Testing has shown that authorized respirators manufactured in China "may vary in their design and performance" and "should not be decontaminated for reuse by health care personnel."
The reissued emergency use authorizations also apply to decontamination systems and specify they are no longer authorized for certain respirators made in China or respirators without approved exhalation valves.
"While we continue to support efforts to meet the urgent need for respirators, we are also doing everything in our authority to ensure health care personnel are adequately protected," Anand Shah, FDA Deputy Commissioner for Medical and Scientific Affairs, said in a statement. "As part of those efforts, we are announcing that we have revised and reissued a number of EUAs to amend which respirators are authorized to be decontaminated."
The U.S. health care systems appears to have a much more plentiful supply of personal protective equipment compared to the pandemic's early days in March and April.