Frontline Health Care Workers Say Clean Masks Are Not Safe Masks, Demand Defense Production Act Be Used To Increase PPE Supply
John Brady, a registered nurse and vice president of AFT Connecticut, spelled it out a few weeks ago: “If we had enacted the Defense Production Act in the beginning, we would have all the PPE we need now. We can put a man on the moon – we can make PPE.”
Brady’s comment came during an interview about concerns voiced by registered nurses in Connecticut and around the country throughout the coronavirus pandemic about the shortage of new N95 masks and personal protective equipment in the United States.
And last week’s COVID-19 outbreak at Backus Hospital in Norwich – which infected at least nine hospital staff members – served as a Labor Day weekend reminder that our frontline healthcare workers continue to face a heightened risk of infection.
The Day of New London reported that the outbreak at Backus Hospital followed an earlier one at Three Rivers Healthcare, a Norwich nursing home where 21 people were infected and three people died of the virus. The state Department of Public Health is investigating how the outbreak occurred.
Hartford Healthcare, which owns Backus Hospital, attributed the outbreak to the inadequate use of PPE.
“Backus Hospital has identified an individual lapse in inappropriate use of PPE,” Dr. Ajay Kumar, Hartford HealthCare’s chief clinical officer, said in a statement, referring to the personal protective equipment doctors, nurses and other health care workers wear when treating COVID-19 patients and others. “Backus Hospital immediately addressed the lapse, conducted contact tracing and performed COVID-19 testing following its standard response plan. Any potential exposure has been contained and Backus Hospital is operating as usual.”
Before the pandemic, N95 masks were designated only for single use and were to be discarded immediately – even after only leaving a hospital room – in order to avoid cross contamination. But it quickly became clear that there would not be enough PPE to handle surges in cases.
On Feb. 4, the Centers for Disease Control and Prevention changed its guidance on PPE usage when the Health and Human Services Secretary authorized emergency use of additional respiratory protective devices in health care settings. The guidance was updated April 2 to explain that the use of PPE would depend largely on a hospital’s capacity and supply. The guidance has not changed since.
Months later, and despite what you may hear from leaders at the state and federal levels, frontline healthcare workers say PPE supplies are still low, and they are fed up with the lack of progress toward increasing that supply in order to get back to using things like N95 masks the way they were designed to be used – once per visit with a patient.
Decontamination Was Only Supposed To Be A Stopgap Measure
One of the ways the federal government tried to stretch PPE supplies was by awarding a six-month, $415 million contract to Battelle, an Ohio-based company that developed a controversial decontamination system for N95 masks. The company said their system, which had not received a standard Food and Drug Administration approval but instead was given a temporary emergency authorization, could clean masks for up to 20 uses.
The Department of Defense hired Battelle to set up 60 decontamination facilities throughout the country. One of those is on Chapel Street in New Haven.
U.S. Sen. Chris Murphy, a Democrat who has been vocal with his criticism of the Trump administration, says decontamination of the masks was only envisioned as a stopgap measure based on the urgency to preserve mask supplies in the early months of the pandemic.
It’s why he and U.S. Sen. Tammy Baldwin introduced legislation months ago to force the federal government to take over the supply chain for PPE and testing materials.
“If you’re talking about handing out masks on a daily or near-daily basis to every single school child in this country starting in the fall, we don’t have the capability to produce that number right now,” Murphy said in July. “We’re going to have to dramatically upscale.”
The Defense Production Act allows the federal government, in national emergencies, to require private manufacturers to manufacture specific items like N95 masks.
Murphy said there’s no lack of manufacturers in Connecticut and across the country that would be willing to switch their manufacturing process if the federal government was offering a contract.
But that hasn’t happened and in June, Battelle’s six-month authorization of use was extended by the FDA.
The New Haven facility was the seventh that Battelle set up, and when it launched in April it had already signed on nearly 40 hospitals and health care facilities in Connecticut, New York, Rhode Island, and Massachusetts.
Battelle workers pick up used N95 respirator masks from the hospitals and transport them to the Chapel Street facility where the masks are then placed inside large decontamination units. The units are subsequently filled with vaporized hydrogen peroxide, and the masks stay in that solution for roughly two-and-a-half hours.
Then Battelle workers de-gas the chamber, let the masks dry, and redistribute them to the original hospitals. Bags of decontaminated N95 masks are arriving at hospitals around the state for use by staff, as well as by members of the public who come in for care or with a loved one.
According to the FDA authorization, the masks must be labeled and the risk of using them is deemed to “outweigh the known and potential risks of such product.”
Battelle has said N95 masks can withstand the decontamination process up to 20 times without losing their ability to filter out viral particles, but some in the health care profession have their doubts.
Nurses Aren’t Buying It
At least one Connecticut nurse, who spoke on the condition of anonymity out of fear of retribution from their employer, doesn’t want to take that risk, suggesting that a clean mask is not necessarily a safe mask.
“We’re all in a field test without signing or agreeing to anything,” the nurse said, adding that decontamination was only one factor. “It is a cleaning method. It cannot maintain a mask’s constitution. Once the integrity of a mask is lost they are ineffective to block viral contaminants. The humidity of breathing, CO2 build up, oils from a person’s face, and wear and tear also take their toll on a mask, breaking down protective filtration fibers and reducing a tight fit seal along the edges.”
The nurse continued: “Decontamination methods aside, the very wearing of a mask reduces its integrity and degrades its efficacy. That was an established fact pre-pandemic and it remains a fact. The reality of the science doesn’t change just because we are desperate and short on supplies.”
Similar objections have been voiced in multiple states.
NBC reported that nurses and scientists from around the country have said that the masks begin to degrade after two or three decontaminations by Battelle, rather than 20, and the company’s own recent field testing only confirmed the integrity of the masks for four cycles of use and decontamination.
In June, the Massachusetts Nurses Association and a national nurses group renewed their call for hospitals to stop cleaning and reusing masks, because they believe it puts them at risk of exposure to the virus.
Nurses also told NBC that the masks often don’t fit correctly after just a few decontaminations – and a bad fit means the mask is essentially useless as a protective device.
Brady, of AFT Connecticut, said his members have also reported that the masks have a strong chemical odor after decontamination. “We don’t know if that is safe,” he said, adding that his members say the masks’ elastic bands are easier to break after a decontamination.
Overall, though, Brady says he and his colleagues are frustrated that the PPE supply is still not back to pre-pandemic levels.
“The fact that we’re still doing this … is ridiculous,” Brady said, adding that before the pandemic, wearing the same PPE from one contagious patient’s room to another would have been a firing offense. “The fact that the president hasn’t used the Defense Production Act [to produce N95 masks and other PPE] is inexcusable.”
The House passed the HEROES Act in mid-May but the bill has yet to be approved by the Republican-led Senate, where it faces strong opposition.
Adam Steinberg, vice president of medical affairs for Hartford Hospital, said they are using the masks cleaned by Battelle on a “trial basis.” He declined to say how big the trial was.
“Like everything with COVID, we’re trying everything,” Steinberg said last month.
It’s not clear exactly how Yale New Haven Health System is using the Battelle system.
Dr. Patrick Kenney, medical director of the supply chain for Yale Medicine and Yale New Haven Health, declined several interview requests for this story. He is reportedly seeking to use a similar vaporization process to kill three types of viruses. Yale has four working fumigation machines and four designated rooms for the process. Kenney told several news organizations that, in theory, they could recycle up to 15,000 respirator masks a day if necessary.
Testing the Decontamination Process
The FDA’s use authorization for the Battelle cleaning system is based on the company’s own 2016 study, which, according to Battelle, “simply reports visual inspections of masks” after various amounts of decontaminations. During that testing, the masks were placed on mannequins – rather than human faces – and their fit was visually inspected.
In response to questions about its technology, Battelle said its cleaning system is a new innovation and was “developed, built, tested, and validate[d] in March 2020.”
It was never widely used in any commercial manner before the COVID-19 pandemic.
“The CCDS research team performs don/doff on standard NIOSH [mannequin] head forms in between decontamination cycles to simulate the stresses on the straps that occur when the FFR [filtering facepiece respirator] is put on a person and when it is removed,” Battelle said.
Asked if the company had conducted any additional studies that included fit testing on actual humans, complete with a hood and bitter agent protocols, Battelle responded in the affirmative:
“Yes. Battelle obtained Institutional Review Board (IRB) approval to perform fit factor testing with human subjects. Samples of six different FFR (four from 3M and two from Moldex) were tested as part of this study, with samples having gone through three decontamination cycles. The overall conclusion from this study was that three cycles of decontamination did not adversely impact the fit performance of FFR.”
However, The Boston Globe reported in July that Richard Peltier, an environmental health scientist at the University of Massachusetts Amherst, had been awarded a grant by the National Science Foundation to test the efficacy of respirator masks following various sterilization methods.
According to the Globe, Peltier had little trouble acquiring treated masks from other hospitals in the state, and had so far tested masks decontaminated in five or six different ways. But his requests for Battelle-treated masks to Partners HealthCare — the largest health system in Massachusetts — had been rebuffed.
The Globe further reported that Battelle acknowledged that during its field testing with Massachusetts General Hospital — designed to assess the impact on form and fit from actual use — the company had only examined masks that had gone through four decontamination cycles. Despite the lower number of cycles — four instead of the 20 that the company had previously boasted — a Battelle spokeswoman said the results of that testing have been excellent.
But the Globe also reported that Peltier said that Battelle also had turned him down when he reached out about obtaining decontaminated masks for additional testing. Battelle spokeswoman Katy Delaney didn’t directly respond to a question from the Globe about why Battelle had declined to take part in the study.