The U.S. Food and Drug Administration is alerting health care workers about certain N95 respirators, or masks, that are no longer considered safe or approved to use due to "serious" quality concerns, the FDA said in a statement.
The FDA issued the alert to health care facility risk managers, procurement staff, and health care personnel on Aug. 25 to stop using N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd.
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"The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng because the company did not implement, maintain, and control a quality management system," the FDA said.
N95 respirators that the FDA no longer approves include the following:
TC-84A-4329, TC-84A-4330, TC-84A-4331, TC-84A-4332, TC-84A-4334, TC-84A-4335, TC-84A-4336, TC-84A-4337, TC-84A-4398, TC-84A-4399, TC-84A-4400, TC-84A-4401, TC-84A-4463, TC-84A-4464, TC-84A-4465, TC-84A-4466, TC-84A-4467, TC-84A-4468, TC-84A-4469, TC-84A-4470, TC-84A-4471, TC-84A-4472, TC-84A-4473, TC-84A-4483, TC-84A-4484, TC-84A-4485, TC-84A-4486, TC-84A-4487, TC-84A-8150, TC-84A-8425, TC-84A-8543, TC-84A-8544, TC-84A-8545, TC-84A-8546, TC-84A-8547, TC-84A-8634, TC-84A-8635, and TC-84A-8636.
The FDA suggests that any Shanghai Dasheng masks bearing the numbers above be replaced immediately with approved N95 respirator masks. The NIOSH Certified Equipment list can be found here.
The decision to return to masks was made in late July when the CDC updated its masking guidance, recommending that everyone wear a mask inside or in crowded outdoor areas no matter a person's vaccination status.
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The alert from the FDA comes months after the Biden administration started ending an emergency exception in April. The exception allowed hospitals to ration and reuse N95 medical masks.
Shortages in masks, gowns, swabs, and other medical supplies prompted the Trump administration to issue the guidelines for providers to ration, clean, and reuse disposable equipment, Fox29 reported. Unfortunately, many doctors and nurses only received one N95 mask a week, typically meant to be thrown out after each patient.
However, now, with manufacturers saying they have vast surpluses for sale and hospitals saying they have three to 12-month stockpiles, Fox29 reported.
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Because of this, the government says that hospitals and healthcare providers should try to return to one mask per patient.
"The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies," the agency said in a letter to healthcare personnel and facilities in April.
That letter was not an order, but instead, a recommendation as hospitals are still legally permitted to sterilize and reuse N95s.
The FDA is expected to issue updated guidance and eventually require hospitals to revert to single-use within the coming months, Suzane Schwartz, the director of the FDA's office of strategic partnerships and technology innovation, said.
"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."
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