NIOSH — National Institute for Safety and Health

I’ve been working on an N95 mask production project with a team for about a week now. We just got off the phone with NIOSH. They told us that approval for a new mask production facility in the US will take at minimum 45 days, but more likely 90. A lot of people are gonna die.

That is from Matt Parlmer.  How can we let this persist?

Comments

No idea. For the sake of the country, do it anyways and let them come get you.

Sometimes being a hero has consequences. Doing the right thing usually ends well though.

If that's the best the American governmental bureaucracy can do, then there needs to be a serious shake up in how it's structured. CYA, bureaucrats unwilling to work long hours and take any personal risks are going to result in higher death tolls.

I'm amazed that anyone who has lived in this country for any amount of time would be surprised by this. I can make another prediction: the first impulse on the left is not to remedy the situation, it's to see how they can blame this on Trump.

I'm amazed that anyone who has lived in this country for any amount of time would be surprised by this. I can make another prediction: the first impulse on the left is not to remedy the situation, it's to see how they can blame this on Trump.

Well, Donald Trump is the head of the administrative branch of the federal government. NIOSH is a federal agency. So the head of NIOSH reports to Donald Trump. Why can't Donald Trump tell them to approve the facility immediately on a temporary basis? Is there some federal law that prohibits him from doing that? Or maybe he's too busy tweeting?

Just because someone CLAIMS to have created an N95 mask doesn't mean the mask meets N95 standards. NIOSH is saying they will need 45 days to know that for sure.

You can blame this in Trump if you wish, but it was exactly the same under Obama and Bush I'm pretty certain.

What if we see lots of doctors using this mask fall ill, and then when the development team is asked their response is "I retrospect, we didn't completely understand the specification and our test was wrong. When we correctly test we see the mask lets through a lot more infection than we initially thought. We withdraw the mask."

Do you want that?

You've got doctors using masks repeatedly from patient to patient, and there's people making masks using stuff they bought in a stationary shop. Are you telling me that this mask is worse than the status quo?

You can blame this in Trump if you wish, but it was exactly the same under Obama and Bush I'm pretty certain.

Except that Trump wasted a lot of time claiming that the virus was no big deal, and nothing to worry about. That time might have been spent ramping up production and approval of masks but hey, we'll be down to zero cases in a few days.

So yeah, it might have taken just as long under Bush and Obama, but it would have started a lot sooner.

Maybe. It seems impossible to know for sure. What comparable
events could we compare in previous administrations to get a baseline?

Just because someone CLAIMS to have created an N95 mask doesn't mean the mask meets N95 standards. NIOSH is saying they will need 45 days to know that for sure.

What if we see lots of doctors using this mask fall ill,...

So don't let them sell to doctors until they get certified. Make them put a big sign on the bag, "Not for sale to medical personnel."

You can blame this in Trump if you wish, but it was exactly the same under Obama and Bush I'm pretty certain.

In case you haven't noticed, the country wasn't half shut down due to a virus under Obama and Bush.

So Donald Trump, as head of the executive branch, should tell NIOSH to insist that the company produce masks for the next 45 days that say, "Not certified N95 by NIOSH."

Or better yet, divert some of the money he's diverted to his imbecilic wall with Mexico, to hiring enough NIOSH people that they can certify in 10 days, rather than 45. And advise the company that he will personally by the masks until NIOSH certifies, and donate the masks to people who need them.

Do you want that?

I want the federal government, especially Donald Trump, to get off their asses and do whatever is necessary, within the limits of the law, to get as many filter masks in the hands of citizens as possible. I want him to stop congratulating himself for all the wonderful things he's doing, and get to work.

Oops. Sorry about the blockquote mistakes.

I'm amazed that anyone who has lived in this country for any amount of time would be surprised by this. I can make another prediction: the first impulse on the right is not to remedy the situation, it's to see how they can defend Trump no matter how shitty a job he is doing.

Don’t be ridiculous. He’s a blowhard, but he’s not the one who offshored the production of masks and antibiotics.

Nor is “he” the guy who wrote the rules that decide how long mark testing must go on before new masks can be produced for sale. He IS the guy who can overrule the red tape dominated regulations. So let’s hope he does that.

The nail that sticks up gets hammered down.

When you're holding a hammer, everything looks like a nail.

Relevant:

https://aelkus.github.io/problem/2020/03/18/collective

We have a shortage of doctors too! Let me put on my scrubs and I'll be ready to do some brain surgery! Screw med school and the AMA. They are gatekeepers. For the sake of the country, I'll go play hero!

Is it possible to go to federal court and get a temporary emergency injunction against the regulations on the basis that they will literally kill huge numbers of people?

The right way to do this is probably to waive the requirement for NIOSH certification during the emergency, and maybe try to spin up some much faster testing process for the duration. Under normal circumstances, having the process take 45-90 days to approve your production line isn't a huge problem--that's just not appropriate for a crisis.

Because quality control matters? Claiming to be n95 is not the same as actually meeting that standard.

But hey, anyone can build an airplane in their backyard - why should the aviation authorities have any oversight if you plan to market such planes to a large group of paying customers.

But it's not like building a space shuttle - the technology is not new or particularly complicated. You sew a fine filter between some protective outer layers.

With a complete air tight seal after sewing - which is checked how?

Why would it need to be airtight? It is not as if there is an airtight seal between face and mask. Yeah, let's integrity test them all, they should be ready in about a year or two...

Why would an N95 respirator need to be air tight? Maybe air tight is not the right term - how about creating a seal that allows nothing larger than .3 microns from being breathed in past the filter, with an air tight seal everywhere else against the wearer's skin.

And it is a reasonable assumption that such QC is routine at 3M. or anyone other manufacturer.

"Why would an N95 respirator need to be air tight? Maybe air tight is not the right term - how about creating a seal that allows nothing larger than .3 microns from being breathed in past the filter,..."

....ummm........because then it wouldn't be an N95 filter. :-)

The "95" refers to 95 percent filtration efficiency for particles down to 0.3 micrometers.

Cutting engineering corners for expedience may kill people. It's a lot like the space shuttle. Of course the space shuttle never had the potential to save anyone, or do any other useful thing for that matter.

If the choice is between no mask and one that might not work 1% of the time, the decision isn't hard.

How about a mask that you think is working 100% of the time but is only working 95% of the time? Much worse than no mask at all.

Once there are plenty of "100%" masks, then you wouldn't want a "95%" one. But that isn't the situation. It is no mask or an certified one.

Having worked with real sealing masks in the military, even those with heavy rubber seals are not 100%. Some flimsy fabric thing held in place by elastics is nothing like 100%.

Nils gets it. Congrats to him. Also:

>I’ve been working on an N95 mask production project with a team for about a week now.

"About a week," huh? Where the hell were you, say.... 45 days ago?

Quite an entrepeneur you are, deciding to start up a mask business last Sunday. Stunning predictive insight on your part. And now you're horrified to learn that you can't build a new factory that produces sterile medical gear in ten minutes. At least you're good at finding a gullible professor to broadcast your "plight."

Good point. Better to let bureaucracy save us from a screw up.

We don’t need regulated capitalism right now. That’s for fking losers. We’re head to a depression and a million plus deaths.

We need dirt fking nasty 1860-1890’s style capitalism.

People sling shite against a wall and see what sticks. Guess what that capitalism will kill people. But less than what’s coming. I’d rather be shot at by a hand gun than a machine gun.....

Nils, why can't they fasttrack the certification process? How many serious efforts are there to make more masks? It can't be that many. Send whatever Government Checker to the factory tomorrow, have the Checker check it. Why can't that take two days? Then the Checker can move on to the next mask start-up.

+1
There is an irrational deference to the process, here and for test kits & vaccines, maybe because regulators can’t be blamed if things go wrong (“I was just following protocol!”). Safety matters, but in a deadly pandemic, slowness kills. At the current margin, the cost of no masks > the cost of less-safe masks.

> At the current margin, the cost of no masks > the cost of less-safe masks.

That's not the tradeoff. The tradeoff is a re-using a known good mask versus a mask of questionable quality.

That's not the tradeoff. The tradeoff is a re-using a known good mask versus a mask of questionable quality.

No, that's not necessarily the tradeoff. There are 330 million people in the U.S. Probably less than 10 percent of them have masks. In Hong Kong, virtually everyone is wearing a mask in public.

If NIOSH is so worried about quality, they should simply require that the manufacturer not claim N95 status, and not sell in medical situations until the NIOSH approval is complete (which should be days, not weeks).

It seems we would want the masks to be produced but with labelling that they have not passed some kind of testing.

There are a lot of people who would love an "almost as good" mask right now. There are also people who really need an N95 mask. We can serve both of them.

Exactly, and they are permitted to produce masks that do not meet the N95 standard without this level of quality oversight RIGHT NOW.

That assumes we have enough N95 mask production currently. Though by all means produce what you can. People will ultimately make their own decisions.

+1, you don't want to get more people killed. Make a mask that doesn't need to be guaranteed to meet N95 standards if you're worried about speed over quality. You will have buyers.

Interestingly, that is kind of what is happening right now in usually bureaucratic France: non-compliant washable masks are being produced based on openly-shared designs by all kinds of sewing enthusiasts and textile companies. These are solely intended for people who aren't on the frontline, thus easing the demand for compliant FPP2 masks. One major caveat however: I've only seen mentions of these masks being produced for donation purposes only. Maybe going commercial is what triggers the requirement for compliance?

The issue is NIOSH Certification(R) not necessarily production (that may be a problem later).

In today's WH press briefing (not vouching for accuracy), Pence stated 3M makes N95 masks at a rate of 35M/per month. Only 5M/month are certified for medical use. Likely do to regular demand and *maybe* some additional processing, possibly just labeling and documentation.

If they can temporarily reroute existing production from general industrial to medical thru temporary lifting of regulation, supplies can be increased without increasing actual production.

I would assert that very many medically-certified consumables have industrial equivalents that are near substitutions, maybe just missing superficial requirements.

A temporary relaxation of specific regulations, with liability lifting, but strong penalties for fraudulent representation or reformulation, may be a short-term solution that pushes through the peak.

/end of thread. I don’t think Tyler watched the press conference.

This is also an argument against GM producing ventilators.

Even if a company transferred all of the build data for an FDA certified product, no engineering design or rework, just turnkey production. I would imagine it would take *at least* 45 days for them to retool a production line/procure 1st articles/disrupt existing supply chains even with concurrent FDA certification.

https://multimedia.3m.com/mws/media/1794572O/surgical-n95-vs-standard-n95-which-to-consider.pdf?fbclid=IwAR2Ar19I9A3akGyLihOPCf_XN2d82VecRGCxk81W0OPKnABrxyWvz5VOfYk

"Therefore, if a healthcare facility is prioritizing respirator use – due to, for example, limited supply during a health emergency
– they may want to consider prioritizing use of surgical N95 respirators for those healthcare workers requiring respiratory
protection while performing surgery or other tasks that may expose them to high pressure streams of bodily fluid or
conducting work in a sterile field. For other workers who will not be performing such surgical procedures or do not need to
maintain a sterile field, a standard non-surgical N95 (or equivalent) respirator can be worn to help reduce those workers’
exposure to patient-generated airborne viruses and bacteria"

3M even says itself that the standard industrial use N-95 masks are just fine for medical use, as long as your not performing surgery.

Are you saying the White House misrepresented something obscure that was already true to get credit for something that didn't require them to do anything?

How can we let this persist?

"How can we let this persist?"

Because someone people will go to the mat excusing this type of behavior.

But why not offer protection superior to N95 that don't meet regs because they work completely differently?

Why not innovate?

A plastic bubble covering the head coated with platinum which probably disrupts organics at the atomic level, with air blown through a high intensity UV led lit tubing maze to disrupt organics at the atomic level.

Higher cost, but reusable without sterilization for a long time.

And no one will infect themselves by touching their face.

Because that would probably require at least 18 months for approval under the current regulations and bureaucracy.

Many would settle for adequate supplies of N50 or N70 or N80 masks (I assign hypothetic numbers there) for ample distribution through the general population: availability? manufacture? distribution?

And meanwhile, who is actively promoting COVID-19 treatment with favipiravir? where besides China and Japan? again: licensing? manufacture? distribution?

--and, as ventilators are being used for severe cases of COVID-19, what is the present status (and availability) of silver-coated endotracheal breathing tubes (cited for controlling the onset of pneumonia)?

https://en.wikipedia.org/wiki/Medical_uses_of_silver

Good news. Silver prices are, and have been for some time, hugely cheap/depressed compared to gold.

The current mortality rate in California is .01%. Check out SF chronicle: https://projects.sfchronicle.com/2020/coronavirus-map/.

People die after being in the hospital awhile.

For accurate information on deaths and death rates, go here: https://ourworldindata.org/coronavirus

Perhaps, but it doesn’t mean “a lot of people are gonna die!”. It is scary out there but there’s also room for some meta/perspective, and it would a shame to perpetuate fear-based energy rather than hope through industry and solidarity. A lot of people, in fact, will live! Furthermore, a lot of people may get sick, but many of them won’t die.

Please look at the case fatality rates. Anyone can read the material in the link and decide. The source, from Oxford University, collects data from around the world. We all have an interest in being well informed. Both me, you and your neighbor.

Bill, thanks for the data. While not a math person, I’m looking at mortality rate as the “Total Deaths”/“Total Confirmed Cases” and this is what I get *roughly* for each region:
China 4%
Republic of Korea .9%
Japan 3%
Italy 8%
Spain 4%
Iran 6%
USA 1%
Worldwide 4%

Can someone check my logic and math? Doesn’t this mean that a lot of people are NOT gonna die?

As a math issue, you need to lag some of the data. So, the number of confirmed cases is just the number of infected persons. OK. The number of dead folks are people who were probably in the hospital for awhile before they croaked. OK.

The rate of growth of reported cases is exponential. OK. As the denominator grows bigger, faster, and the rate of folks going into the hospital drags on before they croak....well, I hope by now you see why simple division in early stages has a little bias.

Bring out that calculus and differential calculus book. And, god, don't you hate exponents.

Just was helping my wife tutor a kid on the telephone with algebra as the schools are closed. I taught my wife about simple linear equations, She was surprised that you could figure out how many hamburgers and hotdogs you could purchase with various combinations to meet a $30 budget constraint, and have some money left over if you ate certain combinations. The kid chose all hamburgers.

Thanks, Bill. Yes my numbers are very rough. And yes the actual rate changes quickly but incidence rates are diminishing given global interventions, so the *denominator* will be diminishing as well, but I can’t predict future mortality. Prevalence is another statistic, which I’m having a hard time capturing with this data. If you go into the world thinking you and all will die and the numbers don’t necessarily support it, you bump into a scary self-fulfilling prophecy.

the Our World in Data site for COVID-19 has a great section (well several) on understanding some of the issues around getting to the numbers on death. You have to scroll down. CFR during the event will be biased in two ways -- timing of death tends to lag the reporting of infections and under reporting of mild cases of the infection. The first will bias the numbers during the outbreak to the down side, the later bias them to the upside. We have both problems now.

Still, we have some observations and a general idea of where the impact is and how bad it is compared to other outbreaks.

Even with a lag in mortality reporting, I can’t imagine new deaths are going to sway the numbers considerably. It would be nice to do a confidence interval with this one.

Hospitals kill people

Ventilators also kill a lot of people.

Stupidity kills far more people, though.

+1

And when accounting for time lags being born is 100% certain to kill you.

To be honest I suspect we're going to find that the indirect deaths may well be just as bad as the direct deaths, that the social impact from the economic interruption results in additional deaths, for some parts of the world starvation may become an even greater killer than SARS-CoV-2.

Last, the direct impact economic relationships and trade will have a wealth effect that is not good and the political economy of that may well lead to both internal and external political conflict and frictions (China as already claimed the USA military is actually the responsible party and it the victim -- not really all that good).

Yes, we have things to worry about but I think blowing things out will head us towards the panic path just outlined above. The "We're all gonna die!" rhetoric here pushes us towards that panic path and it is not necessarily where we have to go.

This is a manageable situation -- but yes, some people will in fact loose people they care about. This is part of life.

+1

Those are good points. It's doubtful if anyone knows how this will play out. But that is the nature of such crisis. If we knew, then it wouldn't be a crisis.

It's somewhere between, it's just the Flu, and it's going to drastically effect civilization.

Change is inevitable. What counts is how you leverage it.

If stupidity kills people,
A lot of people are going
To Die

Yes! EUREKA!

Approximately 100% of them over time.

We must beseech the FDA to treat the stupidity virus! Taxpayers unite!

You can't do math. 19/975 = 0.019 ... which is 2%, not 0.01%.
Or you don't know what % means, or something.

Yes, thank you for the correction and for exposing my dark secret that I *CAN’T DO MATH* based on a computational error!? I feel ashamed. But whatever. So mortality is at 2%. My point stands: still a lot of people are NOT GOING TO DIE.

Are you like a parody of a really stupid commenter or something?

Hazel, again many blessings for your kind words. You’re a gem :/ My point is to challenge the construct of “A lot of people are going to die”. AS A HOSPITAL WORKER, I implore everyone to be reality-based and maintain perspective. There are many reasons, statistical and anecdotal, to stay positive. And if you think this is a parody, perhaps the comedy will give you healing laugh.

I'm actually with you that 2% is objectively, not the apocalypse. The problem is that the heathcare system is going to be overcapacity handling so many cases that need hospitalization, which could drive that up, not that we're all going to die.

Geez, finally!

Take a tip from the bong manufacturers and label the masks "for entertainment uses only".

Good one. These procrastinating bureaucrats, to use a Soviet phrase, must be unmasked head to toe.

when the niosh outlaws masks
only outlaws will wear masks.
try manufacturing the masks in Texas
where the governor is smarter/more reasonable

What gives NIOSH approval for approving the production facility?

I think what the writer meant is that the testing, approval, and certification process for a new N95 respiratory protection mask will take 45 to 90 days. That is very different than saying that NIOSH regulates the facility.

See https://www.cdc.gov/niosh/npptl/topics/respirators/cel/default.html

What every private company needs to learn is to lobby their elected leaders directly. A call from the president of the company to his Senators and applicable representatives will probably help NIOSH move along faster. Some groups have realized the world has changed and some groups are stuck in the past. It appears that NIOSH is stuck in the past.

Why wouldn't they should stop calling their masks N-95 (which requires verification) and simply label them fashion masks? There is no need for consumer safety regulation or certification of such a product since no claim is made.

Then they can't be used for medical purposes. But if they were sold, I'd pay extra for ones with FU NIOSH! on the front.

Well, they will be used for medical purposes if and when the N95-certified masks run out.

These are just fashion masks. They will be used for strictly non-medical purposes, such as wearing them wherever people congregate, as is normal for fashion items.
A doctor may even suggest that their patient wear a mask to boost their confidence. Not a treatment advice, but something to the effect of:: Sleep well, exercise, wear a face mask: it looks good on you.

The issue is not a plant coming on line, but the inadequacy of strategic reserves.

Here is a history of past declarations of medical emergencies and the failure of funding for public health preparedness. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5594396/

You get what you pay for.

Oh come on. That has nothing to do with why the NIOSH is saying it will take 45-90 days to approve a mask for manufacturing.

"You get what you pay for."

Yes, and we pay far more that what other countries do.

"The National Institute for Occupational Safety and Health will have an operating budget of $336.3 million – a $1.1 million increase from FY 2018."

Re: "The National Institute for Occupational Safety and Health will have an operating budget of $336.3 million – a $1.1 million increase from FY 2018."

What does that have to do with the price of bananas in Uruguay? Or, for that matter masks or their availability?

They clearly needed to have purchased more masks and ventilators, and, guess what, they were probably constrained by a limit on expenditures during previous administrations. Dah. How quickly we forget.

> They clearly needed to have purchased more masks and ventilators, and, guess what, they were probably constrained by a limit on expenditures during previous administrations.

Masks expire after 4-5 years. You can't keep them around. Which means if you are assuming a pandemic is coming that will required 100X the number of masks normally needed in a year, then it means every year your throwing away 99X of masks. That is, if you use 1M masks in a normal year, you will throw away 99M masks a year if the pandemic never happened that year.

Kind of nuts. Masks are not MREs

It's insurance and not a product.

And how do we know this is for real and not another internet hoax?

I am not going to defend this one. Someone should get the certifiers on an military jet and out there to expedite things.

Brazil has officially decided to adopt a virtual plenary for its Congress.

>A lot of people are gonna die.

You keep hoping that, Ty, but it keeps continuing to look like just another bad flu season in the USA.

Sorry bud! Keep at it, though!

Go to Vietnam or even China you can get approval in 3 days.

By the way this is one benefit of the pandemic. The costs and delays involved in regulatory approvals are ridiculous, expensive and unjustifiable. All the time.

I'd suggest getting ahold of your local federal politician, scream at them for a few minutes. I suspect the regulator will be calling you back within a few hours with a slightly different attitude.

"Go to Vietnam or even China you can get approval in 3 days."
Evidently, totalitarian regimes are great.

This is the interesting thing here. The totalitarian regimes when it comes to operating a business are in the overwhelmingly regulated western democracies. In the authoritarian countries of Asia, there is almost total freedom when it comes to doing business.

The ridiculousness of this situation was going to be exposed dramatically at one point, and it is happening now.

From and Instapundit reader:

Just a little Covid tidbit from the small business world. My bank reached out to me early this week and said that they were allowing all of their commercial customers to go to interest only payments simply by sending them a request. They called back today to say that their regulator, the OCC, had informed them that they would consider any such modifications TDR ( Troubled Debt Restructuring). Needless to say, the bank can no longer do it. It’s almost as if the bureaucracy is actively working against us.

I walked to look at a job this morning, taking me through the empty downtown of my small town. Lots of friends and customers on the street. They all had fear in their eyes. Not from the virus, we don't have any cases close. But from bankruptcy, from trying to figure out a way to survive, for their workers to survive.

I love to see the disgusting bureaucracy exposed this way. These are awful people. They all have enormous latitude in these situations, and how they react in this crisis is an indication of who they are, personally.

Break the law, hope that administration is closing one eye, bribe them, get declared not guilty before a jury

Taiwan's continued existence as an nation independent from China is completely dependent on US military support. Why in the world can't we convince them to sell us a ton of masks? Taiwan, a nation of 20 million people, has nearly ramped up to production of 10 million per day.

This is the worst take i've heard. and playing on people's fears with hyperbolic statements is unethical.

I don't know his motivations, but i feel like money is involved. I mean, where was this guy a month ago? and are you really surprised that you can't build a facility like this in a month? i mean on what planet do you live. seriously.

And to all those other people on here talking about proceeding without approval....How willing are you to use an uncertified or "certified-lite" N95 mask....i think that could kill a lot of people too.

Read the accompanying CDC statement: "Strategies for Optimizing the Supply of Face-masks".

...HCP might use homemade masks (e.g., bandana scarf).

When it's a last resort, (*if*) what are you going to reach for, the bandana or the non-certified N95 mask?

As a physician who will soon be exposed to the tsunami of Covid19 patients i would prefer not to get infected by wearing an incompletely tested or validated mask. How many here have had to take care of an actual patient coughing up a plume of airborne viruses. Do you know what fit testing is and the rigor by which these masks need to perform in these settings. It takes only a microscopic defect in the air seal to inhale airborne viruses. While i am all for expedited approval it should not be at the expense of healthy front-line clinicians, nurses, respiratory therapists, etc, otherwise there will be no one left to take care at all.

The point isn't to avoid certifying the mask. The point is that it shouldn't take 90 days to do so.

Have you ever spray painted a car and used a paint respirator? They remove 99.9% of all airborne contaminants. Check the 3M N95 model for grinding and sanding. It comes in white instead of blue

Agreed, I have no idea how long it takes to get actual quality measures, but I want everyone in my ED wearing things that will keep them from getting sick as long as possible. Eventually community spread will occur, but I would prefer if we did not lose a whole pulm team to one bad batch of masks at the same time.

The data I've seen says mere surgical masks are ALMOST as good as N95. (x3 reduction in risk vs x4) against influenza. This is to be expected. Even N95 lets stuff through. Or you get it by another vector, making the debate moot. There is decreasing effectiveness at the margin.

https://smartairfilters.com/en/blog/n95-mask-surgical-prevent-transmission-coronavirus/?fbclid=IwAR3J5DosRybaZD7Bl2LF39rpd0MorV5rvqKsvp3KF8-B3KjKM7RJk90rgOo

Yes, yes, I know they are commercial, but it seems to check out.

My take: N95 are vastly over-rated. All this obsession about "airtight fit" really overstates their power and marginal advantage. They are 25% better than a cheap alternative, even if that cheap alternative performs no better than a mere surgical mask.

The best is not the enemy of the good here. It is the black-hearted blood-sworn foe of all that is right and holy.

Why havn't state government decided to push down the demand for N95 masks by closing dental offices, dermatology clinics, and any medical office that is not involved in acute or life threatening diseases. Can't people wait for their Lysick surgery, tummy tuck, etc.

Such shut downs would free up supplies for acute care clinics, and emergency rooms. The same would be for any elective surgeries at hospitals or same day surgery clinics. It would also help for family practice clinics to suspend doing annual physicals and start using tele-medicine for follow up appointments.

That is what the White House has been saying for two days. All elective medical procedures are to be postponed so that the resources are available as you describe.

Who the frack is Matt Palmer (what is a Helvetic-Temasekan vanguardist? as he describes himself) and why should we care what he tweets? Why does TC? More hysteria from him, since any reasonable post ought to include justification, not mere sentiment, before writing "How can we let this persist?". At least from a self-recommending "academic". His post has absolutely zero reasoned argument. And that's what I'm beginning to expect from him.

Complacency?

Instructions for making active charcoal are readily available online, e.g. https://www.wikihow.com/Make-Activated-Charcoal (which even has a section on making a home gas mask).

You can probably use coffee filters and various wire mesh (copper might be a good choice) along with cloth for the main mask.

Molding kits are readily available -- just look for any arts supply store or for one specializing in making special effects type molds for acting and you can make custom fit mask for you entire face.

It's not like we have a critical shortage of latex or silicon or plaster of paris. I suppose finding some wood to make the charcoal from in an urban setting might be a problem.

Solution: https://mobile.twitter.com/GusHurwitz/status/1240698188253683712

Tyler or Alex, can’t you guys call the engineering departments at places you know people. Start an Apollo 13 type set of back up plans.

Shoot, seems like fixing a mask that seals to a tube that runs out the window to clean air could work. Just sanitize it between patients.

I don’t know, but some smart engineers have got to be able to come up with contingency plans right. If our health care workers get sick, we are in trouble.

No so much. Forced vital capacity is typically only a few liters of air, you need to get air from the tip of the tube all the way to the aveoli in the lungs and then back out again. Around 10 meters you will have serious trouble clearing the dead space to get good respiration.

Worse, FVC is with full use of the accessory muscles of breathing. If you are young and highly fit you can keep those going for a long time. But a lot of physicians are not, nor are the nurses. So well end up going down much closer to typical tidal volumes and people would die once their chest walls fatigued (which outside of cardio folks are rarely all that strong).

You could attach a pump to the air hose, but that gets into space and power issues. Not to mention becoming a significant upkeep burden.

But even more directly have you ever tried to see how people move when tethered? The typical code will be a giant mess of tangled tethers in no time flat. Further where, exactly is this clean air of which you speak? Aerosols can drift pretty massive distances and hang in the air for a long time (this is why humidity is a godsend for slowing viral spread).

So now we are talking about adding filters to complicated machinery ... why not just do filters on faces?

The truth is, if I have a 1% error rate for my mask, I would likely be infected within the week.

Having docs go down is going to be huge. And I am willing to write off a lot of stuff before losing the guys who can manage the vents.

Very well... Just saying we have a lot of smart people sitting idle right now. And now is there chance to help save the world. Someone has to be able to come up with something in the next 2 weeks before shit really hits the fan right?

Damn, I bet the readers of this blog could it. So come on folks... try to save the world. Clearly that’s a joke, but the first time in my life it feels as real as any movie I have seen.

If you want a good project. Design a cheap, reliable valve that lets me ventilate two (or preferably more) patients with different tidal volumes effectively from one vent. Most patients have TVs that are vastly lower than what we need the machine for and if we had some sort of reliable way to split the flow disproportionately that would be immensely helpful (right now we have the trouble that if one patient has trouble on a split vent they all do and you still need closely matched TVs).

In theory you might be able to double our ventilator capacity overnight, though I suspect the gains would be smaller, but still thousands of lives saved if the worst cases come to pass.

45 days for approval of a medical device? That sounds very fast actually.

It is not a medical device. Those are aproved by the Center for Devices and Radiological Health. It is a worker protection device and just has to demonstrate that it complies with ASTM F2100-11 standards.

I found this interesting link for an explanation of the types of medical masks.

https://www.cardinalhealth.com/content/dam/corp/web/documents/whitepaper/Face%20Mask%20Selection%20Guide.pdf

Don’t worry. Even if the masks were easy to manufacture and allowed under current regulations, commenters here would still applaud the guy from Tennessee who bought up all the masks off the shelves so he could resell them at ten times the price.

Better yet. Maybe he could hijack the trucks delivering the masks because the point-of-sale retailers were going to have the audacity to sell the masks at a below black market monopoly rate. After all high prices are just a signal that consumers still have disposable income. Gotta get it all.

Yippee Capitalism!!

CDC now saying scarves are ok.
https://www.cnn.com/videos/health/2020/03/19/cdc-guidelines-masks-coronavirus-gupta-newday-vpx.cnn

Scarves are ok, but don't you dare use an N95 mask that hasn't been approved for medical use!

The point is that anything is better than nothing. A scarf may stop a droplet bearing virii even though it may have only an 85 percent chance of stopping a lone virus.
If the probability that a single virus will find a cell to successfully infect is less than 100 percent, you don't need to stop 100 percent even of lone virii.
Every little bit helps. Every little bit hurts.
The masks could be marketed without the N95 certification.

What should be considered is a partial review/audit approach. validated 3rd parties (professors, health admins, medical device engineers etc..) could be drafted into a audit /validation role and once a firm signs up for a design/production process lifecycle those drafted semi-experts own the spec process to validate with the new producer. They act as an interface to the FDA/NIH/CDC etc.. to document and QA the lifecycle and support the ERRL's (exceptions, rules, regulations & legislation).. Its klunky but it would work in less then 45-90 days.

[Excerpt] Historically, increased defense spending to support a war effort has been followed by heightened Congressional scrutiny and an increase in procurement fraud investigations and prosecutions.During the Civil War, Congressional hearings "revealed instances of the same horses being sold twice to the army, sand being substituted for gunpowder, and crates full of sawdust being shipped to the front lines labeled as muskets."See 144 Cong. Rec. S7675-76 (daily ed. July 8, 1998) (statement of Sen. Grassley).As a result, the False Claims Act ("FCA") was enacted to combat fraud committed by government contractors against the Union Army.

The U.S. military build up before and during World War II resulted in an increase in government contracts and a surge of qui tam cases. See U.S. ex. rel. Springfield Terminal Ry Co. v. Quinn , 14 F.3d 645 (D.C. Cir. 1994) (discussing history of FCA).Similarly, post-World War II conflicts and the resulting build-up of defense spending saw an increase in procurement fraud investigations and False Claims actions. See, e.g., U.S. v. Hangar One , 563 F.2d 1155 (5th Cir. 1977) (fraudulent inspection case against contractor supplying artillery shells for Vietnam war).

This post is ludicrous unless Tyler can tell us how masks can be certified more quickly. Is it just possible that it really does take a bit of time to make sure the design works, and no corners have been cut to get sales?

I have a close relative who is a health care worker. I don't want her using a 737-Max type mask. Is it better than no mask? No. Because it's better to know whether you are protected or not.

Libertarians are jackasses.

"This post is ludicrous unless Tyler can tell us how masks can be certified more quickly."

NIOSH says 45 days. Presumably, they're not working on weekends. Presumably, they're not working three shifts. Presumably, they've got people doing other things besides mask certification. Any decent manager can muster and re-allocate resources to meet emergencies (e.g. a large portion of the country being shut down because of concerns about COVID-19).

When I worked as a co-op student at the Air Force Materials Lab at Wright Patterson Air Force Base, things went at a leisurely pace. People took more than their allowable time for lunch. People got in a little late and/or left a little early. They chatted and did things not directly related to work.

The only time that changed was when there was a question about materials for the Space Shuttle. That was the one time when everything was all business. People worked the full day or even a little more. There were no extra-long lunch breaks.

I have a close relative who is a health care worker. I don't want her using a 737-Max type mask.

So NIOSH can simply tell the company they can't certify for health care workers until full approval, but until then sell masks that are clearly marked (on the bag, or even the mask itself) that it's not NIOSH certified.

P.S. If you think no mask is better than a "737-Max" type mask, I don't think you really know much about the subject. Any mask is better than no mask...both for the health care provider and the patients (e.g., if the health care provider has COVID-19 but is not yet symptomatic...not to mention if the health care provider has COVID-19 and happens to sneeze/cough near the patient).

We also really, really need more PAPR units and hoods. I actually prefer using one of those over an N 95. Shouldn't be that hard to make either. Pretty much just a hair dryer w/o the heating element.

Steve

"We also really, really need more PAPR units and hoods. I actually prefer using one of those over an N 95."

It's pretty hard to communicate with a PAPR unit and hood. I had a relative who went to ER and was pretty freaked out (extremely rapid heart rate, hyperventilation) simply due having six doctors by the bed asking various questions, and with the BP, ECG, pulse oximeter, etc. I can't imagine what it would have been like if they'd all had PAPR units and hoods.

https://www.calpaclab.com/pureflo-pf50-esm-papr-cleanroom-lab-safety-respirator-pureflo/gt-pr05802-g-0a2

We want people in public wearing masks so they reduce the amount of mucus and saliva that gets sprayed into the air. An imperfect mask, while imperfect, is better than no mask at this task.

We don't want health professionals wearing imperfect masks because they will get infected sooner or later and may die. Even if they don't die they can be out of action for weeks at a time when they are badly needed.

I think it's a good idea for everyone to wear a "snot catcher" in public. But because we can't give the impression that it's okay for symptomatic people to be in public, they may need to be promoted on their limited ability to prevent people from getting infected. And that's okay. In my country at least, the majority of people will wear face masks even if the immediate benefit to them is not large.

NPR story on why N95 masks are so hard to make.

https://www.npr.org/sections/goatsandsoda/2020/03/16/814929294/covid-19-has-caused-a-shortage-of-face-masks-but-theyre-surprisingly-hard-to-mak

Many regulatory agencies do not have regulations that pass cost benefit tests. Why is that? Can't Congress fix that, requiring periodic re-assessments of regulation?

Problem seems to have been solved. Congress approved a change in the law that will allow 3M etc to sell industrial N95 masks into the medical market.

A vetocracy doesn't work. Too many agencies with veto or delay power freeze our economy.

Comments for this post are closed