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FDA: N95 masks, now plentiful

Posted by S. Kit on
FDA: N95 masks, now plentiful

President Joe Biden's administration has initiated a process of ending an emergency exception that gave hospitals the ability to ration and reuse N95 medical respirators--the critical medical equipment to protect frontline workers against COVID-19.

Many thousands of health workers have lost their lives due to the coronavirus pandemic, by being exposed and infected while treating patients without the proper protection.

Because of the critical shortage of personal protective equipment, the Trump administration asked medical providers to ration, clean and reuse disposable equipment such as masks, gowns, and swabs. This practice saw doctors and nurses reusing the same N95 mask for a week, when they're normally designed to be discarded after each patient encounter.

American Manufacturers now say the they have tens of millions of masks for sale, and medical providers say they have up to a year's worth of supply. 

For these reasons, the government says that hospitals and medical providers should try to go back to one mask per patient.

The guidance from the FDA is not a mandate: hospitals are still legally allowed to sterilize and reuse N95 masks. Although, during the next few weeks and months, the FDA will update guidance, and will require medical providers to go back to single-use, said Suzanne Schwartz, director of the FDA’s office of strategic partnerships and technology innovation.

“The ability to decontaminate was purely a last resort, an extreme measure,” Schwartz said. “From the FDA’s perspective, there is a need for us to move back towards contingency and conventional strategies, which is, you use the respirator for the interaction, and then you dispose of it and get a new one. We are in unison, in sync, with both NIOSH and OSHA in that position.”

Many ICU nurses, like Mike Hill, who works at a Northern California Sutter Hospital, said he and his colleagues still don't have much access to N95 respirators. 

“I think it’s ridiculous for Sutter to want to do extended use when the masks are inexpensive, like a dollar apiece. They should want to make sure to protect the nurses, we’re the frontline workers,” he said. “It puts the patients and us at risk for infection. They were never intended for extended use.”

Hill’s colleague, Sutter nurse Janine Paiste-Ponder, 59, was among those medical caregivers who lost their lives after being infected to the coronovarius at the workplace in the past year. Following her July 2020 death, a California’s Division of Occupational Safety and Health investigation at Sutter Health’s Alta Bates Summit Medical Center led to $155,250 in fines for numerous Covid-related workplace safety violations.

U.S.-manufacturers of N95 masks, say the devices were designed to be used only once, not reused from one patient to the next.

Prestige Ameritech CEO, Mike Bowen, said he has millions of unsold masks, as do other U.S. manufacturers which invested and ramped up during the pandemic.

“While nurses pleaded for clean masks, American N95 makers were filling their warehouses with N95s that hospitals weren’t buying. Starting today, America’s healthcare workers can and should demand clean, new N95 masks,” he said. “The N95 mask shortage is over,” he said. Read the full AP story here.

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