Tuesday, June 9, 2020

FDA Removes Many Respirators Manufactured in China from Approved List for Decontamination

In a June 7 press release, the FDA announced that it has modified its guidance related to the decontamination of many respirators manufactured in China. 

“In response to public health and safety concerns about the appropriateness of decontaminating certain respirators, the agency is reissuing certain emergency use authorizations (EUAs) to specify which respirators are appropriate for decontamination. Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel.” 

“For example, the FDA has learned from the Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) testing that authorized respirators manufactured in China may vary in their design and performance. As such, the FDA has determined that the available information does not support the decontamination of these respirators and has accordingly revised the relevant EUAs. In addition, the FDA is also revising relevant EUAs to no longer authorize decontamination or reuse of respirators that have exhalation valve” 

The list of respirator models that no longer have Emergency Use Authorization for decontamination can be found here.   

Please email COVID19@ahca.org for additional questions, or visit ahcancal.org/coronavirus for more information.

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