NOTICE: Philips Discontinues Numerous Devices and Halts Dreamstation Sales in the U.S.

[Sleeprider]

In the SEC filing, Philips announced as follows (bold added for emphasis):

[b]Philips Respironics consent decree [/b]

• Philips agrees on the terms of a consent decree with the US Department of Justice (DOJ), representing the US Food and Drug Administration (FDA). The consent decree primarily focuses on Philips Respironics’ business operations in the US.
  
• The consent decree is being finalized and will be submitted to the relevant US court for approval. The decree will provide Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business
  
• In the US, Philips Respironics will continue to service sleep and respiratory care devices already with healthcare providers and patients, and supply accessories (including patient interfaces), consumables (including patient circuits), and replacement parts (including repair kits). Until the relevant requirements of the consent decree are met, Philips Respironics will not sell new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the US.
  
• Outside the US, Philips Respironics will continue to provide new sleep and respiratory care devices, accessories (including patient interfaces), consumables (including patient circuits), replacement parts (including repair kits) and services, subject to certain requirements.
  
• As a consequence of addressing this consent decree, which is a multi-year plan, Philips recorded a provision of EUR 363 million in Q4 2023 that relates to remediation activities, inventory write-downs and onerous contract provisions. In 2024, Philips expects around 100 basis points of costs that relate to remediation activities and disgorgement payments for Philips Respironics sales in the US.
  
• Further details will become available once the consent decree has been finalized and submitted to the relevant US court for approval.
  

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+MASS

DEVICE

Philips has a serious BrightView recall due to potential falling components

The FDA issued a Class I recall for the Philips BrightView SPECT imaging systems.

Under specific circumstances, the detector may move downward due to a potential component (lead screw) failure. According to a Philips spokesperson, this comes with a risk of contacting the patients.

The FDA described the issue by saying the “detector may unexpectedly fall due to a component failure.” According to the agency, if a detector is positioned below the center of the system gantry, there is the potential for abrasion, contusion, laceration, or fracture to the patient’s lower limbs and an interruption to normal system operation. If the detector is positioned above the center of the gantry, there still could be an interruption to normal system operation.

Philips has a Class I BrightView recall for potential falling detector (massdevice.com)

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STAT


The Philips CPAP nightmare exposes shortcomings in medical device regulation

America’s outdated approach to medical device oversight starts with limited testing before FDA authorization for the vast majority of marketed devices and ends with patchwork monitoring of patient safety. 

None of the 14 recalled devices underwent more than limited testing in humans before reaching the market. In the decade preceding the recall, Philips received thousands of reports of device malfunction but failed to disclose these complaints to the FDA and the public despite legal obligations to do so.

As clinicians and experts in medical device regulation, we sought to draw the medical community’s attention to the recall when it began and highlighted the need for the FDA to initiate rigorous real-world studies to assess patient harms associated with Philips’ devices and called for the agency to accelerate resolutions for patients. Nonetheless, progress remains lacking to date. 

The FDA might be America’s original consumer protection agency, but it’s operating with a handicap when it comes to medical device oversight. By law, the FDA is limited in the amount of information it can request from manufacturers to evaluate medical devices’ safety and effectiveness. And if safety issues occur, it is typically manufacturers, not the FDA, that are expected to police themselves by reporting problems and conducting recalls. The result is a system that all too often puts innovation and profits overregulation and patients. In the case of Philips Respironics, patients were left between a rock and a hard place — either stopping the use of a device that provided necessary respiratory support or continuing to expose themselves to potentially serious health risks.

The Philips CPAP disaster exposes public health shortcomings - STAT (statnews.com)

[Sleeprider]

Slightly off-topic, most of the Chinese PAP machines are being sold under an emergency use authorization from the FDA. Compared to Philips, those machines have not even been looked at. We are seeing some of the new EUA devices being sold as CPAP but also having bilevel and ST capabilities.

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Sleeprider

Some more facts concerning China and ResMed to ponder:

While the finished products sold outside of China are assembled or created outside of China, like the (US) it’s important to note that there are Chinese-made components used in ResMed products. These components contribute to the overall functionality and performance of the devices.

[WakeUpTime]

The Philips CPAP disaster exposes public health shortcomings - STAT (statnews.com)
The FDA might be America’s original consumer protection agency, but it’s operating with a handicap when it comes to medical device oversight. By law, the FDA is limited in the amount of information it can request from manufacturers to evaluate medical devices’ safety and effectiveness.

For the FDA, with just a few reports of a faulty food item, the entire inventory of that item can be quickly flagged and disposed of, including those already with consumers - and the production system completely shut down for analysis.  Those early particle reports from many years ago didn't seem to generate that urgency.  Those particles are potentially consumed into one's lungs so they shouldn't be treated lightly.

The second issue is nature of the particles.  It's bad enough that any particle (proven toxic or currently thought to be non-toxic) mistakenly enters one lungs, but there's the issue of the long-term effects of the consumption of those chemicals.  Now, when I hear a questionable component is "safe", I convert that to say:

...for what we know now, with the short historical use window,
the component hasn't been proven to quickly cause noticeable measurable harm,
under the very specific controlled conditions that we set, in the majority of selected healthy people.

That's not to say that something is actually "safe".  Here's a family of products that were labeled "medical prescription required", yet it didn't seem to get the same FDA attention that prescription medications get.  We pay much higher amounts to justify it, but we didn't get the return on investment.

We only recently got a "just stop everything".  The push for that perhaps should have come in the early days of the first reports of the particles breaking down.  We certainly get quick action when it comes to foreign substances appearing in our food.  There will be changes and updated policies at the FDA, but it shouldn't have taken so many years.

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ProPublica

FDA Repeatedly Rejected Safety Claims Made by Philips After the CPAP Recall but Waited to Alert the Public, Emails Show
As Philips reassured patients that millions of recalled machines were safe, internal emails show federal regulators privately told the company its testing didn’t account for the impact of long-term harm from tainted devices.

The new results, Philips said, found the machines were not expected to “result in long-term health consequences.”

But a series of emails obtained by ProPublica and the Pittsburgh Post-Gazette show the Food and Drug Administration quickly rejected those safety claims, telling Philips that the new tests failed to account for the impact on patients who had used the devices for years. The FDA also said it still considered the machines a significant health threat that could inflict severe injury or even death.

The FDA did not publicize its assessment, even though patients across the country were at risk and an untold number continued using their recalled machines while waiting for Philips to send replacements.

At the time, the FDA made only one public reference to the dispute — on the fourth page of a 14-page letter to Philips in May 2022. Customers would have had to find it on the agency’s website and then wade through scientific language about “cytotoxicity failure,” “novel continuous sampling” and other complex concepts.

In the emails to Philips, the FDA described a litany of concerns, notably that the company’s analysis did not consider the “real world” use of the devices, which send air directly into patients' noses, mouths, and lungs for hours at a time.

From the outset of the recall, there was little debate that Philips had a serious problem: Noise-reducing foam that the company had fitted inside the devices years earlier was crumbling.

Both Philips and the FDA at the time described potential health risks for patients exposed to the material, including respiratory tract illnesses, headaches, nausea, and toxic and carcinogenic effects.

FDA Repeatedly Rejected Safety Claims About Philips Breathing Machines, Emails Show — ProPublica

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Gerald E. McGinnis,

Bio-engineering pioneer, inventor, and entrepreneur, passed away peacefully in his sleep, after a long and courageous battle with Parkinson's Disease, on January 25, 2024, just a few months shy of his 90th birthday.

Attached is a video tribute by Nicko

Thank You Jerry (youtube.com)

[WakeUpTime]

We will see what games DME tries to play tomorrow.  May call my Representative and/or Senator's office.  

DMEs are profit centers.  Many of them continued to be very supportive of Philips throughout the Recall for many reasons: (1) They're already committed since they were the Philips faulty device reseller and (2) Philips was very generous in offering easy inventory replacements and (3) Many of those DMEs became the middleman in the faulty device swaps.  

As a result of the third events (device swaps), those DMEs quietly have closets filled with free DS1 and DS2 replacements that were either unable to be connected to original faulty device owners or were no longer wanted by original faulty device owners.

Those DME owners were expecting to be rewarded for their loyalty and previous brand investment, and they were expecting to sell their free inventory at a 100% profit margin.  Philips' recent (FDA-influenced) decision to halt device sales has tremendously affected that assumed future profit for those DMEs and worse, attached a very dark shadow of uncertainty over existing Philips replacement device users.  

Their ability to continue to attempt to sell those free, or existing-inventory, replacements is falling dramatically to near zero.  No doubt there will be an underground market to move all that free replacement DME inventory through to other markets outside of the U.S.; but that window may be quickly closing too, as it's highly likely that the UK, Canada, France, Australia, etc., as those country health agencies will push for the same no-sales status on all Philips devices too.  The underground market may then shift to other markets, but news travels fast thanks to the internet.

Philips was more effective at establishing and controlling CPAP DMEs than anyone else, through its (now proven) illegal marketing techniques (including the sharing of patient sleep center data) and very strong financial incentives.  It's going to be very difficult to recapture those Philips DMEs now for many reasons: (1) DMEs will be upset about their now-"dead" product inventory, (2) Philips has new marketing constraints, and (3) Philips has a tarnished brand reputation.

Regarding the many other Philips discontinued products, it will be interesting to follow that market.  For products that don't have equivalent competitor replacement options, the DME resale value may remain high as some rush to secure future inventory.  Although those products fill a need that may not have many other options at the moment, some may question the quality of the Philips brand label - but any medical solution is better than no medical solution, though the serviceability of those obsolete products will become difficult and very expensive.

Lastly, ResMed retail DMEs are pushing ResMed to protect their profit margins by pressuring high volume internet resellers to not disclose lower prices.  It'll be interesting to see if ResMed favors sales volume or profitability, now that their market share of new paying-customer system purchases will continue to be extremely high for a long time to come, at least in the U.S. market.  Hopefully ResMed will continue to provide very competitive pricing as a way of combating newer brands of unknown quality. No doubt ResMed will want to be very cautious now about appearing to dominate the marketplace through new policies, wanting to avoid the anti-competitive marketing violations seen with Philips.

[WakeUpTime]

Link to updated list of discontinued Philips respiratory products and end-of-service dates:

https://www.usa.philips.com/healthcare/e...lio-update

Last updated February 6, 2024