Coronavirus

U.S. Needs Billions of New Masks to Combat Coronavirus. Feds Say It'll Take Up To 90 Days to Approve New Mask-Making Facilities.

Established makers of N95 masks are ramping up production as fast as they can. New manufacturers hoping to help meet demand are running into regulatory roadblocks.

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America is suffering from a shortage of almost everything it needs to combat the spread of COVID-19. Hospital beds, ventilators, gloves, and gowns are all in short supply.

That's particularly true of the N95 masks that help medical professionals avoid catching and spreading the virus as they tend to patients. The N95 designation refers to the ability of these masks to filter out 95 percent of airborne particles.

In early March, the U.S. Department of Health and Human Services (HHS) said that the country's stockpile of N95 masks was enough to meet about 1 percent of the three billion masks we would need during a true pandemic.

The pandemic is here now and so are the severe shortages.

The New York Times reported yesterday that California Gov. Gavin Newsom (D) says his state is short hundreds of millions of masks. New York Gov. Andrew Cuomo (D) is begging companies to start producing more masks and promising that the state government will pay top dollar for them.

The Centers for Disease Control and Prevention (CDC) is advising healthcare workers without masks to wear scarves and bandanas instead.

Large mask makers say they are doing everything to ramp up production. Meanwhile, the medical establishment and some in the media are urging the Trump administration to invoke Cold War-era emergency legislation to force private manufacturers to make even more.

At the same time, government regulations are stifling the ability of manufacturers to set up new N95 mask production facilities—handicapping the private sector's ability to respond to the current crisis.

That response includes the Open PPE Project, a group of about 15 engineers, technologists, and others who are attempting to set up their own N95 mask production facility, which they hope can then be used as a model for other companies and organizations to copy.

"We're trying to source materials, design N95 masks, and mass produce them," says Matt Chisholm, a spokesperson for the project. "On top of that, we're hopeful that our learning will allow us to put the information out there for other people and groups to do exactly what we're doing to mitigate the supply chain problems of there not being enough masks."

The Open PPE Project is in the process of setting up its own manufacturing line in Michigan. Chisholm says that they just secured a source of blown polypropylene, a common material used in making N95 mask filters.

Chisholm declined to give a rough date for when the Open PPE project would be capable of churning out masks. However long it does take, he says, getting the necessary government approvals could add up to three extra months.

The production of N95 masks is regulated by the CDC's National Institute for Occupational Safety and Health (NIOSH). Prospective makers of N95 masks must submit detailed written applications to NOISH, and send finished products to its Personal Protective Technology Laboratory for testing. NIOSH staff must also personally inspect new manufacturing sites before they're allowed to start pumping out masks.

Chisholm says regulators have told the Open PPE Project that getting agency approval could take anywhere from 45 to 90 days.

"The problem with that is that you have possibly 45 days to 90 days of product that could be used to save lives that is now sidelined," he says. Complicating things further, he continues, is that NOISH inspectors are under travel restrictions (as are most federal workers), potentially delaying approval even longer.

With shortages only likely to grow worse as the spread of COVID-19 accelerates, that means many healthcare workers are having to go without.

"About a week ago, we were told that we were going to get PPE-appropriate N95 masks, surgical masks, and gowns and gloves would be ordered," says one hospice worker who spoke with Reason last Friday. "But then I guess like everywhere supplies were not readily available."

This hospice worker, who asked not to be named because she doesn't have permission from her employer to speak to the press, says she was given a PPE bag containing a single N95 mask, plus gloves, a rubber gown, and foot coverings, all of which she was told to reuse.

"Pretty quickly you realize that's not sufficient, especially considering the population we serve," she says, noting that the elderly are particularly vulnerable to the COVID-19 virus. "I used to work in a hospital. I'm thinking of all this as disposable. You see one case and then you throw it all away. That realization hit pretty quickly."

Her story is being repeated across the country as doctors and nurses report being forced to reuse masks or go without them completely.

3M, one of the largest makers of N95 masks, says that it is producing 35 million respirators per month in the U.S. and that within 12 months it plans to double global production capacity to 2 billion masks a year. It also says it is exploring coalitions with other companies to expand mask production further.

Honeywell, another major mask manufacturer, claims it has more than doubled its mask production, according to The New York Times.

That's a lot of masks, but nowhere near enough to meet the current demands of the country's medical sector, let alone the demands of other essential workers and volunteers who are out in public right now, potentially dealing with sick people.

Last week, Congress passed a new law that allows mask producers to sell NIOSH-approved N95 masks to healthcare workers. Previously these masks also had to get separate approval from the Food and Drug Administration before they could be marketed and sold to medical staff.

That action will allow companies to ship more masks directly to the hospitals and clinics that need them the most. But it won't do anything to boost the aggregate number of masks being made.

Chisolm suggests that the Trump administration should go further by giving NIOSH more flexibility in approving new N95 makers. Allowing university labs to test prospective manufacturers' products would be one way to speed things up, he says.

Getting enough masks for everyone will require more companies and factories to get into the production game. That could mean GM pumping out masks instead of cars, or something more decentralized along the lines of what the Open PPE Project envisions.

Neither is going to happen as quickly as we need it to happen so long as the federal government takes months to approve new mask-making facilities.

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  2. Neither is going to happen as quickly as we need it to happen so long as the federal government takes months to approve new mask-making facilities.

    So what happens if a new manufacturer goes public and says ‘approve us now or we’re moving on to other things’?

    1. So what happens if a new manufacturer goes public and says ‘approve us now or we’re moving on to other things’?

      Something something… “EVUL KKKORPORAYSHUNZ” mumble mumble… “PROFITZ OVR PEEPUL!1!11!!!!!1!!!!!!”

    2. Bureaucrats gonna bureaucrat.

      Maybe we’ll get a little pendulum swing against apparatchik control of our lives out of this.

  3. Obviously, we need to massively increase the budget for the CDC so that they can hire some people to form a panel on the subject of forming an exploratory committee to examine the feasibility of writing new regulations on the subject of hiring more inspectors.

    1. It should only take about 18 months. That’ll be in plenty of time to get N95 masks to the gravediggers.
      Whatever would we do without regulatory authorities to keep us from doing it?

  4. Fuck the CDC. They have fucked up so many things.

  5. I sure hope everyone remembers after this is over how the federal regulatory bureaucracy totally fucked everything up by creating or worsening these shortages with their idiotic rules.

    Oh who am I kidding, it’ll all be Trump’s fault because “orange man bad.”

  6. FYI, word coming out of Italy is that the number of virus cases might actually be ten times higher than initially reported.

    That means the death rate isn’t 9.2%–it’s actually 0.92 percent, if true. And that’s in a country with a population that skews older, loves to gather in large numbers and get handsy with each other, smokes, and has been defying the lockdown orders to such an extent that around 11,000 people a day are getting fined for being outdoors.

    Yep, totally worth putting a bullet in the economy’s head for this. Sounds like the solution should have been like what I said a few days ago–tell older populations to stay home, anyone showing symptoms only go to the hospital if those symptoms get worse, otherwise stay home, and let everyone else get back to work.

    1. Oh, no. It’s lots more fun to run around with our hair on fire, screaming. With the press to egg us on.

    2. If only we had enough testing we could figure that out! Legit two months into this thing and they are STILL dragging their feet. It’s almost like they don’t want the most useful data, they want the scariest data.

  7. Look, Britschgi – if that’s your real name – we already know the best way to fight this virus. And that’s to STAY AND HOME AND LISTEN TO POLITICIANS! OK? If we just let anyone have a mask, then they might be less inclined to cower in fear at home. And then they might want to actually go outside. AND THAT WOULD MEAN THEY AREN’T LISTENING TO THE GOVERNMENT!

    Do you understand what this means? DO YOU?

    It means that they would no longer be deferring to the authority bequeathed on on these politicians by voters who can’t find their elbows from their assholes and needed to be bused to the polls during a two week window prior to the actual election day. Because they obviously care enough not to vote unless someone helps them do it. AND THAT WOULD BE COMPLETELY UNAMERICAN. And unsafe.

    WE ARE DOING THIS TO KEEP YOU SAFE, AMERICA! Don’t you understand? How in the hell can we eliminate all risk from life if you don’t let us try and eliminate all risk from life? I’ll tell you how…. GET EVERYONE TO PANIC MORE!

    And besides, the FDA has rules in place in order to keep people safe from stuff like infectious diseases and pandemics. You wouldn’t want to die from that, would you? They got this under control.

  8. https://www.washingtonexaminer.com/news/los-angeles-times-and-bloomberg-news-federal-stockpile-of-n95-masks-was-depleted-under-obama-and-never-restocked

    “The national shortage of N95 respirator masks can be traced back to 2009 after the H1N1 swine flu pandemic, when the Obama administration was advised to replenish a national stockpile but did not, according to reports from Bloomberg News and the Los Angeles Times.”

    1. Too busy feathering their own nest, ensuring a sufficiently diverse workforce, and finding other areas of public health to investigate, instead of being bothered with actually fulfilling their stated mission.

      Is there anything, anything at all in the US government that Obama didn’t politicize and fuck up in the process?

  9. getting the necessary government approvals could add up to three extra three months.

    So, *nine* months? 😉

    1. 3M and Honeywell need to submit their applications for baby-sized N95 masks now to have them on the shelves when the #coronababies get here.

  10. Chisholm says that they just secured a source of blown polypropylene, a common material used in making N95 mask filters.

    In 10 yrs. we’ll all be able to 3D print blown polypropylene masks on our 3D printers at home.

    1. In 10 years the plague zombies will be eating our faces.

      Ha ha, I actually don’t know this.

      It could be 5 years.

      1. Depends on whether we keep the total deaths below 1M for the next 2-3 mos.

  11. “advising healthcare workers without masks to wear scarves and bandanas”

    Those sound like the kind of masks robbers wear…maybe our leaders could stock up for their own use?

    1. I suggest that people should just cut some eyes holes into a furnace filter and duct tape it to their face.

      1. I think… we all think the filter with duct tape was a nice idea. But – not pointin’ any fingers – they coulda been done better. So, how ’bout, no filters this time – but next time, we do the filters right, and then we go full regalia.

    2. We’re gonna need billions of bandanas.

  12. Hell, yes!
    Let everyone make masks in their basements from recycled belly-button lint and used tissues. Who needs any kind of quality control in a time of “crisis”?
    I bet China would be willing to donate (for a small shipping fee) a bunch of formaldehyde soaked fabric.

  13. Government’s only competency is in incompetency, and government’s only efficiency is in inefficiency.

    1. “We’re the government – and we’re here to help!!??!!??”
      Oh Please; Just go away!

      1. BGNBG’s earlier comments suggested your (and my) assumptions were correct; seems not so.
        A bit smug, but perhaps some helpful comments?

    2. “Government’s only competency is in incompetency, and government’s only efficiency is in inefficiency.”

      Now that you are being more specific, your comments are far more ‘reasonable’.

  14. Better ask the almighty parents if its okay to purchase a face mask. Land of the Free?? Is that a joke?

  15. There are currently 52,000 cases of the Chinese virus in the US the vast majority of which will not require hospitalization. Even if the number increases 10 fold why do we need billions of masks? And why are hospital beds, ventilators, gloves, and gowns all in short supply when most people have very mild or no symptoms?

  16. What happens if Trump invoke the Defense Production Act to force companies to manufacture things they do not normally produce, like , say forcing Ford into making ventilators? First, how long would it take to even get that done and get the first units off the line? Are those units going to get approved? If someone dies on a Ford-made ventilator, will Ford get sued because of it (you know they will)? Does DPA provide indemnification?

    How about we just let the normal manufacturers do their best to meet the needs? Do we really want medical products made by people being *forced* to make them?

    1. Current ventilator manufacturers don’t have near enough capacity to manufacture the number necessary, even if you cut Cuomo’s hysterical blathering by a factor of twenty. On the other hand, Hanes has volunteered to make masks…
      But you’re quite correct that forcing companies to make something completely different from their usual product line is a recipe for shoddy, useless output that wastes raw material. The attitude that would like to compel that thinks that all you have to do is walk onto Caterpillar’s production floor with a government order and a posse of lawmen and bark, “Ventilators! Now!” to get results. You might as well do it in Chase Manhattan’s headquarters.

      1. Yeah, it’s one thing if the manufacturing equipment is the same and all you need to do is change some software (I’m thinking things like vacuum table plastic molders that can take a sheet of plastic, heat it up and mold face shields or car parts). Maybe just changing some molds or software in a 3d printer or CNC machine making parts is doable, but asking a car company to start making ventilators seems unproductive at best, and likely dangerous to the folks getting those units.

    2. mpercy
      March.24.2020 at 7:39 pm
      “What happens if Trump invoke the Defense Production Act to force companies to manufacture things they do not normally produce, like , say forcing Ford into making ventilators?”

      The first thing that would happen is idiots whining that
      A. Trump has no authority to do so
      And, secondly,
      B. Microsoft makes really crummy masks and it’s Trump’s fault.

  17. We had a run at the mask issue down here. A bunch of ladies got together to make cloth surgical style masks for the nursing homes, etc. Turns out, that’s not legal. They can’t use them.

    So the debate began. The decision was not to make them just to hand them out to random people. You know, under the theory of “screw that noise”.

    And now I read “suggest they wear scarves and bandanas”. Can’t wear a specifically made mask – -either of cloth from amateurs or of actual nonwoven filter that just isn’t yet approved from a manufacturer — but go right ahead and wrap a scarf around your face. That’s so much better.

    Good lord. We are idiots.

  18. Of course, the answer to all of this that we haven’t really hammered home yet – quit depending on the government for this sort of regulation.

    Underwriter’s Laboratories does a great job. Plenty of other industry groups do just fine without government intervention. The internet works just fine with working groups instead of the world’s politicians regulating it.

    So why not industry seals of approval instead of this nonsense. I guarantee that UL would have no trouble getting something approved in days if it was needed like this.

    Someone needs to put two and two together and start moving us away from FDA and ATF style regulatory agencies. We’d be a lot better off if we subscribed to private entities for those services.

  19. Since South Korea and China are pretty much over their infections, why don’t we just import masks from these countries? Well, the answer is most likely that it’s forbidden because they’re not approved by the alphabet agencies. Same with importing life-saving medicines at a fraction of the cost of domestic medicines.

  20. Needs “billions” of masks?
    CNN called; they want to see your resume.

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  22. South Korea is the best fighter, we should follow them.

  23. Where are they going to get the polypropylene once the Progressives ban fossil fuels?

    1. After they’ve stopped rich white men from creating diseases, masks won’t be needed.

  24. The time to provision for face masks, hand sanitizer, etc. is past. That country so rich with worlds most EXPENSIVE health care system is folding is RiDICULOUS.

    We are paying for effete government, cynicism in anything planned and lobby’s priorities…but THANK GOD for that tax cut!

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