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

[btreger]

RE >above<

The FDA answers your concern:

The FDA is reviewing the adequacy of Philips Respironics’ proposed recall strategy as it becomes available from Philips and is recommending changes as appropriate.

The FDA can use advisory actions, administrative actions, and enforcement actions when a firm’s voluntary action is not rapid or complete, or when the firm is uncooperative.

I for one put the blame solely at the hands of the FDA, and their horrendous process for allowing medical products to be marketed.

They do have by law the ability to do a lot if they feel they are threatened by Philips and their inability to act in a sufficient time period.

The question is, will they?? 

[mrmagloo]

>> I for one put the blame solely at the hands of the FDA, and their horrendous process for allowing medical products to be marketed. <<

Hmm, and Philips bares no responsibility for presenting perhaps inadequate or misleading documents in the first place? Do you really expect the FDA to handle independent scientific testing - LONG TERM testing - for every single product on the market? Who exactly would fund such a monster?

Imho, big government is bad enough - what you are inferring is ridiculous. I think the FDA could definitely increase their scrutiny in a number of areas, in particular supplements, etc, which clearly is out of control. However, they absolutely need to rely on the research that large medical device mfr's provide, review them, and hold them accountable for the accuracy, if there are any breaches in that trust. Sounds like they are doing exactly that.

Why are you blaming the FDA - Clearly they have been amping up the pressure on Philips, which is exactly what they should be doing.

If anyone is at fault here, it's Philips. The buck stops right there.

[btreger]

they absolutely need to rely on the research that large medical device mfr's provide, review them, and hold them accountable for the accuracy, if there are any breaches in that trust. Sounds like they are doing exactly that.

This sounds like you are aware of, or have seen the research Philips had submitted to get their 18 recalled products manufactured. This would be big news to all of us, so please share whatever research you have obtained.

[mrmagloo]

LOL, you very much misread my post by a pretty large margin.  If you want copies of the pertinent applications, please feel free to make a FOIA request.

Not sure how you came to that conclusion, but what you are suggesting is unrealistic.  Listen, we are all frustrated, but it's important to focus our outrage on the right parties.

The FDA has no more culpability here than the NHTSA has for the Takata recall. Think about it.

[Sea Papper]

If anyone is at fault here, it's Philips. The buck stops right there.

Very true, the FDA can't micro-manage every design detail in every medical device. They have to trust the equipment manufacturer has followed CFR 21 and performed the due diligence as per the required document submittals. That said, when a manufacturer has failed to follow the process correctly to the point of causing injuries, they should be looking at felony criminal charges and punishing fines for all of the participants as outlined in CFR 21. 

Material bio-compatibility is a critical medical device requirement that Philips failed to perform correctly. How could this be nothing more than felonious fraud in the name of saving a few pennies on each unit. 

Another obvious problem is the complete disregard for the QA process outlined in CFR 21. How much time elapsed between the first adverse event reported to the FDA and the voluntary recall? In other words how many people were injured while Philips failed to correctly follow CFR 21? 

The FDA can't review all the product designs on the market but they should use the full force of the law to make the sting so bad as to deter future criminal activity by a medical device manufacturer. Time for the FDA to toss a few incompetent designers, QA people, and C suite executives into jail, fine them into oblivion, and bar them from the marketplace. 

The following fines are applicable for each offense:

• Up to $100,000 for a misdemeanor by an individual that does not result in death.
  
• Up to $200,000 for a misdemeanor by a corporation that does not result in death.
  
• Up to $250,000 for a misdemeanor by an individual that results in death, or a felony.
  
• Up to $500,000 for a misdemeanor by a corporation that results in death, or a felony.
  

The maximum imprisonment for a misdemeanor under the Act remains a year for each offense.

The FDA could use the fines to buy replacement devices for affected patients from a reputable company like ResMed. 

ACCOUNTABILITY!

[mrmagloo]

@Sea Papper - I agreed 110%. However, the various government oversight agencies tend not to send strong deterrent messages as pesky politicians tend to get in the way after large political contributions, or when a substantial number of constituent jobs are threatened as a result. So more often that not, you hear about a lot of stomping around, and fines that seem substantial, but are in reality a drop in the bucket, and life goes on. Sucky situation for sure, but that's what we have. The alternative would strangle the life out of innovation and business. People have to think this through.

[WakeUpTime]

There remain many that are still unfamiliar with the recall, or who are only recently finding out about it.  Philips has stated continuously in media interviews, through its executive branch and its public relations department, that it has contacted its customers "by letter", etc.  One of the other constant messages is that the "complaint" percentage is quite small.

As a few of the posters in this thread have previously reminded us, we (recalled device end-users) are not Philips "customers".  Philips' "customers", from their point of view, are equipment providers (DMEs) and large account purchasers (hospitals, country medical agencies such as U.S. Veterans Affairs, select insurance companies, etc.).  Let's keep that in mind when Philips talks about putting the interests of its "customers" above everything else.

Historically, I've purchased from 3-4 DMEs, and had sleep studies at two different hospitals.  I've yet to receive direct contact by any means from any of them regarding the recall.  One would think that Philips would put out a directive to all its resellers that they must make direct contact with all previous recalled system purchasers by any means, in order to continue to be an "authorized equipment reseller".

Regarding Philips' stating it has a very low complaint percentage, related to foam particles, in the past, I've looked into how I would register an "official complaint" with Philips.  The best I could find asked for my "Login" account ID - implying it's for Philips "customers" only.  Therefore, we had to go through someone like our DME to register our complaint, and then motivate them to write up a separate incident report for Philips.  What would most DMEs likely tell us in the past?  Perhaps something like "There aren't any reports of other incidents or recalls".  (An endless futile loop, without Philips ever knowing the real impact on end-users.)

[Helena]

We were not informed of the recall by Philips, nor by Apria, nor by the pulmonologist. A friend heard it on the news, and I read about it on a veterans' site, and then called Philips with the serial number.

No letter, nor phone call, nothing from Philips.

[Deborah K.]

No one has ever contacted my husband and me either.  I learned about it from this and one other board.  I watch very little television, so if I were not on a cpap board, I likely still would not know about the recall.  That is not acceptable.  

[Glen e]

It really is amazing how no one has contacted everyone that uses a Phillips about the recall. But there is one way that you can spread the word passively… I frequent about six or eight forums for various hobbies: cars , aquariums, auto detailing etc. and I changed my signature to the following:

Glen
Using a Phillips CPAP machine? Stop/recall/poss cancer

As of this morning, I’ve had 25 people write me through direct message on the various forums and thank me profusely because they didn’t know a damn thing about it. I send them the link to this thread.