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

[Sleeprider]

Updated first post with new updated list.

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FDA

Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants

Hampton, NH – On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into proximity to certain medical implants or metallic implants, it could interfere with the implant's performance or position, potentially resulting in serious injury or death.

Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets. This is a voluntary action based on information obtained from post-market surveillance.

Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non-Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This applies to all lot/UDI numbers.

Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants | FDA

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SleepReview

Amid scrutiny over CPAP cleaning devices, including legal disputes and FDA warnings, the industry sees a movement back to manual cleaning methods.

Michelle Worley, RN, director of clinical operations at Aeroflow Sleep, a CPAP equipment and supplies provider, says, “It will not remove dirt and debris.” 

The FDA has previously stated that it does not have evidence of whether CPAP cleaning devices work to clean or disinfect CPAP equipment of germs or allergens.

Worley says Aeroflow Sleep does not recommend CPAP cleaners to patients. Instead, patients are advised to wash their CPAP equipment in mild soap and water to prevent the build-up of bacteria and deterioration of materials. 

Despite the confusion and potential health risks associated with CPAP cleaners, Gilkison says that patients ultimately benefit from the increased scrutiny of these devices. “Patients have won because they’re getting a better education about what these devices do and what they don’t do and what’s important. And that’s being compliant with the CPAP manufacturers’ guidelines,” he says.

The Changing Landscape of CPAP Cleaners Post Philips Recall | Sleep Review (sleepreviewmag.com)

[MaNoise]

Has there been discussion on why there is foam in all of the manufacturers machines and what alternative design would be safer?
I understand the foam is likely for sound dampening.

[Phaleronic]

Foam as sound abatement is just a stupid idea-foamless air chambers are hardly any louder.

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The Journalist's Resource

How they did it: A reporting team led by Pittsburgh Post-Gazette and ProPublica exposes a dangerous defect in the popular breathing machine

The reporters found:

Philips continued to aggressively market the machines while its experts warned of the dangers the devices were posing to patients.
Philips failed to turn over more than 3,700 complaints about the eventually-recalled machines, sometimes waiting years before submitting them to the FDA. The FDA requires companies to disclose patient complaints to the agency within 30 days.
Other leading device makers also submitted late reports about patient complaints involving flawed pacemakers, prosthetics, dialysis machines, and screws and plates for bones. In 2023, 1 in 8 reports from medical device companies, including more than 232,000 complaints, were submitted to the FDA past the 30-day deadline.
As a result of the investigation:

The Government Accountability Office is launching an investigation of the FDA’s oversight of medical devices. It’s the first in a decade. Sens. Richard Blumenthal (D-CT) and Dick Durbin (D-IL) asked the GAO to investigate how the FDA tracks warnings about dangerous devices, oversees recalls, and takes action against companies.
Rep. Jan Schakowsky (D-IL), the ranking member of the House Energy and Commerce subcommittee that oversees consumer product safety, also called for investigations.
Connecticut’s Attorney General William Tong called for third-party experts to conduct safety tests on recalled machines.
Philips Respironics announced in January that it was going to stop manufacturing and selling all CPAP machines in the United States.

In an interview, Sallah and Cenziper, both Pulitzer Prize winners, share these 11 reporting tips for journalists.

1. To strengthen a reporting project, collaborate with other newsrooms.

2. Collaborate with student journalists.

3. Share information to gain patients’ trust.

4. Take the time to gain the trust of internal sources.

5. Understand the science.

6. Find several experts to guide you.

7. You’ve heard it before, but here it is again: Avoid acronyms and jargon.

8. Don’t settle for long wait periods for your public records (FOIA) requests.

9. Read the documents. Don’t settle for numbers.

10. When covering medical devices, understand the role of regulators.

11. Keep a timeline.

How they did it: A reporting team led by Pittsburgh Post-Gazette and ProPublica exposes dangerous defect in popular breathing machine (journalistsresource.org)

[MaNoise]

Foam as sound abatement is just a stupid idea-foamless air chambers are hardly any louder.

I agree, I would prefer silicone lined airways if it could last & or casing to be sealed & double walled.

Put some thoughts on this thread:
CPAP compressed air path design, foam, filtration & maintenance 
re. considering advocating for some design standards for all CPAP manufacturers to meet.

[WakeUpTime]

"Statement from Philips on Sleep Product Withdrawals"
Mar 22, 2024
https://sleepreviewmag.com/sleep-treatme...thdrawals/

Mario Fante, global external relations director at Philips, answered questions about its market exit in several sleep product categories.

Are there any specific products that Philips recommends to replace these discontinued products?

Philips Respironics does not provide recommendations of this kind.
We understand the impact of this announcement on our customers and patients. While these changes are difficult, they are necessary to help us refocus our portfolio on solutions that will most effectively serve patients and customers in the future.

Is there anything you would like to add or emphasize for our readers?

Philips remains committed to the sleep and respiratory care business, though we recognize the significant impact this has on our customers in the US. While these changes are difficult, they are necessary to help us refocus our portfolio to effectively meet the needs of our customers and their patients. As we have stated, we continue to offer and provide our mask and accessories portfolio products.

[WakeUpTime]

"After Philips: Filling the Diagnostics Void
Sleep Industry Stunned by Philips’ Exit"
https://sleepreviewmag.com/sleep-diagnos...tics-void/
Mar 22, 2024

“This took me by surprise as we just ordered and received 30 devices from them,” Kunz says. “We were under the impression [diagnostics] was the direction they were going, along with increasing focus on their mask sales.”

“This took me by surprise as we just ordered and received 30 devices from them,” Kunz says. “We were under the impression [diagnostics] was the direction they were going, along with increasing focus on their mask sales.”

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PHILIPS

Explained: Philips Respironics consent decree

In January 2024, Philips agreed on the terms of a consent decree with the FDA and DOJ. The consent decree is being finalized and will be submitted to the relevant US court for approval. The consent decree primarily focuses on Philips Respironics’ business operations in the US. The consent decree provides Philips Respironics with a roadmap of defined actions, milestones, and deliverables to meet relevant regulatory requirements. 

     Note: This article addresses the following FAQs, per Philips.
 
What is a consent decree?

Why did the U.S. government seek a consent decree from Philips Respironics?  

Why did Philips Respironics agree to enter a consent decree?
 
What are the main terms of the consent decree?
 
Does the consent decree only affect customers and patients in the US, or will it have an effect outside of the US?

Explained: Philips Respironics consent decree | Philips