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FDA relaxes oversight of ventilators in effort to boost supply
Seeking Alpha ^ | 3/22/20 | Douglas W. House

Posted on 03/22/2020 1:20:42 PM PDT by Freedom of Speech Wins

Aimed at increasing the availability of ventilators and accessories, the FDA has temporarily relaxed its standardsenabling medical device makers to more easily make changes to existing products (e.g. changing suppliers or materials without the normal sign-off process). This includes the use of non-medical device manufacturers which will add substantial capacity.Hospitals and healthcare professionals may use ventilators normally intended for other environments (e.g., masks used when transporting patients in an ambulance). Healthcare personnel will also be able to use ventilators beyond their indicated shelf lives.The FDA is encouraging all ventilator makers, domestic or foreign, to apply for emergency use authorization to allow U.S. distribution.

https://seekingalpha.com/news/3554042-fda-relaxes-oversight-of-ventilators-in-effort-to-boost-supply?source=email_rt_mc_readmore&utm_medium=email&utm_source=seeking_alpha&mail_subject=lake-fda-relaxes-oversight-of-ventilators-in-effort-to-boost-supply&utm_campaign=rta-stock-news&utm_content=link-3

(Excerpt) Read more at seekingalpha.com ...


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: coronavirus; health; ventilators
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1 posted on 03/22/2020 1:20:42 PM PDT by Freedom of Speech Wins
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To: Freedom of Speech Wins

Seeing once again how FDA is a big road blocker to business during normal times


2 posted on 03/22/2020 1:22:05 PM PDT by RummyChick
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To: Freedom of Speech Wins

I read that a CPAP machine can be used as a poor substitute. (ie better than nothing)


3 posted on 03/22/2020 1:22:52 PM PDT by Drango (1776 = 2020)
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To: Freedom of Speech Wins

Unconstitutional FDA does more harm than good, as with all of the 80%+ unconstitutional portion of the now totalitarian federal government.

Anyone else feel like we should dismantle the unconstitutional portion of this beast and recover our Free Constitutional Republic?

Those in favor say, “Aye”.


4 posted on 03/22/2020 1:25:16 PM PDT by Jim W N (MAGA by restoring the Gospel of the Grace of Christ and our Free Constitutional Republic!)
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To: Freedom of Speech Wins

They’re just doing that NOW? Where have they been?

Those people need some boots in their rear ends.


5 posted on 03/22/2020 1:29:24 PM PDT by Jeff Chandler (BLACK LIVES MAGA)
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To: Freedom of Speech Wins

Wow, it only took two months.


6 posted on 03/22/2020 1:31:37 PM PDT by Mr Ramsbotham ("God is a spirit, and man His means of walking on the earth.")
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To: Drango

Not from what I’ve read. My guess is ventilators suck and blow. CPAPs just blow.


7 posted on 03/22/2020 1:35:17 PM PDT by meatloaf
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To: Freedom of Speech Wins

I wonder if CPAP devices can be modified for use as a ventilator.


8 posted on 03/22/2020 1:37:29 PM PDT by Oldeconomybuyer (The problem with socialism is that you eventually run out of other people's money.)
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To: Freedom of Speech Wins

Oh gee, look how nice those totalitarians are to “loosen” their rules to actually allow the free market to make things happen.

Those totalitarians in government are all so helpful. Yes, folks, this is sarcasm.

JoMa


9 posted on 03/22/2020 1:39:15 PM PDT by joma89 (Buy weapons and ammo, folks.)
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To: Oldeconomybuyer

The pressure on a CPAP is set via the programming. I doubt it goes high enough to be used as a ventilator or can be used to
expel air to exhale.


10 posted on 03/22/2020 1:40:16 PM PDT by meatloaf
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To: Drango

My mom has a nebulizer (from pneumonia) with several unused pipes and boxes of Albuterol ampules. Heck...I figured we could dip into those if needs be.


11 posted on 03/22/2020 1:41:28 PM PDT by RushIsMyTeddyBear ("Progressives" (elitist Communists) "Love you to death".)
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To: Freedom of Speech Wins

Why does no one point out that the medical equipment shortage today stems in large part from the heavy Obamacare taxes levied on medical equipment companies? This raised the prices of domestic suppliers, caused hospitals to look for cheaper sources, and drove many of our medical suppliers to China. Now Pelosi, who was Speaker at the time and bludgeoned that disastrous bill through the House with her over-sized gavel, wants to blame Pres. Trump for the mess she and Obama caused. Despicable.


12 posted on 03/22/2020 1:43:14 PM PDT by txrefugee
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To: Drango

A Breathalyzer is also a poor substitute, but was sufficient for the usurper.


13 posted on 03/22/2020 1:43:37 PM PDT by C210N
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To: Freedom of Speech Wins

Basically it’s an admission by the FDA that this is all a regulatory screw up.


14 posted on 03/22/2020 1:44:44 PM PDT by Brilliant
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To: Drango

I read that it is possible to hook up multiple patients to a respirator provided some proper valves are attached.


15 posted on 03/22/2020 2:26:06 PM PDT by cornfedcowboy
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To: joma89

You guys don’t want the lesson I could give you on ventilators and I haven’t managed a patient on a vent in 2 decades. They are MUCH more complex now. You can’t just turn a ceiling fan or a Bennet machine into a ventilator. Stop it! Honestly, some of you are making me embarrassed to be part of the freeper family.


16 posted on 03/22/2020 2:29:00 PM PDT by wastoute (Government cannot redistribute wealth. Government can only redistribute poverty.)
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To: cornfedcowboy
I read that it is possible to hook up multiple patients to a respirator provided some proper valves are attached.

The machine, oxygen and air tanks,intubation tubes or masks, control valve are components of a system controlled by a respiratory technician. Hard to imagine a single respiratory tech working and monitoring multiple controls for multiple patients with varying conditions and needs. Could happen but I suspect human rapid burnout results.

See simple conceptual instruction video below to see how it operates in real world and imagine that with contagious virus.

How a Ventilator Works

17 posted on 03/22/2020 2:57:01 PM PDT by Covenantor (We are ruled...by liars who refuse them news, and by fools who cannot govern. " Chesterton)
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To: wastoute

See my 17 reply video link...does that begin to illustrate the complexities of ventilators to the layman?


18 posted on 03/22/2020 2:59:39 PM PDT by Covenantor (We are ruled...by liars who refuse them news, and by fools who cannot govern. " Chesterton)
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To: Freedom of Speech Wins

When this is over, the FDA will order those ventilators destroyed.


19 posted on 03/22/2020 3:04:22 PM PDT by IndispensableDestiny
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To: Freedom of Speech Wins

Good to hear, but it would be nice if they would get around to thinking of these thing long BEFORE there’s a huge shortage of them.


20 posted on 03/22/2020 3:39:31 PM PDT by BobL (If some people here don't want to prep for Coronavirus, they can explain it to their families)
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