Shouldn't N95's be going to hospitals?

There’s Plenty of N95 Masks. Hospitals Just Aren’t Allowed to Buy Them.

I haven't slept much the past 2 weeks.

The messages come in thick and fast.

“Do you want N95 FDA-certified masks? We have 400,000 in stock.”

2 hours later: “All sold out.”

I get a call at 3am from my Chinese partner: “This one factory won’t even talk to me. They’re booked until November.”

I wake up. Another call: “I drove 4 hours to another factory in Hangzhou. They wouldn’t let me take verification photos until I give them all the money upfront.”

I’ve had to go through herculean efforts to get these sorts of proofs of veracity. Even an established buying relationship won’t get you these proof videos.

The factories can’t be bothered.

They’re drowning in work and money is thrown at them from every corner of the globe, no questions asked.

The TL;DR Summary

  • FDA, NIOSH-certified N95s are almost impossible to get because factories are overwhelmed with orders for the next 6 months.
  • Medical masks are also difficult to import and cost 3x as much, if you are even able to find them.
  • We will not be able to just magically increase supply of FDA-certified masks overnight across the globe.
  • Other performance standards are roughly equivalent to FDA-certified N95’s.
  • Healthcare workers are reusing 1 mask for a week or wearing bandannas, which is worse than using masks graded to equivalent foreign standards.
  • Hospitals are terrified of liability in purchasing, but may accept donations without the liability hurdle. Or at least, healthcare workers can personally accept donations. Therefore, charities can help fill the gap by importing equivalent masks so frontline responders get them ASAP.

The Goal

I’ve stopped all my other commitments and am working on importing masks full time. I’ve been vetting factories, investing working capital, and air freighting more masks to the USA to supply charities and hospitals.

My goal is to get as many masks into as many hands as possible, prioritizing healthcare workers.

We also need the general public to wear masks, but not at the expense of

healthcare workers.

I understand why guidelines say healthy people should not bother. But it’s disingenuous to say that potentially asymptomatic citizens should wear nothing at all. But that’s a topic for another article.

Meanwhile, in the USA

Hospitals are desperate for personal protective equipment (PPE). They’re taking donations without any requirements for certification whatsoever because there’s simply not enough. Nurses are wearing bandannas or reusing a single mask for a week.

Hospitals, rightfully, are skittish to buy without the gold stamp of NIOSH certification and FDA approval.

Companies procuring masks for government use are looking for working capital loans, wasting precious time.

Charities want to buy masks, but they’re knowingly or unknowingly dealing with brokers and middlemen, not all of them trustworthy.

No one knows who to trust.

And citizens are angry at profiteers — but at the same time, they miss crucial parts of the picture, not realizing that a factory is charging the importer $4, up from 80 cents a month ago. What are businesses supposed to do, take 80% losses to sell them at the same prices as before?

The ultimate problem?

Everyone’s searching for a unicorn.

Why It’s (Almost) Impossible to buy NIOSH-certified, FDA-certified Medical Grade N95s

These gold standard (FDA certified, NIOSH certified) factories are:

  1. Overwhelmed. They’ve literally disconnected their phones. They won’t respond to your WeChat messages. They’re inundated by tire kickers and buyers from around the world, trying to gather up certificates, or worse, bad actors trying to pass off their certificates as their own.
  2. Overtaken by the Chinese government for domestic production.
  3. Bought out for months by an Iranian billionaire.
  4. Buyers are showing up at factories with bags of cash and getting into fights while waiting for stock as they try to outbid each other for scarce stock.
  5. Counterfeited by other factories trying to ride off their certifications, pretending to be official distributors, or pretending to be direct sales reps.
  6. Charging $2.8–5 a mask. That’s factory price, not retail.

FDA Emergency Use Authorization (EUA)

Due to the shortage, the FDA has now approved use of foreign respirator standards. Read more here.

Got masks? Now good luck getting them past customs.

Still managed to get your hands on some of these masks? It’s not impossible, just unlikely, so color me impressed.

However, we haven’t gotten to import/export issues.

(Caveat: I am not an expert. This is my understanding from my research, I welcome anyone more knowledgeable to add or correct to this.)

  1. Medical devices are classed as Class 1, Class 2, or Class 3, with 3 being the most restricted. Medical masks are Class 2.
  2. Class 2 requires something called an FDA 510k premarket authorization for sale. This means “My mask does the same thing as other N95s.”
  3. The 510k requirement for masks was waived in 2018 by the FDA if the mask is not marketed as preventing disease, i.e. something you buy at Home Depot to protect yourself from inhaling dust particles. This does not necessarily mean it is ineffective. It means you cannot market it as a medical mask.
  4. If you want to import a medical mask, you need a medical importer license specifically for medical masks. Many companies do not have this, even if they obtain legitimate supply.
  5. Since it’s an FDA-regulated product, you have a significant risk of being stopped Chinese customs or seized at US customs, or just as dangerous, held up for weeks.
  6. Trump and the Chinese Communist Party are not getting along so great. Masks exports have become another geopolitical chess piece. This bullet point makes me so sad to write, but it needs to be mentioned as a complicating factor.

Why is this happening?

Why can’t we just produce more in the US?

Why can’t China just produce more FDA certified masks?

Why can’t we just let masks into the country?

Simple answers are wrong.

There’s not a single person to blame.

Here’s the major problems in the supply chain:

  1. Production capacity: A factory can’t 10x production on a week’s notice. A factory capable of churning out 100,000 a masks a day has a physical limitation on hiring, buying machines, training, and doing quality assurance.
  2. Know how: Anyone can make a regular fabric mask. But you can’t expect a factory that used to make skirts to immediately have competence in producing specialized medical equipment with stringent regulatory and testing standards. I commend US companies that are switching to creating masks — but understand that they cannot be our saving grace when our risk increases exponentially with each day that goes by.
  3. Raw material limitations: N95s use a layer of material — the 95% filtering material — that uses ‘melt blown filament’ to trap tiny particles. Melt blown filament machines are expensive and take 6 months themselves to produce. There just aren’t enough machines. Don’t have this layer? You don’t have a N95 mask.
  4. Certification limitations: FDA Certification is multilayered. The factory needs to be certified. But then the N95 mask needs to be certified separately, unless it is Class 2 exempt (so not marketed for medical use) as mentioned previously. Both of these take time. Other types of certifications, including European standards, require testing of each batch that takes weeks.
  5. FDA manpower limitations: FDA inspectors are already working overtime in China to certify factories and products, but they have only so many people with so many hours.
  6. Legal liabilities: Sadly, hospitals stand more to lose from providing uncertified PPE than providing nothing at all.

In peacetime, these regulations provide peace of mind and quality assurance to buyers who can’t afford to take risks.

These are medical devices, not fidget spinners. It makes sense.

But we’re not in peacetime. We’re in wartime.

And we need to go into this with clear eyes and understand the risks and consequences of failing to act.

Doing business in China is not like doing business in the US.

Trust is ultimate.

You trust your eyes, ears, and those you’ve done business with before. Relationships are your true form of accountability, not contracts, and certainly not the court.

Agree on a price? Two hours later, it’s 10% higher. Take it or leave it.

Think you found a cache of masks? Just try putting them through your 5 layers of due diligence, if they agree (good luck). By the time you’re done, the masks are gone.

A cottage industry of Chinese brokers, each more untrustworthy than the last, are faking certifications and selling marked up products from factories that are already marking their goods up 4–5x from before this insanity descended.

Dozens if not hundreds of factories have switched from producing curtains or knee braces to N95 masks and surgical masks.

Are they producing the masks? Are their certifications real? Who are you communicating with, and what’s their real relationship to the factory?

Let me tell you how we need to act to solve this crisis.

And now.

Don’t let ‘perfect’ be the enemy of saving lives.

Masks are not ventilators. They’re preventative, not curative, and they are designed to be disposable.

But due to the shortage, nurses are getting one mask to use for a full week.

The CDC literally said they should try wearing bandannas if they run out of masks.

CDC EXCERPT: In settings where facemasks are not available, [healthcare professionals] might use homemade masks (e.g., bandana, scarf) for care of patients with COVID-19 as a last resort.

This is not hypothetical. It’s already happening.

(Inti Ocon / AFP/Getty Images)

Is it really better to get them one gold standard N95 and have them try to disinfect it and reuse it for a full week of seeing patients?

Even if we manage to find the tiny bit of limited supply, gold standard masks charge a 3x premium over masks that are graded to essentially the same standard as others, just without that liability exculpating stamp of approval.

Don’t believe me? Here’s the 3M table on testing standards between different mask types.

To summarize: All of these standards filter over 95% of airborne particles using the same test agent. All have essentially the same breathability standards or the wearer (flow rate, inward leakage, inhalation resistance, exhalation resistance).

FROM 3M: Based on this comparison, it is reasonable to consider China KN95, AS/NZ P2, Korea 1st Class, and Japan DS FFRs as “equivalent” to US NIOSH N95 and European FFP2 respirators

We need to import all masks that follow the 95% filtration standards.

Yes, we need to prioritize buying supply that has proper certifications from the best sources we can find.

Yes, we need to weed out obvious counterfeits and fakes.

Yes, we need to try to get to the factory directly — but keep in mind that we just may not be able to.

Yes, we need to try to prioritize CE certified masks if we can’t find FDA ones. But as of last report on March 27th, those factories are now also booked for months.

We cannot pretend we are in a buyer’s market for these masks.

We are not.

We cannot pretend we have the luxury of time.

We do not.

We cannot sit behind our keyboards and rage that things should not be like this, that we should not be in this situation, that it is unfair.

You’re right.

But it does not matter.

Because we need to act now.

Do not let fear paralyze you.

I’ve been perplexed watching how people are terrified to pull the trigger on purchases because of lack of 100% assurance.

I’m here to tell you that 100% assurance does not exist, and especially not now.

When fear paralyzes you, frontline workers pay the price.

It’s imperative we act.

It’s imperative we do not let perfect compliance — which are not guarantees anyway, given counterfeiting — get in the way of delivering masks as quickly as possible.

In my professional life, my job is to assess risk, remove as much as risk as possible, and achieve the outcome.

But don’t trust me or the FDA, look at the testing standard table above.

The Solution

Here is how you can help.

For those sourcing masks from China:

  • Do your best to verify, but understand the situation on the ground. Try to follow best practices for factory verification. But do not expect it to be easy. Your best bet is to place a smaller order first in order to convince factory owners to produce a verification video.
  • Use an on the ground inspector to inspect goods before they get released. Try to find someone who knows the product, who will cut it open and ensure the inner layers are the quality they are supposed to be.
  • Expect that factories will demand 100% payment upfront.
  • Once you have identified a factory that passes your diligence, move fast. Wire money and place at least a small order because otherwise they will ignore you and move onto those that make decisions more quickly.
  • Prices will rise. Do not expect any quote you receive to be good for longer than 1 day.
  • Prioritize purchasing comparable foreign standards and importing as PPE rather than focusing on medical grade N95s. They will be cheaper — generally 1/3 the price — and you will have fewer issues with customs. There are also more of them.
  • Set your own standard for “good enough”.
  • Cross check with testing databases and certificates but understand you may not be able to get 100% certainty if you are trying to buy in any real volume within a short turnaround (1–2weeks).
  • A single factory will generally be able to produce 50–300k masks a day.

For charities:

  • Understand that factories will require 100% payment upfront. If you are not comfortable with this, go through someone who has already vetted, paid, and imported inventory and buy through them.
  • Ask for certifications. But understand that verification can be truly hard to obtain thanks to rapidly changing markets and lines of paying customers that don’t care.
  • If you read my recommendations above and feel comfortable, prioritize purchases of KN95s that have been vetted for quality and understand you will be serving more people

For hospitals:

  • Read the EUA and understand that the rules have now been widened around what you’re allowed to buy.

For government:

  • Understand the supply chain problems. I’m not a policy wonk; I can’t make strong recommendations here, only provide my personal working experience in this field.

For donors and private citizens:

  • Be realistic and think about the end goal. Do not get excessively hung up on certifications of the masks that are bought by charities. There’s a balance. Do we want to make sure we are bringing in the best product possible? Yes. But if that product simply does not exist, would you rather no masks be donated at all? If you are not comfortable with that risk, do not donate.

In Summary

Donate to charities. They have more leeway and less regulatory red tape which makes them the perfect way to get product to those that need them in time.

Charities, don’t let perfect be the enemy of saving lives. Understand what is happening in the supply chains so you have reasonable expectations of what is available for sale, and therefore available for donation to hospitals and healthcare workers.

Don’t spend all your time and energy hunting for a unicorn when there are millions of masks that can achieve more impact with the precious funds you have.