We’re telling you guys, if you really want to know what’s going on in the world keep an eye on Brit Hume’s feed, especially with the coronavirus and each and every spin corporate media is trying to push to support their anti-Trump narrative. Dude is seriously on his game.
Like this:
The Covid 19 emergency meets the regulatory state. The regulatory state is winning. Thread. https://t.co/h0KmFeE6HS
— Brit Hume (@brithume) March 26, 2020
Wait, the ‘shortage’ of masks and respirators isn’t Trump’s fault?!
But we were assured that orange man IS indeed bad!
FYI, this thread from Paul Matzko about what is really going on with masks and respirators will tick you off because it was just the other day we were writing about issues with testing and why there was so much ‘fail’ in the beginning.
Wondered why it's been so hard to ramp up production of surgical masks and respirators? Why haven't private companies flooded into the market to meet peak demand?
Because they are regulated medical devices & new versions require FDA approval which can take months to obtain. 1/
— Paul Matzko (@PMatzko) March 25, 2020
The FDA.
Again.
Sensing a disconcerting pattern here, folks.
Take a look at this FDA regulation, intended to ease (!) the application process for "premarket notification." That means you have to do all of this–and get FDA sign off–before your new surgical mask gets anywhere near shelves. 2/ https://t.co/fNzWcXKeFl
— Paul Matzko (@PMatzko) March 25, 2020
Let's say that you're a garment manufacturer in NYC, but, of course, retail sales are down, so you're looking for another revenue stream. Why not make surgical masks, keeping your doors open, employees employed, and saving lives? It's a win-win-win! 3/
— Paul Matzko (@PMatzko) March 25, 2020
Recommended
USA USA USA!
Capitalism for the win!
Yup.
But how long do you think it would take you to jump through these hurdles, and do you think someone without an army of regulatory compliance officers would be reasonably able to do so at all? 4/
— Paul Matzko (@PMatzko) March 25, 2020
Gotta love it when our own government gets in our way.
Check this out:
To start, you must:
– do a compositional side-by-side analysis of your mask vs all other masks currently sold. Hire a few materials scientists, okay.
– measure "tensile strength" & "impact resistance." Hire the Mythbusters and have them whack it with a hammer.
— Paul Matzko (@PMatzko) March 25, 2020
FFS
– perform detailed "risk analysis," for fluid/bacteria resistance and "flammability." Hmmm, better open a branch office for all those extra materials scientists and medical researchers. This is multiple major studies (though a Boring Company flamethrower might work in a pinch.)
— Paul Matzko (@PMatzko) March 25, 2020
– but wait, don't forget that masks touch skin! What if it gives you a rash!!! Okay, fine, we'll fill out the "standard ISO-10993," yeah, you know, the one for “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Sprinkle in a couple more clinicians.
— Paul Matzko (@PMatzko) March 25, 2020
This is insanity.
I could go on and on. There is no world in which any company not already deeply invested in manufacturing surgical masks could jump through these hurdles in time to mitigate the desperate shortage of PPE for medical professionals on the COVID-19 front lines. None.
— Paul Matzko (@PMatzko) March 25, 2020
And we could have a discussion over whether these steps are necessary in ordinary times. But we aren't living in ordinary times.
Just as the FDA waived its COVID-19 testing regs (after weeks of delay), it should waive its surgical mask/respirator regulations for the duration.
— Paul Matzko (@PMatzko) March 25, 2020
We haven’t seen ‘ordinary times’ in decades, but we digress.
And yes, it should waive its surgical mask/respirator regulations for the time being.
But since it hasn't, the supply of officially-approved masks has remained artificially constricted. New entrants are effectively barred from selling unapproved masks.
— Paul Matzko (@PMatzko) March 25, 2020
Stupid.
So stupid.
If willing to expose themselves to immense legal liability, new manufacturers could give masks away, but you're not going to get meaningful quantities that way. It's merely fodder for pleasant 5 o'clock news stories about making a few 1000s for donation to the local clinic.
— Paul Matzko (@PMatzko) March 25, 2020
But because most people are unaware that masks/respirators are considered medical devices and just how onerous the applicable rules are, it leaves people thinking that the PPE crisis is a market failure, when it is anything but.
— Paul Matzko (@PMatzko) March 25, 2020
A market failure AND DON’T FORGET, a Trump failure.
That leads folks to consider towards heavy-handed measures, like the government seizing the means of mask production. This is problematic for a bunch of reasons (& likely less effective), but it's also completely unnecessary if the FDA would just DROP THE DAMN RULES.
— Paul Matzko (@PMatzko) March 25, 2020
And to think, Senators Chris Murphy and Brian Schatz (for brains) want to give the government more control over these items.
Yeah, that’s a big pass you guys.
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