Feds OK’d Export of Millions of N95 Masks as U.S. Workers Cried for More

By Christina Jewett, Senior Correspondent with the KHN enterprise team, is writing about health care workers dying of COVID-19 for the Lost on the Frontline project. Her reporting on secretive FDA device-reporting loopholes resulted in the release of 5.7 million records and was recognized with the Barlett & Steele Gold award, the SPJ Sunshine Award and an Edward R. Murrow award and was a Goldsmith Award finalist, among others. She previously worked at Reveal/The Center for Investigative Reporting, where her work on hospital billing practices with colleagues was recognized with a George Polk Award. Before that, she worked at. Originally published at Kaiser Health News.

In the midst of a national shortage of N95 masks, the U.S. government quietly granted an exception to its export ban on protective gear, allowing as many as 5 million of the masks per month to be shipped overseas.

The Federal Emergency Management Agency issued the waiver in the final moments of Donald Trump’s presidency last month, allowing a Texas company to export its products after it failed to secure U.S. customers, according to the FEMA letter obtained by KHN.

National Nurses United president Zenei Triunfo-Cortez called the export waiver “unconscionable” and said N95s remain under lock and key in many hospitals. She said she still has to “beg” for a new N95 if hers gets soiled during a shift caring for covid-19 patients.

Health care employers “and a federal agency that is supposed to be protecting the people of America are not doing their jobs,” she said. “They have no regard for our safety.”

The disconnect between front-line workers going without better protection and federal officials suddenly exporting masks boils down to one thing, workplace-safety experts say: The government has not pivoted quickly enough to lift supply chain crisis-mode guidelines and force employers to take costly and sometimes cumbersome steps to better protect workers with top-quality gear.

The FEMA letter references the challenge that Fort Worth-based Prestige Ameritech faced in finding customers for its government-approved, high-end respirators: Hospitals did not want to “fit test” employees to its N95s, a 15-minute process per employee to ensure that a new N95 model seals to the face, according to company president Mike Bowen.

Bowen said he ramped up N95 production during the pandemic from 75,000 to 9.6 million per month. Lately, he said, he can’t sell them to major buyers, does not have the infrastructure to sell them to small buyers and has so many in storage that he may need to lay off workers and wind down production.

The FEMA letter references those challenges and says the waiver was granted in the “national defense interest” to ensure he keeps production running at pace. The letter was transmitted to Border Patrol officials who oversee exports 103 minutes before Joe Biden was sworn into office.

Yet even with the waiver, Bowen said, he hasn’t been able to find an overseas buyer. He said he can’t understand the contradictory information he’s getting: Front-line workers say they need more N95s, but hospitals say they don’t.

“There is a disconnect someplace, and I don’t know where it is,” Bowen said. “Why aren’t my phones ringing off the hook if there’s a shortage?”

A FEMA official said by email that the waiver could be revoked at any time if U.S. demand increases and that the agency could require the company to “satisfy domestic demand” before exporting N95s.

Although prices fall considerably for those buying in bulk, prices for smaller lots of N95s have reached $4 to $7 each, according to Get Us PPE, a nonprofit meant to match front-line workers with needed gear.

The requirement for employers to perform fit tests annually was set aside amid the public health emergency, giving employers little incentive to veer from the industry-standard models like 3M that were used for years. And the Centers for Disease Control and Prevention has left guidelines in place that say a limited cadre of health care workers should get N95s, which can be reused and rationed.

That adds up to an unusual situation in which U.S. mask supplies have surged, but employers’ motivation to buy the best protective gear has not, said Peg Seminario, a former union health and safety official who recently signed a letter urging the CDC to update its guidelines to reflect the risk of inhaling the virus.

“This is crazy,” she said. “We could … crush this pandemic where the biggest risks of infection are and we’re not doing it.”

Started by a group of emergency room doctors in March, Get Us PPE said it gets 89% of requests for gear — often N95s — from health workers outside of hospitals, like community clinics, covid testing sites and psychiatric care facilities. Demand rose throughout January, with 28% of front-line workers seeking N95s reporting that their site had none.

Yet the volunteer-run group has been able to fulfill only about 15% of the requests it receives. Dr. Ali Raja, a founder of the group and executive vice chair of the emergency department at Massachusetts General Hospital, said the need is vast outside of hospitals, but small facilities scrambling for gear are not connecting to bulk sellers like Bowen’s firm.

“There was nothing out there — no centralized place for all facilities to report PPE needs,” Raja said. “We don’t want to be the website with the best data on this. We want that to be the federal government.”

On the last day of 2020, FEMA extended its rule prohibiting anyone from exporting PPE, including N95s, without first getting express approval from the agency. The rule says the fall and winter surge in covid cases meant “domestic supply of the allocated PPE has not kept pace with demand and is not anticipated to do so.”

The U.S. Strategic National Stockpile has not yet met its goal for N95 respirators, according to a U.S. Government Accountability Office report. The report said that as of Dec. 18, there were 190 million N95 respirators in storage — well short of its goal of 300 million.

“GAO remains deeply troubled that agencies have not acted on recommendations to more fully address critical gaps in the medical supply chain,” the government watchdog report says.

Another twist to the saga is that millions of counterfeit N95s stamped “3M,” an industry standard that has long been used in previously required annual fit tests, have flooded hospital shelves even as federal agents rush to seize them at U.S. ports.

A prominent group of scientistswrote to the CDC on Monday to point out guidelines that urgently need to be changed to protect workers from inhaling tiny airborne virus particles. Their letter noted that the “CDC does not recommend the use of N95 respirators” outside health care settings, even though outsize risks are documented for bus drivers, prison guards and meatpacking staffers.

CDC guidelines also allow hospitals to limit which workers get the N95s, leaving out those in community settings and lower-level workers who typically spend the most time next to patients.

In the Lost on the Frontline project, KHN and The Guardian have documented the deaths of hundreds of more than 3,440 front-line health workers, of whom 2 in 3 were workers of color and 56% worked outside of hospitals. For more than 120 who died, family members had concerns about PPE, including the extensive reuse of N95s or the use of surgical masks for direct care of covid patients.

KHN senior correspondent JoNel Aleccia contributed to this report.

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17 comments

  1. Altandmain

    As a Canadian, we were on the receiving end of the export bans the Trump administration tried to impose. I would be highly disappointed in the US government if there is another attempt at an export ban. Disappointed, but not surprised.

    https://www.cbc.ca/news/business/3m-n95-masks-1.5520326

    We desperately need masks ourselves here too. At my old job, one of our production supervisors has a girlfriend who is a nurse and they are worried about the shortages too. Our Premier, who I disagree with on a lot of issues, but who has handled the pandemic reasonably well, condemned the move.

    https://toronto.ctvnews.ca/ontario-premier-slams-donald-trump-s-decision-to-cease-exports-of-n95-masks-to-canada-1.4881717

    The US and Canada were able to work out a deal, but I think it is clear that there is a shortage of PPE throughout the world. Let’s just say that the US can’t do an export ban without there being huge diplomatic repercussions, which seems to be what this article is implying should be done because of the desperate situation in the US.

    The other lesson that needs to be learned is that free trade and false economic theories like comparative advantage don’t work. We need to have a large enough domestic manufacturing capacity to sustain ourselves and the ability to surge production in the event of a pandemic. We smaller nations can’t depend on the larger nations.

    I hope that this leads to a careful re-evaluation of globalization and the pro-rich economic theories that were used to justify it.

    1. JEHR

      Yes, the Canadian example is interesting. Trump decided that no N95 masks should be sold to other countries without his realizing that an important component of the masks was made only in Canada and if he refused to sell to other countries, Canada could have (but didn’t) refused to use those important components so that the masks would not be made. Globalization is a two-edged sword and I will support any initiative in Canada to have our own manufacturing base for important things like PPE.

  2. ambrit

    All I can say is to paraphrase “Shrub” Bush, “Heck of a job, Covid!”
    I’d love to see a poster showing The Knight playing chess with Death. Death will be wearing a tee-shirt with the logo ‘FEMA’ on the front and ‘CDC’ on the back.

    1. skippy

      I remember the old how green is your cactus rendition where shrub was Howard, as he, was only a little Bush …

  3. The Historian

    The headline to this article is somewhat misleading – it makes it sound like we are exporting masks even though there is a big unfulfilled market in the US. But as the producer interviewed in the article says, he can’t sell them to Americans because the powers that be won’t buy them even though their employees are clamoring for them.

    I think this is the most important statement in whole article:

    “The disconnect between front-line workers going without better protection and federal officials suddenly exporting masks boils down to one thing, workplace-safety experts say: The government has not pivoted quickly enough to lift supply chain crisis-mode guidelines and force employers to take costly and sometimes cumbersome steps to better protect workers with top-quality gear.”

    Protect workers? When there is a dollar to be made? Pshaw! Totally unAmerican!

    1. Whiteylockmandoubled

      Hospitals are all in bulk supply purchasing cooperatives that sole-source just-in-time deliveries.

      They’re supposed to be cost savers, but they’re not. They’re plagued by the usual US monopoly issues and outright corruption.

      If those networks are an obstacle to the purchase and distribution of PPE to health care workers, the Biden Administration should find a regulatory hook, void the contracts, force the hospitals to liquidate their endowments’ fracking limited partnership shares and buy from suppliers like the one in this article.

      Then lock every executive in every “health system” C-Suite with an N-95 shortage up for manslaughter. That any CEO of a major non-rural hospital is walking around free right now is all the evidence you need that we are governed by a rapacious oligarchy in which the Rule Of Law is always, always for Thee and not Me.

  4. Kaligula

    Free market!

    Yeah, how’s it working for you so far? Fucked up PPE supply line & health care delivery, screwed up power supply and water supply, “great” vax distribution – anything else???

    Works “great”, this capitalistic “free market”, yeah… (Makes you want to barf!)

  5. Dave in Austin

    In Austin/Travis County, TX the public health officials have big stocks of N-95 masks, which they give out for free to medical and hospital workers. The supply is great enough that friends in the medical industry have been passing on a few masks to me, which I now use regularly.

    The simple N-95 3M masks are sold through 3 M at, I believe, in the 10-20 cent range when you buy by the case. At the moment they are still restricted to “official channels” so I’m technically getting the masks on the black market but with no money changing hands. My family’s attitude toward WW II rationing was “If any rich person can go to a restaurant and buy a steak dinner without a ration coupon why shouldn’t I do the same think for steak and condensed milk on the black market?” Alister Cooke in his book “the American Home Front” says by 1944-5 every restaurant in the ritzy part of NYC had bootlegged steak.

    The article is about a high-end mask with special face-fitting technology that the manufacturer wants to sell for $10+ and can find no takers, either domestic users or foreign users.

    1. CoryP

      The article is about a high-end mask with special face-fitting technology that the manufacturer wants to sell for $10+ and can find no takers, either domestic users or foreign users.

      Wow thanks! I didn’t get that from the article but it makes a lot more sense of the statement about fit-testing which sounded strange to me.

      I’ll have to read the article again.

      1. Shonde

        Even 3M respirators need face-fitting.

        As to the $10 plus cost, why does their website show the public can buy the masks at 300 for about $900 which is about $3 per mask? This is the public cost.

        The company has separate health care links for ordering which I assume has a lower bulk cost.

        My comment above has a link to their website showing this information.

        1. CoryP

          The requirement for employers to perform fit tests annually was set aside amid the public health emergency, giving employers little incentive to veer from the industry-standard models like 3M that were used for years.

          This was the part I found confusing.

          I think it says that:
          1) since they no longer have to fit-test annually
          and 2) switching manufacturers would necessitate a new fit-test (I assume)
          3) they are staying with 3M since they already know peoples’ sizes, as it saves on testing.

          (I suppose the price of the masks themselves is secondary to this argument)

          Of course this doesn’t take into account the change in weight/face shape which is I believe the reason you fit-test annually in the first place. So even by staying with 3M and saving money on testing, they are still putting their staff at risk of using an ill fitting mask.

          1. RMO

            Talked with a nurse friend of mine – she says the fitment test she has to do takes about five minutes. That kind of surprised me as I was basing my time estimate on how long it took me to do a test fitting of a half-mask respirator. We had to put it on, stick our heads in a big bag, have the tester spray in some wretch-inducing spray (methyl mercaptan I think) and stay there for a while to confirm that none of it got inside the mask. That took about ten to fifteen minuted per person.

            1. Displaced Platitudes

              To pass an annual fitment test for 20+ employees at my school district required possibly 15 minutes total. Adjust the straps on your half-mask or full-mask, hold valves closed, inhale, hold valves closed, exhale. Any leakage requires refitting straps and mask. Once satisfied, a pipette of nasty stuff is waved around your face while you inhale and exhale. Coughing is an indication that you failed and need to retest.
              This was a state certified test and the only other requirement was an annual pulmonary function test that took 5-10 minutes per employee (the 2nd requirement was due to entering confined spaces, so may not apply to health care workers).

  6. JTMcPhee

    Then there’s Washington state, where the state government is sitting on millions of masks, “enough for 100 for every health care worker in the state.” http://www.chronline.com/community/washington-stockpiles-n95-masks-as-hospitals-see-demand-rise-in-new-coronavirus-wave/article_0ed84814-2519-11eb-9fce-e7a1db37b2de.html

    Multi-tiered process for hospitals and other health care nexuses to apply for a supply to the agency hoarding the masks. And the stockpiled masks require a different fit training, and hospitals often are still resisting, on cost grounds, the many calls by exposed staff for necessary PPE.

    “In the end, there can be only one market:” “ As the state’s N95 stockpile continues to grow, officials are exploring ways to distribute more than just an emergency supply. In addition to the BYD masks, the state expects more than 1 million 3M masks in the coming months. One new option is under consideration, said Schuler, the governor’s adviser: reselling the masks at cost to Washington providers.

    Looks like WA PMC have created a “worst of all possible worlds” situation, a market-forces-driven bureaucracy. Wonder what has happened to that old “find a need and fill it” spiritual direction… (note: “need,” not “want,” and manufacturers of demand need not apply…)

  7. Wukchumni

    Early in the pandemic 3M laid off 1,500 employees, with another 2,900 let go in December.

    Not what you would expect of a corporation whose name is synonymous with N95’s, in a hot market.

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