Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators

Details

• Personal Author:
  Nwoko J ; Rengasamy S ; Sbarra D ; Shaffer, Richard A.
• Description:
  Background: Surgical N95 filtering facepiece respirators (FFRs), certified by the National Institute for Occupational Safety and Health (NIOSH) as a respirator and cleared by the Food and Drug Administration (FDA) as a surgical mask, are often used to protect from the inhalation of infectious aerosols and from splashes/sprays of body fluids in health care facilities. A shortage of respirators can be expected during a pandemic. The availability of surgical N95 FFRs can potentially be increased by incorporating FDA clearance requirements in the NIOSH respirator approval process. Methods: Fluid resistance of NIOSH-approved N95 FFRs, and FDA-cleared surgical N95 FFRs and surgical masks was tested using the ASTM F1862 method at 450 and 635 cm/sec velocities and compared with the results from a third-party independent laboratory. Blood penetration through different layers of filter media of masks were also analyzed visually. Results: Four N95 FFR models showed no test failures at both velocities. The penetration results obtained in the NIOSH laboratory were comparable to those from the third-party independent laboratory. The number of respirator samples failing the test increased with increasing test velocity. Conclusions: The results indicate that several NIOSH-approved N95 FFR models would likely pass FDA clearance requirements for resistance to synthetic blood penetration. [Description provided by NIOSH]
• Subjects:
  Aerosols Blood Blood-Borne Pathogens Body Fluids Hematologic Diseases Occupational Health Personal Protective Equipment Respiratory Protective Devices Safety
• Keywords:
  Aerosol Particles Author Keywords: Fluid Resistance Blood-borne Pathogens Bloodborne Pathogens Body Fluids FDA Clearance N95 Filtering Facepiece Respirators NIOSH Certification Surgical Masks
• ISSN:
  0196-6553
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  OSHA Region 3 ; Pennsylvania
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  NPPTL - National Personal Protective Technology Laboratory
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  43
• Issue:
  11
• NIOSHTIC Number:
  nn:20046591
• Citation:
  Am J Infect Control 2015 Nov; 43(11):1190-1196
• Contact Point Address:
  Samy Rengasamy, PhD, National Personal Protective Technology Laboratory, National Institute for Occupational Safety and Health, 626 Cochrans Mill Rd, Pittsburgh, PA 15236
• Email:
  rda5@cdc.gov
• Federal Fiscal Year:
  2016
• Peer Reviewed:
  True
• Source Full Name:
  American Journal of Infection Control
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:f12f27c15bb444e1fca16b28217c94ba6404e76a5a96d0f8c46bb418fd438686b7b27f6d7825ad724e97a3583fd5cc9298485b25ae1d726f46481180110180d0
• Download URL:
  https://stacks.cdc.gov/view/cdc/201602/cdc_201602_DS1.pdf
• File Type:
  [PDF - 608.62 KB ]