With the number of cases testing positive for the novel coronavirus keeps burgeoning every hour of a day, the world finds an acute shortage of the needed medical equipment and apparatus to prevent the further spread of the contagion.
Among these, the most needed protective device is the face masks – N95 masks.
Acute shortage of N95 masks
As hospitals around the country desperately seek N95 respirator masks to protect healthcare workers treating COVID-19 patients, the difficulty gets intensified as the federal government blocks the imports of what might be the world's most abundant alternative.
As an alternative to the shortage of N95 masks, the Chinese government has issued KN95 masks. These too, designed to filter out at least 95% of particles that are 0.3 microns or larger in size — the same measure used for the scarce N95 mask.
Similar to the N95, it fits closely around the nose and mouth, creating a seal that decreases the risk of infection. According to the Centers for Disease Control, the KN95 masks are equally effective as N95, which is certified under the US testing standards.
US govt deterred to use KN95 masks
While the issue is that the US government sees with the new type of masks is that they comply slightly differently with their norms and are made in factories that have not been certified by the US government.
By law, the masks, along with most medical devices, can't be imported or sold in the United States without the consent of the Food and Drug Administration.
While in the previous week, to ease the national shortfall of protective gear, the FDA issued emergency authorization for non-N95 respirators that had been certified by five foreign countries as well as the European Union. It thus conspicuously left the KN95 masks out of the emergency authorization.
It's in China where a significant majority of all respirator masks, including both the N95 and KN95, are manufactured. And as the number of cases in China, the epicentre of the contagion has subsided, the US, on the other hand, gets it enormously.
The importers are but hesitant to order KN95 masks because, without the FDA's seal of approval, they worry they'll get held up at customs. Most of the hospitals too refuse to accept them, even as free donations, as they fear its legal liability.