N95 Masks: New Guidance for Addressing Shortages
An ECRI lab tour
View a recording of our April 15, 2020, live-streamed lab webcast. This video features updated recommendations from ECRI experts on new CDC recommendations, expanded decontamination options—Sterrad and Battelle, and importing of equivalent N95 masks. This video addresses critically important issues impacting hospitals now as they care for patients with coronavirus. The presentation concludes with an informative Q&A session based on questions from hospitals around the globe.
- Dr. Andrew Furman, Executive Director, Clinical Excellence, ECRI
- Amanda Sivek, PhD, Principal Project Officer I, Device Evaluation, ECRI
- Chris Lavanchy, Engineering Director, Device Evaluation, ECRI
- Tim Browne, Director, Supply Chain Services, ECRI
- Jason Launders, Director of Operations, Device Evaluation, ECRI
Lab tour recording
Webcast poll results
ECRI is here to help
Our interdisciplinary staff is here to help you address your most challenging issues in your response to COVID-19. We have compiled free resources in the ECRI COVID-19 Resource Center. Please contact us for assistance and to learn more.
Summary of recommendations
Additional ECRI Resources
- Strategies for Addressing Expected or Known N95 Respirator Shortages. Health Devices Alerts Accession No. H0577. 2020 Apr 8.
- Strategies to Combat Inadequate Supplies of Isolation Gowns. Health Devices Alerts Accession No. H0578. 2020 Apr 8.
- Safety of Extended Use and Reuse of N95 Respirators. Clinical Evidence Assessment. 2020 Mar.
- Disinfection of N95 Respirators: UV Light May Be Considered For Limited Reuse Situations. Health Devices Alerts Accession No. S0394. 2020 Apr 9.
Websites for assessing legitimacy of vendors and imported N95 alternative mask products
- Assolombarda | China's National Medical Products Administration (NMPA)-approved manufacturers of PPE: List of NMPA-approved manufacturers of PPE and medical devices. (cited 2020 Apr 17)
- National Institute for Occupational Safety and Health | NIOSH alerts to counterfeit/misrepresented NIOSN approval products: Counterfeit respirators / misrepresentation of NIOSH-approval. (2020 Apr 8; cited 2020 Apr 17)
- National Personal Protective Technology Laboratory (NPPTL) | NIOSH search tool for N95-equivalent approval numbers: Certified equipment list search. (2020 Apr 6; cited 2020 Apr 17)
- Food and Drug Administration (FDA) | Search tool for company FDA registration: U.S. establishment registration & device listing. (2020 Apr 13; cited 2020 Apr 17)
- Food and Drug Administration (FDA) | FDA list of authorized respirator manufacturers outside the United States: U.S. authorized imported, non-NIOSH approved respirators manufactured in China. In: Non-NIOSH-approved disposable filtering facepiece respirators manufactured in China - Appendix A: Authorized respirators. (2020 Apr 16; cited 2020 Apr 17)
- 3M | 3M document guidance on finding N95 respirator alternatives: Possible alternatives to surgical filtering facepiece respirators: healthcare. (Rev. 2. 2020 Mar; cited 2020 Apr 17)
- 3M | 3M document comparing international performance standards to guide N95 respirator alternatives: Comparison of FFP2, KN95, and N95 and other filtering facepiece respirator classes. (Rev. 2. 2020 Jan; cited 2020 Apr 17).
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