Recommended Requirements, Test Methods, and Pass/Fail Criteria for a “B95” Respirator for Healthcare Workers
Ronald E. Shaffer*, Ziqing Zhuang, Michael S. Bergman, Raymond J. Roberge, and Jung-Hyun Kim
National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL), Pittsburgh, PA
* Corresponding author & E-mail:
Lewis J. Radonovich, Megan Gosch, and Aaron E. Eagan
Department of Veterans Affairs (VA), National Center for Occupational Health and Infection Control (COHIC), Gainesville, FL
Project BREATHE (Better Respiratory Equipment using Advanced Technology for Healthcare Employees) seeks to improve respirator compliance for healthcare workers by promoting the development of more acceptable respirators. Previous work identified 28 idealized characteristics and suggested the need for development of a new voluntary standard (“B95” respirator). The goals of this manuscript are (1) to identify criteria for successful adoption of a voluntary B95 standard, (2) use these criteria to update Project BREATHE characteristics, and (3) to make preliminary recommendations for B95 requirements, test methods, and pass/fail criteria. Criteria necessary for widespread adoption of a voluntary consensus standard were identified and used to provide recommendations for how the standards development process should proceed. After a reassessment process, only seven (25%) of the Project BREATHE characteristics remained a high priority and had a suitable test method available to reliably quantify performance. In the area of Safety & Effectiveness, one human subject test and one machine test were identified that address Project BREATHE characteristics related to respirator fit, reuse, and gauging fit. For Comfort & Tolerability, eight test methods – three machine and five involving human test subjects - were identified to address Project BREATHE characteristics related to breathing resistance, facial heat, air exchange, and moisture management. Pass/fail criteria were mostly identified using published data (where possible) from existing respirator models as the baseline. Overall, we feel that the proposed B95 respirator requirements, criteria, and test methods will provide a good starting point for deliberation and advancement through the consensus standards development process.
Keywords: respiratory protection, healthcare, infection control, comfort, fit, standards