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F.D.A. Bans Faulty Masks, 3 Weeks After Failed Tests F.D.A. Bans Faulty Masks, 3 Weeks After Failed Tests
(3 days later)
For three weeks the Food and Drug Administration allowed the sale of several types of N95-style face masks for American health care workers despite evidence from other parts of the federal government that the masks were not effective for blocking the coronavirus.For three weeks the Food and Drug Administration allowed the sale of several types of N95-style face masks for American health care workers despite evidence from other parts of the federal government that the masks were not effective for blocking the coronavirus.
Millions of these masks, produced in China, have been bought by or donated to American hospitals and distributed to others on the front line of the Covid-19 outbreak. Starting in mid-April, tests conducted by the Centers for Disease Control and Prevention revealed that some of the products did not meet medical standards for protection against the coronavirus.Millions of these masks, produced in China, have been bought by or donated to American hospitals and distributed to others on the front line of the Covid-19 outbreak. Starting in mid-April, tests conducted by the Centers for Disease Control and Prevention revealed that some of the products did not meet medical standards for protection against the coronavirus.
But it wasn’t until Thursday that the F.D.A. barred more than 65 of the 80 authorized manufacturers in China from exporting N95-style face masks to the United States for medical use, citing poor quality.But it wasn’t until Thursday that the F.D.A. barred more than 65 of the 80 authorized manufacturers in China from exporting N95-style face masks to the United States for medical use, citing poor quality.
“While the F.D.A. continues to take action to balance the urgent need of supplies of respirators for health care personnel, we are also doing everything in our authority to ensure health care personnel receive adequate protection,” an F.D.A. spokeswoman said in a statement. She added that the agency would collaborate with the C.D.C. to increase the supply of masks and ensure their integrity.“While the F.D.A. continues to take action to balance the urgent need of supplies of respirators for health care personnel, we are also doing everything in our authority to ensure health care personnel receive adequate protection,” an F.D.A. spokeswoman said in a statement. She added that the agency would collaborate with the C.D.C. to increase the supply of masks and ensure their integrity.
She did not comment on the delay between the failed tests and the F.D.A.’s action.She did not comment on the delay between the failed tests and the F.D.A.’s action.
N95 masks, many of which are also produced in China, provide better protection against coronavirus particles than cloth or surgical masks, and are coveted by health care providers and emergency medical workers. On April 3, drastic shortages of the N95 masks led the F.D.A. to allow imports of similar masks, also from China. Millions of them have been imported.N95 masks, many of which are also produced in China, provide better protection against coronavirus particles than cloth or surgical masks, and are coveted by health care providers and emergency medical workers. On April 3, drastic shortages of the N95 masks led the F.D.A. to allow imports of similar masks, also from China. Millions of them have been imported.
These masks, known as KN95, were never tested by American regulators, but were required to be vetted by an accredited test laboratory, which can be outside the United States, showing that they met the standards of the C.D.C. Those standards call for filtering 95 percent of particles that are 0.3 microns or larger, including the new coronavirus.These masks, known as KN95, were never tested by American regulators, but were required to be vetted by an accredited test laboratory, which can be outside the United States, showing that they met the standards of the C.D.C. Those standards call for filtering 95 percent of particles that are 0.3 microns or larger, including the new coronavirus.
As an additional safeguard, the C.D.C. and the F.D.A. initiated their own review to make sure the masks met these performance standards. On Thursday, the F.D.A. said that too many of them failed to filter out a sufficient percentage of particles.As an additional safeguard, the C.D.C. and the F.D.A. initiated their own review to make sure the masks met these performance standards. On Thursday, the F.D.A. said that too many of them failed to filter out a sufficient percentage of particles.
In tests of about 11 masks that the F.D.A. had authorized to be sold to American hospitals, seven flunked. One mask removed as little as 24 to 35 percent of particles, according to a C.D.C. test on April 15. Others just barely missed the cut, such as masks from DaddyBaby, a company in Fuzhou, China, that typically makes diapers. Those masks removed between 91 percent and 93.5 percent of particles.In tests of about 11 masks that the F.D.A. had authorized to be sold to American hospitals, seven flunked. One mask removed as little as 24 to 35 percent of particles, according to a C.D.C. test on April 15. Others just barely missed the cut, such as masks from DaddyBaby, a company in Fuzhou, China, that typically makes diapers. Those masks removed between 91 percent and 93.5 percent of particles.
The health agencies also tested some KN95 masks that did not have agency approval. One of these, the F.D.A. said, blocked roughly 1 percent of the particles. While the C.D.C. tested only about 10 masks that had been allowed, the F.D.A. removed all other masks from its list that hadn’t yet been tested and gave their manufacturers 45 days to get tests in order to be reinstated.The health agencies also tested some KN95 masks that did not have agency approval. One of these, the F.D.A. said, blocked roughly 1 percent of the particles. While the C.D.C. tested only about 10 masks that had been allowed, the F.D.A. removed all other masks from its list that hadn’t yet been tested and gave their manufacturers 45 days to get tests in order to be reinstated.
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Many of the tests were conducted weeks ago, according to C.D.C. documents, yet the F.D.A. didn’t remove the masks until Thursday. It was unclear why there was such a delay. It was also unclear how many of the faulty masks were sold to American health care workers, where they ended up and whether the U.S. government was tracking that number. An F.D.A. spokeswoman didn’t immediately respond to questions on the issue.Many of the tests were conducted weeks ago, according to C.D.C. documents, yet the F.D.A. didn’t remove the masks until Thursday. It was unclear why there was such a delay. It was also unclear how many of the faulty masks were sold to American health care workers, where they ended up and whether the U.S. government was tracking that number. An F.D.A. spokeswoman didn’t immediately respond to questions on the issue.
Hospitals and health care workers have been wary of KN95 masks, but because of the shortage of official N95 masks, many have ended up with them anyhow.Hospitals and health care workers have been wary of KN95 masks, but because of the shortage of official N95 masks, many have ended up with them anyhow.
Updated June 2, 2020 Updated June 5, 2020
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
More than 40 million people — the equivalent of 1 in 4 U.S. workers — have filed for unemployment benefits since the pandemic took hold. One in five who were working in February reported losing a job or being furloughed in March or the beginning of April, data from a Federal Reserve survey released on May 14 showed, and that pain was highly concentrated among low earners. Fully 39 percent of former workers living in a household earning $40,000 or less lost work, compared with 13 percent in those making more than $100,000, a Fed official said.
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
Last month, the New England Patriots football team used its plane to transport roughly one million masks from China to Massachusetts, drawing positive headlines even from the New York newspapers. A week later, medical workers began expressing concerns that the masks that Massachusetts officials purchased were not the top-of-the-line N95 respirators, but rather lower-grade KN95 masks that were potentially not safe to use while caring for coronavirus patients.Last month, the New England Patriots football team used its plane to transport roughly one million masks from China to Massachusetts, drawing positive headlines even from the New York newspapers. A week later, medical workers began expressing concerns that the masks that Massachusetts officials purchased were not the top-of-the-line N95 respirators, but rather lower-grade KN95 masks that were potentially not safe to use while caring for coronavirus patients.
“We are not using these on Covid 19 patient areas or in any areas,” Michael Augustine, the supply chain director at Harrington Memorial Hospital in Southbridge, Mass., said in an email at the time. “The packaging on the masks state they are not to be used in medical and surgical environments. These are essentially parked in storage and will not be utilized.”“We are not using these on Covid 19 patient areas or in any areas,” Michael Augustine, the supply chain director at Harrington Memorial Hospital in Southbridge, Mass., said in an email at the time. “The packaging on the masks state they are not to be used in medical and surgical environments. These are essentially parked in storage and will not be utilized.”
Jay Park, an emergency-medicine doctor in New York who has been vetting mask suppliers for nonprofits, said that the F.D.A.’s reaction to the test results showed the agency hadn’t properly screened the masks before approving them for medical use. “They relied on the self-reported test results from China,” he said. “Are you kidding me?”Jay Park, an emergency-medicine doctor in New York who has been vetting mask suppliers for nonprofits, said that the F.D.A.’s reaction to the test results showed the agency hadn’t properly screened the masks before approving them for medical use. “They relied on the self-reported test results from China,” he said. “Are you kidding me?”