FDA allowed imports of faulty face masks for weeks, NYT finds

The FDA allowed manufacturers from other countries to sell face masks to the U.S. for three weeks despite evidence that the masks were not effective in blocking COVID-19, according to a report from The New York Times.

The FDA began allowing imports of masks similar to N95 masks — which are more effective in blocking viruses than cloth or surgical masks — on April 3 because of severe mask shortages in the U.S. Many of the masks were produced in China and have been bought or donated to U.S. hospitals, according to the Times

But the masks were never tested by U.S. regulators and only were required to be vetted by an accredited laboratory — even if that lab was not in the U.S. The lab was required to show the masks met CDC standards.

When the CDC started conducting its own reviews of the masks in mid-April, its tests showed some of the masks didn't meet standards for protecting against COVID-19, according to documents obtained by the Times

But the FDA didn't stop any of the masks from being sold in the U.S. until May 7, when it blocked more than 65 of the 80 authorized manufacturers in China from exporting the masks to the U.S. for medical use. The agency said too many of the masks failed to filter out a sufficient percentage of particles.

Although many of the tests were conducted weeks ago, the FDA didn't remove the masks until May 7, according to the Times. It's unclear why there was a delay. 

An FDA spokesperson told Becker's Hospital Review: "The FDA, in collaboration with [the] CDC ... is increasing surveillance and sampling of all [masks] imported from China – all [mask] shipments from China that come into the U.S. will be subject to random sampling and testing by [the] CDC to determine whether the [mask] meets the 95 percent particulate filtration standard. The continued surveillance and sampling will inform the FDA’s decision to allow the entry of products that meet the performance standard, refuse products that do not and identify situations where relabeling the products for use as face masks only is appropriate."

"This is an unprecedented pandemic and while the FDA continues to take action to balance the urgent need of supplies of [masks] for healthcare personnel, we are also doing everything in our authority to ensure healthcare personnel receive adequate protection. We will continue to collaborate with the CDC to increase the availability of [masks] and ensure the integrity of these products," the spokesperson continued.

It's also unclear how many of the masks were sold to U.S. healthcare workers and where they ended up. The New England Patriots team used its plane last month to transport about 1 million masks from China to Massachusetts, according to the Times

Read the full article here.


Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars