MOBILE, Ala. (WKRG) — Due to the shortage of N95 masks, the Food and Drug Administration approved the use of some KN95 respirators. But throughout the coronavirus pandemic, authorities have been warning that in some cases, counterfeit masks are ending up in the hands of those who really need the real thing.
After WKRG News 5 aired a story about the counterfeits last week, a local woman with triple lung disease reached out to Cherish Lombard to say thank you for the warning. She had KN95 masks that said they were “FDA approved.”
This is what happened. Authentic N95 masks, or respirators, are approved for use by the National Institute for Occupational Safety and Health, or NIOSH. But during a public health emergency, like the coronavirus pandemic, the FDA can use its emergency use authorization authority to allow the use of unapproved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met. Products like KN95 masks. That criteria is that the respirators are supposed to filter out 95 percent of small airborne particles.
But on May 7, 2020, the FDA released a “revised” list of 75 previously cleared KN95 respirator manufacturers — all in China — that ended up failing to meet that 95-percent filtration standard. Debroah Blakely’s respirators were on the list.
“I actually purchased a couple of them. They would only allow two per customer. So I said, ‘Okay, these are really good ones,'” she said.
Because of Debroah’s lung condition, she couldn’t be there for the entire interview, so Cherish also spoke with her son, Adrian.
“She has a triple lung disease. She has asthma and Sarcoidosis of the lungs so she can’t be exposed to any of this type of things. It was your broadcast actually that led us to our findings that the KN95 respirators were in fact inferior. We’re going out in confidence thinking that we’re safe in our masks. Your report on the KN95 respirators, it in a way saved our lives,” Adrian Hosey said.
Some of the inadequate respirators have even unknowingly been donated to hospitals and nursing homes. So before you buy any respirator, just know that there are still some on the market that do not meet standards.
No longer FDA-approved KN95 manufacturers: https://www.fda.gov/media/137928/download
Authorized KN95 manufacturers: https://www.fda.gov/media/136663/download
You can call the CDC to find out if your masks are NIOSH-approved. The number is 1-800-232-4636.
Adrian and Debroah are donating moisturizers to first responders to help soothe the skin where their masks rub against their faces. You can learn more about their company here.
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