FDA Prevents Import of Masks

The KN95 mask is China’s version of the N95 mask. 3M, America’s largest manufacturer of N95 masks, said in January that the masks are equivalent. But the FDA is not allowing KN95s into the country.

Buzzfeed: The KN95 mask is a Chinese alternative to the scarce N95 mask, but the FDA refuses to allow it into the country.

…By law, masks, along with most medical devices, can’t be imported or sold in the United States without the Food and Drug Administration’s say-so. Last week, to ease the national shortfall of protective gear, the FDA issued an emergency authorization for non-N95 respirators that had been certified by five foreign countries as well as the European Union. It conspicuously left the KN95 masks out of the emergency authorization.

The omission was all the more startling because in late February the Centers for Disease Control and Prevention said that KN95 masks were one of numerous “suitable alternatives” to N95 masks “when supplies are short.”

…Allowing the importation and use of KN95 could help to greatly alleviate the scarcity.

“The KN95 masks are far more readily available,” said Bob Tilton, who owns a New Jersey–based cosmetics packaging importer and earlier this month decided to use his familiarity with Chinese supply chains to bring in masks and other personal protective equipment to sell to hospitals. “The N95s are much harder to grab.”

Yet without the FDA’s seal of approval, importers are hesitant to order KN95 masks because they worry they’ll get held up at customs.

It’s not just the FDA that is to blame, however. America’s legal system is also to blame:

Many hospitals are refusing to accept them, even as free donations, because they fear legal liability should a health care worker get ill while using a nonpermitted device…Although some hospitals flat-out reject KN95 masks at any price on advice of their lawyers, people rounding up masks to give to hospitals have found that individual doctors or nurses will often accept the donations, given the dire need.

Consider that last bit of insanity. The ethical and common-law type rule is very simple: Do everything reasonable to protect your hospital workers. But what some feckless hospital administrators are actually doing is following “the law” even if it conflicts with the ethical rule.

Comments

"feckless hospital administrators"? Someone could get canned for exposing a hospital to such liability. Easy for you to call someone feckless when you have tenure and they could be out on their ass with an economy that is about to tank hard. This is all on the FDA.

It's hard without knowing the details but I'd say hospital administrators who allow their staff to go under-masked due to this kind of concern probably *do* deserve some significant criticism.

But where does the buck (of responsibility) stop? This is a political matter, so the buck stops with *the voters*, who have facilitated the creation of this bureaucratic mess.

I wouldn't say this is a bureaucratic mess. Under normal circumstances this type of regulation is extremely important. It's just a matter of not having good oversight, management, and leadership during a crisis.

...and I don't mean at the hospital level

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Doctors and nurses are risking their lives. Surely administrators can risk losing their jobs.

It's easy to risk lives. You die and that's the end of it. What about the people who are doomed to live on with no jobs, no family, etc?

Today is a special day: after two months of buying surgical masks and respirators and sending them to family in China...

I opened a package from Asia, full of surgical masks and respirators! Thankfully there are functional countries out there still, and those of us with families can receive necessary emergency medical supplies.

To quote Michael Scott: "... oh how the turntables"

Wear your N95 respirator if you go outside..... These people used hand sanitizer before and after and had no physical contact, and now 45/60 are sick and some are dead.

https://www.latimes.com/world-nation/story/2020-03-29/coronavirus-choir-outbreak

A gathering for church choir singing is literally one of the worst things you could be doing. Washing hands won't stop the fact that the aerosolized viruses launched into the air by singing for hours likely entered directly into their lungs. A mask would have helped but would defeat the point of singing. Just don't do it.

Yes, of course.

It’s just an easy extreme example to demonstrate a major method of transmission. At the end of this, if there is one, I suspect we’ll learn how critical respirators and masks were to slowing/stopping disease transmission in East Asia.

For medical personnel, who are apparently around 12% of the confirmed cases in Spain, as of roughly 48 hours ago. Anyone who is using a N95 mask to provide themselves a sense of personal safety that is then is rationalized as a contribution to public health is deluding themselves.

There are people considerably more deserving of such resources at this point. Some of whom will inevitably die regardless, if one needs a further rationalization as justification.

When you go outside, avoid people completely. After all, any reasonably aware person in Europe or the U.S. has already stocked up on food for at least a couple of weeks for their household, and is thus able to remain isolated long enough to know they aren't spreadinf the virus.

Leave the masks to those who have actually do not have the option of not handling those who are infected.

We are a mask manufacturer from China with a daily output of 300000 masks. We can provide kn95 masks to the United States / jufuzhili@gmail.com/

I don't think hospitals refusing masks of unknown origin is a bad idea. You don't want to compromise the safety and security of medical workers and patients because they used bad gear.

I do agree that the KN95 situation needs to be scrutinized. It's not clear to me why they aren't letting them in but there might be a national security or quality standards issue they are looking at.

Why isn't bad gear better than no gear? There must be some other reason.

Gresham's law.

I don't think that would apply assuming these masks are clearly labeled as KN95. If nothing else, they could be sold to the general public, police, ect.

Really? You mean all those Chinese and Korean (and probably other locations as well) "Ralph Loren Polo" shirts and Nike gear were real? Even the one people bough that included the logos unattached but ready to be sewn on.

A simply KN95 stamp itself is largely meaningless. Just as an N95 stamp might be from some unknown domestic source. It's just we have a lot more examples of that from the Asian suppliers.

"A simply KN95 stamp itself is largely meaningless. "

As long as they are "stamped KN95" they can't be confused with N95 masks and thus trigger Gresham's Law.

These are masks that you the general public can use. They will certainly be as good as any other cheap mask and better than a scarf. At the very least, they will lower demand for N95 masks which will lower prices for those.

You sound like a complete moron.

The Dutch government has ordered a recall of around 600,000 masks out of a shipment of 1.3 million from China after they failed to meet quality standards.

The defective masks had already been distributed to several hospitals currently battling the COVID-19 outbreak, news agency AFP and Dutch media reported. The Dutch Health Ministry has kept the rest of the shipment on hold.

An inspection revealed that the FFP2 masks did not protect the face properly or had defective filter membranes. The fine filters stop the virus from entering the mouth or nose. The masks failed more than one inspection.

"A second test also revealed that the masks did not meet the quality norms. Now it has been decided not to use any of this shipment," said the Health Ministry said in a statement to news agency AFP.

Did they prevent the virus exiting the mouth and nose, though? As that is what the Chinese say they are supposed to do.

Well, the ill fitting would seem to be a prima facia problem. And this was being distributed as medical equipment. Likely, it would still be better than a home made cloth mask.

A bit more reporting - "A number of European governments have rejected Chinese-made equipment designed to combat the coronavirus outbreak.

Thousands of testing kits and medical masks are below standard or defective, according to authorities in Spain, Turkey and the Netherlands.

On Saturday, the Dutch health ministry announced it had recalled 600,000 face masks. The equipment had arrived from a Chinese manufacturer on 21 March, and had already been distributed to front-line medical teams.

Dutch officials said that the masks did not fit and that their filters did not work as intended, even though they had a quality certificate,"

The Australians have also noticed problems, in part because some people are just too enthusiastic when it comes to taking advantage of an economic opportunity involving health - "Authorities have begun seizing Chinese-made faulty face masks and other protective clothing that is being exported to Australia to help halt the spread of coronavirus.

The ABC has learnt that in recent weeks, Australian Border Force (ABF) officers have intercepted several deliveries of personal protective equipment (PPE) that have been found to be counterfeit or otherwise faulty.

One law enforcement official, who spoke on the condition of anonymity, estimated the ABF had already seized 800,000 masks with a combined value of more than $1.2 million on the Australian market.

"We started seeing this stuff arriving roughly three weeks ago when news of the pandemic was really taking off," the official told the ABC."

Those darned regulators! I've been pretty worried watching the likes of Alex call for deregulation and importation. Those of us whose lives depend on the equipment working (which is difficult to tell by looking) want some standards.

On the other hand, I have been in the same boat of accepting donations because the eschelons above reality think that our supplies will hold. If they were required to do these intubations they wouldn't be so sanguine. I'd take a (real, working) KN95 over a 10x reused N95.

It does kill me to see random scared civilians wearing N95 while shopping. I'm reusing respirators and will probably soon be using unapproved decontamination methods because you panic bought them.

Bad masks are better than no masks. As a result of this kind of scrutiny, the Chinese government has banned the export of masks that don’t meet foreign regulatory standards. A friend of mine was about to receive a shipment of surgical masks from family in China that he was planning to share with everyone and now he says they aren’t allowed to mail them because they don’t meet European regulatory standards. That’s crazy.

It depends. I don't see the harm in selling substandard masks to the public if it is labeled as such (your friend should have gotten his masks) but I wouldn't sell it to hospitals or other essential services. You can't place more risks on these people.

But what about price gouging? If only the federal government did some combination of imposing price controls, nationalizing the supply, and prohibiting exports, all would be well. Corn Laws 2020!

Hospitals, doctors and insurance companies are irrationally fearful of lawsuits (the bark is scarier than the bite). I hope this changes post-COVID.

China makes junk masks so the FDA is not wrong here. Netherlands had to recall 600k faulty masks. Spain, Czech, and Turkey did the same thing. They probably keep the good ones for themselves and export crap. Let's not add the logistical nightmare of a recall on top of the logistical nightmare of a pandemic.

* https://www.scmp.com/news/china/diplomacy/article/3077428/netherlands-recalls-600000-face-masks-china-due-low-quality
* https://www.foxnews.com/world/netherlands-becomes-latest-country-to-reject-china-made-coronavirus-test-kits-gear

Agreed, Alex, you are posting some great stuff here but you keep missing some of the underlying geopolitical realities here. Yes, there needs to be de-regulation of the procurement process.

However, let's not pretend that what the CCP are doing is not happening. Their testing kits are completely useless, with a false negative rate that is beyond hopeless. Even the Europeans are rejecting the masks and testing kits after eagerly accepting them. The bottom line, the quality is not sufficient to get the job done. Medical supply chains will be moving out of CCP control after all this is said and done.

And using Australia as an example. much of what is being delivered is likely not under CCP control, because such fraud reflects extremely poorly on a country that has always cared about appearances,

See, now that's good trolling. I genuinely laughed.

The error here is to treat “China” as a single entity and say things like “China makes junk masks.” China has many companies and of course some are fly by night operators. China also has large, certified mask manufacturers who have been selling medical equipment In world markets for many years. Of course, any purchase should be tested as responsible buyers are doing.

And that was such poor trolling that Alex needed to point out how uninformed your comment really was.

That was superb trolling. It is not common for someone like Alex or Tyler to make a comment pointing out just how ignorant some random MR commenter is.

Cheap is better than nothing? Remember even a T-shirt wrapped around your nose keeps out 70% of viruses, a study found.

Bonus trivia: I bought a pair of cheap tennis shoes here in the "China store" in Greece (closed even before the quarantine from irrational fear from customers, I bought a nice, functional digital watch for literally 5 Euro, I tipped them 10 E since it was embarrassing to be so cheap) for $12. No name, cheap hard plastic soles, but they work pretty good and from a distance look respectable. If they last a year I'll be satisfied.

"Cheap is better than nothing?"

Nothing means you can't proceed and have to choose another way. Cheap means you could proceed but it's unreliable. I'm no doctor but they probably want to use high reliability tools or choose a different procedure to minimize risks.

Imagine taking a cheap gun that doesnt work to a gunfight. I wouldnt say cheap is necessarily better then nothing.

Based on the seriousness and life risking the current situation entails I don't think my example is that off base

Potential Legal Liability for Withdrawing or Withholding Ventilators During COVID-19: Assessing the Risks and Identifying Needed Reforms https://jamanetwork.com/journals/jama/fullarticle/2764239?guestAccessKey=e394931c-2012-48bf-a25a-df7f014fad9a&utm_source=silverchair&utm_medium=email&utm_campaign=a

Anybody who's ordered anything from China knows there's counterfeiting going on. A fake USB plug or t-shirt is not a big deal but a fake N95 respirator is a BIG deal.

@H Y? Because of patent infringement? Good man, though I am not even that hard-core when it comes to patent infringement during a national emergency.

Well except there is no national emergency nor is there an emergency exception to patent law. But sure you are free to petition your legislator to change that.

March 13, the decision on the state of emergency was announced by Mr Trump in a live address from the White House Rose Garden.

28 USC 1498 - "The United States government can use any patented invention, copyright, or protection of plant variety, original design or semiconductor design, subject to providing compensation of the owner of the right, under 28 U.S.C. §1498."

You may want to petition someone to help you become informed.

The "US legal system" already anticipated the issue and a solution:

The “Public Readiness and Emergency Preparedness Act” (PREP Act),147 created § 319F-3 of the Public Health Service Act, which limits liability with respect to pandemic flu and other public health countermeasures. Specifically, upon a declaration by the Secretary of Health and Human Services of a public health emergency or the credible risk of such emergency,148 the PREP Act would, with respect to a “covered countermeasure,” eliminate liability, with one exception, i.e.,“willful misconduct,” for the United States, and for manufacturers, distributors, program planners, persons who prescribe, administer or dispense the countermeasure, and employees of any of the above. A “covered countermeasure” includes (A) “a qualified pandemic or epidemic product,” (B) “a security countermeasure,” or (C) a drug, biological product, or device that is authorized for emergency use in accordance with section 564 of the Federal, Food, Drug, and Cosmetic Act (FFDCA). Each of the terms in (A), (B), and (C) is itself defined in the PREP Act.

See: https://www.hrsa.gov/get-health-care/conditions/counter-measures-comp/rules-and-regs.html

The Dept of Health and Human Services declared a Public Health Emergency effective January 27, 2020.

http://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx

It appears to me that the respiratory masks are already covered by the countermeasures program; however, the Dept of H&HA could easily clarify that by issuing a specific declaration:

https://www.hrsa.gov/get-health-care/conditions/counter-measures-comp/cm-prep.html

The comment, as well as some of the others, seem to confuse a few things -- mostly because they don't fully state what they want to say.

N95 is not a patent but a standard in the USA. The law around using existing patents in an emergency such as this is apply manufactures being able to use a patented process or product to increase supply without first having to get permission from the patent owner expressly (or that is how I was understanding the rule). However they still need to provide reasonable compensation for the use of that intellectual work.

It is not clear that law would extend to non-USA producers.

It is far from clear that the Chinese makes makers are using any USA patented process or product specification or if they are they are providing reasonable compensation for an use of a patent.

So we should separate out domestic producers and international supplies I would think. Moreover, it would hardly be the FDA that would make any call on the use of patented processes or products by either domestic or foreign producers.

Sorry to disappoint you, but my comment had nothing to do with patents because the statute I referred to does not focus on liability for patent infringement...

This issue, liability coverage for health care workers in a crisis, needs to be addressed, probably by public policy. The same goes for products being rushed into service. I'm not saying this to keep people from using products that might help, but just the opposite. If you address the issue, you won't have people worrying about it. Al's post was good.

"But what some feckless hospital administrators are actually doing is following “the law” even if it conflicts with the ethical rule"

It's almost like we live in a statute and not a common law system, oh wait we do. And it's almost like people fear political prosecution by government prosecutors for personal gain, oh wait we have that to.

Incentives matter. They could change the law tomorrow, they haven't and won't. Don't have on people for following the law in a system that routinely jails people arbitrarily.

Tyler is so desperate to fearmonger that people following the law are now "feckless."

Again, any POTUS has emergency powers to override almost any policy in the executive branch, of which the FDA is a part. The basic problem is that the market system tends toward just-in-time allocation, and so it does not stock, maintain and update an inventory for a general emergency. We've been in a 50-year era of economists preaching that the market is best, while barely acknowledging that prices are only 1/2 of social decision-making; voting is the other half -- and that the information required for consumer choice is far inferior to the information required for voting intelligently.

the information required for consumer choice is far inferior to the information required for voting intelligently.

What? There's no end of information available to assist in making a consumer choice, albeit much of it is promotional. On the other hand, the information available for making a voting decision, when it's not simple fantasy, concerns future policy decisions that can't be predicted regardless of candidate positions.

The amount of information to vote intelligently encompasses domestic conditions, foreign situations, economic and ecological facts which are, in total, voluminous. That is why almost everyone votes emotionally instead, on a few trumped-up issues. (Then they complain about the "future policy decisions", because in truth they really don't know what is happening, nor the level of competence of whom they voted for.)

On the other hand, the amount of information required to make an individual consumer demand about a product is inferior, i.e. lesser. It is more or less given by the sources you adumbrated (although a lot of information is not supplied about economic and ecological effects of the production chain, so you also rely implicitly upon laws and regulations that are not immediately evident).

The problem in both cases, prices and voting, is that your attention is limited by daily time and personal space, i.e. you have a cognitive (and emotional) budget. Thus prices and voting are both faulty, although they're all we've got, to avoid dictatorship.

Markets address the allocation of resources imperfectly, yet their relative success made it look like individuals are capable of possessing complete information. When it became evident that it wasn't perfect, economists latched onto "satisficing" and theories of imperfect information, etc.

But the problems of political governance which cannot be marketized go beyond anything that economics (as presently constituted) is equipped to address, and show that the assumption that individuals can know enough to vote intelligently is (presently) untenable.

Ridiculous to call this a market problem. The federal government drew down its stash of PPE, and there was a bipartisan consensus not to replace it.

To be fair, the national stockpile is too small. It only held 52 million masks at most. That's what a tiny country like Taiwan produces in less than a week. Either we make storage much bigger or we find a way to keep domestic production always available, possibly even nationalizing it so we don't get lose our supply to foreign bidders during a pandemic and the CDC can't veto its use.

The reason WHY there was a bipartisan consensus not to replace it, is because of the ideology that markets will take care of things just in time.
It is not a "market problem" in the sense that they should never have expected markets to handle it.

Is the FDA "preventing" these masks from China from being imported to the US?

https://www.wsj.com/articles/a-million-n95-masks-are-coming-from-chinaon-board-the-new-england-patriots-plane-11585821600?mod=hp_lead_pos5

There are apparently better alternatives to the KN-95 masks to protect US hospital workers. The ethical question is---is it more ethical to provide your hospital employees with the best masks available or an inferior one (giving false security)? If the choice is between none at all or the best available, then the answer is easy. But, have we reached that point? I'm not qualified to answer that question and I seriously doubt Alex Tabarrok is, either, although I will refrain from calling him "feckless".

Why would a hospital be more at risk of suit from a worker who got sick from a using an "inferior" mask more than one who got sick from using no mask when the hospital turned down the "inferior" masks. Could this not be an excuse for some other reason?

Of course, this also points to the larger problem of not having cross-certifications of drugs and devices between countries, in other words, as "single market" as the EU has internally.

No manufacturer in any country can guarantee that wearing their mask positively prevents acquiring or passing along the infection. It doesn't matter if samples from a batch of masks pass tests since the mask of a particular wearer could have failed. Individuals that religiously wear masks are perhaps less likely to contract the virus but there's still a risk involved. Mask have become the new bicycle helmets ala mode.

The EU's single market for PPE was an early casualty of the pandemic.

This post seems to be in something of a vacuum. Yes, the standards as defined, are very similar and equipment meeting those standards should be considered reasonable substitutes.

However, multiple countries have reported receiving such faulty equipment from China that they stopped using the equipment and returned it. Part of that problem is that, per other reports, more than half of the 100 Chinese companies selling these items are not licensed to sell the goods in China. That raises a lot of questions about how to validate the source to ensure you are actually getting equipment meeting the standard and not merely labeled as such. (Note, China has now stepped in to prevent such companies from selling outside of China when they would not be allowed to sell within China.)

So the bottle neck here is not only FDA regulations but validation of the incoming equipment. If we don't have a good customs QA process in place we might not want the regulations relaxed.

>3M, America’s largest manufacturer of N95 masks, said in January that the masks are equivalent.

Oh, well then.

Suddenly, if a corporation says something, IT MUST BE TRUE.

Whatever suits your purposes, Ty.

Let me spell it out. 3M is saying their *competition* is an equivalent product. Do you see now why Alex cites that as credible?

https://www.patriots.com/news/news-blitz-4-2-airkraft-enlisted-in-coronavirus-fight

We are still exporting medical equipment to countries that restrict exports to us in return. Allowing our companies to abide by pre-arranged deals is noble, but there should be reciprocity by nation at least:

MSNBC's Natasha Bertrand on twitter 3/31/2020: "The government has yet to curtail exports by US companies, however—roughly 280 million masks in US warehouses were purchased by foreign buyers on Monday alone, per Forbes. FEMA told us it “has not actively encouraged or discouraged U.S. companies from exporting overseas.”

Hi,

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Do not mark time in public for hours to purchase the masks, which means to expose yourself to potential virus service providers. We are offering the EU accepted medical masks accredited by Nelson Laboratories under EN14683 :2005 Type II requirement.

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info@bfemask.com

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Make sure and also god bless every person!
Seriously,
Matthew, from Hong Kong

I believe there is Good Samaritan laws out there that would protect the medical field from liability for using KN95 masks in time of crisis. As long as they "reasonably believed" the use to be medically beneficial. There are several reputable medical equipment manufactures in China the are manufacturing KN95 masks that meet same specs as N95. Stop the political bullshit US bureaucracy and allow the use of KN95. CDC approves as part of "Strategy during Crisis..." yet FDA omits them from there Emergency Use Authorization except from one Chinese company. Again, BS. No time to waste. USE KN95 to supplement for now. Can always close the window with an Executive Order followed by Code of Federal Regulation rules change later.

This is a difficult decision. If the FDA approves more masks, it can help doctors and nurses and the general public to protect against viruses, but if the quality standards are ignored because of the rush to import masks, it will be a very serious infection s consequence.

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