Table 2.
Project BREATHE recommendations
| Feature/characteristic | B95 recommendations∗ |
|---|---|
| 1. Safety and effectiveness | Respirators should meet all current NIOSH (eg, 42 CFR Part 84) and FDA standards (eg, 510(k) process for class II medical devices) and be used within an OSHA respiratory protection program, including fit testing. |
| 2. Self-contamination† | Users need to be able to easily and reproducibly don and doff respirators without self-contamination in a clinical environment. |
| 3. Fomite transmission† | Respirators should not be a conduit for fomite transmission of pathogens between persons. |
| 4. Respirator fit† | Respirators (available in 1 or few sizes) should be well fitting and capable of passing an OSHA-accepted fit test on a majority (∼90%) of US health care workers. |
| 5. Blood and body fluids | Respirators should serve as a barrier to protect the wearer from blood and body fluids. |
| 6. Reuse† | Respirators should be durable enough for the respirator to provide expected levels of protection (eg, protection factor of 10 or greater for a half-mask respirator) after multiple brief worker-patient encounters, if necessary, during a crisis. |
| 7. Repeated disinfection durability† | Respirators should be durable enough to provide expected levels of protection after 50 disinfections, each taking < 60 seconds to complete. |
| 8. Shelf-life durability† | Respirators should be durable enough to provide expected levels of protection after being stored in air-conditioned space for 10 years at 21°C-23°C (69°F-73°F) and 45%-55% relative humidity. |
| 9. Gauging fit† | Respirators should have a manufacturer-specified fit assessment technique (eg, a user seal check) that is capable of detecting inadequate fit (which would result in less than expected protection) with at least 75% accuracy during work activities. |
| 10. Hearing integrity† | Respirators should not impede, and preferably improve, the wearer’s ability to hear in a hospital environment. |
| 11. Speech intelligibility† | Respirators should not impede, and preferably improve, the ability of others to hear the wearer’s spoken words. |
| 12. Visual field† | Respirators should cause minimal obstruction of the wearer’s visual field. |
| 13. Facial visualization† | Respirators should be transparent, to the extent feasible, allowing visualization of the wearer’s face. |
| 14. Equipment compatibility | Respirators should not interfere with other equipment (eg, stethoscope) used in health care. |
| 15. Breathing resistance | Respirators should have a breathing resistance (eg, filter air flow resistance) low enough that it does not impact tolerance (eg, should be < 10-mm water pressure drop on average at 85 liters per minute). |
| 16. Facial irritation | Respirators should not cause facial irritation. |
| 17. Allergenicity | Respirators should not cause allergic reactions. |
| 18. Facial pressure† | Respirators should be constructed such that they cause minimal discomfort from pressure on the face (eg, facial pressure should be low enough to be comfortable and tolerable for (1) >2 hours of uninterrupted wear and (2) >8 hours with 15-minute break periods every 2 hours). |
| 19. Facial heat† | Respirators should be constructed such the level of facial heat rise is low enough to be comfortable for (1) >2 hours of uninterrupted wear and (2) >8 hours with 15-minute break periods every 2 hours. |
| 20. Air exchange† | Respirators should be constructed such that they have adequate air exchange from the environment and do not cause unnecessary buildup of respiratory gases (eg, CO2 dead space retention should be low enough to be comfortable for (1) >2 hours of uninterrupted wear and (2) >8 hours with 15-minute break periods every 2 hours. |
| 21. Moisture management† | Respirators should be constructed such that they have adequate air exchange from the environment and do not cause unnecessary buildup of humidity in the dead space (eg, respirator dead space humidity levels should be maintained at levels perceived as comfortable for (1) >2 hours of uninterrupted wear and (2) >8 hours with 15-minute break periods every 2 hours. |
| 22. Mass features† | Respirators should be positioned on the face in a fashion that is comfortable and tolerable for (1) >2 hours of uninterrupted wear and (2) >8 hours with 15-minute break periods every 2 hours. Respirator weight and mass distribution should be evaluated with a standardized and validated practical performance test for which performance criteria are developed. |
| 23. Odor† | Respirators should be non-malodorous. |
| 24. Prolonged tolerability† | Respirators should be comfortable enough to be worn for a prolonged period of time during a crisis (eg, for 10 consecutive days under the following circumstances: (1) >2 hours of uninterrupted wear and (2) >8 hours with 15-minute break periods every 2 hours). |
| 25. Employer desirability† | Respirators should be viewed by employers as an important and desirable component of their worker safety and infection control programs. |
| 26. Employee desirability† | Respirators should be viewed by employees as an important and desirable component of their workplace safety and infection control programs. |
| 27. Patient desirability† | Respirators should be viewed by patients/visitors as an important and desirable component of workplace safety and infection control programs. |
| 28. Cost-effective for employers† | Respirator usage should be cost-effective. |
∗
Adapted from the Project BREATHE final report by editing for clarity, combining objectives and recommendations, and removing the column with current standards.
†
Not a current NIOSH/FDA Surgical N95 requirement.