Local lab aiming to improve face mask quality
WASHINGTON — Three years ago, a federal laboratory perched on a hill south of Pittsburgh sponsored a national study that recommended an expansion of durable, reusable face masks for front-line health care workers — pointing to past global health emergencies that strained supplies of the disposable N95 surgical masks.
“Urgent action is needed,” the 212-page report concluded, “to protect the health and safety
of health care workers, particularly in an influenza pandemic or an epidemic of an airborne transmissible disease.”
This year, the National Personal Protective Technology Laboratory, which is based in South Park and traces its century-old roots in the Pittsburgh region to the approval of the first coal mine respirator, is spearheading efforts with manufacturers and health care providers to improve the supply and effectiveness of masks amid the COVID-19 pandemic.
In doing so, the lab has helped to make the region a testing ground to prepare the country for the next public health emergency by shoring up and reinforcing the national stockpile of protective equipment.
The lab has sought to demonstrate the alternative, reusable masks by working closely with Allegheny Health Network and MSA Safety, the Cranberry-based producer of on-the-job protective equipment that also has early-20th-century origins in mine safety.
MSA produced the masks, known as elastomeric respirators. They are made of thick silicon that snugly covers the mouth and nose and features protruding filters on each side. The mask, which is bulkier than the N95 and can withstand multiple cleanings, was much more familiar in industrial workplaces than in hospital rooms.
But AHN’s facilities faced a global pandemic where supplies of N95 masks — as well as face shields, gowns, gloves — were in such high demand that the federal stockpile was quickly depleted. Local governments and health systems, forced to compete for supplies, saw instances of price gouging.
In March, AHN began a trial run of using MSA’s reusable masks at its nine hospitals in Pennsylvania and western New York.
The nation was confronting exactly the supply strain that officials at the laboratory had seen before and feared would happen again. This time, Maryann D’Alessandro, the laboratory’s director, said she hopes to finally gather enough research to update federal guidance on the masks. The partnership between MSA and AHN is a key to cut through the bureaucracy and overcome some longtime resistance to change at hospitals.
“We’ve been working to bring elastomerics into health care for quite some time,” Ms. D’Alessandro, who has worked at the lab since 2003, said in an interview this month.
“It’s a complex regulatory landscape when it comes to respirators. There’s a culture issue that has to be addressed, and not every health care organization wanted to do that.”
Born in coal mines
There is precedent for the kind of challenge doctors face in COVID-19 wards today.
In the early days of coal mining, workers went underground with little protection against dangerous gases and dust. In 1920 — just as the nation was recovering from the Spanish flu pandemic — the U. S. Bureau of Mines approved the country’s first self-contained breathing apparatus for coal miners.
That approval brought together federal workplace safety officials, who established research space in a federal laboratory complex south of Pittsburgh, and Mine Safety Appliance Co., today known as MSA Safety, which produced the boxy apparatus.
By the early 2000s, the modern-day PPE laboratory was founded as part of National Institute for Occupational Safety and Health, an arm of the U.S. Department of Health and Human Services that is tasked with conducting research, quality control and making recommendations, including the federal respirator approval program. In January, the laboratory marked the 100-year anniversary of the coal respirator with a celebration and a video charting its history.
The lab, with about 100 employees, has a wide range of chambers and test equipment to measure filtration efficiency and protection against dust and aerosols, Ms. D’Alessandro said.
In one chamber, a mannequin programmed to sweat heavily tests the effectiveness of protective clothing for workers in warm climates. Those findings, she said, were used to inform health workers in Africa during the 2014-15 outbreak of Ebola, which was transmitted through direct contact with blood and other bodily fluids.
For all its endeavors, elastomeric masks tended to fall by the wayside. Discussions of expanding the reusable masks in health care occasionally surfaced, Ms. D’Alessandro said, such as during the spread of avian influenza in the mid-2000s and during the H1N1 pandemic in 2009 and 2010. In 2014, the lab issued a grant to the University of Maryland to study the masks.
But N95 masks were always the priority, mostly due to their familiarity with health providers, she said. So federal research tended to focus on best methods to decontaminate and reuse N95 masks.
Opportunity emerges
But the idea of reusing N95 masks alarmed Sri Chalikonda, AHN’s chief medical operations officer, at the outset of the pandemic this year.
“That told us that the situation in the worldwide supply chain was so dire that people were taking single-use items and reusing them,” Dr. Chalikonda said. “And we saw the angst that created in caregivers across the country.”
AHN, as it was drawing up an N95 reuse protocol, also sought to find an alternative, he said. The provider turned to MSA, which had already donated a supply of N95 masks to hospitals in the region, and asked about its other respirators.
“Is there any reason why we can’t look at those in health care?” Dr. Chalikonda asked.
The answer: Well, no, not really.
Zane Frund, a lead scientist at MSA, said the company believed its elastomeric masks could provide benefits during the COVID-19 pandemic and beyond. The mask was reusable with MSA’s disinfectant protocols, had flexibility to fit on almost all faces, and featured a filter that can remove 99.97% of airborne
particles, compared with the N95 mask’s namesake rating of 95%.
“We felt there was an increased need, as did NIOSH,” said Mr. Frund, who was the keynote speaker at the laboratory’s 100-year celebration in January. “Here we have surge, here we have insufficient supply — what can we do?”
As AHN began to deploy 8,000 of the masks to its facilities, Dr. Chalikonda evaluated their use.
His resulting study, published in June in the Journal of the American College of Surgeons, found that the elastomeric masks cost AHN at least 10 times less per month compared with disinfecting and reusing N95 masks. And in about 2,000 fit tests, he found the elastomeric mask fit about 94% of the time. No employee involved in the study asked for an N95, he reported.
Because the mouth is covered by the mask, communication could sometimes be difficult with patients, who often want to see a reassuring smile, Dr. Chalikonda said in the interview. But those are simple design issues that come with transferring an industrial mask to a consumerfacing workplace.
AHN, with a $350,000 grant from the laboratory, will share its implementation plan and a survey of how caregivers viewed them.
A stockpile of reusable respirators “is going to be a staple for every health care network,” Dr. Chalikonda said. “We have to be ready for whatever is coming next.”
“Doing it now when we have a group of engaged caregivers who can help design and implement is gonna be the key, not waiting until we need to do it again,” he added.
Long-term solution?
The AHN study is one of a series of parallel efforts at the laboratory, which has organized a pilot program to test the masks with at least 95 health providers, public safety agencies and first responders nationwide. The lab also continues to work with the University of Maryland and three other universities on best practices and optimal design.
The research will all inform NIOSH’s updated guidance on elastomeric masks, expected to be released about a year from now, Ms. D’Alessandro said.
That work is being done even as the laboratory continues its regular duties at a faster pace. It has issued double the number of approvals for new sources of
respirator manufacturing, as companies like 3M, Honeywell and General Motors opened production lines to help supply N95 masks.
The laboratory has also been tasked with testing imported PPE — and found 60% of the foreign equipment fails to meet its self-reported standards.
Congress allocated the lab $20 million for the fiscal year 2020, which ended Sept. 30 and whose budgetary levels have been maintained by temporary shortterm spending bills. The lab received an additional $12.5 million to support the respirator approval activities, a spokeswoman confirmed.
Ms. D’Alessandro said
she would love to see more PPE research centers that can support and supplement the work the lab has performed for years pop up across the country.
“There’s so much to do in this space,” she said.