A FDA attempt to address a shortage of protective face masks has instead kick off the floodgates to 3,500 Chinese manufacturers’ selling products of widely fluctuating quality, potentially putting people at risk and leaving some U.S. states with stockpiles of masks they no longer trust as protective gear, a Wall Street Journal analysis report.
When the U.S. was facing a severe shortage of N95 masks in the early days of the pandemic, the FDA made an emergency decision to allow importation of millions of Chinese-made KN95 masks that were supposed to provide similar levels of protection. However, the agency itself created confusion about which Chinese brands could be trusted for medical use, in part by giving and then revoking its stamp of approval to masks that turned out to be subpar.
According to the report, the agency also relaxed its rules governing Chinese masks aimed at the general public, allowing hundreds of brands to be sold with little oversight and few quality checks. But now the FDA has posted a list of Chinese-made respirators that are “authorized” and “no longer authorized” for medical use, but the list can be confusing and contradictory.
Suzanne Schwartz, a senior FDA gadget regulator, mentioned in an announcement that the company has been consistently responding to new knowledge and science through the pandemic. In approving Chinese language respirators, she mentioned, the company initially inbuilt safeguards as a result of considerations about fraudulent KN95s and has twice tightened guidelines primarily based on recent data.
Among the many points recognized within the Wall Street Journal evaluation:
State businesses submitted orders for greater than 180 million KN95 masks to guard staff, in keeping with public information, a lot of which at the moment are sitting undesirable in warehouses as a result of high quality considerations. In the meantime, federal businesses have distributed thousands and thousands of further KN95 masks to states, which can have the identical high quality points.
Practically one-fifth of Chinese language masks makers were just weeks old when the FDA initially accepted them for medical use, whereas others used faux certifications or incomplete assessments to assert their masks met Chinese language or European requirements, in keeping with a assessment of Chinese language company registries and firm advertising and marketing supplies.
Greater than 3,500 Chinese language producers which have registered to promote KN95s within the U.S. have been by no means totally vetted by any U.S. company; some make virus-protection or filtration effectivity claims the FDA explicitly forbade when it relaxed the foundations.
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