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+--- Thread: [News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS (/Thread-News-RECALL-THREAD-IMPORTANT-PHILIPS-DREAMSTATION-SYSTEM-ONE-USERS)
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-03-2021
Additional HME News
MEDICARE ALERT ON RECALL IS ‘DISAPPOINTING’
Liz Beaulieu, Editor
Updated 10:18 AM CDT, Fri September 3, 2021
WASHINGTON – Medicare’s recent alert to beneficiaries on the Philips recall of certain CPAP devices resulted in a wave of repercussions for HME providers, including a rash of phone calls from upset patients.
While technically correct, the alert made it sound like providers have repairs or replacements at the ready, when they don’t. Philips just announced on Sept. 1 that it has received approval from the U.S. Food and Drug Administration for its repair plans, and supply chain issues are severely impacting a provider’s ability to access replacements – not only from Philips but also from other manufacturers.
“It’s disappointing,” said Ronda Buhrmester, senior director of payer relations and reimbursement for VGM & Associates. “Suppliers are doing everything they can, so it’s disappointing that this is causing more tension and stress and frustration for them. Their phones are ringing off the hook with patients demanding new machines because of the notice.”
Medicare alert on recall is ‘disappointing’ | HME News
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-03-2021
This Is What The FDA Told Us:
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.
The FDA is working with Philips Respironics to assure the company sufficiently evaluates the device problems, the scope of the recall, and the most appropriate mitigation strategies, including adequate corrective actions by the company. The FDA will continue to share updates with the public as new information becomes available.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-04-2021
RE: >above<
FDA Mission
The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Unless the FDA has totally abdicated its responsibilities as a US Government Agency and as described above its commitment to all US citizens affected by the Philips extremely dangerous foam, and all of the recalled products. We are no closer to a solution than we were a month ago.
If that statement is accurate as of today, that would mean that Philips maliciously started its own false media campaign stating it had received approval to start a repair and replacement program, knowing it had not received the necessary clearance to do so.
As stated in previous posts from different news outlets, all the DME's and their customers are in total confusion on what is really going on right now. If Philips is really shipping repair and replacement equipment they have done so with apparently having done any form of any strategic or logistics planning.
I guess all we can do is sit back and see what the real story is.
TODAY'S RECALL NEWS - WakeUpTime - 09-06-2021
CBS News consumer investigative correspondent Anna Werner asked, "What are you telling your patients to do?"
CBS NEWS - September 6, 2021
But since the recall, she said her doctor advised her not to use the machine – and she's struggling without it. "I'm very tired, I'm very slow," said Jozefa. Her son said Medicare turned her down for a replacement machine, and she can't afford to spend hundreds of dollars to buy a new one. Kamil said, "She called several times to her insurance and Medicare, and they're saying, because it hasn't been five years, even though it's not her fault at all, they're not willing to pay for a new machine."
Philips now says it will "replace or repair devices" … "within approximately 12 months" once the FDA approves a solution.
Philips said its testing revealed "possible risks," which raises questions for Dr. Claman: "Is this just the tip of the iceberg, or is this all there is?"
But he has a message for Philips: "To tell me that it could take up to a year? That's a year that I could be putting myself in jeopardy," Colbert said. "People just cannot afford to wait 12 months for a resolution."
Colbert has also joined a lawsuit against Philips, he said, to push them to act faster on this problem.
Philips did not respond to CBS News' request for comment on the lawsuit.
Recall of sleep apnea aids leaves some people feeling stuck between two risky choices
PBS - September 6, 2021
For many patients, including Bisogno, there isn’t a lot they can do but wait. They’re worried about the potential dangers of a device meant to keep them healthy, but without a replacement, they’re stuck.
Many have taken to social media to vent their frustrations, in particular about how poorly the recall was communicated to users. It’s these posts that have alerted many people to the problem in the first place rather than Philips Respironics, or the durable medical equipment companies that sell the devices, or the users’ physicians.
That was the case for Bisogno, who found out about his machine from a social media post looking for interviewees for this article. “That’s not the way I wanted to find out,” said Bisogno. “I would have liked to find out about it any way — a message in a bottle would have been fine — if it would have got to me first.”
https://whyy.org/articles/recall-of-sleep-apnea-aids-leaves-some-people-feeling-stuck-between-two-risky-choices/
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-07-2021
CBS NEWS
SEPTEMBER 7, 2021 / 7:22 AM / CBS NEWS
Philips now says it will "replace or repair devices" … "within approximately 12 months" once the FDA approves a solution.
Sleep apnea sufferers frustrated over CPAP machine recall - CBS News
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - btreger - 09-07-2021
WHYY
PBS NPR
ByHannah FullmerSeptember 6, 2021
Recall of sleep apnea aids leaves some people feeling stuck between two risky choices
Many have taken to social media to vent their frustrations, in particular about how poorly the recall was communicated to users. It’s these posts that have alerted many people to the problem in the first place rather than Philips Respironics, or the durable medical equipment companies that sell the devices, or the users’ physicians.
Sound familiar
How recall of sleep apnea aids has some people feeling stuck - WHYY
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - MikeE3 - 09-08-2021
I'm expecting a Fed-Ex delivery from Respironics Inc. today or tomorrow. Could it be a replacement machine?
I never contacted my DME (Rotech) and they never contacted me about the recall. This must be related to my registration of my DS1 with Phillips weeks after the recall was announced.
More to come when the package arrives.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - mrmagloo - 09-08-2021
It will be interesting to see how this plays out if they are not communicating the expectations before shipping out new machines. Whether they include a return label for the old machines, or just instruct folks to dispose. They sure aren't being very forthcoming with information as of yet, and I'm rather shocked they are making any moves before communicating with the recipients.
PHILIPS DELIVERIES - WakeUpTime - 09-08-2021
(09-08-2021, 08:24 AM)MikeE3 Wrote: I'm expecting a Fed-Ex delivery from Respironics Inc. today or tomorrow.
One would think that current DS1 owners, especially those still under warranty (if Philips is capable of easily cross-checking for that), would get DS2 replacements very quickly. They won't be the ones waiting up to 12 months for replacements. If Philips is indeed producing about 26,000 DS2 units each week at the moment, they should have about 200,000 DS2s ready to ship out, in addition to the inventory of DS2 units that they were already producing prior to the recall - unless of course that Philips media interview estimates were grossly exaggerated and "supply chain issues" are more extensive than we were lead to believe.
My guess is that your FedEx package is a return-label and empty return-shipping box. Congratulations for being one of the first to experience some results. I wonder if more-recent DS1 purchasers who indicated that they were SoClean users in their recall registration will be the first to see replacements.
There must be mounting pressure on Philips these days that is likely spilling over into its other operations. After awhile, the consequences of not taking action become overwhelming to many operations. Meanwhile customer, media and political inquires substantially mount.
My System One BiPAP unit likely won't see a fix for many months to come. Most Philips corporate responses refer to DreamStation 1s. It's my guess that Philips won't differentiate between DS1s out-of-warranty - it's likely too difficult for them. Replacement DS2 is a relatively easy process - return old, ship new. Philips can also manage that process in-house.
Fixing older (non-DS1) units will be a much more complicated task. I wonder if Philips will contract that out to third-party service companies. Let's remember too that it's an international recall. Fixing systems, especially older models, will likely generate a lot of talk along with a few mistakes.
(09-08-2021, 09:56 AM)mrmagloo Wrote: They sure aren't being very forthcoming with information as of yet...
Philips may have reasoned to not openly communicate their schedule. If there are 2-4M recalled device owners, that's a lot of people who will demand their fix/replacement be next. It may get very political amongst multiple countries, customer-types, medical agencies, local and regional issues, lawsuits, etc.
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS - DaveCar - 09-08-2021
" I'm expecting a Fed-Ex delivery from Respironics "
A small but growing list of people on a FB page Im on, are having the same thing. A call about a delivery, and then boom there's a new DS2 with a box ready to ship out the old unit.
The Australians have the sweet deal, they get their money back in full - because of the recall classification and some consumer protection rules.
That's the option I would love to have.