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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-19-2021, 12:09 PM)pholynyk Wrote: ... The included link is https://cts-sct.ca/wp-content/uploads/20...9_2021.pdf

That Canadian document is extremely well put together.  It's a great read for all recalled device users from every country and includes a good summary of web-links.  

More countries keep getting added to the general Philips' Recall site (U.S., Canada, U.K., etc.).  Also, some customers purchased their machines from the U.S. but use it in another country, that may or may not have their own official country recall.  I wonder which would take precedence: country of purchase, or country of usage.  There are some countries that don't have a critical mass of users for Philips to setup a significant presence.

If those who might not already know, it's the amazing Gideon that created and is updating the Wiki for the Philips Recall.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
"On De-Foaming any PAP machine, IMHO DON'T!!! In the US it would be illegal to transfer any De-Foamed PAP machine to another user. "

Oh great so we cannot help helpless people who do not have the skills to help them selfs.????

How illegal is it?? Can you post the stature??

Rich
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-19-2021, 05:40 PM)racprops Wrote: "On De-Foaming any PAP machine, IMHO DON'T!!! In the US it would be illegal to transfer any De-Foamed PAP machine to another user. "
Oh great so we cannot help helpless people who do not have the skills to help them selfs.????
How illegal is it?? Can you post the stature??
Rich


Rich, in the U.S. it's illegal to transfer a Class II medical device to anyone unless it's being done by a licensed DME and issued to a patient who provides that DME with a valid prescription for the device.  Find the FDA links yourself, they're out there-- you'll likely have to wade through several pages to find them, and there's more than one section that deals with Class II device regulations.  I'm not going to waste time tracking down the applicable links for you, as I've already done that in the past for forum purposes.  A person selling, trading or transferring a customer-altered Class II medical device is plainly acting against FDA regulations already, because a Class II medical device can't legally be sold, traded or transferred by anyone except a licensed DME in the first place.  So technically, Gideon's statement is correct.

Regardless of the legal issues, would you trust some dude on eBay selling de-foamed DreamStations?  I sure wouldn't.

If you want to help others by either selling or giving away DreamStation machines that you've personally defoamed, nothing is stopping you from helping "helpless people who do not have the skills to help them selves".  Just get yourself a website and start up your organization.  You can help as many people as you want.  I'll leave you to decide whether or not to comply with FDA regs for your new startup.

As far as defoaming your own device, go for it if you want.  Nothing's stopping you from doing that.  Gideon did preface his statement with "IMHO" ("in my humble opinion") in case you didn't see that.   Opinions are allowed on Apnea Board, including your opinion on the merits of attempting to defoam a medical device.

Coffee
SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.




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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Thanks for that info SuperSleeper ...seems that is not stopping MANY companies from reselling used machines...

I am on a bunch of Facebook sites and there are people who just spent $3000.00 and now cannot get them replaced or changed and really need their machine and they are fit to be tied.

So far all I have done is shown what I did and with all kinds of disclaimers ETC.

I even started my own personal Facebook site I call "Coyle Medical speculations" with a collection of all the notes and posts I have made.

I am currently posting my fix for the Older System Ones.

I have been considering offering to help people with their machines.

Rich
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I honestly didn't even think about just transferring a Class 2 Medical device.  
I had read, your turn to find it, that it is illegal to modify a Class 2 Medical Device.  Yes, I accept that you can modify your own devices to your heart's content.
In the following post, I suggested you post your defoaming procedures, both the PR and the ResMed, in new threads because it would help the readers find them.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
There has been mention in several recent posts that describe the recalled Philips products as class II medical devices. I had no idea what that meant so I started searching for answers.

FDA approved vs. FDA cleared

"FDA approved" means that the agency has determined that the "benefits of the product outweigh the known risks for the intended use." Manufacturers must submit a premarket approval (PMA) application and the results of clinical testing in order to get approval.

Class II and Class I medical devices are usually "cleared" by the FDA, which means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. Those already-cleared products are called a predicate.

Companies must submit a "premarket notification submission" or 510(k) to the FDA so that it can review the product and clear it. Once the FDA declares that a new medical device is substantially equivalent to a predicate, it is "cleared," and can be marketed and sold in the US.

This is the 510 submission for the DramStation on March 24, 2011

Manufacturer
Philips Respironics 

Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.  Classification. Class II (performance standards

The proprietary name of the new device: Philips Respironics BiPAP C Series (BiPAP AVAPS - BiPAP SIT)
Respironics BiPAP AVAPS Ventilatory numbers: Support System (cleared under K092818 8- date of concurrence: January 22, 2010) 

Conclusion:

No Clinical Testing was ever required for these products prior to them being put on the market. They were never approved but cleared.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The FDA will certainly read more than the manufacturers test results. A description of the parameters of the tests, their conditions, etc etc will be reviewed to look for lacks or bias.

A major manufacturer of many types of medical devices isn't going to risk their reputation and the expense of a possible recall, and possible penalties, because of their own shoddy testing. PR seems to not have considered foam degradation over years; or possibly their tests showed no such issue. Remember that not all devices show foam degradation, and in fact it may be a very small number that do, because of some sort of environmental conditions that weren't considered.

OR: PR did in fact skimp on their testing. And the FDA didn't catch it. Or PR tried to ignore the issue when they became aware of it, thinking it was a tiny percent of machines that were affected. I think we'll find out.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
btreger, I see your point of the difference between approved and cleared.  The DS machines were likely cleared, not necessarily approved, therefore (as far as that part of the regs is concerned) no FDA testing was required, as long as the manufacturer can prove that their device was "substantially equivalent" to an already-approved device.

I haven't reviewed all the other areas of FDA regs that deal with Class II devices in a long time, so there's possibly other areas that apply to these issues.

I did note that the FDA definition of  "Substantial Equivalence" lists the procedures they can use to determine that, which does seem to at least include looking at any clinical testing that was done (link):

Quote:This performance data can include clinical data and non-clinical bench performance data, including engineering performance testing, sterility, electromagnetic compatibility, software validation, biocompatibility evaluation, among other data.

So while Philips could have indeed conducted extensive clinical testing for the DS devices, that testing was not explicitly mandated under the "cleared" device regs, but indeed it would likely be difficult for PR to obtain "clearance" for the device had they not had substantial backup in the way of clinical data or testing to show that their DS machines were indeed "substantially equivalent' to already-approved machines.

I doubt that Philips would have not done any degree of testing for a device they planned on asking FDA clearance for.

The question (as hegel indicated) is:  What did Philips know and when did they know it?    Thinking-about
SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.




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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Well, maybe you should do a re-read.

To get FDA approval manufactures must submit they conducted clinical tests and the results

To get FDA Cleared approval, which these products have, all they have to demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval. No Clinical Tests have to be Submitted

There is a difference between FDA Approved and FDA Cleared

The requirements are different

I can repeat myself again if you want!
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
See my post above -  I agree with you.   Smile

But that said, it does not prove that no clinical testing was done.  It simply means that no clinical testing was required for clearance.
SuperSleeper
Apnea Board Administrator
www.ApneaBoard.com


INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.




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