- Good day mates.
We all ready to fall a little bit further
down the rabbit hole?
Here we go.
So this is a follow-up to my recent video,
on the FDA manufacturing site inspection,
regarding the Phillips Foamgate Recall.
And if you haven't watched that video part one,
I highly recommend you go back and watch it.
Just click the link above.
Because it's gonna make part two of this video,
a whole lot easier to understand.
And just before I begin,
I do wanna quickly say thank you to all of you,
you know who you are.
Who supported that video,
shared, liked, commented on that video.
You might not understand it just yet,
but you're playing a very important role,
in holding Phillips to account.
And also making sure,
that everyone finds out about this information, all right?
People need to know this story.
So thank you very much.
Now that original FDA 483 Site Inspection Report,
although comprehensive,
left many questions unanswered.
It was heavily redacted, heavily censored.
So in this video,
I'm gonna try and fill in the blanks, all right?
Unclassified for all of you.
Now that 28 page site inspection report
exposed some horrifying truths about Phillips,
and how they operate as a company.
Their management failures,
their severe lack of risk analysis,
how they deal with customer complaints?
There's 222,000 complaints
that had no follow-up, no investigation.
But at this point in time,
there is only one question we need an answer for.
And that question is this.
Is the new silicone foam found in the DS-2?
And that used in the recall replacement devices,
those refurbished DS-1s that some of you are saving.
The same foam used in that A-series.
The one that failed the safety tests
as part of ISO 1-8562-2,
tests for the emissions of particulate matter.
And ISO 1-8562-3,
tests for the emissions of volatile organic compounds.
VOCs from the gas pathway of a medical device,
is the same foam used across all those devices.
That is the question.
The stakes have never been higher.
If it is the same silicone foam
used in all of those devices,
including the one that failed the safety tests,
then they're in big trouble.
It really is game over,
do not pass go, do not collect $200, go directly to jail.
However, if somehow they did use different silicone foam
in different devices,
and they can prove with lab analysis,
independent lab analysis,
that the silicone foam is safe.
Then they're still screwed,
but just a little less screwed.
And perhaps the recall can continue as planned.
Okay, let's fall a little bit further
down the recall rabbit hole.
Here again is the most important part
of that FDA press release.
Silicone based foam.
During the 2021 manufacturing facility inspection,
the FDA obtained additional information,
not previously available to the agency
regarding the silicone based foam
used in a singular similar A-series device
marketed outside the US.
Which failed safety tests
for the release of certain chemicals of concerned
called volatile organic compounds.
Similar testing provided by Phillips
to the FDA on devices authorized for marketing in the US
had demonstrated acceptable results.
The FDA has requested that Phillips Resperonics
retain an independent laboratory
to perform additional testing,
to determine what,
if any potential risks may be posed to patients
by the silicone based foam.
That is by far the most important part of that document.
However, there's a few little parts missing.
(soft beat music)
So what's clearly happened here.
Is the FDA has approved this original recall
based on safety testing performed by Phillips.
Phillips did the test themselves,
they provided the reports.
Why on earth,
the FDA didn't request independent lab results
prior to approving the recall is beyond me,
especially with Phillip's track record.
I mean, clearly that was a big, big mistake, come on.
So let's talk a little bit more about this, A-series device.
The one that failed the safety tests
that contains the silicone foam
and is not included as part of the ongoing class one recall.
So here in Australia,
there are two, A-series devices
that are included in the recall.
And they had the BiPAP A30 and the BiPAP A40.
Both released before 2015,
and both with the pay A pay U off phone,
the bad stuff, that's caused the recall.
I think the FDA is referencing this device.
The BiPAP A40 EFL Ventilator
that was released late 2020,
and not included in the recall.
Now I want you all to pay really close attention
to that release date,
it's extremely important.
As it clearly shows that the A40 EFL that A-series device,
was being manufactured at the exact same time
as the dream station too.
So that being said,
it is extremely likely that they used the same silicone foam
in both devices.
And if that is the case,
which I believe it is,
then we already have our independent safety test results.
We already have them.
"Recent test results dated 24th of August, 2021
documents that A-series failed VOC testing.
Compounds of concern were identified
due to their carcinogenic mutagenic properties,
and patients would be exposed to high concentrations
if they utilized an A-series device
for sustained periods of time, night after night."
If the foam is the same in the DS-2,
we don't need any more test results,
it's game over.
And the question needs to be asked,
why on earth did Phillips have that report
on this obscure A-series device, anyway?
Why did they have that report there?
I think perhaps Phillips
who we know did the original safety tests themselves.
Those used to get the recall approved
by the FDA in the first place,
might for once in their history,
be doing their own risk analysis.
Just to make sure
they weren't making the same mistake twice,
but unfortunately the test results
were not what they were hoping for.
And I know exactly what you're thinking.
Could Philips management really be so stupid
as to repeat the same mistake twice,
abso-fucking-lutely.
You might remember in the first video
observation seven and eight,
discuss how Phillips was not evaluating
their raw foam suppliers?
"You have not established data
documentation or written agreements
that clearly describes or references
the quality requirements of your raw foam supplier."
(soft beat music)
All right, so just for a moment,
let's all try and think like a Phillips executive.
And one of those foam gate meetings,
way back in early 2020,
when I know they've got big problems.
There's a huge storm coming and it's closing in fast.
They've got to batten down those hatches.
They know there's going to be a recall,
but they need to get that dream station to safe and ready,
but they're running out of time.
There's no time left for proper risk analysis,
no time left for proper supplier evaluation.
And once again, they make a big, big mistake
they choose the wrong foam.
So everyone's asking me the question.
Nico, will there be a recall of the recall?
(sighs)
The odds are certainly increasing that's for sure.
The evidence thus far,
those safety reports certainly suggest there should be one,
but will that actually happen?
I'm personally not so sure.
Maybe just maybe the FDA is giving Phillips
a little bit of a lifeline
by asking them to obtain independent laboratory results.
To show that these recall replacement devices are safe.
I mean, they already those independent
test results right there.
They have the failed safety report.
It's right there in black and white.
So something just doesn't add up.
Part of me thinks that perhaps Phillips
is just too big to fail.
They're too important right now,
especially during a pandemic,
there's just too many people that rely on these devices.
People like yourselves,
all the CPAPs, all the BiPAPs,
all the ventilators.
And how do you go and recall all these devices again,
when there's no supply to replace them with?
We know Rosemead, can't keep up
their devices already sold out all around the world.
We know about the component shortages,
we know about the supply chain issues.
So I just don't know what they're going to do,
but perhaps the FDA is going to do a cost benefit analysis
and potentially give Philips one more life
so they can continue playing the game.
Until next time guys,
look after your mates and I'll see you soon.
Bye for now.
(soft beat music)