Providing Clarity Regarding the Regulation of Respirators Used in Health Care Settings

Posted on by Christopher Coffey, PhD; Maryann D’Alessandro, PhD; John Howard, MD; Meghan Kiederer, BA; and Susan Moore, PhD

 

A Discussion Paper, Streamlining Regulatory Oversight of Respirators Used in Health Care Settings will Improve Worker Protection, was recently published in the National Academy of Medicine’s NAM Perspectives journal by respiratory experts outside of the federal government. This paper highlights continued confusion amongst interested parties including health care organizations and manufacturers seeking approval regarding federal regulations and guidance on the use of air-purifying respirators (APRs) in health care settings. This confusion results from multiple regulatory oversight processes and is creating barriers to the use of certain NIOSH Approved® respirators, raising the cost of effective respiratory protection, and placing the safety of health care workers (HCWs), support staff, and patients at risk. The authors propose retiring the “Surgical” N95® (SN95) filtering facepiece respirator (FFR) designation, given that all NIOSH Approved APRs meet Occupational Safety and Health Administration (OSHA) requirements, are widely used across diverse industries, and have been shown to adequately protect HCWs and patients.

The NAM Perspectives paper emphasizes that a broad range of NIOSH Approved respirators—including FFRs, elastomeric half mask respirators (EHMRs), and powered air-purifying respirators (PAPRs)—are appropriate for use in health care to protect users from airborne infectious diseases and do not compromise patient or worker safety. It also highlights potential steps to address confusion about which respirators can be used in health care settings.

Why is this important?

Currently there remains a lack of regulatory alignment among OSHA, the Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health (NIOSH) regarding respirator approval for use in health care. Specifically, FDA requires that the devices used are appropriate for the hazards present. In surgical settings, the HCW may be exposed to blood spurts at arterial pressure or flames from surgical instruments and protecting the patient means only exposing them to biocompatible materials. Thus, respirators tested to fluid resistance, flammability, and biocompatability standards are to be used. This has led to NIOSH Approved respirators labeled and marketed for use in health care as “Surgical N95 FFRs” (also known as SN95 FFRs). These additional tests are relevant to surgical setting hazards and have no bearing on respiratory protection, which is instead assured by NIOSH’s comprehensive respiratory protective device regulations (i.e., 42 Code of Federal Regulations, Part 84) that are required by OSHA for respirators used in occupational settings. OSHA does not require the SN95 product. If the HCW is exposed to particulate hazards and hazards requiring fluid resistance protection, OSHA requires that the appropriate combinations of respirators, goggles, and/or face shields, or full facepiece respirators be selected according to the task’s need.

Shirley et al. described that the SN95 designation that has no bearing on the level of respiratory protection provided has led to respirator overregulation and contributed to supply chains that are increasingly expensive, complicated, and vulnerable to shortages during surges (Shirley et al., 2017). Confusion around regulatory requirements of multiple agencies can lead respirator manufacturers to submit their devices to extensive, expensive, and sometimes, redundant evaluation processes. This is a particular challenge for smaller manufacturers with fewer resources. The additional burden is also likely to discourage manufacturers from marketing their devices to health care organizations, which has implications for respirator supply and respiratory protection options for HCWs.

The SN95 designation may also lead HCWs, purchasers, and others to mistakenly believe that only SN95 FFRs can be used in health care settings. However, it is worth noting again, there is no indication that the FDA-required flammability testing or resistance to fluid penetration at high pressure is relevant or necessary for the majority of health care settings and work tasks. That being said, there is even evidence to show that these other respirator types are capable of providing these non-respiratory protections. Studies have investigated the ability of other respirator types [e.g., NIOSH Approved N95 FFRs, EHMRs and PAPRs] to meet the FDA requirements. Portnoff et al. tested five models of N95 FFRs and PAPRs with hoods against the ASTM F1862 synthetic blood penetration test. Three out of five N95 FFR models showed resistance to synthetic blood penetration at 450 cm/sec, similar to SN95 FFRs. All five PAPR hood models resisted liquid penetration at 450 cm/sec and four models at 635 cm/sec (Portnoff et al., 2021). Rengasamy et al. also used the ASTM 1862 method to test six N95 FFRs. They found four of the six would likely meet the FDA fluid resistance requirement. The two that did not meet the requirement did have some fluid resistance (Rengasamy et al., 2015). In 2018, Rengasamy et al. evaluated 11 N95 FFRs and 5 models of PAPR hoods for flammability using the Consumer Product Safety Commission (CPSC) CS-191-53 flammability (16 CFR 1610) method. All N95 FFRs and PAPR hoods met the Class 1 or normal flammability requirements (Rengasamy et al., 2018). In 2021, Rengasamy et al. retested the 11 models from their 2018 study for flammability using the CPSC 16 CFR 1610 method. Again, all models met the Class 1 requirements. In addition, six of these 11 models were tested for fluid resistance in the 2015 study (Rengasamy et al., 2015). An additional five models were tested for fluid resistance (using ASTM 1862 standard test method) in this study. Seven models met the requirements for fluid resistance, five models had high-level resistance and the other two had either low or medium level resistance (Rengasamy et al., 2021). The results of these studies showed that at least some commercially available NIOSH Approved N95 FFR models and PAPRs with hoods would pass FDA clearance for fluid resistance and flammability.

During the COVID-19 pandemic, there was a shortage of N95 FFRs. Because of this shortage, hospitals began to issue EMHRs as well as PAPRs to their employees as alternative respiratory protection. A study which evaluated a mass deployment of PAPRs (approximately 5500 units) in a Southampton, United Kingdom hospital found the use of PAPRs to be feasible. A PAPR was preferred by HCWs over other products for its comfort, for the feeling of safety, and overall experience as well as by patients since the HCWs’ faces were visible. Economic analysis indicated PAPRs were a highly cost-effective and alternative solution (Munro et al., 2021). Other studies have shown EMHRs are another feasible alternative to N95 FFRs. A study conducted in Allegheny Health Network hospitals found implementing an EHMR program was not only feasible but less expensive than N95 FFR programs relying on reuse and disinfection (Chalikonda et al., 2020). Other studies have also found the implementation of EHMRs to be feasible and in some cases with HCWs feeling more protected (Maleczek et al., 2022; Hines et al., 2019; McMahon et al., 2021; Frund et al., 2022; Haas et al., 2024; Haas et al. 2024; Haas et al., 2023; Hines et al., 2023; Ramsdell et al., 2023).

There is a current misconception that SN95 FFRs provide an increased level of respiratory protection over NIOSH Approved N95 FFRs. However, both N95 FFRs and SN95 FFRs meet the same NIOSH 42CFR84 regulations. NIOSH Approved EHMRs and PAPRs are reusable alternatives to the FFR when respiratory protection is needed in a health care setting. These current and potential misconceptions could contribute to respirator supply and access issues in periods of surge if HCWs and their hospital systems believe they can only use SN95 FFRs, placing HCWs at increased respiratory hazard exposure risk. The Hospital Respiratory Protection Program Toolkit co-authored by NIOSH and OSHA explains that a face shield with a FFR or a SN95 respirator be used when protection from fluids is needed. A face shield is preferred as it offers splash protection to the entire face. Similarly, if flammability was a concern, there are better environmental and personal protective protections.

Next Steps

The agencies recognize there is a need to reimagine how HCWs can best be protected and served. Efforts will continue across agencies to achieve more clarity on these issues and address the confusion in the marketplace. The following resources are available to help improve clarity:

 

N95 and NIOSH Approved are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United States and several international jurisdictions.

 

Christopher Coffey, PhD, is a former Associate Director for Science of the NIOSH National Personal Protective Technology Laboratory (NPPTL) and an ATL Contractor in the NIOSH NPPTL.

Maryann D’Alessandro, PhD, is the Director of the NIOSH National Personal Protective Technology Laboratory.

John Howard, MD, is the Director of NIOSH.

Meghan Kiederer, BA, is a Health Communication Specialist in the NIOSH National Personal Protective Technology Laboratory.

Susan Moore, PhD, is the Associate Director for Science of the NIOSH National Personal Protective Technology Laboratory.

 

References

Chalikonda S, Waltenbaugh H, Angelilli S, Dumont T, Kvasager C, Sauber T, Servello N, Singh A, Diaz-Garcia R. 2020. Implementation of an Elastomeric Mask Program as a Strategy to Eliminate Disposable N95 Mask Use and Resterilization: Results from a Large Academic Medical Center. J Am Coll Surg. 231(3):333-338. https://journals.lww.com/journalacs/abstract/2020/09000/implementation_of_an_elastomeric_mask_program_as_a.5.aspx.

Frund, Z.Z., Oh, S.H., Chalikonda, S., Angelilli S., and Waltenbaugh, H. 2022. Filtration performance and breathing resistance of elastomeric half mask respirator P100 filter cartridges after repeated and extended use in healthcare settings, Journal of Occupational and Environmental Hygiene, 19:4, 223-233, https://doi.org/10.1080/15459624.2022.2041649.

Haas, E.J., Edirisooriva, M., Furek, A. & Casey, M. (2024, May). Reusable respirators: The impact on safety climate across health settings. Professional Safety, 69(5): 20-26.

Haas, E.J., Furek, A., & Greenawald, L.A. 2024. Identifying leadership practices to support the uptake of reusable elastomeric half mask respirators in health delivery settings, Healthcare Management Forum, 0(0): 1-7, https://doi.org/10.1177/08404704241226698.

Haas, E.J., Yoon, K., McClain, C., Sietsema, M., Hornbeck, A., Hines, S., Chalikonda, S., Angelilli, S., Waltenbaugh, H., Thurman, P., Napoli, M. & Fernando, R. 2023. Examining the Impact of Elastomeric Half Mask Respirator Knowledge and User Barriers on Safety Climate Perceptions in Health Care Settings. Workplace Health & Safety, 71(7): 337-346.

Hines S.E., C. Brown, M. Oliver, P, Gucer, M. French, R. Hogan, T. Roth, J. Chang, M. McDiarmid. 2019. User acceptance of reusable respirators in health care. Am J Infect Control. 2019;47:648–55. https://doi.org/10.1016/j.ajic.2018.11.021.

Hines, S.E., Thurman, P., Zhuang, E., Chen, H., McDiarmid, M., Chalikonda, S., Angelilli, S., Waltenbaugh, H., Napoli, M., Haas, E.J., McClain, C., Sietsema, M. & Fernando, R. 2023. Elastomeric half-mask respirator disinfection practices among healthcare personnel. American Journal of Industrial Medicine, 66(10): 1056-1068, https://doi.org/ 10.1002/ajim.23538.

Maleczek, M., F. Toemboel, M. Van Erp, F. Thalhammer, and B. Rössler. 2022. Reusable respirators as personal protective equipment in clinical practice: User experience in times of a pandemic. Wiener Klinische Wochenschrif 134(13-14):522–528. https://doi.org/10.1007/s00508-022-02022-1.

McMahon, K., D. Jeanmonod, R. Check, L. Rivard, V.Balakrishnan, B. Kelly, J. Pester, and R. Jeanmonod. 2021. The pragmatic use of industrial elastomeric facemasks in health care practice during the COVID-19 pandemic. American Journal of Emergency Medicine 48:273–275. https://doi.org/10.1016/j.ajem.2021.05.025.

Munro, A., J. Prieto, E. Mentzakis, M. Dibas, N. Mahobia, P. Baker, S. Herbert, T. Smith, M. Hine, J. Hall, A. McClarren, M. Davidson, J. Brooks, J. Fisher, D. Griffiths, H. Morgan, C. Giulietti, S. N. Faust, and P. Elkington. 2021. Powered respirators are effective, sustainable, and cost-effective personal protective equipment for SARS-CoV-2. Frontiers in Medical Technology. 3:729658 https://doi.org/10.3389/fmedt.2021.729658.

Portnoff, L., S. Rengasamy, G. Niezgoda, D. Sbarra, A. Pissano, and J. Furlong. 2021. Effects of volume, velocity, and composition on the resistance to synthetic blood penetration of N95 filtering facepiece respirators and other head/facial personal protective equipment. Journal of Occupational and Environmental Hygiene 18(2):84–89. https://doi.org/10.1080/15459624.2020.1854457.

Ramsdell, K., Haas, E.J. & Furek, A. 2023. The Role of Reusable Respirator Protection Among Ambulance Companies: Lessons Learned During the EHMR Demonstration Project. Journal of Emergency Medical Services

Rengasamy, S., G. Niezgoda, and R. Shaffer. 2018. Flammability of respirators and other head and facial personal protective equipment. Journal of The International Society for Respiratory Protection 35(1):1–13.Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6198820/  (accessed June 7, 2024).

Rengasamy, S., D. Sbarra, and M. Horvatin. 2021. Do industrial N95 respirators meet the requirements to be used in healthcare? – A possible solution to respirator shortages during the next pandemic. American Journal of Infection Control 49(9):1194–1196. https://doi.org/10.1016/j.ajic.2021.03.014.

Rengasamy, S., D. Sbarra, J. Nwoko, and R. Shaffer. 2015. Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators. American Journal of Infection Control 43(11):1190–1196. https://doi.org/10.1016/j.ajic.2015.06.014.

Shirley, M., Hawes Clever, L., Prezant, D.J., and Rupe, K. 2017. Respiratory Protection for Health Care Workers: Simplify Procedures and Improve Health. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. https://doi.org/10.31478/201703c.

Posted on by Christopher Coffey, PhD; Maryann D’Alessandro, PhD; John Howard, MD; Meghan Kiederer, BA; and Susan Moore, PhD

12 comments on “Providing Clarity Regarding the Regulation of Respirators Used in Health Care Settings”

Comments listed below are posted by individuals not associated with CDC, unless otherwise stated. These comments do not represent the official views of CDC, and CDC does not guarantee that any information posted by individuals on this site is correct, and disclaims any liability for any loss or damage resulting from reliance on any such information. Read more about our comment policy ».

    Thank you for this excellent comprehensive compilation of regulatory information, research and advice on use of respirators in healthcare settings and related studies, which makes a really useful single-point citation for multiple relevant aspects.

    It’s not strictly a regulatory aspect, but to improve its use as a one-stop information source, it may be worthwhile adding a section and references to cover the point that infectious and non-infectious airborne particles are removed equivalently by respirator filters. While to those versed in respirator technology, this is an obvious consequence of the laws of physics, I observe, too often, that even senior authorities and respected journals on the medical side have claimed that there is a difference between abilities of (what they state to be) “industrial” and “medical” respirator products to remove infectious particles – even when regulations, standards and manufacturer instructions never make a distinction. I recall that NIOSH has undertaken some studies on this aspect in the past. This false distinction may lead to assumption of equipment shortage even when capable products are available, or “blaming” respirator filter performance for unrelated issues.

    And sorry, having grown up nearby, I need to note it’s “Southampton” not “South Hampton”.

    Thank you very much.

    Simon Smith PhD
    Volunteer Chair, Canadian Standards Biological Aerosols Working Group

    Thank you for your comment noting the important point that “infectious and non-infectious airborne particles are removed equivalently by respirator filters”. Research confirms that whether a particle is living/infectious does not affect its ability to be filtered. NIOSH Approved filtering facepiece respirators can be used to protect workers from potentially harmful aerosol particles regardless of if they are virus, bacteria, dust, or even engineered nanoparticles. For more information, please see some of our additional resources on this topic below. And thank you for the note on Southampton. We have changed the blog text.

    A Particle is a Particle (youtube.com)

    Do We Need to Challenge Respirator Filters With Biological Aerosols? | Blogs | CDC

    Harnish, D., B. Heimbuch, M. Husband, A. Lumley, K. Kinney, R. Shaffer et al.: Challenge of N95 Filtering Facepiece Respirators with Viable H1N1 Influenza Aerosols. Infection control and hospital epidemiology: the official journal of the Society of Hospital Epidemiologists of America 34(5): 494 (2013).

    This is a great resource that has been needed for some time. We must remember where we came from and where we are now. The FDA performance requirement for a procedural/medical mask was primarily intended to protect against blood spurts at arterial pressure or flames from surgical instruments and protecting the patient means only exposing them to biocompatible materials as explained above. Procedural/medical masks were never intended to provide protection against a virus as they have no filtering capabilities nor do they provide a complete and effective seal. Fast forward to COVID-19, we finally realize the need to provide our HCW with a proper respirator that seals and filters. As noted above, many or most of the N95 FFR’s provide the fluid protection however as per OSHA guidance for PPE selection, you should wear a faceshield if a risk of splash to the face exists. In the end, a HCW works in a workplace and falls under OSHA regulations. In its simplest form, if a hazard exists in the workplace, the employer is required to eliminate the hazard or provide PPE to protect the workers against the hazard. COVID-19 has brought to the forefront, that the healthcare environment is a workplace and we must protect our HCW’s according to the OSHA requirements. NIOSH certified respirator products ensures the products are properly tested and will provide the protection needed whether its a construction site, foundry operation or healthcare environment. We must clear up the confusion so we are better prepared for the next event.

    Christopher Coffey, Maryann D’Alessandro, John Howard, Meghan Kiederer, and Susan Moore says:

    Thank you for your comment. The agencies will continue to work together to improve regulatory clarity.

    These current and potential misconceptions about respiratory protection in healthcare not only contributed to respirator supply and access issues during the COVID pandemic, they may also prevent an effective response to the bird flu crisis.

    Reporting today shows that bird flu cases across the country have more than doubled in the last few days.

    A July 2022 New York Times investigation indicated that over 3600 HCW deaths were attributed to the failure to promote and put other more protective alternatives such as elastomeric respirators into widespread use during respirator shortages.

    In January, National Nurses United, the largest nursing union in the country, reported that hospitals were once again facing N95 shortages. The union said that 3/10 nurses report a lack of supply of N95s with 1/5 nurses now going back to N95 reuse.

    https://www.nationalnursesunited.org/ninth-covid-survey-nurses-face-worsening-working-conditions

    Despite the practice of reusing N95s being banned, there is no corrective action taking place to discourage it from continuing. HCWs and their hospitals systems believing they can only use SN95 or N95 FFRs, not only continues to place HCWs at increased respiratory hazard exposure risk, it is also now putting the safety of farm workers at risk.

    The lack of awareness on farms to alternative respiratory options including elastomeric respirators and PAPRs has already resulted in many farms giving up on using respiratory protection to protect workers.

    It was reported in May that the reason farms are not using respiratory protection for bird flu is that after using N95s in those environments, they became wet and stopped working. PAPRs and elastomeric respirators are designed to be used in those wet environments and are already used for protection on farms such as for pesticides and grain dust so there is no reason they cannot be used for protection from bird flu.

    At a webinar in June that included the CDC Director in charge of the bird flu response, farms were only told about N95s. In addition, farms were told that these types of protections weren’t really practical for workers to use despite being recommended by the CDC.

    https://www.youtube.com/watch?v=Gj1bkWoYGAQ

    During the same webinar, it was mentioned that some farms are experiencing N95 shortages and that the way to deal with those shortages is to conserve them until farms are in hot zones.

    The use of PAPRs and elastomeric respirators are meant to be safely reused for years so there is no excuse to recommend conserving PPE until the hazard has already started spreading in the community.

    Promoting and using them would not only prevent the need to conserve PPE, it would better protect workers than N95s plus would provide a more cost effective option so money doesn’t become a barrier to protecting workers.

    Studies show that N95s have many downsides compared to elastomeric respirators. While a worker performing a quick head movement with an N95 breaks their seal and exposes them to an airborne hazard 1/4 times, an elastomeric respirator never breaks the seal.

    https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777504

    Another great benefit to elastomeric respirators is that there are source control options that filter the air in both directions so that not only HCWs can be better protected, their patients can be better protected as well.

    https://www.fda.gov/news-events/fda-voices/elastomeric-respirator-innovations-play-critical-role-response-covid-19

    It’s time to rethink what we use and promote in healthcare, not only for HCWs but also for patients. The current recommendations for patients with diseases such as measles is to provide them with surgical mask. Those masks allow airborne diseases to contaminate the hospital as patients are moved from one location to another.

    Workers and other patients would not know that a measles patient has accidentally contaminated the air and that the virus could linger for hours after a patient has been moved from one area to another. This is why it is important to provide those patients with a source control elastomeric respirator.

    If hospitals had a fit test machine, they could effectively ensure staff as well as infected patients could be properly fitted with an elastomeric at moment’s notice. Once an infected patient has been discharged, the elastomeric could then be cleaned and disinfected then put in storage until another patient would need it.

    This would effectively put an end to hospital acquired infections and prevent a large source for community transmission. We don’t need to think outside the box to prevent transmission in hospitals, we simply need to think past N95s.

    Christopher Coffey, Maryann D’Alessandro, John Howard, Meghan Kiederer, and Susan Moore says:

    Thank you for your comment which clearly demonstrates your interest and passion about this topic. One of our goals is to increase the awareness about the suite of NIOSH Approved ® air purifying respirators (APRs) and their utility in the health care space. We appreciate your comments and continue to identify opportunities to increase awareness and improve clarity about the use of NIOSH Approved APRs in health care.

    The insightful comments of Simon and Claudio emphasize the importance of clearing up misconceptions about respirator capabilities and ensuring clear, unified regulatory guidance across health care settings. Including information on the equivalence of infectious and non-infectious particle filtration would indeed add value to this resource, highlighting that respirators designed for various industries offer comparable protection against airborne hazards.

    This discussion underscores the necessity of maintaining clarity in respirator regulations to protect health care workers effectively, especially during pandemics.

    Best regards,
    Thomas Torkuma Yaaju

    Thank you for continuing to work toward clarity on the topic of respiratory protection for healthcare workers. It seems that our need increases but our understanding does not.
    I would like to point out one misconception regarding the need for fluid resistance outside the surgical suite. Arterial lines are frequently placed, maintained, and accessed on patients in emergency departments and intensive care units. The arteriovenous fistulas of dialysis patients, puncture wounds and other traumas, and wound irrigation may all expose HCW to jetted blood and other potentially infectious materials.
    Additionally, as discussed in Rengasamy’s 2021 article about industrial respirators, “Outside the surgical setting, for routine patient care, these velocities also may simulate the velocities of virus-packed particles expelled from an infected person’s mouth and nose during cough and sneeze.” Beyond the cough and sneeze, tracheostomy care, oral care, dental procedures, intubations, and bronchoscopies may all be performed or attended in routine settings and require fluid resistance.
    I believe we need to expand our ability to protect all workers from exposure to the blood and body fluids of others in both respiratory and eye protection. The ability of a respirator to resist fluid splashes, sprays, and jets should be more clearly identified in labeling, packaging, and HCW education. Healthcare facilities should be encouraged by our federal safety partners and accreditation organizations to provide and promote a culture of safety for patients and staff through improved infection prevention strategies, including the correct, consistent use of PPE.

    Thank you, Ms. Morgan for your thoughtful comments regarding the exposures outside of the surgical setting. Your examples clearly articulate the need for face shields or goggles in the environments you described. This information is very helpful as we continue to identify opportunities to provide clarity.

    At our hospital, Infection Prevention staff and others are concerned about the potential to spread contaminated air from the respirator wearer (HCW) to the patient by way of exhaled/expelled air through the exhalation valve of the elastomeric respirator. I would request a reply that addresses this concern and provides supporting documentation that corroborates the position. Thank you very much and I appreciate your time and efforts.

    Thank you for your comment.

    Healthcare personnel (HCP) should not use elastomeric respirators with unfiltered exhalation valves as source control in surgical and other healthcare settings because these valves can release unfiltered exhaled air into the surroundings, potentially contaminating the sterile field and exposing others to contaminants.

    As of this posting, NIOSH has approved 19 elastomeric respirators without exhalation valves that are acceptable for use in healthcare settings. NIOSH also has a robust research portfolio which includes research in healthcare settings describing the use of elastomeric respirators without exhalation valves in these settings as we identified in the blog.

    The NIOSH Certified Equipment List (CEL) identifies the elastomeric respirators without exhalation valves (Certified Equipment List Search Results). Some approval holders may have an approved respirator with a filtered exhalation valve. Approval holders should be contacted directly to identify the relevant approvals as they are not identified on the CEL. HCP can use both types in surgical settings.

    Healthcare facilities may have their own policies regarding the use of respirators with exhalation valves. Check with your Occupational Health Clinic or Infection Control Staff to understand your facility’s policies.
    Please visit the NIOSH webpage, Respirator Exhalation Valve Research for more information on research that NIOSH is conducting to determine the potential for respirators with exhalation valves.

    That is a very common question and a great one to ask.

    While it used to be assumed that having a respirator with an exhalation valve would not work as well as a surgical mask to protect patients, NIOSH studies show that exhalation valves outperformed surgical masks for source control.

    https://www.cdc.gov/niosh/docs/2021-107/pdfs/2021-107.pdf?id=10.26616/NIOSHPUB2021107

    While those same studies showed that the exhalation valve could be easily covered if additional source control was needed, there are NIOSH approved elastomeric respirators designed for the healthcare market that do not have exhalation valves and filter the air on the inhale and exhale.

    https://www.fda.gov/news-events/fda-voices/elastomeric-respirator-innovations-play-critical-role-response-covid-19

    The CDC created a great chart on the different options for respiratory protection and lists source control elastomeric respirators as the best option to protect the wearer and the best option to protect those around the wearer as well.

    https://www.cdc.gov/niosh/topics/publicppe/community-ppe.html

    There are many reasons to upgrade healthcare workers to elastomeric respirators from N95s. While N95s often lose their seal during quick head movements, elastomeric respirators are designed to protect workers even with quick head movements.

    https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2777504

    In addition, elastomeric respirators are designed for years of reuse with a hospital only needing to change the filter once a year, unless the filter becomes damaged or soiled, making it the most cost effective option as well.

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