FDA Relaxes Rules To Allow for More Ventilators, Finally

Restrictions have been loosened to help ramp up production.

The Food and Drug Administration (FDA) is easing up on some regulations so that ventilators can be manufactured and implemented more quickly to respond to the spread of COVID-19.

In new guidance issued on Monday, the FDA said that it will practice "enforcement discretion" by allowing manufacturers of ventilators to allow for some modifications of hardware, software, and materials. This allows manufacturers more flexibility in response to supply shortages that could keep them from ramping up production.

The new guidance will also allow for the quicker addition of new production lines and alternative production locations, meaning that if other companies that have space to install production lines of their own (GM, for example, has offered unused space in its shuttered plants) those companies are free to do so. Of course, non-medical manufacturers have massive logistical challenges and it may still take months for them to actually be in a position to make ventilators. The FDA's temporary "discretion" will only remove some bureaucratic barriers.

The FDA is also temporarily easing up on regulations about where ventilators can be used, allowing ventilators that are authorized for use in one environment to be used in others. For example, a ventilator that is approved only for home use may now also be used in a health care facility. Devices used to help people with sleep apnea may now be legally modified to help people with COVID-19-related respiratory problems.

These are all welcome actions but they should have happened much sooner. There was ample warning that COVID-19 was coming to America. New York City, which has become a massive viral epicenter, is now worried about running out of sufficient ventilators.

Today, New York Gov. Andrew Cuomo (D) complained that the White House hasn't used the Defense Production Act to mandate the manufacture of new ventilators.

I do not understand the reluctance to use the federal Defense Production Act to manufacture ventilators.

If not now, when?

— Archive: Governor Andrew Cuomo (@NYGovCuomo) March 24, 2020

But the Defense Production Act isn't a silver bullet. It could take months for new supply lines to develop (though I do have some faith that rapid innovation could occur). Executive fiat can only do so much.

Cuomo should be demanding to know why it took so long for the FDA to get out of the way.

Comments

[Á àß äẞç ãþÇđ âÞ¢Đæ ǎB€Ðëf ảhf]

Cuomo is more likely to wonder why he is not actually in charge instead of shouting advice from the sidelines.

[Unicorn Abattoir]

Cuomo can handle things! He's smart! Not like everybody says...

Seriously, he needs to steer clear of rowboats.

[Dakesq]

If Cuomo was so smart, why didn't he use NYS resources to stockpile ventilators years ago so they would be ready just in case of a pandemic?

[aajax]

The New York State Senate was controlled by those "fiscally conservative" Republicans when the ventilators were cut out of the budget. The governor does not have a half billion dollars to spend at his personal discretion.

[Rich]

The Food and Drug Administration (FDA) is easing up on some regulations so that ventilators can be manufactured and implemented more quickly

, at the cost of killing people with those shitty ventilators!

[wstu]

I would rather take a 10% chance of dying with a shitty ventilator than a 95% chance of dying with no ventilator. Without easing FDA regulations, it will take months to over a year for approval to even make ventilators.

[Rich]

Oh, right on. My point was more along the lines of: Why were those restrictions "needed" in the first place?

[wagnert in atlanta]

Those restrictions were needed in small part to keep defective designs from making it into the market, and in large part to keep a large, sluggish force of rubber-stampers from having to go on welfare. The FDA has needed an extensive dose of butt-kicking for years. This may be just the time to administer it.

[aajax]

How would you like to have a nice fat stockpile of expensive ventilators on hand and then find out they didn't work for some reason?

[Jerryskids]

I'm getting a kick out of Cuomo whining about Trump failing to use his vast powers to send aid to New York without recognizing that Trump's vast powers to help New York are also Trump's vast powers to tell Cuomo to fuck off.

"Lord, why did you never once answer my prayers?"
"But I did answer your prayers - I said 'No.' "

[Longtobefree]

And occasionally, I said "HELL NO!".

[Star1988]

Who are they going to get to operate 40,000 ventilators? They are not CPAP machines where you throw a mask over the face and walk away for 8 hours.

Patients on ventilators need to be intubated, sedated, and often, suctioned every few minutes to get rid of the excretions coming up from their lungs! And the settings need to be constantly monitored and adjusted to prevent serious lung damage. Tiny increases in pressure can destroy alveoli.

They are being talked about in the press like some kind of magical cure-all wonder drug. While they can give terrific results when run by trained, experienced professionals, I don't see how just throwing out another 40,000, with nobody to run them, is going to lead to statistically meaningful results.

[soldiermedic76]

I keep hearing about mobilizing the military too. The vast majority of the military medical field, however, are in the reserves and guard. When I got out in 2005 it was like 90% of the Army Medical Department were actually reservist and guardsman. So if we mobilize the reserves and guard, where will those medical personal come from? The same civilian (mostly) hospitals they are already working at.

[Red Rocks White Privilege]

The plot twist, from what I'm hearing, is that by the time things get bad enough that you have to be put on a ventilator, your chances of surviving are bad. Like, 95% dying bad. And using these things can cost up to six or even seven figures because of our over-bloated medical price cartels.

Seems like the best solution is to mass-produce hydroxychloroquine, start administering it to anyone that has the virus, document the results, and save the vents for people that wouldn't be on death's door anyway.

[Nardz]

Like "testing" before, "ventilators" is the new cudgel

[Rich]

Well, we can always use them when the vaping pandemic kicks in.

[Earth Skeptic]

But EVERYTHING must be done, regardless of cost, efficacy, and side effects.

Tis the new ethic of the decade.

[Star1988]

Yeah. The earliest published study out of China had a 2 out of 26 survival rate for ECMO. And i'm guessing those 2 have barely functioning lungs for the rest of their brutal lives.

[Lester224]

In N.Y. they are recruiting retired doctors, medical students and nursing students to act as "reserve staff". Desperate measures for desperate times.

[Cynical Asshole]

When the only thing a bureaucracy can do to help is to get out of the way, one has to start to wonder what the point of keeping that bureaucracy around is.

[Richard L Pratt]

I love the way you think.

[wagnert in atlanta]

He has the keys to the kingdom.

[soldiermedic76]

Serious question: if Trump is re-elected could he make a valid argument that these regulations that were loosened weren't needed in the first place? I think he could get traction with that argument.

[Unicorn Abattoir]

Cuomo should be demanding to know why it took so long for the FDA to get out of the way.

I'm not holding my breath waiting for Cuomo to question government bureaucracy.

[Brandybuck]

I work in the medical device industry. I started a new job this week with a leading medical manufacturer. As such I am in the middle of reviewing all the development and manufacturing procedures in place for getting devices out the door and into the hands of medical professionals and patients.

It's fucking complex. Mind boggling complex. You guys have no clue how complex this is unless you've been in medical.

That the government is streamlining approvals for supply chain changes is near miraculous.

[soldiermedic76]

But the answer is to put the government in charge of all medical, at least according to the Democrats.

[Nardz]

Well, that company is going bankrupt soon then

[Unicorn Abattoir]

You guys have no clue how complex this is unless you’ve been in medical defense or nuclear.

FTFY

[Signer]

I am having trouble with Cuomo's math and how he reached the figure of 30,000 ventilators needed. I've seen no one question how he got to that number.
And why does he think the War Powers Act can magically turn Ford into a ventilator manufacturer overnight?
I think people are distracted by his theatrics and aren't really listening to how ridiculous he is being. I mean, they staged a bunch of medical supplies as his backdrop. It's all showmanship.

[JimCherry]

More "rules" now shown to be both useless and counterproductive. When this particular panic is over, government needs to look very seriously at all the rules that are in place, and try to justify them, or just get rid of them.

[aajax]

Never blame the government unless it is impossible to pin the problem on private industry.