URGENT FDA Notice Regarding Filtering Facepiece Respirators (FFPs)

The FDA revised one criterion for Emergency Use Autorization (EUA) for Non-NIOSH-Approved disposable FFPs manufactured in China. As a result, several respirators failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH. Therefore, these have been removed from Appendix A as they may not reliably provide a minimum percent particulate filtration efficiency and cannot be reliably decontaminated. Please refer to the NIOSH page for the results and removed companies: https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

Please view the FDA letter in its entirety here: https://www.fda.gov/medical-devices/letters-health-care-providers/certain-filtering-facepiece-respirators-china-may-not-provide-adequate-respiratory-protection-letter.

A webinar for factors to be considered when purchasing respirators from another country, produced by CDC/NIOSH can be found here: https://www.cdc.gov/niosh/npptl/webinars/Webinar-Factors-To-Consider.html

7 views0 comments

Recent Posts

See All

The Centers for Disease Control and Prevention National Safety Healthcare Network (CDC NHSN) published in January guidance for the Patient Safety Component Manual. Please check your specific areas to

Becton, Dickinson and Company have issued a voluntary recall of the 2Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) better known as ChloraP