Federal officials announced new measures to bring fresh, new N95 masks to healthcare workers and expand their use in other industries after scientists argued that the highly protective masks are essential in keeping workers safe from Covid-19.
The changes come because U.S. mask makers say demand from hospitals is so sluggish that they have laid off 2,000 workers and fear that some new protective equipment companies may collapse. However, in a letter to lawmakers, hospitals cite ongoing concerns about scarcity of supplies and say the boundaries at which workers should receive N95 must remain in place.
New Measures Include: The Food and Drug Administration Plans To Revoke Approval Of The Widespread Practice Of The Crisis Time To Decontaminate N95 Respirators And Bring Them Back To The Front Line For Reuse.
An official from the Center for Disease Control and Prevention also announced a change to its policy that N95 protective respirators would be reserved for health workers. Now they are “prioritized” for these workers, but are fine for bulk sales to other employers – a move that should drive aggregate demand.
A group of prominent scientists wrote to the White House in February saying that a larger proportion of US workers needed more protection from the virus in the air. And on March 1, U.S. mask makers wrote to President Joe Biden deciphering a flood of nearly 300 million N95 or equivalent respirators made in that country that were sitting unused in warehouses.
KHN also reported that federal officials in January approved the export of US N95s amid increasing unsold inventory, a move a nurses union leader described as “irresponsible”.
Lloyd Armbrust, president of the American Mask Manufacturers Association, made a U-turn last year to launch Crossbow American and manufacture masks near Austin, Texas … Decided to take matters into our own hands. He said he was pleased that federal officials had responded to concerns raised by US mask makers, and he expects sales to grow in the coming months.
But he said it was a shock to the emerging industry to spend many months trying to penetrate the U.S. healthcare market, which is dominated by large group buying organizations and where the preference for purchases from China is deeply ingrained.
“Who knows how many health care workers will become infected and potentially die from a non-existent logistics problem,” he said. “That was very frustrating. As a person, it was difficult for me to understand. “
According to Armbrust, around 50 US mask manufacturers that the association represents have reported in a survey that they have laid off around 2,000 workers collectively in recent months due to sluggish demand. You expect some businesses to fail.
Mike Bowen, vice president of Prestige Ameritech, another Texas-based N95 manufacturer, said he cut production because he had 11 million masks on hand. “I’m waiting to see if [the] The FDA’s announcement will encourage hospitals to buy more N95, ”he said via email. “If you do that, we’ll do what you need. We have a lot of N95 production capacity. “
But even last month, the American Hospital Association issued a letter to lawmakers citing supply chain concerns and endorsing existing CDC guidelines that allow healthcare workers to use a surgical mask unless an aerosol generating process is in place. (Although some experts now say that a cough produces more aerosols than such procedures.)
Another change by the CDC would allow large retailers like Amazon to sell N95 in bulk to companies outside the healthcare sector, said Maryann D’Alessandro, director of the CDC laboratory at the National Institute of Safety and Health at Work for Personal Protection Technology.
Researchers and journalists have found an increased workplace risk for bus drivers, meat packaging, and manufacturing and food processing workers who work in cramped conditions.
D’Alessandro said the agency has also approved several models of long-life “elastomeric” respirators to be reused, including one from 3M, and signed a contract to increase strategic national inventory by 375,000.
This move could serve to protect more healthcare workers in the event of a spike or a new pandemic. Studies have shown that healthcare workers are two to five times more likely to get Covid than the average person.
KHN and The Guardian counted more than 3,600 healthcare workers who have died in the past 12 months, including many people of color and most of them outside of hospitals. In interviews with families and colleagues, dozens expressed concerns about inadequate protective equipment.
During the pandemic, workers using N95 respirators were routinely asked to put them in a brown paper bag so they could be disinfected with gas, UV light, or other means, and then returned to them for reuse. Nurses have complained that the single-use respirators return misshapen or with a chemical odor.
The FDA sent a letter to healthcare providers Friday urging them to “deviate from strategies to maintain crisis capacity,” including disinfecting and reusing single-use N95s.
The letter is a step in revoking the “emergency clearances” that allowed companies to disinfect and reuse N95, said Suzanne Schwartz, director of the FDA’s Office for Strategic Partnerships and Technological Innovation.
“That should never be anything other than a crisis measure,” Schwartz said in an interview. “We want to make sure that healthcare facilities are in a situation where they have respirators or reusable equipment on hand.”
National Nurses United polls conducted in November and February show that approximately 80% of nurses reported using refurbished breathing apparatus.
The changes are “tiny steps” in the right direction, but do not meet the requirements to fully protect nurses, said Jane Thomason, senior industrial hygienist at National Nurses United.
She said about half of more than 9,000 nurses surveyed work in hospitals where patients are not generally screened for Covid, showing the potential for pre- or asymptomatic patients to infect staff.
The CDC guidelines updated in February recommending health workers use N95 or well-fitted masks to care for patients with Covid remain non-binding, allowing employers to give nurses and other health workers surgical masks instead of N95 protective masks.
The practice was controversial even after the initial supply chain breakdown. doctors on twitter responded strongly to a recent debate by the University of Calgary in which two scientists pointed to evidence that Covid is in the air – which deserves N95 protection for frontline health workers.
Another doctor argued that the coronavirus is mainly spread through droplets – a position held by many U.S. hospital managers.
Nurses called for high levels of protection against an airborne virus at the start of the pandemic, but had to protest in many places to get it or to go without it.
Since last summer, increasing evidence has shown that health care workers in surgical masks are more likely to contract the coronavirus than workers in respirators. Harvard researchers and in Israel have identified specific cases where a patient or visitor to a surgical mask infected health care workers who were also wearing a surgical mask.
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