PE-PUR foam, the unreasonable risk associated with the products was not 
caused by the use of ozone cleaning agents, nor did the use of ozone to clean the 
products constitute a failure to exercise due care.

4. Patients and providers cannot readily mitigate the unreasonable risk associated with 
the recalled devices, therefore repairing, replacing and/or issuing a refund for the 
affected devices is necessary.

Philips 518(b) Notice of Opportunity for Hearing - May 2, 2022 (fda.gov)

[WakeUpTime]

[FDA] “although the use of ozone cleaners by device users may have exacerbated degradation of the PE-PUR foam, evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”... the foam’s degradation can actually be primarily attributed to “long-term exposure to environmental conditions of high temperature combined with high humidity”.

[Attorneys] “Philips knew as far back as 2015 that the foam is used in the recalled devices would degrade, creating an unreasonable health hazard to patients, but waited until June 2021 to issue a recall.”  “Philips’ actions have forced millions of sleep apnea patients to choose between using an unsafe product or going without needed treatment. Rather than taking ownership of its mistakes, the company continues to deflect blame and attempt to cover up the full extent of the risks to users.

One year later, in a thread with more than 200,000 views, we have a concise accurate summary of what brought millions of patients to a worldwide medical recall.  Compensation will need to be made to all device users amongst 4 categories:

(1) The Philips faulty devices contributed to a premature death
(2) The Philips faulty devices caused or contributed to ongoing illnesses
(3) The Philips faulty devices added to increase risks for future illnesses
(4) The Philips faulty devices caused an undue increase in medical expenses for users purchasing replacement products

It's my hope that the class-actions don't ignore the last two categories.