Even among the surreal sights of an intensive care unit crowded with Covid-19 patients, Dr. Elaine Fajardo’s mask stands out.
Jet-black silicone with magenta-capped filters protruding from both sides, it is more commonly the protection of choice at construction sites and industrial plants. But for Dr. Fajardo, it has been a precious and potentially lifesaving medical resource.
“I think these really saved us from a crisis,” said Dr. Fajardo, a pulmonary and critical care physician at the Yale New Haven Hospital in Connecticut.
In the past, Dr. Fajardo, like most health care workers, relied on disposable N95 masks, which are in critically short supply globally because of the coronavirus pandemic. Now she is the beneficiary of a prescient decision: As the virus raged in China, Yale hospital administrators bought about 1,200 of the reusable silicone masks, known as elastomeric respirators, and gave them to doctors, nurses and respiratory therapists starting in March.
Government-supported research predicted over a decade ago that a pandemic would cause a dire shortage of disposable masks, and multiple federal agencies urged hospitals and policymakers to consider stockpiling elastomerics, which are designed to be cleaned and reused for years and are government-certified to protect at least as well as N95s. Last year, researchers simulating a pandemic found that health care workers could be rapidly fitted and trained to use the masks, and last month the Centers for Disease Control and Prevention published guidance on deploying them in response to the coronavirus.
But only a handful of U.S. hospitals are using the masks widely, and the federal government — including the agency that manages the Strategic National Stockpile — has made no effort to boost production or facilitate their distribution, an examination by The New York Times found. At the same time, the shortage of disposable N95s is so severe that federal regulators have taken the extraordinary step of allowing them to be used multiple times with little-tested decontamination methods.
The Federal Emergency Management Agency said it “is not actively seeking out procurement” of elastomerics. The Department of Health and Human Services said the stockpile it manages “has not received any requests for elastomeric respirators and does not hold them in inventory.” When asked why the masks were not being deployed despite the studies and previous government guidance, each agency referred The Times to the other.
As the virus continues to spread and medical centers plan for a predicted second wave of infections, health workers who use elastomerics expressed bewilderment at their untapped potential.
“I don’t think that there’s anything we’re doing that is markedly unique that would be difficult to implement anywhere else,” said Dr. Richard Martinello, Yale New Haven’s medical director for infection prevention.
Idled industrial facilities likely have elastomerics sitting unused, and more could be produced relatively quickly by repurposing manufacturing lines, according to occupational health experts and industry officials. At least one manufacturer, MSA Safety, has hired additional workers and increased production at a factory in Jacksonville, N.C., and the company says it has the capacity to ramp up further.
“For where we are today with health care workers reusing single-use respirators, it’s crazy that we’re not deploying multiple-use elastomerics more broadly in hospital settings,” said Akhil Agrawal, president of American Medical Depot, which supplies medical centers across the country.
Elastomerics pose practical challenges, including fitting and cleaning, but the primary obstacles to wider adoption have been cultural and economic: concern about the masks’ industrial appearance and reluctance to consider alternatives when N95s were cheap and abundant.
“The basic concepts are proven,” said Dr. Ron Shaffer, who ran the research branch of a C.D.C. lab focused on protective gear for workers from 2003 to 2018. “Yes, there are some questions about the exact way you disinfect them and clean the parts and things like that, but at a fundamental level, the products are designed for that.”
Hospitals in at least four major U.S. health systems are using elastomerics to protect against the coronavirus. In interviews, administrators credited the devices with helping to prevent shortages of personal protective equipment, and workers expressed gratitude.
“It allows me to feel safe, to focus my attention on the place it needs to be, which is on patient care,” said Dr. Andrea Levine, a pulmonary and critical care physician in the I.C.U. at the University of Maryland Medical Center in Baltimore.
Administrators said they suspected many other medical centers didn’t know about elastomerics. “I do think that part of this is around education,” said Dr. Sri Chalikonda, chief medical operations officer for Allegheny Health Network, which is using the masks at multiple hospitals near Pittsburgh. “It wasn’t that it was an option that was turned down. It was an option that probably wasn’t given.”
Anticipating continued N95 shortages and spikes in demand, administrators said elastomerics offered a hedge.
“We don’t know how long this pandemic is going to last, and we don’t know if it’s going to be cyclical,” Dr. Chalikonda said. “Having these in stock, able to be put on a shelf somewhere and brought back out as needed, has really given us a lot more comfort that we can control our own destiny.”
‘The Best Approach to Preparedness’
The H1N1 flu pandemic in 2009 that claimed an estimated 12,000 lives in the United States was a jolt to Dr. Charlie Little. As medical director of emergency preparedness at the University of Colorado Hospital near Denver, he planned for the unthinkable. But when the flu arrived, Dr. Little watched the hospital burn through much of its supply of N95s, and when he tried or buy more, there were few to be had.
The following year he began planning for the inevitable next pandemic. The same supply chain vulnerabilities would recur, he reasoned, but stockpiling enough N95s would consume a prohibitively large chunk of the hospital’s budget and storage space. Another option, battery-powered respirators, required costly maintenance and, at roughly $800 each, were too expensive.
A third possibility was elastomerics. Many models were certified to provide protection at least as good as that of N95s. They could be reused for years, requiring only an occasional filter replacement, and cost about $30 or $40 apiece.
One elastomeric could do the work of hundreds of N95s, maybe thousands, and would occupy a fraction of the storage space.
The hospital bought about 600 elastomerics, which sat for a decade in a climate-controlled room — until coronavirus cases began appearing in the Denver area this March.
Dr. Abigail Lara now wears one in a Covid-19 section of the I.C.U. “It takes a little bit of getting used to, but I find them to be comfortable,” she said. “I think we all appreciate that we were given this level of protection.”
Dr. Little’s worries about the supply of N95s were shared by government researchers.
After an outbreak of another illness caused by a novel coronavirus — Severe Acute Respiratory Syndrome, or SARS — in 2003, dependence on N95s became a concern for multiple federal agencies.
C.D.C. studies estimated that during a pandemic American medical and emergency-response workers would need at least 1.7 billion N95s — more than the United States typically produced in a year. There was little room to ramp up domestic production, researchers found, and in a crisis, other countries might stop exporting them.
Using them “could substantially reduce the supply-demand gap,” C.D.C. researchers found. Stockpiling elastomerics was also the least expensive option, according to V.A. and O.S.H.A. analyses. Buying a mix of N95s and elastomerics “is the best approach to preparedness for most health care organizations,” a V.A. study concluded in 2015.
But elastomerics remain a rarity in hospitals, and a panel convened by the National Academies of Sciences, Engineering and Medicine in 2018 identified “only a few” U.S. health care facilities using them widely.
The panel found elastomerics effective and viable both for routine use and during a crisis. But there were practical hurdles, including the need for standardized guidance on wearing and cleaning the masks.
“Without attention to this issue, facilities may be ill prepared to respond to a respiratory disease pandemic that exhausts respirator supplies and could put the safety of health care workers and the care of patients at risk,” the report concluded.
The C.D.C. lab commissioned a series of studies. The first began last year and was nearly finished when the coronavirus hit.
‘I Feel Secure’
As the virus spread and N95s became scarce, Dr. Chalikonda and his colleagues at the Allegheny Health Network searched for alternatives.
They found their answer from MSA Safety, a Pennsylvania-based company that makes safety gear — including elastomerics — for construction and industrial workers. Dr. Chalikonda, a surgeon charged with overseeing parts of the supply chain for the network’s hospitals, dug into the research on the reusable masks.
“We could not find any studies that would support us not doing this,” he said. “Exactly to the contrary, we found that there were instances in health care where these were appropriate.”
Hospitals were already training and fitting employees to wear N95s properly, and C.D.C.-funded researchers found that similar training for elastomerics could be accomplished quickly — something confirmed by Dr. Chalikonda and officials at the other hospital systems using them.
“I got fitted for it, and I used it that day on patients,” said Madison Childers, an I.C.U. nurse at Allegheny’s Jefferson Hospital.
“I don’t worry about it slipping off my nose or moving when I talk,” said Dr. Tiffany DuMont, a pulmonary and critical care physician at Allegheny General Hospital in Pittsburgh. “I feel secure in it that I could do what I needed to do for that patient without worrying that I’m not being protected.”
Past concerns about the masks’ industrial appearance are now largely moot, as many patients are sedated, tethered to unfamiliar machines and surrounded by workers outfitted with an array of other protective gear. Aside from the occasional cultural reference — Darth Vader, Predator, the meth-cooking leads in “Breaking Bad” — patients rarely mention the masks, the health workers said.
In March, the F.D.A. cleared up previous regulatory uncertainty by formally authorizing the use of elastomerics in hospitals. (Some models shouldn’t be used during surgery, the C.D.C. advises, but an agency spokeswoman said this was a narrow restriction that generally didn’t apply in emergency rooms or I.C.U.s.)
Government-backed studies have demonstrated effective techniques for cleaning and disinfecting the masks, and the C.D.C. offered guidance in April. At the four medical centers whose employees spoke with The Times, similar systems are in place. Workers use disinfecting wipes on them periodically — which takes just minutes — and at the end of a shift, most send their masks for cleaning at sterile processing facilities.
Some front-line workers using elastomerics said they were likely to return to N95s after the pandemic, but others said they planned to continue using the new masks.
“I think I will always hold on to and cherish my elastomeric,” said Dr. Levine of the University of Maryland Medical Center. She envisions a day when she is meeting with medical students in her office and they see the unusual mask.
“‘Dr. Levine, why do you keep your elastomeric in your top desk drawer?’” she imagines them asking. “I’ll say, ‘Because that’s how I made it through Covid.’”
Source: NY times