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Friday, February 23, 2024

The Defense Production Act Won’t Fix America’s N95 Face Mask Shortage

The metastasizing coronavirus outbreak in the United States has left health care providers and government officials facing a humbling reality as they scramble to procure medical gear that is key to containing the pandemic: On the global market for medical gear, America is just another buyer on a long list.

After weeks of dragging its feet, the Trump administration has deployed the Defense Production Act to plug gaps in the supply of the masks, gowns, and face shields supposed to protect health care workers and keep hospitals up and running. But a review of government pandemic preparedness documents, and interviews with emergency medicine specialists and supply chain experts, reveals that the American government is ill prepared to deploy the Cold War–era law to deliver gear to strapped US hospitals.

“We’re in new territory with the Defense Production Act,” says Christopher Kirchhoff, a former Obama administration aide who authored a 2016 report on the lessons learned from the 2014 Ebola epidemic. “It’s never really been used in a broad mobilization to address the kind of situation we are in.”

With federal stockpiles nearly exhausted, public health officials are pleading with the Trump administration to use the Defense Production Act to lead a wartime mobilization of US industry to make the masks desperately needed by health care workers. The act allows the government to compel companies to prioritize its own orders, provide financial support for increasing production, and allocate supplies. But these powers are geared toward intervening in global supply chains, and it remains unlikely that domestic US production can be increased with sufficient speed to make a difference.

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A key provision of the DPA allows the government to put a so-called “priority rating” on contracts, which puts its orders at the front of the line, but that does nothing to increase supply. “What we are dealing with here is that there isn’t sufficient supply, and that’s a situation where the priority rating system isn’t a sufficient answer,” says Dave Kaufman, a former senior official at the Federal Emergency Management Agency.

The Trump administration began using the DPA in earnest last week, in an effort that immediately descended into farce and recrimination. On Thursday, President Donald Trump denounced the manufacturing giant 3M on Twitter and issued a vague order granting FEMA the authority under the DPA to acquire from 3M any number of N95 masks, which are perhaps the most sought after and difficult-to-obtain piece of medical gear for Covid-19 responders.

3M CEO Mike Roman went on CNBC to defend his company, warning that restricting exports from 3M’s US factories to Canada and Latin America could precipitate a public health emergency. In many countries, 3M is the only supplier of respirators, said Roman. By banning exports of medical gear, the US may incite other countries to do the same, which would further exacerbate supply shortages.

“The narrative that we aren’t doing everything we can as a company is just not true,” Roman said, adding that his company is rapidly increasing supply of N95 masks in the US, to around 35 million a month, and is on track to double that by year’s end.

But that figure represents a small percentage of what’s needed. Ordinary N95 production in the US is estimated at 1.5 billion annually. A 2015 study by government public health researchers estimated that a flu pandemic similar to what is currently playing out would require 1.7 to 3.5 billion respirators, a figure that would increase to between 2.6 to 4.3 billion as more Americans become sick. Under a “maximum demand scenario” during which “all eligible health care and emergency response workers would use respirators from the beginning of the pandemic until its end,” 7.3 billion would be required.

With the Centers for Disease Control recommending that all Americans start wearing masks—though not ones as sophisticated as N95s—demand for protective gear will only increase.

N95 masks, called that because they filter out 95 percent of particles smaller than .3 microns, represent a tricky production problem. They must sit snug enough to create a seal and fit to the individual’s face. The masks consist of two layers of cloth with a piece of melt-blown polypropylene in between. The polypropylene is extruded at extremely small diameters, then settles and cools in a random pattern. The fibers are electrically charged, attracting particles while allowing air to pass through.

“That’s an extremely specialized manufacturing process,” says Doug Shultz, CEO of the manufacturing company Factor, who is working to source manufacturing facilities in the US for medical PPE production. Shultz says he had reviewed an estimate from a manufacturer of the machines that make melt-blown polypropylene that said the company expected a manufacturing facility begun in November to be online in July.

This complex, sluggish supply chain raises questions about whether the US government can effectively intervene in the market. “It’s a production capacity problem,” says Kaufman, the former FEMA official who is now the vice president and director for safety and security at the think tank CNA. “The DPA is designed to stimulate that, but it’s not an overnight solution.”

The DPA grants the federal government the authority to force companies to put orders from the US government ahead of others. It also grants the government the power to provide financial guarantees and support for certain types of production. While the DPA’s powers are expansive, they are far less so than the WWII-era production acts that it grew out of.

The Trump administration has already invoked the DPA to force General Motors to manufacture ventilators, but public health experts point out that protective gear may be a far more immediate problem. Without proper protective gear, doctors, nurses, and hospital staff are far more likely to fall sick. The availability of ventilators won’t matter much without staff available to operate them.

Under the DPA, the federal government could allocate protective gear to the hardest hit areas of the country, but so far the Trump administration has declined to do so—perhaps because the federal stockpile is nearly depleted and the government lacks gear to allocate.

In the absence of a coordinated approach, US officials appear to be seizing 3M supplies wherever they can find them, though whether the DPA actually grants them that power is far from clear. On Friday, a shipment of 200,000 N95 masks bound for Germany were reportedly seized and diverted to the US, leading one German official to describe the incident as an act of “modern piracy.”

After directing most production of medical gear to the Chinese medical system during that country’s outbreak, factories in China and other Asian manufacturing hubs are beginning to shift supply toward beleaguered medical systems in the US and Europe, according to supply chain experts.

Chinese manufacturers have in several cases rapidly retooled factories to abandon old product lines and shift to medical protective gear. BYD Precision Manufacture, which makes electric cars and lithium batteries, is now churning out a Chinese equivalent of an N95 mask, which the US Food and Drug Administration finally approved on Friday for emergency use by American doctors.

Around the world, a small army of consultants and supply chain specialists have mobilized to locate suppliers and vet new manufacturers coming online. Andre Thuvesson, a managing director at the supply chain consultancy Inverto, has teams scouring the Chinese market for producers and matching them with European demand. “We do the best we can to consolidate demand within one country and match it with supply on the market.”

But to get access to N95 masks, countries are paying a premium. N95 masks that could be bought for 30 cents before the coronavirus outbreak are now selling for a dollar a piece in bulk orders. And demand remains massive. European hospitals and health care authorities are purchasing three to six months’ production from Chinese factories that are churning out about 1 million masks per month, Thuvesson says.

In the US, health authorities are making similarly large purchases. On March 21, the Department of Health and Human Services placed an order for 600 million N95 masks. With a lack of domestic manufacturing capacity, the federal government is instead expediting the delivery of supplies from Asian manufacturing centers, with a FEMA-organized air bridge delivering 80 tons of medical supplies to New York on Sunday, with additional flights expected to be carried out. A report Monday from the Office of the Inspector General at the Department of Health and Human Services found that some hospital systems are still experiencing three- to six-month delays in replenishing PPE supplies.

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State medical authorities are continuing to make purchases of medical gear, and they report that competition among them is helping to drive up prices. Ed Raeke, who oversees the purchasing of supplies for Massachusetts General Hospital, says he is seeing 10-fold price increases. Preexisting orders for supplies are sometimes falling through, and his days are spent going through spreadsheet after spreadsheet comparing his hospitals’ quickly rising burn-rate with the supplies he has on hand. “It’s been a mad scramble,” Raeke says. (The situation is so bad that Patriots owner Robert Kraft is using the team plane to ferry supplies to Boston hospitals.)

And for every new supplier comes fear of fraud. “It’s become the Nigerian prince of the internet. Everyone knows someone in China right now who can obtain hundreds of thousands of masks,” says Megan Ranney, an emergency physician at Brown University. “Some of those are legitimate, but it is difficult to sort the wheat from the chaff.”

Ranney is one of the organizers of Getusppe.org, one of several clearinghouses that have popped up in the US to match demand for protective gear with supply. As states and hospitals say they lack the gear they need, these grassroots efforts have recruited tinkerers and small manufacturers to the cause. 3D printing enthusiasts are making face shields, and Brooks Brothers has given up making shirts and is instead producing face masks. But it likely won’t be enough to meet demand in a country where, as of today, more than 350,000 people are infected with the virus, a number that grows dramatically by the day.

Meanwhile, doctors on the front line have no choice but to show up for work treating Covid-19 patients, with or without gear. “Most ER docs have resigned themselves to saying they’re getting it,” says one emergency room doctor in Washington, DC, who spoke on condition of anonymity because he was not authorized to speak to the media. Supplies at his hospital are being rationed; they ran out of shoe covers this week.

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These risks have been evident for years, even as Republicans in Congress have slashed funding for pandemic preparedness. In 2017, a group of US government scientists predicted exactly what would happen to the American supply of medical protective gear in the event of a flu pandemic: widespread shortages, a complete failure of manufacturers to supply desperately needed gear, and doctors forced to work under dangerous circumstances in order to provide care to patients.

Writing in the journal Health Security, scientists from the CDC and HHS tasked with planning the US response to a flu pandemic warned that US stockpiles of respirators, masks, and gowns would fall dangerously short. And because the US health system is geared toward operating at maximum efficiency, there would be little slack in the system to step up production.

What additional production would be generated probably wouldn’t reach American shores anyway, the authors warned. In the event of a pandemic, countries that host medical equipment factories would probably divert supplies to their own populations before allowing masks to be exported.

Three years later, these predictions are all coming true, with devastating consequences for US doctors and patients.

In 2019 the federal government ran an exercise dubbed “Crimson Contagion” that modeled what would happen in the event of a pandemic flu. It offered a sobering conclusion: Government officials charged with disaster response “were not clear” on “the applicability or use” of the DPA. In the exercise, that confusion cost the government precious time to acquire the gear it needed before demand spiked.

Six to eight weeks ago, the government might have been able to make key purchases using the DPA and lay the groundwork for a ramp-up in production, says Kelly Magsamen, a former National Security Council and Defense Department official. “Unfortunately, we’ve lost a significant amount of time.”

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