Deborah Plana1,2,3, Enze Tian1,4,5, Avilash K Cramer1,2, Helen Yang1,6, Mary M Carmack1,6,7, Michael S Sinha1,6, Florence T Bourgeois1,6,7, Sherry H Yu1,8, Peter Masse1,9, Jon Boyer1,9, Minjune Kim5, Jinhan Mo4, Nicole R LeBoeuf10,11, Ju Li12,13, Peter K Sorger14,15,16. 1. Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA. 2. Harvard-MIT Division of Health Sciences & Technology, Cambridge, MA, USA. 3. Harvard Ludwig Cancer Research Center and Department of Systems Biology, Harvard Medical School, Boston, MA, USA. 4. Beijing Key Laboratory of Indoor Air Quality Evaluation and Control, Department of Building Science, Tsinghua University, Beijing, China. 5. Department of Nuclear Science and Engineering and Department of Materials Science and Engineering, MIT, Cambridge, MA, USA. 6. Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA. 7. Computational Health Informatics Program, Boston Children's Hospital, Boston, MA, USA. 8. Department of Dermatology, Yale University School of Medicine, New Haven, CT, USA. 9. Environmental Affairs, Brigham & Women's Hospital, Boston, MA, USA. 10. Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA. nleboeuf@bwh.harvard.edu. 11. Department of Dermatology, Center for Cutaneous Oncology, Brigham and Women's Hospital; Dana-Farber Cancer Institute, Boston, MA, USA. nleboeuf@bwh.harvard.edu. 12. Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA. liju@mit.edu. 13. Department of Nuclear Science and Engineering and Department of Materials Science and Engineering, MIT, Cambridge, MA, USA. liju@mit.edu. 14. Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA. peter_sorger@hms.harvard.edu. 15. Harvard Ludwig Cancer Research Center and Department of Systems Biology, Harvard Medical School, Boston, MA, USA. peter_sorger@hms.harvard.edu. 16. Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, USA. peter_sorger@hms.harvard.edu.
Abstract
BACKGROUND: The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; "masks"). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. METHODS: We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier. We then assembled a testing apparatus at a university laboratory and performed a modified test of filtration performance using KCl and ambient particulate matter on masks from hospital inventories; an accompanying website shows how to build and use the testing apparatus. RESULTS: Over 100 different makes and models of traditional and nontraditional filtering facepiece respirators (N95-type masks) were in the inventory of surveyed U.S. teaching hospitals as opposed to 2-5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many are not correctly labelled and do not perform to accepted standards and a subset are obviously dangerous; many of these masks are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers and inconsistent labeling of KN95 masks, it is difficult to distinguish between legitimate and counterfeit products. CONCLUSIONS: Many FFRs available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations to assist end users in acquiring legitimate products. Institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for regulatory agencies regarding labeling and public disclosure aimed at increasing pandemic resilience.
BACKGROUND: The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; "masks"). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. METHODS: We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier. We then assembled a testing apparatus at a university laboratory and performed a modified test of filtration performance using KCl and ambient particulate matter on masks from hospital inventories; an accompanying website shows how to build and use the testing apparatus. RESULTS: Over 100 different makes and models of traditional and nontraditional filtering facepiece respirators (N95-type masks) were in the inventory of surveyed U.S. teaching hospitals as opposed to 2-5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many are not correctly labelled and do not perform to accepted standards and a subset are obviously dangerous; many of these masks are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers and inconsistent labeling of KN95 masks, it is difficult to distinguish between legitimate and counterfeit products. CONCLUSIONS: Many FFRs available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations to assist end users in acquiring legitimate products. Institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for regulatory agencies regarding labeling and public disclosure aimed at increasing pandemic resilience.
Authors: Robert M Eninger; Takeshi Honda; Atin Adhikari; Helvi Heinonen-Tanski; Tiina Reponen; Sergey A Grinshpun Journal: Ann Occup Hyg Date: 2008-05-13
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