09-20-2021, 06:48 PM
(This post was last modified: 09-20-2021, 07:33 PM by WakeUpTime.)
FDA AND CORPORATIONS
(09-20-2021, 05:02 PM)btreger Wrote: Former FDA Commissioner Scott Gottlieb joins Pfizer’s board of directors
<< above >>
My personal opinion is that they tend to tread lightly on the largest companies as some may know they are possible future employers, at significantly higher pay, as a result of their FDA insider knowledge and possibly even past behaviors. If I'm not mistaken, someone posted earlier that many/most/all Philips device FDA applications in fact are initiated through an independent person/company that is (or is likely) a former FDA official. There are also a few doctors that are publicly on Philips contractor as-needed payroll ("consultants") that are in a similar category. For the past few years, several Philips mask products were reviewed (I'd say "promoted") by one particular doctor, with many media journals picking up that story for the "expert opinion". Philips continues to do an outstanding job at connecting with (and I'd suggest rewarding) industry experts.
[*Note: While some of the above statements are true, some of the above content is also based on personal opinion and speculation rather than facts. Please do not consider the above content as anything more than one person's opinion.]
Having said that, I also believe that there is significant pressure on the FDA at the moment for many reasons, and from many sides, regarding the Philips Recall. The Recall is so vast and significant that it will likely prompt changes in procedures, within the FDA. As with many similar institutions, there will be "more oversight".
On a related note, when searching "Philips CPAP" at OverSight.gov, only one article comes up. The January 2000 reports states that the VA is spending too much on CPAP products. Perhaps that partially explains why the VA, one year later, is instructing most recalled xPAP device users to continue using their faulty products.
Quote:[Report to the VA] "The number of veterans diagnosed with sleep apnea who receive devices and supplies increased dramatically between fiscal years 2014 and 2018. This has significantly increased the financial risk to VA. If VHA does not change its practices and leverage opportunities to save money, the OIG estimates it risks spending about $261.3 million over the next five years on devices and supplies veterans will not use. VHA did not efficiently manage sleep apnea devices and associated supplies."
OverSight.gov (Search "Philips CPAP")
09-20-2021, 07:41 PM
(This post was last modified: 09-20-2021, 08:15 PM by WakeUpTime.)
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-20-2021, 04:32 PM)LindanHotAir Wrote: ...The bag containing the manuals had a link for the clinical manual but a login and password was required for that part of the site.
Thank you for that update! That may indeed be Breaking News on the Recall.
Could it be that you're the first on the board to report receiving a replacement product in which Philips did not have any previous recent patient settings in its cloud, via DreamMapper?
If so, you've just told us two very important things:
- Philips is now replacing DreamStation 1 CPAP/APAP devices for owners that didn't have updated DreamMapper device settings in the Philips Cloud
- Philips is now shipping non-personalized devices to owners and requesting that they connect with a DME for clinician setup
If point #2 is true, that should provide some level of satisfaction to ApneaBoard members, unless Philips has built-in an additional safeguard to force recalled device owners to connect with a DME to use their replacement DS2 device.
Is this where Philips is at now?
COUNTRY / DEVICE TYPE / SUBSET / START DATE / DEVICE UPDATE / POSSIBLE SORT ORDER
US / DreamStation 1 CPAP, APAP / DreamMapper Updated / Sep-1-2021 / New DS2 Direct to Owner / Recall Registration Date (?)
US / DreamStation 1 CPAP, APAP / non-Cloud Updated / Sep-20-2021 / New DS2 Direct to Owner with Clinician Manual Link /
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Yesterday WakeUpTime wrote this:
"The FDA has an opportunity here to improve their reputation a bit. Let's see what they do with that opportunity. Let's see if they're looking out for the best interests of consumers, or politicians, or corporations".
There could be another explanation, they are looking out for themselves.
March 25, 2020 - FDA Recommends CPAP As A Considered Alternative Combatant For Coronavirus Due To Ventilator Shortage
"As a result of this shortage, the U.S. Food & Drug Administration (FDA) recommends “that health care providers and facilities consider alternative devices capable of delivering breaths or pressure support to satisfy medically necessary treatment practices for patients requiring such ventilatory support” including Continuous Positive Airway Pressure (CPAP), auto-CPAP (APAP), and bilevel positive airway pressure (BiPAP or BiLevel) machines that are typically used for the treatment of sleep apnea".
The manufactures they recommended were Philips and ResMed.
So to be crystal clear, some of the products they were recommending for the treatment of Covid patients in ICUs are the same products a year later they were issuing a Class 1 recall because of serious and potentially deadly health consequences.
I do not believe the FDA would want this as a headline in any news media.
This could explain why to many of us they seem to be slow-walking the recall process today.
Just my interpretation of these facts.
FDA Recommends CPAP as an Alternative to Ventilators Given Shortage (healthsqyre.com)
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I don't know but it seems you are reading a little too much in there. The FDA had no clue there was an issue with the Philips products in March of 2020. So, when the issue arose a year later, why would they be at fault for recommending a machine (Philips Products) that had an unknown issue a full year earlier? Are you suggesting the FDA knew about the problem PRIOR to this press release?? That would certainly be a big problem, but that is not the case.
Clearly at the time, in the first and second quarter of 2020, the lack of ventilators was a big topic, and I think they rightfully offered a viable option that may have saved lives. The fact is, at that time, both manufacturers had a good reputation and the capacity to help fill the need. Only later did the FDA and the rest of the world learn that Philips was retarded enough to use a harmful material in their products - ONE Year Later.
The FDA is challenged enough without expecting them to also be capable of seeing the future as well.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-21-2021, 09:53 AM)mrmagloo Wrote: The FDA is challenged enough without expecting them to also be capable of seeing the future as well.
Seeing in the future is not the problem. The problem is how they allow critical medical equipment to be marketed in the first place. The manufactures are allowed to police themselves, no third-party clinical evaluations are required. As we now can see from Philips's fiasco, the FDA should do a complete review of this process and do a complete overhaul.
No one should have to go through what all the Philips users around the world have had to go through over the last six months ever again.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
We went through this weeks ago, and I don't care to retread this. I get that you think the Federal Govt should have a few million researchers, with a multi trillion dollar budget to do comprehensive long term tests on every single item any company would ever like to sell in the US. That is a totally unrealistic expectation.
No doubt Philips screwed the pooch in a big way here, and will absolutely pay dearly for their carelessness.
I do believe that the FDA will get a little shake up in the near term as well, but to suggest that things will not get back to some degree of normal after this passes is very optimistic. All that is needed is a few well placed generous campaign contributions, and all will be back to normal.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-21-2021, 12:40 PM)mrmagloo Wrote: All that is needed is a few well placed generous campaign contributions, and all will be back to normal.
Campain contributions to who and by who? What will that accomplish? It is easy to throughout posts like that, but what is the relevance to this thread and its members? Maybe you can tell us how anything in your post will fix the foam problem, Philips or the FDA.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Parker Waichman LLP Files Injury Lawsuit Against Philips NV And Related Entities On Behalf Of A West Virginia Woman Who Developed Lung Cancer After Using CPAP Machines
By Parker Waichman LLP Sep 21, 2021, Updated 2 min ago
PORT WASHINGTON, N.Y., Sept. 21, 2021 /PRNewswire/ -- Parker Waichman LLP, a national law firm, filed a lawsuit on September 13, 2021, against Koninklijke Philips N.V., and subsidiaries, in United States District Court, District of Massachusetts. The lawsuit, claiming failure to warn, design defect, and breach of warranty, was filed on behalf of Juilette McKinney, of Midway, West Virginia, alleges that Ms. McKinney developed lung cancer as a direct result of her daily use of Philips' continuous positive airway pressure ("CPAP") devices: a System One RemStar Auto CPAP and a DreamStation Auto CPAP.
https://www.salamancapress.com/news/stat...be976.html
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-20-2021, 07:41 PM)WakeUpTime Wrote: Thank you for that update! That may indeed be Breaking News on the Recall.
Could it be that you're the first on the board to report receiving a replacement product in which Philips did not have any previous recent patient settings in its cloud, via DreamMapper?
I looked through my OSCAR statistics and found the settings they loaded were from June 20, and I had changed them after that. They used old data from their cloud server.
The passworded site they referenced was where the clinical manual could be downloaded but only by someone with a clinician account.
The machine itself was not locked so I could get to the clinical settings which are more limited than the DS1.
Is this where Philips is at now?
COUNTRY / DEVICE TYPE / SUBSET / START DATE / DEVICE UPDATE / POSSIBLE SORT ORDER
US / DreamStation 1 CPAP, APAP / Philips cloud Updated / Sep-1-2021 / New DS2 Direct to Owner / Recall Registration Date (?)
Registered second day site was open, received 9/20/21, appears programmed from June 20 cloud data upon power up.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-21-2021, 01:02 PM)btreger Wrote: Campain contributions to who and by who? What will that accomplish? It is easy to throughout posts like that, but what is the relevance to this thread and its members? Maybe you can tell us how anything in your post will fix the foam problem, Philips or the FDA.
There was nothing whatsoever arbitrarily thrown out ( throughout)? I made the assumption that you could immediately recognize the significance of your own posts, about how Sen. Blumenthal was going to shake things up. Do you need me to post links?
As you should know, the ONLY folks capable of making marked and lasting policy change in one of our agencies is the legislature, and perhaps to some degree the upper executives - from one admin to the next. All of which are politicians, which are always in search of campaign contributions, the bigger the better. As such, the traditional game play with massive corporations is, when facing potential increased scrutiny by legislators, they mobilize their lobbyists, and get the campaign contribution machine rolling. Surely you know how it works, right? Do I really have to spell it out?
Nothing wrong with expressing disappointment, even outrage over what is happening - Which I agree is totally unacceptable, and btw, I am a party. However, the stuff you keep posting about reengineering the FDA, totalitarian powers, complete verification, and 3rd party scientific validation is absurd. You don't need a fancy degree to recognize what you keep pontifying is ridiculously impossible. I totally appreciate you posting links to pertinent news, but does the synopsis at the end always have to spiral into a conspiracy theory?
Can we just stick to the facts instead of trying to enflame the situation further?
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