The U.S. Food and Drug Administration has taken steps toward ending an emergency exception that allowed hospitals to ration and reuse N95 medical masks, the agency announced last week.
Thousands of medical providers have died during 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 providers to ration, clean and reuse disposable equipment. Thus, throughout the pandemic, once a week many doctors and nurses were issued an N95 mask, which is normally designed to be tossed after each patient.
Now U.S. manufacturers say they have vast surpluses for sale and hospitals say they have three- to 12-month stockpiles.
In response, the government says hospitals and healthcare providers should try to return to one mask per patient.
“The U.S. Food and Drug Administration is recommending healthcare personnel and facilities transition away from crisis capacity conservation strategies,” said the agency in a letter to healthcare personnel and facilities. The letter is not an order. Hospitals are still legally permitted to sterilize and reuse N95s. But in the coming weeks or months, the FDA will issue updated guidance and, eventually, require hospitals to revert 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.”
