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

[ripnationstates]

this is terrible news

[btreger]

Post-Gazette, ProPublica


Sue FDA for records related to Philips's recall of breathing machines

The Pittsburgh Post-Gazette and ProPublica have filed suit against the U.S. Food and Drug Administration in federal court in New York, accusing the agency of holding back records related to the sweeping recall of breathing machines sold worldwide.

The FDA regulates the medical device industry and categorizes the recall as Class 1, reserved for defects that can cause severe harm or death.

But the agency denied multiple requests by the news organizations to quickly release documents under the Freedom of Information Act, including the company’s prior test reports on the degrading foam and monthly updates by Philips about the status of a recall that has impacted millions of people in the United States and other countries.

Post-Gazette, ProPublica sue FDA for records related to Philips CPAP recall | Pittsburgh Post-Gazette

[btreger]

PITTSBURGH POST-GAZETTE


How we investigated the Philips CPAP recall

To understand the breakdowns that led to one of the most tumultuous medical device recalls in generations, the Pittsburgh Post-Gazette and ProPublica spent a year probing what happened inside Philips Respironics after the company first learned that contaminants were turning up in breathing machines designed to save lives.

Reporters for the two news outlets collaborated with NRC Media in Amsterdam, where Philips’ parent company, Royal Philips, is headquartered, as well as with student journalists from Northwestern University’s Medill Investigative Lab.

Reporters obtained newly unsealed court documents, internal emails, text messages, and public records in the United States and other countries to track Philips’ and its parent company’s response to the problem. Those documents included records from four tests conducted by independent labs brought on by Philips that describe the chemicals released by the foam.

The reporting team also drew on thousands of complaint reports spanning 13 years that were submitted to a national repository known as the Manufacturer and User Facility Device Experience database. The records are maintained by the Food and Drug Administration and describe reports of patient deaths and injuries as well as device malfunctions.

Investigating the Philips Respironics CPAP recall: How we did it | Pittsburgh Post-Gazette

[TimaaaaaaaahRocks]

Post-Gazette, ProPublica


Sue FDA for records related to Philips's recall of breathing machines

The Pittsburgh Post-Gazette and ProPublica have filed suit against the U.S. Food and Drug Administration in federal court in New York, accusing the agency of holding back records related to the sweeping recall of breathing machines sold worldwide.

The FDA regulates the medical device industry and categorizes the recall as Class 1, reserved for defects that can cause severe harm or death.

Allowing a criminal organization to self-regulate itself is obviously detrimental to public health. The harmed resp users should file a class action against the FDA for malfeasance. Going forward the FDA should try actually reading the 510(K)s that come from unethical repeat offenders like respironics with a history of marketing poorly designed and inadequately tested products. Respironics management can't be trusted. The DOJ should investigate FDA's culpability in this matter. And what of the (ir)responsible employees who looked the other way or flew the coop when the realized the company was breaking US law? They get to hide under corporate protection on the back nine at Meadowink. 

The FDA regulates the medical device industry and categorizes the recall as Class 1, reserved for defects that can cause severe harm or death. - well, actually, NO they do not. 
Good on the Post Gazette for putting some positive pressure on FDA. (i got a million of 'em    )

[btreger]

CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health

The FDA remains steadfast in our commitment that patients impacted by the June 2021 recall of certain Philips Respironics ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines deserve relief. While this matter is ongoing, the agency continues to monitor the company's recall progress and share new information with device users, patient care facilities, and other stakeholders. The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.

FDA Activities

Today, as part of our continued efforts to ensure consumers have the latest information on the Philips recall, the FDA published a new resource section on FDA.gov, including a comprehensive timeline of FDA activities related to the June 2021 recall. Patients, consumers, and healthcare providers have played an integral part in providing feedback to the FDA about the Philips recall, and their feedback is reflected in this new resource to ensure it provides timely and accurate information.

CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam | FDA

[btreger]

FIERCE

Biotech

Still 'unsatisfied’ with Philips' handling of CPAP recall, FDA calls for additional safety testing

Since Philips began its recall of millions of respiratory devices in June 2021, the FDA hasn’t been shy about criticizing how the company has handled the recall.

This time, the FDA is taking issue with the independent testing Philips commissioned—on a post-recall request from the regulator—to assess the safety of the polyester-based polyurethane (PE-PUR) foam at the heart of the recall. The foam, added to many of Philips’ CPAP and BiPAP machines and ventilators to muffle sound and vibrations, was found to break down over time and possibly release debris and chemicals into a user’s airflow.

This week’s rebuke appears to have spooked investors. Its stock price plunged nearly 10% overnight, from a closing price near $20 on Thursday afternoon to below $18 on Friday morning.

Additionally, analysts have suggested that the consent decree that’s long been hovering over Philips’ head could soon come crashing down on the company: “The additional testing requirement, continued dissatisfaction of Philips’ handling of the recall and the removal of the device from the shortage list make a Respironics sales ban in the U.S. all the more likely,” a Bernstein analyst wrote this week.

FDA 'remains unsatisfied' with Philips' handling of CPAP recall (fiercebiotech.com)

[eok361]

philips will likely be banned from selling anything in the us. i can't say they don't deserve it. they do. 

it's just too bad that it will lessen both options--and competition--in the field of cpap, and all the other ventilation type machines they produce(d). 

consumers lose all the way around.

[Sleeprider]

Thanks btreger for publishing these summaries and links to articles here. Clearly, consumers (patients) need to be aware of the problems with devices and corporate ethics of the companies that manufacture them. Philips business practices have been questionable for a long time, incentivizing doctors, clinics and institutions to sole-source their devices that clearly are inferior in efficacy. It gets really ugly when the corporate veil is lifted.

[eok361]

Philips business practices have been questionable for a long time, incentivizing doctors, clinics and institutions to sole-source their devices that clearly are inferior in efficacy.

it's right up there (lacking in ethics) with purdue. 

i don't know culpable doctors can be in the philips situation, but the other example is pretty easy to see...imho.

[Cifer123]

   

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Hello. Is it safe now to use Philips Respironics DreamStation Expert Auto Canadian version. I found one for sale at half price. The seller says that the old one was replaced with this one. It has not been started or activated. The label in the device îs 21.03.2023.