UPDATE Donald Trump’s Administration Accepts KN95 Standard For Use!
FDA eases mask regulations, seeks to boost decontamination of used masks
APRIL 3, 2020 FDA changes course and allows China’s KN95 mask to be used in US
(WarOnFlu) 4-01-20
On Monday the FDA approved a process to decontaminate used N95 respirators by the thousands. How many will get infected transporting such a hazardous waste product to be recycled? How that works out is one for the history books to figure out. The most powerful country in the world should not be reduced to dry cleaning used medical PPE.
The most practical solution to limit chances of new infections from used personal protective equipment is to incarcerate all disposable PPE after use on site, and as far as an immediate solution to N95 mask shortages in the USA, well that’s easier than you have been led to believe. A phone call from Mr Donald Trump to the FDA can resolve this in minutes. Here is what has to happen!
THE FDA’s KN95 MASK ISSUE MUST BE UNPOLITICIZED TO SAVE AMERICAN LIVES!
Right now there is a real genocidal war of global proportion targeting the weak that is going to kill hundreds of thousands of Americans! It’s time to remove the unwarranted FDA restrictions that bans much lower cost N95 mask equivalents, referred to as the KN95 from being imported into the USA through US customs from China.
Allowing the importation and use of KN95 could help to greatly alleviate the scarcity of 95% mask in the USA.
UPDATE! Breaking 4-2-2020 The FDA will stop blocking KN95 mask importations
As hospitals around the country desperately seek N95 respirator masks to protect health care workers treating COVID-19 patients, the federal government has blocked imports of what is the world’s most abundant alternative.
That mask is designed to filter out at least 95% of particles that are 0.3 microns or larger in size — the same measure used for the scarce N95 mask. Like the N95, it fits closely around the nose and mouth, creating a seal that decreases the risk of infection. And the Centers for Disease Control has said it’s as effective as N95, which is certified under US testing standards. But this second type of mask, called the KN95, complies with slightly different norms and is made in factories that have not been certified by the US government.
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.”
Yet without the FDA’s seal of approval, importers are hesitant to order KN95 mask because they worry they’ll get held up at customs. Many hospitals are even refusing to accept them as free donations, because they fear legal liability should a health care worker get ill while using non FDA approved mask. Yet there is absolutely NO reason good reason that China’s standard using the exact same scientific criteria is not allow to be imported or used in the USA.
Here is what the world’s largest manufacture of N95 mask has to say about the KN95 equivalent
3M, the world’s largest mask manufacturer, the KN95 is “equivalent” and “can be expected to function very similar” to the N95 mask. That opinion was echoed on Feb. 29 by the CDC, which said the KN95 is one of seven foreign-certified respirators “expected to provide protection to workers.”
So why are the hundreds of millions of KN95 mask available for a little over a dollar right now, yet Americans are unable to locate them and when they do they are paying up to 1200% more money for the same protection because the FDA doesn’t like China’s safety standard that happens to be the exact same as ours. Something doesn’t seem right — American lives must come before the ideals and tensions of a political trade war.
China is willing to sell masks to the USA, but officials at the FDA would rather Americans die than buy!
CDC Mask Suppliers for NIOSH-Approved N95 Particulate Filtering Facepiece Respirators Manufacturers
Listed Alphabetically 3M A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Notes
- How To Tell If N95/KN95 Mask From China is Real or Fake
- CDC’s list of acceptable respirators to use “when supplies are short”
- Comparison of KN95, FFP2, and N95 Face Mask
- Report Fake 3M mask for proper investigation to get suppliers offering fake PPE out of the market as fast as possible. Our front-line workers are being put in great danger.
https://www.fda.gov/media/136403/download
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