Background
Methods
Results
Conclusion
Key Words
History of respiratory protection in health care
National Personal Protective Technology Laboratory. Respirator trusted-source information. Available from: http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/RespSource3healthcare.html. Accessed January 30, 2013.
Occupational Safety and Health Administration. Pandemic influenza preparedness and response guidance for healthcare workers and healthcare employers. OSHA 3328–05R. 2009. Available from: http://www.osha.gov/Publications/OSHA_pandemic_health.pdf. Accessed January 30, 2013.
SHEA, IDSA, APIC. Letter to President Barack Obama. November 5, 2009. Available from: www.idsociety.org/WorkArea/DownloadAsset.aspx?id=15676. Accessed January 30, 2013.
Current state of respiratory protection in health care
American Industrial Hygiene Association Respiratory Protection Committee. Respirator performance terminology. Available from: http://aiha.org/insideaiha/volunteergroups/RPC/Documents/rpc-terms.pdf. Accessed October 18, 2012.
Occupational Health and Safety Administration. Assigned protection factors for the revised respiratory protection standard. OSHA 3352-02. 2009. Available from: http://www.osha.gov/Publications/3352-APF-respirators.pdf. Accessed January 30, 2013.

- •Discomfort experienced by HCP who wear respirators is often associated with the tight-fitting N95 respirator models.27Discomfort was routinely raised as a key factor limiting the practicality of the CDC and OSHA recommendations during the 2009 novel H1N1 influenza pandemic. HCP routinely use surgical masks to protect their face from splashes and sprays and, depending on the hazards, may switch several times throughout the course of their work shift between a surgical mask and a respirator. In general, surgical masks are viewed as more comfortable than respirators. Most HCP are more accustomed to prolonged use of surgical masks29; thus, small differences in comfort between the 2 types of devices are heightened, further leading to the perception that respirators are uncomfortable. In fact, discomfort is the most typical reason HCP cite for improper use of respirators, but this may encompass a variety of sensations and experiences, most commonly facial pressure, facial heat, facial pain, labored movement of facial muscles, or skin itchiness.21,30,31Psychologic manifestations of respirator wear, such as claustrophobia, may also be considered forms of discomfort,32and improper usage of these devices is relatively common,26,33such that it may lead to discomfort.
- •Interference with occupational duties in the field of health care is a common problem as well.21Nearly half of the HCP surveyed by Baig et al reported that an N95 respirator, at least occasionally, interfered with their ability to care for patients,26which is their primary concern.
- •Poor communication has been shown to be a concern with existing N95 respirators. Speech intelligibility may be diminished in some settings when a respirator is worn, especially in noisy environments such as emergency departments, intensive care units, and prehospital environments.34,35Speech intelligibility issues are of particular concern, given the potential for miscommunication leading to critical treatment mistakes.35,36
- •Time constraints are often raised as factors leading to noncompliance, with 2 principle areas of deficit: the OSHA requirement to be fit tested upon being hired and annually thereafter and the time required for proper donning and doffing of respirators. There is a cost—in terms of time and money—to utilize respiratory protection, which competes for the limited resources of HCP and hospitals.37,38

Project Better RESPIRATORY Equipment using Advanced Technologies for Healthcare Employees: Project BREATHE
Department of Veterans Affairs. Better respiratory equipment using advanced technologies for healthcare employees (Project B.R.E.A.T.H.E.). 2012. Available from: http://www.publichealth.va.gov/docs/cohic/project-breathe-report-2009.pdf. Accessed October 16, 2012.
Project BREATHE Working Group participants |
---|
• The National Personal Protective Technology Laboratory in the National Institute for Occupational Safety and Health in the Centers for Disease Control and Prevention (Department of Health and Human Services) |
• Office for Infection Control, Division of Healthcare Quality Promotion in the Centers for Disease Control and Prevention (Department of Health and Human Services) |
• National Center for HIV, STD, and TB Prevention, Division of Healthcare Quality Promotion in the Centers for Disease Control and Prevention (Department of Health and Human Services) |
• The US Army Edgewood Chemical Biological Center (Department of Defense) |
• The Occupational Safety and Health Administration (Department of Labor) |
• The National Institute of Standards and Technology (Department of Commerce) |
• The National Aeronautics and Space Administration |
• Biomedical Advanced Research and Development Authority (Department of Health and Human Services) |
• Office of Public Health and Environmental Hazards in the Veterans Health Administration (Department of Veterans Affairs) |
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. |
B95 respirator
Path forward
- 1.Develop clinically validated B95 test methods: Research and development organizations such as respirator manufacturers, university researchers, and federal agencies, including the Department of Defense, National Institute for Standards and Technology, and NIOSH, are encouraged to develop test methods to measure and quantify the generic Project BREATHE characteristics in Table 2. To know which respirators are most comfortable or achieve the best fit, validated test methods are necessary. In particular, the science that underlies the understanding of factors affecting respirator comfort and tolerability is not well defined. Ultimately, laboratory-based test methods will need to be validated against clinical outcomes. Recent advances from NIOSH32,42,43,44and VA27,30in assessing respirator comfort and tolerability are promising, and Department of Defense45,46and VA47scientists have developed unique approaches to assess hearing and speech intelligibility.
- 2.B95 standards development: Purchasing and procurement decisions for PPE are typically based on voluntary consensus standards, such as those developed by the American Society for Testing and Materials, National Fire Protection Association, International Organization for Standardization, American National Standards Institute, and the Association for the Advancement of Medical Instrumentation or government regulations (eg, NIOSH, FDA, OSHA).48As noted in the 2010 IOM report on Certifying Personal Protective Technologies, many parties benefit from a well-written standard. In the short-term (within the next 5 years), VA and its partners should work with voluntary consensus standards development organizations to develop a B95 respirator standard that incorporates clinically validated test methods, wherever possible. There is precedent for dual certification of respirators that allows the employer to meet OSHA requirements to use a NIOSH-certified respirator while obtaining additional features desired by the end user. For example, in other occupational settings such as firefighting, it is not uncommon to set voluntary consensus standards that exceed minimal performance standards set by government agencies. A good example of this is the National Fire Protection Association 1981 standard for self-contained breathing devices,49which requires NIOSH certification as the baseline. The Federal government sets the minimum set of general requirements for devices used by any worker in any type of workplace setting, but the standards development organizations set special, additional requirements that benefit workers in unique workplace settings. The health care setting is one of those unique workplace environments. Obtaining a B95 standard will not be mandatory for manufacturers but, instead, will be optional. B95 respirators will be the best in class in terms of comfort and fit and tailored for HCP, and thus it will be desirable for manufacturers to have this designation for their products. Hospitals will benefit from more certainty in respirator fit, higher compliance, and less absenteeism. A more long-term effort (>5 years) will include work by OSHA, NIOSH, and FDA to reduce barriers to better performing respirators in health care caused by any outdated, unnecessary, or burdensome federal regulations.
- 3.B95 prototype development: Respirator manufacturers and other research organizations are urged to conduct research and develop prototype devices that incorporate innovative design features such as more breathable filter media, adhesives for improving respirator fit, and devices for cooling and air management that will meet the desirable characteristics in Table 2. Manufacturers, in particular, are encouraged to work with HCP to better understand the challenges faced when wearing respirators while providing patient care and to develop novel solutions. To expedite this effort, US respirator manufacturers were recruited via a Federal Register notice to partner with VA to design and build new prototype B95 respirators, using the Project BREATHE recommendations as guidance. Cooperative Research and Development Agreements were signed in 2012 with 2 manufacturers, and the first prototypes produced by these collaborations are expected in 2013. As a first step, VA plans to test the prototypes in a health care simulator laboratory for usability, communication, and comfort, whereas NIOSH has agreed to conduct laboratory testing involving human test subjects to assess fit and comfort. If fully successful, Project BREATHE will eventually result in the production of at least 1 respirator that addresses some or many of the specific needs of the health care community. Performing B95 prototype development with a select group of leading manufacturers, in parallel with test method and standards development, should help bring new and emerging respirator technologies to the marketplace. End-user feedback obtained by VA and NIOSH on comfort and tolerability will be essential before these devices are commercialized, ensuring that the subjective nature of comfort and tolerability will be thoroughly assessed. Involving end users in the early stages of conceptualization tends to decrease both time and money required to move a product from an idea to the marketplace.50
Conclusion
References
- What is patient safety culture? A review of the literature.J Nurs Scholarsh. 2010; 42: 156-165
- Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis.PLoS ONE. 2011; 6: e26239
- Transmission of pandemic (H1N1) 2009 influenza to healthcare personnel.Clin Infect Dis. 2011; 52: S198-S204
- Respiratory protection guidelines.Am J Respir Crit Care Med. 1996; 154: 1153-1165
- Respiratory protective equipment.Patty's Industrial Hygiene. 2011; : 1169-1233
- A survey of private sector respirator use in the United States: an overview of findings.J Occup Environ Hyg. 2005; 2: 267-276
- Improving respiratory protection programs in healthcare to reduce and control infection.Infect Control Today. 2009; (Available from:) (Accessed October 15, 2012)
- Compliance with OSHA’s respiratory protection standard in hospitals.Am Ind Hyg Assoc J. 1999; 60: 228-236
- Tuberculosis elimination revisited: obstacles, opportunities, and a renewed commitment. Advisory Council for the Elimination of Tuberculosis (ACET).MMWR Morb Mortal Wkly Rep. 1999; 48 (Available from:) (Accessed October 15, 2012): 1-13
- Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care facilities.MMWR Morb Mortal Wkly Rep. 1994; 43 (Available from:) (Accessed October 16, 2012): 1-132
- Personal respiratory protection against Mycobacterium tuberculosis.Clin Chest Med. 1997; 18: 1-17
- Implementing AORN recommended practices for electrosurgery.AORN J. 2012; 95: 373-387
National Personal Protective Technology Laboratory. Respirator trusted-source information. Available from: http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/RespSource3healthcare.html. Accessed January 30, 2013.
Occupational Safety and Health Administration. Pandemic influenza preparedness and response guidance for healthcare workers and healthcare employers. OSHA 3328–05R. 2009. Available from: http://www.osha.gov/Publications/OSHA_pandemic_health.pdf. Accessed January 30, 2013.
- 2007 Guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings.Am J Infect Control. 2007; 35: S65-S164
California Division of Occupational Safety and Health. California Code of Regulations, Title 8; Section 5199. Aerosol Transmissible Disease (ATD) Standard. April 15, 2010.
- Cluster of severe acute respiratory syndrome cases among protected health care workers: Toronto, Canada, April 2003.MMWR Morb Mortal Wkly Rep. 2003; 52 (Available from:) (Accessed October 18, 2012): 433-436
- Respiratory protection for healthcare workers in the workplace against novel H1N1 influenza A: a letter report.National Academies Press, Washington [DC]2009
SHEA, IDSA, APIC. Letter to President Barack Obama. November 5, 2009. Available from: www.idsociety.org/WorkArea/DownloadAsset.aspx?id=15676. Accessed January 30, 2013.
- Nurses’ ability and willingness to work during pandemic flu.J Nurs Manage. 2011; 19: 98-108
- Preparing for an influenza pandemic: personal protective equipment for healthcare workers.National Academies Press, Washington [DC]2008
American Industrial Hygiene Association Respiratory Protection Committee. Respirator performance terminology. Available from: http://aiha.org/insideaiha/volunteergroups/RPC/Documents/rpc-terms.pdf. Accessed October 18, 2012.
Occupational Health and Safety Administration. Assigned protection factors for the revised respiratory protection standard. OSHA 3352-02. 2009. Available from: http://www.osha.gov/Publications/3352-APF-respirators.pdf. Accessed January 30, 2013.
- Impact of the 2009 influenza A (H1N1) pandemic on Canadian health care workers: a survey on vaccination, illness, absenteeism, and personal protective equipment.Am J Infect Control. 2012; 40: 611-616
- Preventing transmission of pandemic influenza and other viral respiratory diseased.National Academies Press, Washington [DC]2011
- Health care workers’ views about respirator use and features that should be included in the next generation of respirators.Am J Infect Control. 2010; 38: 18-25
- Respirator tolerance in health care workers.JAMA. 2009; 301: 36-38
- Occupational health and infection control practices related to severe acute respiratory syndrome: health care worker perceptions.AAOHN J. 2005; 53: 257-266
- Preventing the soldiers of health care from becoming victims on the pandemic battlefield: respirators or surgical masks as the armor of choice.Disaster Med Public Health Prep. 2009; 3: S203-S210
- Discomfort and exertion associated with prolonged wear of respiratory protection in a health care setting.J Occup Environ Hyg. 2012; 9: 59-64
- Effects of wearing N95 and surgical facemasks on heart rate, thermal stress and subjective sensations.Int Arch Occup Environ Health. 2005; 78: 501-509
- Physiological impact of the N95 filtering facepiece respirator on healthcare workers.Respir Care. 2010; 55: 569-577
- Factors influencing respirator use at work in respiratory patients.Occup Med. 2011; 61: 576-582
- Does wearing a surgical facemask or N95-respirator impair radio communication?.Air Med J. 2011; 30: 97-102
- Chemical protective clothing; a study into the ability of staff to perform lifesaving procedures.J Accid Emerg Med. 2000; 17: 115-118
- Infection control and anesthesia: lessons learned from the Toronto SARS outbreak.Can J Anesth. 2003; 50: 989-997
- Implementing fit testing for N95 filtering facepiece respirators: practical information from a large cohort of hospital workers.Am J Infect Control. 2008; 36: 298-300
- Respiratory protection against Mycobacterium tuberculosis: quantitative fit test outcomes for five type N95 filtering-facepiece respirators.J Occup Environ Hyg. 2004; 1: 22-28
- The effect of environmental design on reducing nursing errors and increasing efficiency in acute care settings.Environ Behav. 2009; 41: 755-786
Department of Veterans Affairs. Better respiratory equipment using advanced technologies for healthcare employees (Project B.R.E.A.T.H.E.). 2012. Available from: http://www.publichealth.va.gov/docs/cohic/project-breathe-report-2009.pdf. Accessed October 16, 2012.
- Respirator protection devices. Title 42, CFR, Part 84.Washington [DC]: Office of the Federal Register. 1995; 60: 30337-30404
- N95 filtering facepiece respirator dead space temperature and humidity.J Occup Environ Hyg. 2012; 9: 166-171
- Are exhalation valves on N95 filtering facepiece respirators beneficial at low-moderate work rates: an overview.J Occup Environ Hyg. 2012; 9: 617-623
- Protective facemask impact on human thermoregulation: an overview.Ann Occup Hyg. 2012; 56: 102-112
- Speech intelligibility while wearing civilian full-facepiece air-purifying respirators.ECBC-TR-779. US Army Edgewood Chemical and Biological Center Aberdeen Proving Ground Report, Aberdeen [MD]June 2010
- Reassessment of human performance parameter estimates for respiratory protection design and development.ECBC-TR-605. US Army Edgewood Chemical and Biological Center Aberdeen Proving Ground Report, Aberdeen [MD]January 2008
- Diminished speech intelligibility associated with certain types of respirators worn by healthcare workers.J Occup Environ Hyg. 2010; 7: 63-70
- Certifying personal protective technologies: improving worker safety.National Academies Press, Washington [DC]2010
- Standard on open-circuit self-contained breathing apparatus (SCBA) for fire and emergency services.2007 Ed. Batterymarch Park, Quincy [MA]2007
- Requirements engineering: making the connection between software developer and customer.Inform Software Tech. 2000; 42: 419-428
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Footnotes
The views and conclusions contained in this document are those of the authors and should not be interpreted as representing the opinions or policies of the US government. Mention of trade names or commercial products does not constitute their endorsement by the US government.
Conflicts of interest: None to report.