Mask Confusion

As the coronavirus crisis continues, shortages of the respirator masks needed to protect frontline health care workers and others have led to a rush to obtain more—but contradictory and potentially inaccurate statements from federal agencies have sown confusion and may be putting lives at risk. The federal government estimates it currently has a small fraction of the number of masks the country will need in the coming months.

The federal government, state and local agencies, hospitals, individuals, and governments across the world are all desperately scrambling to procure massive numbers of N95 face masks, so-called because they provide protection from 95% of tiny particles in the air and in fluids. Just last week, a vendor of surplus items sold over 7,600 privately owned masks for nearly $27,000. And the White House asked construction companies to donate their masks to hospitals. Earlier in March, the government announced it aims to buy 500 million of the masks. They won’t be ready immediately, but will be delivered over 18 months. Meanwhile, some hospitals are already close to exhausting their current supplies.

Last week, new legislation was signed to give producers of N95 masks protection against lawsuits when they sell the masks to health care workers, clearing the way for manufacturers like 3M and Honeywell to pump out tens of millions more to hospitals, in hopes of beginning to relieve severe shortages. Prior to the bill’s passage, liability protection—in the event someone is harmed by breathing dangerous particles while wearing the protective gear—was available to manufacturers only for masks sold to the construction industry and other industrial users. That liability will now transfer to the U.S. government. One difference between health care and industrial versions of the mask is the health care versions have to be certified to be substantially resistant to fluids and are tested by a “a stream of artificial blood directed at the respirator” whereas the industrial versions do not need to be certified for their resistance to fluids, according to the journal Occupational Safety and Health.

Meanwhile, the mad dash for masks comes amid conflicting and ambiguous statements from key federal agencies about the use of “expired” N95s—millions of which are already held in secret repositories of the nation’s Strategic National Stockpile and elsewhere—as well as guidelines for other types of masks that offer far less protection.

As the health crisis swells, many experts project that America’s health care system will be swamped even if worst-case scenarios are never realized. N95 respirators are seen as critical to keeping up to 18 million health care workers and other frontline responders safe as they care for those diagnosed with COVID-19, the disease caused by the novel coronavirus. The shortage of N95s and other critical gear has prompted the creation of the Twitter hashtag #GetUsPPE and a related website created by a group of health care professionals to help those with medical supplies donate them to hospitals. PPE is an acronym for personal protective equipment.

Last week, the head of an organization that represents America’s nearly four million registered nurses and other nursing professionals met President Donald Trump. American Nurses Association chief Debbie Hatmaker described how some nurses are currently being forced to reuse masks and rely on other materials to protect themselves, creating potentially unsafe conditions for both nurses and patients. “If frontline professionals are put into danger and become sick, it will exacerbate the crisis in the U.S., much like we have seen happen in China and Italy,” Hatmaker said in a statement. Similarly, an NBC News survey of more than 250 health care workers found that “the overwhelming majority of the medical professionals across the country who responded to the NBC News survey expressed concerns about a lack of N95 masks.” The paucity of these masks is also slowing down the rollout of COVID-19 testing, according to the New York Times.

Hatmaker also highlighted ongoing confusion surrounding the use of masks, noting that Centers for Disease Control and Prevention (CDC) guidance from March 2020 was not consistent with Occupational Safety and Health Administration (OSHA) statements.

For example, the CDC says “surgical masks” could be used where there is a greater available supply of them in order to ease the shortage of N95s. Unlike the N95, however, surgical masks of the kind typically worn in operating rooms are loose-fitting and do not seal on the wearer’s face, failing to provide an air-tight filter.

Even the N95 mask may not offer total protection from COVID-19, because it blocks most matter as small as 0.3 microns, while virus particles can range from 0.05 to 0.2 microns in diameter, according to a study published in The Lancet, a medical journal. (A micron is one-thousandth of a millimeter.) But a surgical mask is a step backwards in protection.

A 2019 study published in the Journal of the American Medical Association found “no significant difference” in the rate of flu infection of health care workers who used surgical masks versus those wearing N95 respirators, but there might be some differences in transmission between COVID-19 and the flu. According to the Johns Hopkins School of Medicine, both flu and COVID-19 can be transmitted through “droplets in the air from an infected person coughing, sneezing or talking.” But the airborne particles that cause COVID-19 might linger much longer in the air "even after the ill person is no longer near.” This could mean the well-fitted N95s could confer a greater advantage over looser-fitting surgical masks.

And, as a “last resort,” the CDC guidance states that health care workers could even use a bandana or scarf despite their “unknown” effectiveness at preventing the spread of viruses.

OSHA states that it will relax its enforcement of respirator protection standards as hospitals may have to improvise because of “supply shortages of N95 filtering facepiece respirators due to the COVID-19 outbreak.”

But OSHA still says that “appropriate respiratory protection is required for all health care personnel providing direct care of these patients,” including masks “of equal or higher protection” than the N95 offers, rather than lower, as CDC’s guidance contemplates. OSHA says hospitals should “make a good-faith effort to comply with” the law requiring stringent respiratory protection for health care workers and “use only NIOSH-certified respirators,” a reference to the CDC’s National Institute for Occupational Safety and Health.

Bandanas and scarves don’t make the cut. That said, a 2006 study on respiratory protection during pandemic flu by the non-profit Institute of Medicine stated that it “recognizes that in the absence of any alternative, some members of the public may improvise respiratory protection (e.g., T-shirts, handkerchiefs, scarves) against transmission,” but “they are not likely to be as protective as medical masks or respirators.” And, according to the institute, now called the National Academy of Medicine, “their use may give wearers a false sense of protection that will encourage risk taking and/or decrease attention to other hygiene measures” and “the level of protection offered also may be contingent on the tightness of the fit of the device to the wearer’s face.”

Hatmaker is calling on the two apparently uncoordinated federal bureaucracies—CDC and OSHA—to “align” their statements on the matter. While CDC’s declarations are advisory, OHSA formulates regulations that implement federal law to protect workers.

Neither the CDC nor OSHA responded to POGO’s requests for comments.

The CDC also issued ambiguous guidance in late February on whether N95 masks can be used safely past their manufacturer’s expiration date. The recently auctioned masks mentioned earlier expired between 2011 and 2013, and millions more in the Strategic National Stockpile are expired. The sales notice on the auctioneer’s website carried a disclaimer that purchasers would be accepting the masks “as is” and without recourse.

Roughly 40% of the N95 government stockpiled masks—an estimated 5 million of the 12 million to 13 million—are expired. As of early March, the Department of Health and Human Services estimated that the U.S. has only about 1% of the N95 masks it would need for a “full-blown” pandemic, which would require up to 3.5 billion N95 masks over a year. If the pandemic is less severe, tens of millions of masks would still be needed each month. Last month, Health and Human Services Secretary Alex Azar estimated a minimum of 300 million would be necessary.

The numbers are so large partly because, in a health care setting, the masks are only supposed to be used once, then discarded, to minimize the risk of contamination. The CDC’s guidance from this March says, in a “crisis” situation, some reuse of facemasks could be allowed “for multiple encounters with different patients,” but since “it is unknown what the potential contribution of contact transmission is for SARS-CoV-2”—the technical name for the novel coronavirus—health care providers should avoid touching “outer surfaces of the mask” and ensure “that mask removal and replacement be done in a careful and deliberate manner.”

In an indication of just how limited the strategic stockpile of N95s is, Washington state, one of the epicenters of the COVID-19 outbreak in the U.S., recently asked for 233,000 N95 masks and 200,000 surgical masks, and the Strategic National Stockpile initially only agreed to provide half of the surgical masks and less than half of the N95 marks though the stockpile later relented, according to the Washington Post.

The CDC’s guidance also prompted a letter of protest by the nurses’ association to top congressional leaders earlier this month.

In a pointed letter to Congress, the nursing association said it is “concerned that CDC recommendations are based solely on supply chain and manufacturing challenges,” and asked lawmakers to “require” the CDC to “explain the science and provide the data behind its guidance.”

An N95 mask that’s expired but properly stored and in unopened packaging might pose no major additional risks, according to the CDC and one stockpile expert POGO spoke with who asked not to be named because of his ongoing work for the government.

Based on an ongoing CDC study, the agency issued guidance in late February stating that several types of N95 masks, “despite being past their manufacturer-designated shelf life, should provide the expected level of protection to the user if the stockpile conditions have generally been in accordance with the manufacturer-recommended storage conditions” and employers have a “respiratory protection program” in accordance with OSHA standards. Hospitals are required by law to meet those standards.

By the same token, even an unexpired N95 mask can pose problems if it’s improperly stored. For instance, if stored in hot temperatures above 86 degrees Fahrenheit, those conditions can eventually lead to “crumbling of nose foam or breaking of headbands” on the mask, according to the company 3M. As OSHA warns, “Workers should visually inspect the N95 respirator to determine if the structural and functional integrity of the respirator has been compromised. Over time, components such as the straps, nose bridge, and nose foam material may degrade, which can affect the quality of the fit and seal.”

One way to extend the use of N95 masks is by disinfecting them with ultraviolet (UV) rays; however, since those rays can break apart materials, a 2016 peer-reviewed study explored whether they “could degrade the ability of a disposable respirator to protect” health care workers “during a pandemic of an infectious respiratory disease.” The study found that UV rays “could be used to effectively disinfect disposable respirators for reuse,” but there are limits to how many times this could be done, and it varies depending on the model of the N95 mask.

Offering less than the best protection may be the only solution in the event of dire shortages. But using substandard masks that provide inadequate protection could put a large number of health care workers at risk of getting sick. And an already overwhelmed health care system could collapse if a significant portion of its workforce falls ill, potentially compounding the death toll and even affecting many people with health issues separate from COVID-19.

During the last pandemic to affect the U.S., the milder than initially projected H1N1 flu pandemic in 2009, one health care worker allegedly fell ill and died because her hospital failed to provide her with an N95 mask, according to a wrongful death lawsuit. A federal judge dismissed the suit for lack of evidence.

But the danger of litigation and damage awards has recently prompted manufacturers of N95 masks to seek waivers of liability from Congress in emergency coronavirus legislation. Companies that make the respirators also sought protection from litigation in the past. In a 2006 letter to President George W. Bush, six manufacturers asked for liability protection as they also lobbied the government to purchase and stockpile masks amid that year’s outbreak of bird flu abroad.

Coverage of that 2006 letter offers a glimpse into one missed preparedness opportunity for the U.S. “France has begun stockpiling 685 million N-95 respirator masks just for first responders, while the U.S. government to date has had one request for proposals for 50 million masks,” according to a trade press article that year. “The recent experience with SARS showed that countries will embargo exports of respirator masks in the case of a global pandemic and the U.S. will need its domestic sources for these masks,” it continued, referring to the outbreak of severe acute respiratory syndrome that was first identified in Asia in 2003.

The expert on the U.S. strategic stockpile told POGO that year after year, for the last two decades, the federal government has failed to stock up adequately. “Budgets have not been requirements-driven,” they said.

And warnings have continued. An October 2019 federal report obtained by the New York Times detailing lessons learned from a mock pandemic preparedness exercise stated that “Domestic supplies of on-hand stock of antiviral medications, needles, syringes, N95 respirators, ventilators, and other ancillary medical supplies are limited and difficult to restock, because they are often manufactured overseas.”

Meanwhile, China, the world’s largest supplier of N95 masks and the location where COVID-19 first appeared, has been withholding its exports of the respirators.

And while he has laid the groundwork to use the Defense Production Act, Trump continues to resist requests from governors and hospitals to use that law to compel U.S. companies to further ramp up production of N95 masks and other vital medical equipment, such as ventilators that help people in respiratory distress breathe. The Trump administration invoked the law to provide more bottled water and other supplies for Puerto Rico after Hurricane Maria hit in 2017. In 2003, the law was also used “to accelerate deliveries” of personal protective equipment of a different kind: body armor for U.S. troops in Iraq.