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

[WakeUpTime]

And so it begins...

Philips Respironics Discontinues Sales of Sleep Apnea Devices Under Terms of Consent Decree With FDA

Philips Respironics will halt sales of new sleep apnea machines in the U.S. in a settlement with the Food and Drug Administration (FDA) over safety hazards with the devices, the company announced Monday in a filing with the Securities and Exchange Commission.

SEC Filing
AARP Article Philips to Stop Selling Sleep Apnea Devices
Reuters: Philips US Sales of Sleep Apnea Devices Halted
Amid Recall Crisis, Philips Agrees To Stop Selling Troubled Sleep Apnea Machines in the United States

"Philips Axes Sleep and Respiratory Lines"
BREAKING NEWS  |  Jan 25, 2024
Sleep Review Magazine
https://sleepreviewmag.com/sleep-treatme...ory-lines/

Amid ongoing scrutiny and regulatory challenges since its June 2021 recall of certain CPAPs, BiPAPs, and ventilators, Philips Respironics is discontinuing the sale of sleep diagnostic and certain respiratory care products, including the Alice NightOne home sleep test and DreamStation Go CPAP, in the United States and US territories.

According to a portfolio update on its website,

“Philips Respironics will focus on the sale of consumables and accessories, including masks, and
will not return to the sale of hospital ventilation products, certain home ventilation products,
portable and stationary oxygen concentrators and sleep diagnostic products.”

“We have streamlined our portfolio to enable us to focus on programs that are best suited to changing market dynamics and will most effectively serve patients and customers in the future. We will be here to support customers and patients through the end of service for these products as well as products that will continue to be actively sold. Customers will be contacted directly regarding any order cancellations resulting from our portfolio changes.”

According to the notice, changes to Philips’ commercial portfolio will not affect the company’s “commitment to the remediation of devices impacted by the June 2021 recall of certain CPAP, BiPAP and mechanical ventilator devices.”

[Jay51]

Much appreciated post WakeUpTime.  I have been using the Evo ventilator pretty much every night now for about 15 months.  I have gotten used to it.  Will all the things going on with Philips, I have wondered about the future with my Evo ventilator.  I appreciate the timeline you posted.  It gives me time to start planning for the future of my own personal apnea/hypoventilation treatment.  I have looked at several other machines with algorithms close to the AVAPS Evo.  I plan on trying to use an Evo for as long as possible.  I have even searched the used market for ventilators.  

Thanks again my friend for this heads up.  Thanks Sleeprider for starting this thread.

[WakeUpTime]

"Gerald E. 'Jerry' McGinnis, legendary CPAP inventor and Respironics founder, dies at 89" *
NEWS  |  January 27, 2024  |  Pittsburgh Post-Gazette  
https://www.post-gazette.com/news/obitua...2401260087

Mr. McGinnis was widely revered as the progenitor of the first mass-produced breathing machine in the United States — a device that has treated millions around the world who suffer from sleep apnea, a chronic and potentially deadly condition in which breathing starts and stops intermittently during the night.

*See also the posting made earlier on the recent interview of Gerald McGinnis less than one month ago.
(https://www.apneaboard.com/forums/Thread...#pid497219)

"Philips recall crisis casts a shadow over legacy of Respironics founder"
CPAP inventor Gerald McGinnis says the recall is a 'disappointment and embarrassment'
Pittsburgh Post-Gazette  |  December 30, 2023

In an extensive interview — his first in the aftermath of the recall — the 89-year-old engineer described his profound disappointment in what happened to the brand that he created as well as concerns about company practices that risked the safety of millions. “If you hurt somebody, the game is over,” he said. “You’ve got to take responsibility.”

https://en.wikipedia.org/wiki/Respironics

In 1976, company (Respironics) founder Gerald McGinnis opened the company's first manufacturing facility for anesthesia masks near Pittsburgh, Pennsylvania. The company introduced the first continuous positive airway pressure (CPAP) machine for the treatment of sleep apnea in 1985. In 1992, Respironics received a patent for bi-level technology. This technology was originally intended as an improvement on CPAP, however, its use has expanded into the treatment of other breathing disorders such as chronic obstructive pulmonary disease (COPD).

*Notes:

• The CPAP machine was first invented by Colin Sullivan (Australia) in 1980, 5 years before the start of Respironics' production of CPAP machines in the U.S. Dr. Sullivan first conceived of the concept while working with another physician while at the University of Toronto (Canada). Upon returning to Australia, Dr. Sullivan implemented his technology concept and began his initial application of his CPAP concept. https://en.wikipedia.org/wiki/Colin_Sull...physician)
  
  
• One might say that Respironics founder Gerald McGinnis was to CPAP what Henry Ford was to the mass production of the automobile. Although Gerald McGinnis was not the initial inventor of the first CPAP machine, Mr. McGinnis and Respironics (est. 1976) was also an inventor of additional respiratory products and technologies, some of which predate the invention of the CPAP machine in Australia.
  
  
• In 2007, Respironics announced it entered into a merger agreement with Philips for $5.1 billion.
  

[btreger]

CNBC

Philips’ U.S. sales of sleep apnea devices face years-long halt after FDA deal

Dutch health technology company Philips will not sell new devices to treat sleep apnea in the U.S. in the coming years as it works to comply with a settlement with the Food and Drug Administration (FDA) announced on Monday.

Philips said it had reached what is known as a consent decree that spells out the improvements it needs to make at its Respironics plants in the U.S.

Until the conditions are met, no new Respironics devices will be sold in the U.S., the company said.

Philips' U.S. sales of sleep apnea devices face years-long halt after FDA deal (cnbc.com)

[WakeUpTime]

"Philips will not sell new devices to treat sleep apnea in the U.S. in the coming years"

[CNBC]  “We believe it will be very difficult for Philips to recover its U.S. Respironics market position.”

That could make a significant impact on the market.  I'm not sure how Respironics comes back from this.  They definitely can't return to the market in 1-2 years with the existing DS2 design, though I suppose they will try to market the DS2 in other countries - though that might be difficult when people realize the product is 'banned for sale in the U.S.'.  

ResMed, and ResMed resellers may seek to take advantage of this significant news, though ResMed had been providing very competitive device pricing in 2023.  If I were in the market for a new ResMed device, and it was an out-of-pocket purchase, and there was a current opportunity to purchase at a sale price, I'd consider acting now just to be safe.  But ResMed will likely now increase their production of Series 11 devices to reflect this news.

The FDA's many coming reviews of the manufacturing facilities may further push Philips for even newer foam or a redesign too.  I wonder how current (free or paid) DS2 users are feeling about this news.  I wonder how DMEs are feeling about this news.  All those Philips DMEs that have closets filled with free unallocated new DS2 replacement devices won't be happy about this news.  They were hoping to resell them at retail prices.  It's unlikely that users will wish to pay much of any price for a DS2 device as a result of this news.

Although I've been a fierce critic of the decisions made in the past, mainly by the Group Think of stock-price-focused Philips' now-retired executives, I'm concerned about the overall marketplace for users going forward.  ResMed won't need to be as competitive now with pricing as there will be an ongoing strong demand for their devices, uninterrupted now by the return of the DS2 to the market.  

This will also give much more support for the new players that have entered the market.  Although that's generally good for any marketplace, I'm surprised how new (unproven long-term) brands are using very similar designs, features, and descriptions, to sell their life-sustaining medical products.  Breathing response algorithms can be very complex, and no one knows for certain about the materials used in their devices; and they won't have billions available to rectify any product liability.  

2024, instead of providing a new opportunity for a relaunch for Philips, is proving to be a devesting year for the Respironics division.  I would expect more layoffs to take place at the U.S. Respironics office.

Anyone not monitoring this thread has been missing out on some very significant news in the past week.  Several of these news stores (discontinued product lines and this halt on DreamStation sales) might deserve their own threads since their implications are so significant. Alternatively, it may even be important enough for an ApneaBoard member newsletter update, for the members who haven't been on the board for awhile.

[btreger]

FIERCE

Biotech

More Info on the Philips Consent Decree

Once the order is approved, Philips will have “a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business,” according to the release. Though Philips didn’t spell out the exact requirements it’ll need to meet, it did note that the plan is a “multi-year” one.

Until it meets all of the requirements, the company will not be allowed to sell its respiratory care devices in the U.S.—though it may continue to provide customers with new and replacement components and support services to help maintain already-sold machines.

Outside of the U.S., meanwhile, where sales of CPAP and BiPAP machines have recently restarted in the wake of the 2021 recall, the company will be able to continue selling its respiratory devices, albeit “subject to certain requirements,” it said.

Philips agrees to FDA consent decree halting CPAP sales in US (fiercebiotech.com)

[WakeUpTime]

[Fierce Biotech] "Outside of the U.S., meanwhile, where sales of CPAP and BiPAP machines have recently restarted in the wake of the 2021 recall, the company will be able to continue selling its respiratory devices"

I'll be very surprised if the Health Agencies in many western countries (U.K., Australia, Canada, France, etc.) don't follow the U.S. FDA's actions.  If I were in another country and learned that the U.S. FDA requested a halt of production for year(s) based on potential quality issues that could impact patients' health, I'd react very quickly or face significant criticism, ridicule, or liability down the road for not acting in a similar way.  It's also much cheaper for them to do that than to conduct their own country's internal investigation into the quality of currently manufactured DreamStations.  I'll be very surprised if this event becomes exclusive to the U.S.

[SuperSleeper]

So, basically NO MORE Phillips CPAP machines are going to be sold for the foreseeable future.

Yeah, I definitely say that's a HUGE impact upon the market.

Hopefully that won't mean a dramatic rise in the prices of other manufacturers' CPAP machines.  The Philips market share was rather large, around the world even.

But, yeah... this is a "WOW" moment for the CPAP market.

[btreger]

I'll be very surprised if the Health Agencies in many western countries (U.K., Australia, Canada, France, etc.) don't follow the U.S. FDA's actions.  If I were in another country and learned that the U.S. FDA requested a halt of production for year(s) based on potential quality issues that could impact patients' health, I'd react very quickly or face significant criticism, ridicule, or liability down the road for not acting in a similar way.  It's also much cheaper for them to do that than to conduct their own country's internal investigation into the quality of currently manufactured DreamStations.  I'll be very surprised if this event becomes exclusive to the U.S.

Philips will still be able in the US to continue providing customers with new and replacement components and support services to help maintain already-sold machines.

[btreger]

So, basically NO MORE Phillips CPAP machines are going to be sold for the foreseeable future.

But, yeah... this is a "WOW" moment for the CPAP market.

I have been thinking about that ever since I first posted this news. Now, after more than 2.5 years of doing posts. what impact do you see going forward on this thread if any?