New federal N95 mask guidelines aim to expand their use amid sluggish sales
The measures come as U.S. mask-makers say demand by hospitals is so light that they’ve laid off 2,000 workers and fear some new protective-gear companies could collapse.
Federal officials have announced new measures to help get fresh, new N95 masks to healthcare workers and to expand use of the highly protective masks in other industries after scientists argued that these are essential to keep workers safe from COVID-19.
The changes come as U.S. mask-makers say demand by hospitals is so sluggish that they’ve laid off 2,000 workers and fear some new protective-gear companies could collapse.
Yet in a letter to lawmakers, hospitals cite concerns about scarce supplies, saying limits on which workers should get N95s should stay in place.
Among the new moves:
- The federal Food and Drug Administration plans eventually to revoke its approval of the widespread crisis-era practice of decontaminating N95 respirators and returning them to front-line workers to use again.
- A federal Centers for Disease Control and Prevention official announced a tweak to its guidelines, which used to say N95 respirators were reserved for health workers. Now, they are “prioritized” for those workers but will be OK for bulk sales to other employers — a step that should boost demand.
A group of prominent scientists had written to the White House in February, saying a broader swath of workers need more protection from the airborne virus. On March 1, U.S. mask-makers wrote to President Joe Biden complaining about a glut of nearly 300 million N95 or equivalent respirators that were made in this country and sitting unused in warehouses.
KHN also reported that in January federal officials approved the export of U.S. N95s amid mounting unsold inventory, a move that a nurses union leader called “unconscionable.”
Lloyd Armbrust, president of the American Mask Manufacturers Association, took a career U-turn to launch Armbrust American and start making masks last year near Austin, Texas, saying he was troubled by “cheap, flimsy” personal protective equipment coming in from overseas.
“We … decided to take matters into our own hands,” he said then.
He says he’s gratified to see federal officials respond to U.S. mask-makers’ concerns and that he expects to see sales rise.
He said it’s been a shock for the upstart industry to try and fail over many months to break into the U.S. healthcare market — dominated by large group-purchasing organizations — where the preference to buy from China is ingrained.
“Who knows how many healthcare workers are getting infected, maybe dying, because of a logistics problem that doesn’t exist,” Armbrust said. “That was very frustrating. As a human, that was hard for me to understand.”
He said about 50 U.S. mask-makers that the association represents reported in a survey that they’ve collectively laid off about 2,000 workers in recent months amid sluggish demand and that some companies are expected to fail.
Mike Bowen, vice president of Prestige Ameritech, another Texas-based N95 maker, said he has reduced production because he has 11 million masks on hand.
“I am waiting to see if [the] FDA announcement will make hospitals buy more N95s,” Bowen said. “If they do, we’ll make what they need. We have a lot of N95 manufacturing capacity.”
Yet even through last month, the American Hospital Association, based in downtown Chicago, cited supply-chain concerns in a letter to lawmakers and endorsed existing CDC guidelines that allow health workers to use a less-protective surgical mask rather than an N95 mask unless performing an aerosol-generating procedure — though some experts say a cough produces more aerosols than such procedures.
Another change by the CDC would allow major retailers like Amazon to sell N95s in bulk to non-healthcare businesses, said Maryann D’Alessandro, director of the CDC’s National Institute for Occupational Safety and Health lab for personal protective technology.
Researchers have noted elevated workplace risk to bus drivers, meatpacking employees and those in manufacturing and food processing who labor in crowded conditions.
D’Alessandro said the CDC also approved several models of durable elastomeric respirators that are meant to be reused, including one made by 3M, and signed a contract to add 375,000 to the Strategic National Stockpile.
That move might protect more healthcare workers in the case of a variant surge or new pandemic. Health workers were two to five times more likely than the average person to get coronavirus, studies have shown.
KHN and The Guardian have counted more than 3,600 healthcare workers who died over the past 12 months, including many people of color and most of them working outside of hospitals. In interviews with families and colleagues, dozens raised concerns about what they described as inadequate protective gear.
Throughout the pandemic, workers who used N95 respirators routinely have been asked to put them in a paper sack so they could be disinfected by gas, ultraviolet light or other means and then returned to them to wear again. Nurses have complained that the respirators, which are designed to be used once, come back misshapen or with a chemical odor.
In an April 9 letter, the FDA urged healthcare providers to “transition away from crisis capacity conservation strategies” — that includes the disinfection and reuse of disposable N95s.
The letter is one step toward revoking the emergency-use authorizations that allowed companies to disinfect and reuse N95s, according to Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation.
“That was never intended to be anything other than a crisis measure,” Schwartz said in an interview. “We want to be sure healthcare facilities are getting themselves in a situation where they have respirators or reusables in stock.”
Surveys by the National Nurses United union in November and February found that about 80% of nurses reported using reprocessed respirators.
The changes are “tiny steps” in the right direction but fall short of what’s needed to fully protect nurses, said Jane Thomason, lead industrial hygienist for National Nurses United.
Thomason said about half of more than 9,000 nurses surveyed reported they work in hospitals where patients aren’t universally screened for COVID, presenting the potential for pre- or asymptomatic patients to infect staffers.
The CDC guidance that was updated in February, advising health workers to use N95s or well-fitted masks to care for coronavirus patients, remains nonbinding, Thomason said. That means employers can still have nurses and other health workers wear surgical masks instead of the more protective N95s.
The practice has been controversial. On Twitter, doctors reacted strongly to a recent debate held by the University of Calgary in which two academics pointed to evidence that COVID-19 is airborne —meriting N95 protection for front-line health workers.
Another doctor argued that the coronavirus is primarily spread by droplets — a position held by many U.S. hospital leaders.
Since last summer, growing evidence has shown that health workers in surgical masks are more likely than those in respirators to catch the coronavirus. Harvard researchers and others in Israel pinpointed instances in which a patient or visitor in a surgical mask infected healthcare workers also wearing a surgical mask.
KHN(Kaiser Health News) is a national newsroom producing in-depth journalism on health issues.