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

[btreger]

ProPublica


“With Every Breath,” a new documentary from ProPublica and the Pittsburgh Post-Gazette"

This is an intimate glimpse into what happens when patients and a doctor learn that a lifesaving device may be causing harm.

Weaving personal stories with lush cinematography, “With Every Breath” visualizes the stories of three people, who face the unanswerable question of how their health has been impacted, and a sleep medicine doctor who leads her patients through the chaotic recall. The film humanizes a public health crisis that has affected millions.

ProPublica Documentary: The Human Toll of Philips CPAP Recall — ProPublica

[PAPPER101]

Very important post! - Thanks!

Shouldn't the manufacturers be required to conduct such VOC's / etc. lab testing on all of the components within their "Medical" products before they can submit for FDA approval?

On May 1, 2019 - I delivered my "Formal Complaint" to the executives at PHILIPS Re: "Burning Odor coming from my PR-DRSTN CPAP Machine".
- PHILIPS was instantly in total denial and just brushed me off without even offering to conduct a defect assessment.

* This was about two (2) years (24+ months) prior to the official announcement of the "Recall".

As a result of the PHILIPS flagrant disregard for safety, at that time I also requested their MSDS Data on the machine components (i.e. Humidifier Chamber, etc.).
- PHILIPS refused to provide anything regarding their toxic VOC's lab tests except for the generic statement "Our equipment meets with all of the safety guidelines".

Perhaps we PAP users are just a bunch of unsuspecting guinea pigs for "medical experimentation"?

"Redacted" seems to be a common theme (as a substitute) for scientifically establishing "Safe & Effective" as a fact over these past few years!

[PAPPER101]

Very important post! - Thanks!

I watched a segment of this series last week and I found it's a high quality production.

Although I wish they would go more in-depth into the regulatory "guidelines" for the manufacturing of such "medical devices".

As this safety issue has become an on-going saga for PAPPERS, I wonder if it'll soon become a full TV series (i.e. S-12 - EP-33...)?

[Sheepish]

ProPublica


“With Every Breath,” a new documentary from ProPublica and the Pittsburgh Post-Gazette"

This is an intimate glimpse into what happens when patients and a doctor learn that a lifesaving device may be causing harm.

Weaving personal stories with lush cinematography, “With Every Breath” visualizes the stories of three people, who face the unanswerable question of how their health has been impacted, and a sleep medicine doctor who leads her patients through the chaotic recall. The film humanizes a public health crisis that has affected millions.

ProPublica Documentary: The Human Toll of Philips CPAP Recall — ProPublica

Allow me to repost that excellent report directly on our board:

[TimaaaaaaaahRocks]

Shouldn't the manufacturers be required to conduct such VOC's / etc. lab testing on all of the components within their "Medical" products before they can submit for FDA approval?

Yes, they are REQUIRED to evaluate the biocompatibility of all materials used in a medical device. Pretty simple concept. In the case of a CPAP machine or other pie hole air things - one must consider the air circuit human interface. Hence, you can't be forcing particulates or toxic compounds into the air circuit. 

https://www.fda.gov/medical-devices/bioc...ssment-fda

"The Agency makes a clearance or approval decision for a medical device as it is supplied in its final finished form. The Agency does not clear or approve individual materials that are used in the fabrication of medical devices. Therefore, the risk assessment should evaluate not only the materials used in the device, but also the processing of the materials, the manufacturing methods (including the sterilization process), and any residuals from manufacturing aids used during the process."

Problem is the FDA does not critique the 510K submittals and the sociopaths at these companies are only worried about the stock price. FDA allows the device maker to basically self-certify the biocompatibility of materials. This is what happens when MBAs make design and testing decisions based solely on cost. Respironics violated a dumpster load of federal regulations, again. 

[btreger]

ProPublica


Congressional Watchdog Will Launch Inquiry Into FDA Oversight of Medical Device Recalls

Congressional investigators are launching an inquiry into the Food and Drug Administration’s oversight of medical device recalls for the first time in years following reports that the agency failed to issue warnings about breathing machines capable of sending hazardous particles and fumes into the lungs of patients.

The news organizations revealed that the agency had received hundreds of complaints about breathing machines manufactured by Philips Respironics long before the company announced a massive recall in 2021, but took no action to alert patients or doctors.

Philips withheld thousands of additional complaints over 11 years while customers who relied on the machines to breathe reported respiratory problems, kidney and liver conditions, and cancer, the news organizations found.

GAO Will Open Investigation Into FDA Oversight of Medical Device Recalls — ProPublica

[Sheepish]

Health Canada, the Canadian counterpart to the FDA, is basically a guy in a cubicle with a high-speed internet connection to the FDA, and whose skillset boils down to dexterous mastery of the keyboard shortcuts Ctrl+C and Ctrl+V.

[DaveL]

@Sheepish

Thanks. This is my thought exactly.

Thanks for reposting that video.

[btreger]

Pittsburgh Post-Gazette


Congressional watchdog will launch inquiry into FDA oversight of medical device recalls

Congressional investigators are launching an inquiry into the Food and Drug Administration’s oversight of medical device recalls for the first time in years following reports that the agency failed to issue warnings about breathing machines capable of sending hazardous particles and fumes into the lungs of patients.

In 2022, the FDA received 3 million reports about malfunctioning devices — nearly 30 times more than in 2005, government records show. Nearly one-third described injuries and deaths.

Device safety advocates said the GAO should review whether the FDA regularly uses the information in health records, insurance claims, medical device registries, and other sources — data they said would greatly improve the agency’s ability to track dangerous products.

The FDA moved to create a center to bring together that data years ago, but a comprehensive new system is still not in place, records and interviews show.

Former FDA analyst Madris Kinard also said the FDA should do more to ensure device safety before being marketed and sold. A controversial process at the agency allows device makers to gain clearance for a new product by showing that it is substantially equivalent to one already on the market.

Ms. Kinard said the FDA should investigate whether those older models had any safety issues before newer versions are cleared.

Congressional watchdog will launch an inquiry into FDA oversight of medical device recalls | Pittsburgh Post-Gazette

[sauerkraut]

The fda has become a rubber stamp cheering section for the medical device
and pharmaceutical companies .. The fda looks at what ever information they
are given !! Then without doing their Own Research approves what ever the
corporation wants to sell to the general public .. Then the politicans grant immunity
from suits and class actions eliminating any recourse for Us Common People !!
The first example that comes to mind of is the covid vaccine ..
Even if People can sue, the lawyers are the only ones getting rich !!

The federal government has abdicated its responsibilities in many areas ..
Not just the fda look at the mess called the faa and boeing ..
Then you have home land security at the border !!

I can only say let the Buyer Beware !!