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[News] PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
#11
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(11-15-2021, 08:21 PM)StratCat48 Wrote: The stringent ISO testing is usually, but not always performed by an independent lab. It would be interesting to know if Philips has a facilities capable of the required testing or if they contracted it out. Whoever did the ISO testing would certainly have comprehensive documentation to back up the findings for reports.

I also winder about the foreign device the FDA cited as falling. Was it the same ISO tests? Who conducted those tests? How much detail do they have on either set if tests (reviewed the full test reports or just summary data?)

I sort of wonder if the FDA is just being overly cautious in asking for a 3rd set of tests. They don't outright call the testing Philips submitted a problem, just that they want a 3rd party test to clear up the conflicting results.

Or was the full report not submitted /reviewed? Did the FDA just accept the summary that it passed fbe tests? I don't know how the FDA handles such, but if similar to the FAA they may have a designated person at Philips or even accept a summary instead if reviewing a full report.

With this being a 501k similar to a previously approved device how much dud that affect the process. (Similar to the FAA and the Boeing 737Max being similar to the previous 737NG).
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#12
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(11-15-2021, 09:17 PM)StevesSp Wrote: It is many years since I had any interaction with the FDA, but I will just say that they did nothing to convince me they were solely focused on consumers' health. Rather, it seemed their job was to protect and support large American corporations against smaller competitors and overseas suppliers.

I don’t know when or in what capacity you dealt with the FDA but in my twenty years of face to face interactions with FDA inspectors in semiannual inspections of Pfizer pharmaceutical manufacturing plants I never saw any indication that they were there to support or protect our operations. Their requirements were very strict and the inspections quite rigorous. The relation ship was definitely not cozy but ranged from cool businesslike to, at some times, adversarial. It was always clear they were there with intent of finding as many issues as they could to issue 483 citations.

Part of my responsibility was to review 483 documents from inspections of other companies and I saw no indication that any received any type of preferential treatment. Citations always required significant corrective actions that ranged from process changes to product recalls and in some cases the requirement to bring in 3rd party organizations to oversee quality control.

After retiring from Pfizer I joined one of the third party consulting firms that oversaw corrective actions when mandated by the FDA due lack of confidence in a firm’s management. The FDA emphasis was on strict quality control in all phases of the manufacturing process.
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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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#13
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(11-15-2021, 11:52 PM)ST Dog Wrote: Or was the full report not submitted /reviewed? Did the FDA just accept the summary that it passed fbe tests? I don't know how the FDA handles such, but if similar to the FAA they may have a designated person at Philips or even accept a summary instead if reviewing a full report.
In my experience it was very unusual for the FDA to accept a summary report on an issue of concern. They usually wanted to see detailed reports and discuss them with the person responsible for the investigation. I never saw a case where they accepted the findings of a designated person employed by the firm being inspected.
My experience was in pharmaceutical production. They may handle things differently with medical devices but I doubt it.
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#14
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(11-16-2021, 12:36 AM)Melman Wrote: In my experience it was very unusual for the FDA to accept a summary report on an issue of concern. They usually wanted to see detailed reports and discuss them with the person responsible for the investigation. I never saw a case where they accepted the findings of a designated person employed by the firm being inspected.

Post inspection corrections is different than initial approval too.

I wonder how much of a concern it was though?
Even that's not clear. Now post recall it is but when the DS2 was approved? 

But I've never dealt with the FDA. And while I've not dealt with the FAA, I do a similar job for the DoD and know a bit about how our process differs from the FAA and how DERs/DARs operate (designated engineering/airworthiness representative).
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#15
[split] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
In the Form 483 document the FDA uses abbreviations that they fail to define.

CAPA stands for Corrective And Preventive Action.
CAPA INV stands for an informal CAPA process which is a precursor to a formal CAPA.
HHE stands for Health Hazard Evaluation.
SCAR stands for Supplier Corrective Action Report.

Many of you will recall that Philips cited a 0.03% complaint rate in 2020. See for example https://www.usa.philips.com/a-w/about/ne...vices.html. A 0.03% complaint rate is 1 complaint for every 3,333 devices.

However, the Form 483 document specifies that over 15,000,000 devices are affected by the recall and that over 222,000 complaints were received by Philips between Jan. 1, 2008 and Nov. 9, 2021.  That is roughly 1 complaint for every 68 devices, a complaint rate of 1.48%.

Although the Form 483 is not the FDA's final determination, it points to the kind of egregious and reckless behavior that is elicited from private sector managers and executives by the FDA's lax regulatory environment.
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#16
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
Sleep Review:

FDA to Philips: Safety Risks May Exist with the Replacement Foam for Recalled Devices

Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue the use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the agency has determined that discontinuing the use of one of these devices may be more harmful to a patient’s health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment.

According to Philips Respironics, it has conducted testing to support the new silicone replacement foam. Silicone foam testing provided by Philips Respironics to the FDA on devices authorized for marketing in the US had demonstrated acceptable results. Philips Respironics continues to coordinate with the FDA and other competent authorities on its testing. The company states, “The test referenced by the FDA did not relate to DreamStation 2, but to an A-Series PAP device. In accordance with normal practice and timeline, Philips Respironics will submit its explanation to this particular finding for review by the FDA, as another VOC testing of the ASeries PAP device with the silicone foam demonstrated acceptable results. The testing to support the use of silicone foam in the DreamStation 2 device was previously submitted to the FDA and demonstrated acceptable results.


https://sleepreviewmag.com/sleep-treatme...d-devices/
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#17
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
I am not sure how this relates to DS2 but from all the information that has come out since this recall began, it appears that if Ozone cleaning equipment or products are used to clean these pap machines, then the risk of foam disintegration is elevated .
So people who have used equipment like SoClean to sanitize their DS machines, are at higher risk and ahould stop using their machines .
I have never used an Ozone product to clean my DS and I will continue to use it and O have cleared it with both my doc and my DM.
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#18
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(11-18-2021, 12:02 PM)btreger Wrote: FDA to Philips: Safety Risks May Exist with the Replacement Foam for Recalled Devices
The company states, “The test referenced by the FDA did not relate to DreamStation 2, but to an A-Series PAP device. In accordance with normal practice and timeline, Philips Respironics will submit its explanation to this particular finding for review by the FDA, as another VOC testing of the ASeries PAP device with the silicone foam demonstrated acceptable results. The testing to support the use of silicone foam in the DreamStation 2 device was previously submitted to the FDA and demonstrated acceptable results.
After re-reading this several times it hit me with what was said:
 "the silicone foam demonstrated acceptable results"
So if acceptable is a 5 rating for example or lower, and Philips came in at a 4.8, would they expect us to feel good about that. Considering they had at least 10 years to correct this problem they should have shot for a 0 rating, leaving no doubt and no need for any further discussions.
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#19
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
I just received my DS2 today and, after reading about Foamgate 2 with this silicone foam and am now wondering if I should return my new DS2 and just continue using my DS1. I've watched a number of YouTube videos and am feeling uncomfortable about even using the DS2. Any advice on this?   Before this recall, I would have been eligible for a new CPAP machine in Feb, 2021. But, I'm not sure that insurance would pay for that because I was eligible for the recall, even if I return the DS2, and stick with my DS1.  If the silicone foam is that dangerous and Philips isn't doing a good job of rectifying the problem, I'm not so sure that I want to stay with their brand.  Any insights and advice would be greatly appreciated.

Also, does anyone know how to be able to see OptiStart in the Provider Mode?  I'm not seeing it and want to turn it on, as it's turned on in my DS1 and I like the feature. But unlike in DS1, this option doesn't even show up in DS2 as a submenu under the Therapy tab.  Do I need to have the hose and mask attached in order to make it visible?  

Thanks
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#20
RE: PHILIPS FDA Update 11-12-2021 Silicone Foam Defective in DS2
(11-19-2021, 11:02 PM)rr4terps Wrote: I just received my DS2 today and, after reading about Foamgate 2 with this silicone foam and am now wondering if I should return my new DS2 and just continue using my DS1. I've watched a number of YouTube videos and am feeling uncomfortable about even using the DS2. Any advice on this?   Before this recall, I would have been eligible for a new CPAP machine in Feb, 2021. But, I'm not sure that insurance would pay for that because I was eligible for the recall, even if I return the DS2, and stick with my DS1.  If the silicone foam is that dangerous and Philips isn't doing a good job of rectifying the problem, I'm not so sure that I want to stay with their brand.  Any insights and advice would be greatly appreciated.

Also, does anyone know how to be able to see OptiStart in the Provider Mode?  I'm not seeing it and want to turn it on, as it's turned on in my DS1 and I like the feature. But unlike in DS1, this option doesn't even show up in DS2 as a submenu under the Therapy tab.  Do I need to have the hose and mask attached in order to make it visible?  

Thanks

Evidently you can't as it appears as the Opti-Start setting needs to be performed through Care Orchestrator.

https://www.apria.com/wp-content/uploads..._03-21.pdf

"4. How do I disable Opti-Start?
You can disable Opti-Start through Care Orchestrator in the Prescription section. Note that it takes 30 hours of patient therapy use before the Opti-Start pressure is determined and implemented when Opti-Start is enabled."
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