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

 

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:

• Supplementing the Supply of N95s with Reusable Elastomeric Half Mask Respirators
• Who Does What? The Roles of NIOSH, OSHA, and the FDA in Respiratory Protection in the Workplace
• Elastomeric Half Mask Respirator Resources
• The Respiratory Protection Information Trusted Source – Healthcare Setting Specific FAQs
• Considerations for Respirator Selection in Healthcare

 

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.