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The Biden government has taken the first step to end an emergency exception that allowed hospitals to ration and reuse N95 medical masks, the first line of defense between frontline workers and the deadly coronavirus.
Thousands of medical providers have died from the COVID-19 pandemic, many exposed and infected while caring for patients without adequate protection.
Critical shortages of masks, gowns, swabs, and other medical supplies prompted the Trump administration to issue guidelines for vendors to ration, clean, and reuse single-use devices. During the pandemic, many doctors and nurses were given an N95 mask once a week, which is usually supposed to be thrown after each patient.
Now U.S. manufacturers say they have enormous surpluses on sale, and hospitals say they have stocks of three to 12 months.
In response, the government says hospitals and healthcare providers should try to revert to one mask per patient.
“The US Food and Drug Administration (FDA) recommends that health workers and facilities deviate from crisis capacity maintenance strategies,” the agency said in a letter to health workers and facilities earlier this month.
The letter is not an order: hospitals are still allowed to legally sterilize and reuse N95s. But in the coming weeks or months, the FDA will be issuing updated guidance and eventually requiring hospitals to revert to single-use use, said Suzanne Schwartz, director of the FDA’s Office for Strategic Partnerships and Technological Innovation.
“The ability to decontaminate was only a last resort, an extreme measure,” said Schwartz. “From the FDA’s point of view, we need to go back to contingency and conventional strategies. That means you use the ventilator to interact, discard it and get a new one. We agree to synchronize with NIOSH and OSHA in that position.”
The National Nurses Union, the largest professional association of registered nurses in the country, calls the new guidelines “a tiny step in the right direction”. But the organization, which represents 170,000 nurses, said the direction “ultimately fails” at protecting nurses because it allows employers to choose normal N95 care at their own discretion.
“But we know the reality – there is plenty of N95 supply,” the union said in a statement calling on the administration to update and enforce their standards.
Intensive care nurse Mike Hill, who works at a Sutter Hospital in Northern California and is a member of the California Nurses Association, said he and his colleagues still don’t have full access to N95 masks.
“I find it ridiculous when Sutter wants to be used for long periods of time when the masks are cheap, like a dollar a piece. You should want to make sure the nurses are protected, we are the frontline workers,” he said. “It puts patients and us at risk of infection. They were never intended for long-term use.”
Hill’s colleague, 59-year-old Sutter nurse Janine Paiste-Ponder, was among hundreds of medical caregivers who died in the workplace over the past year after exposure to COVID-19. After her death in July 2020, an investigation by the California Department of Occupational Safety and Health at Sutter Health’s Alta Bates Summit Medical Center resulted in fines of $ 155,250 for numerous COVID-related safety violations in the workplace.
Mike Bowen, CEO of Prestige Ameritech, whose Fort Worth, Texas facility is the largest U.S. manufacturer of N95 masks, said the devices were designed for single use only and have not been reused from patient to patient.
He said he had millions of unsold masks, as did other U.S. manufacturers that invested and ramped up during the pandemic.
“While nurses advocated clean masks, American N95 manufacturers were stocking up with N95s that hospitals weren’t buying. As of today, America’s healthcare workers can and should request clean, new N95 masks,” he said. “The shortage of N95 masks is over,” he said.
Congresswoman Anna Eshoo said the deadly shortage was “a national embarrassment and should never happen again”.
“This is welcome news and shows our progress in eradicating COVID-19,” said the California Democrat. “We need to ensure this type of shortage never occurs again by reinvesting in a sustainable supply of high-quality, American-made PPE.”
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