China Fucked you with the virus, now they are kyou with the masks
A Food and Drug Administration effort to address a shortage of protective masks has instead opened the floodgates to 3,500 Chinese manufacturers’ selling products of widely varying quality, potentially putting the public at risk and leaving some U.S. states with stockpiles of masks they no longer trust as protective gear, a Wall Street Journal analysis found. Facing a severe shortage of N95 respirator masks in the early days of the coronavirus pandemic, the FDA made an emergency decision to allow importation of millions of Chinese-made masks, generally called KN95s, that were supposed to provide similar levels of virus protection. But the FDA itself created confusion about which Chinese brands could be trusted for medical use, in part by giving—then revoking—its stamp of approval to masks that turned out to be subpar. Some of the companies given initial approval were just weeks old or posted incomplete mask-quality tests, the Journal found. The agency also relaxed its rules governing Chinese masks aimed at the general public, allowing hundreds of brands to be sold with little oversight and few quality checks, regulatory records show, rendering the KN95 label all but meaningless. The FDA now posts lists of Chinese-made respirators that are “authorized” and “no longer authorized” for medical use. Some manufacturers’ products are on both lists, distinguished only by often-similar model numbers. The FDA lists one model from the same manufacturer as both authorized and no longer authorized. The changes and conflicting information have led to confusion for health-care providers.
As the pandemic worsened, Chinese manufacturers registered hundreds of KN95mask brands with the FDA. Registration doesn’t mean they have FDA approval.Daily KN95 mask registrations with FDA Source: FDANote: Includes active registrations with KN95 inproduct name.
Suzanne Schwartz, a senior FDA device regulator, said in a statement that the agency has been constantly responding to new data and science during the pandemic. In approving Chinese respirators, she said, the agency initially built in safeguards due to concerns about fraudulent KN95s and has twice tightened rules based on fresh information. “We have provided regulatory flexibility where it is needed most,” she said.
The FDA said its main goal was to help hospitals obtain quality masks and that it has never told the general public to use KN95s. It relaxed restrictions on masks of many kinds in response to public demand for face coverings during the pandemic, the agency said.
N95 respirators, so-called because they filter out only 95% of very small particles, are viewed as critical to protect doctors, nurses, paramedics and other front-line workers from catching the disease caused by the novel coronavirus. N95 masks and high-quality substitutes—if they can be found—are particularly valuable now that the virus has surged in the south, southwestern and western parts of the U.S. Among the issues identified in the Journal analysis:
*State agencies submitted orders for more than 180 million KN95 masks to protect workers, according to public records, many of which are now sitting unwanted in warehouses due to quality concerns. Meanwhile, federal agencies have distributed millions of additional KN95 masks to states, which may have the same quality issues.
*More than 60% of foreign-made masks, nearly all Chinese made, have failed basic U.S. government quality tests that looked at 220 such brands, according to U.S. regulatory data.
*More than 3,500 Chinese manufacturers that have registered to sell KN95s in the U.S. were never fully vetted by any U.S. agency; some make virus-protection or filtration efficiency claims the FDA explicitly forbade when it relaxed the rules.
Complaints about fit are common with KN95s. The vast majority—even those authorized as medical respirators by the FDA—are secured with ear loops. Nearly all U.S.-authorized N95 masks use headstraps, which federal regulators and users say provide a more secure, airtight fit to keep out viruses.
The city of Portsmouth, N.H., which used KN95s to protect city workers, ran into quality problems and complaints from staffers that some fit poorly. If a respirator mask isn’t airtight, occupational-safety experts say, viruses can leak in.
The city is no longer trying to buy KN95s. “They don’t seal properly. They smell musty,” a spokeswoman said. “But if you absolutely had to have a mask, it’s better than nothing.”
The explosion of KN95s in the U.S. can be traced back to March, as the pandemic began to spread. Federal officials realized there was a severe shortage of U.S.-certified N95 masks made both domestically and abroad.
When tested by the National Institute for Occupational Safety and Health, most foreign masks failed. Some of the manufacturers claimed the models tested were counterfeits,according to Niosh.Foreign masks tested in 2020Source: Niosh
At least 22 of the Chinese companies on the initial FDA emergency-use authorization list—including some still on the list—were named in fake or invalid certifications claiming their products passed European health and safety tests or were certified in Europe, according to a review of company marketing materials from official websites and from middlemen purchasing masks. Many claimed European certification in their packaging sold in the U.S., or stamped on their products.