Welcome to the first annual Respiratory Protection Week!

Dr. Christopher Coffey, PhD – NIOSH

This portion of the webinar will describe the different PAPRs and the NIOSH approval requirements, including:

1. Overview of PAPR types
2. Current approval performance requirements
3. Proposed changes to approval requirements
4. Relationship of proposal to use of PAPRs in healthcare

Dr. Julie Cahn, DNP, RN, CNOR, CNS-CP – AORN

This portion of the webinar will cover the Association of periOperative Registered Nurses (AORN) recommendations related to PAPR use in the OR.

1. Recommendations on PAPR use in the OR
2. Real-life challenges when PAPRs are needed for use in the OR
3. Clarifying confusion on surgical helmet systems and mask selection in the OR
4. Further considerations

Maryann Gruden, MSN, CRNP, NP-C, COHN-S/CM – AOHP

This portion of the webinar will provide an overview of the numerous respiratory protection resources that are available for both respiratory protection program leaders and healthcare staff.

1. Role of respirators in the hierarchy of safety controls
2. Description of the 2011 IOM letter report on respiratory protection
3. Review respiratory protection resources provided by governmental and non-governmental agencies/organizations

Dr. Christopher Coffey has worked for NIOSH since 1978. He is currently the Associate Director for Science for the National Personal Protective Technology Laboratory. During his career, he has been involved with the NIOSH approval program for air-purifying respirators and fit testing research. He is currently on the team that is developing a proposed modification to the PAPR approval requirements, which could result in smaller and lighter weight PAPRs having the same effective particulate protections currently approved while increasing their utility in the healthcare sector.

Dr. Julie Cahn has worked as a perioperative nurse since 2003 in eight different facilities across the United States from Boston to Honolulu. Prior to joining AORN, much of her work revolved around professional development of perioperative nurses and ensuring excellence in patient outcomes. She is the lead author of the AORN Guideline for Sterile Technique which includes some guidance on the use of PAPRs in the OR.

MaryAnn Gruden is a certified Occupational Health Nurse-Specialist/Case Manager. She has spent 27 years managing occupational health services in the healthcare setting. One of her many responsibilities was ensuring appropriate respiratory protection for staff. Since the 2011 Institute of Medicine Letter Report on Occupational Health Nurses (OHN) and Respiratory Protection: Improving Education and Training, and as a member of the national Executive Board of the Association of Occupational Health Professionals in Healthcare (AOHP), she was a member of the national advisory group that developed OHN respiratory protection competencies and training programs. In addition, she served on The Joint Commission’s Respiratory Protection Technical Expert Panel. Currently, she continues to advocate for healthcare worker safety as an occupational health consultant.

Mary Ogg is a senior perioperative practice specialist at the Association of periOperative Registered Nurses (AORN) concentrating on patient and workplace safety. While at AORN she authored the Guideline for Surgical Smoke Safety and developed the surgical smoke tool kit. She has worked with NIOSH on several respiratory protection projects.

Megan Casey (moderator) is a Nurse Epidemiologist and Team Lead at NIOSH’s National Personal Protective Technology Laboratory supervising the Surveillance and Interventions Team. She also coordinates NIOSH research related to the healthcare and social assistance industry sector. She came to NIOSH as a CDC Epidemic Intelligence Service Officer in 2014 conducting workplace health hazard evaluations and performing occupational health surveillance. Prior to joining NIOSH, she was a Nurse Epidemiologist with county health department, a nurse caring for breast cancer patients, and a policy analyst for Ohio Medicaid.

Jon Szalajda, Deputy Director for the NIOSH National Personal Protective Technology Laboratory

Over the past thirty years, the nature of emergency response has changed. Because of changes in the approach to firefighting due to modern construction, preparing for the potential of Chemical, Biological, Radiological, and Nuclear terrorism events, and the need for respiratory protection during manmade or natural disasters, respiratory protection technology is evolving as well. This presentation will provide an overview of evolutions in standard requirements that address the changes in respiratory protection.

Stephanie Griffin, PhD, CIH; Dylan Staack, MPH; Jeff Burgess, MD, MS, MPH, University of Arizona

Firefighter overhaul is a phase of firefighting following knockdown of the flames when firefighters search for and extinguish hidden sources of combustion. The current recommendation for respiratory protection during overhaul is to use a self-contained breathing apparatus (SCBA), but an air-purifying respirator (APR) with suitable filters could potentially provide another option for first responders if the APR was found to provide adequate protection. Chemical, biological, radiological and nuclear (CBRN) canisters are designed to protect against many of the chemicals found in smoke. This portion of the webinar will discuss a recent study that was designed to measure the protective capability of an APR with CBRN canister used during overhaul compared with the protection offered by an SCBA.

Jonathan (Jon) Szalajda became the Deputy Director for the National Personal Protective Technology Laboratory (NPPTL) division of NIOSH in September, 2015. Since joining NPPTL in 2001, Jon has held various leadership roles in the organization. Some of his duties included being responsible for developing and promulgating new approval Personal Protective Equipment (PPE) related standards and regulations, including NIOSH’s Chemical, Biological, Radiological, and Nuclear (CBRN) respirator standards. Prior to coming to NIOSH, Jon was a proposal manager for Bombardier Transportation and was the systems manager for the M40 Mask program with the Department of the Army. He holds a BS degree in Chemical Engineering from Penn State and MS degrees in engineering from the George Washington University and the University of Pittsburgh. He has worked in the fields of respiratory protection and PPE for over 30 years. Jon is currently a member of NFPA Respiratory Protection Technical Committees, the Vice-Chairman of the ASTM-ANSI F23.65 committee on Respiratory Protection, and a past president of the AIHA Respiratory Protection Committee.

Dr. Griffin graduated from the University of Arizona in August 2014 with a Ph.D. in Environmental Health Sciences and a multidisciplinary minor in health economics. She earned her Masters of Science in Industrial Hygiene from the University of Washington in 2007 where she studied occupational noise exposure. Dr. Griffin has twenty years of environmental health and industrial hygiene experience having served as an Environmental Health Specialist with the U.S. EPA from 1999-2002 and as an Environmental Health Officer with the US Public Health Service, assigned to the U.S. EPA and the U.S. Coast Guard, from 2002-2011. She currently serves on the MEZCOPH as Assistant Professor in the Department of Community, Environment and Policy where her research efforts are focused on occupational health and safety in firefighting and mining.

Dylan Staack was a Project Manager at the University of Arizona Mel and Enid Zuckerman College of Public Health at the time of this study. His work with Dr. Jeff Burgess and Dr. Stephanie Griffin has focused on characterizing and assessing firefighter carcinogen exposures during overhaul, diesel exhaust exposure in firehouses, and heat stress exposures in mining. Since finishing at the University of Arizona, Dylan has taken over as the National Training and Support Manager at REPSS, a firm that helps companies equip themselves with the necessary tools to monitor environmental and occupational exposures.

Dr. Jeff Burgess is the Associate Dean for Research and Professor at the University of Arizona Mel and Enid Zuckerman College of Public Health. His research focus includes reduction of exposures and injuries in firefighters and miners and environmental health disparities among Native Americans.

Speaker: Mike Bergman

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Objective: NIOSH has initiated efforts to update powered air-purifying respirator (PAPR) certification standards. PAPRs with loose-fitting facepieces require a minimum airflow of 170 Lpm for NIOSH certification. Advanced headforms are currently used at NIOSH for respirator performance research. To support standards development, this preliminary study used an advanced headform to assess the performance of two models of loose-fitting PAPRs at different breathing work rates and PAPR flow rates.

Methods: Two models of NIOSH-approved loose-fitting PAPRs (Models A and B) were evaluated. PAPRs were mounted onto a medium-sized NIOSH static advanced headform mounted onto a torso and connected to a breathing machine. Faceseal leakage of sodium chloride aerosol was assessed by a particle counting method over a 2-minute sample period. High efficiency particulate air (HEPA)-filtered supplied-air was delivered to each PAPR’s facepiece using a mass flow regulator with digital controller. Combinations of different work rates (LOW: 25 Lpm, MODERATE: 48 Lpm, and HIGH: 88 Lpm) and supplied-air flow rates (50 – 215 Lpm) were assessed. Manikin penetration factors (mPF) were calculated as the ratio of the test chamber concentration to the in-facepiece concentration. Geometric mean (GM) and 5th percentile mPFs were calculated. A 5th percentile GM mPF > 250 (i.e., 10 times greater than the OSHA assigned protection factor of 25) was chosen as the benchmark for acceptable performance. Analysis of variance tests were used to assess the variables affecting mPF.

Results: Work rate, supplied-air flow rate, and their interaction significantly affected PAPR performance. At the LOW work rate, Models A and B achieved acceptable performance for flowrates from 206–62 and 215–75 Lpm, respectively. At the MODERATE work rate, Models A and B achieved acceptable performance for flowrates from 206–125 and 215–125 Lpm, respectively. At the HIGH work rate, neither model could achieve acceptable performance at flow rates < 170 Lpm.

Conclusions: Acceptable respirator performance was observed at the LOW and MODERATE work rates for supplied-are flow rates down to the range of approximately 75 Lpm and 125 Lpm, respectively. These results indicate that PAPRs may be able to be designed with blower motors delivering < 170 Lpm for some workplace applications. Additional future research is needed to understand how head/facial movements also affect faceseal leakage; robotically moving advanced headforms can be used for these future studies.

Speaker: Marisa Fries

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Introduction: In recent years, wildfires in the United States (U.S.) have been increasing in frequency and size. Wildfire smoke containing gases and fine particles poses a significant health risk to workers and community members. Approved respiratory protection equipment may be necessary in these dangerous settings.

Methods: Wildfire-related information requests received by the National Personal Protective Technology Laboratory (NPPTL) were reviewed from 2015-2018. Review of respiratory protection webpage visits during the same time period were evaluated and compared to the 20 most destructive California wildfires in history.

Results: Wildfire-related questions and information requests frequently came from the general public (78%, N=25/32). Occupational inquiries came from employers and workers in construction, agriculture, law enforcement, public health, healthcare, and social assistance. Visits to the NIOSH-approved N95 respirator webpage increased at the same time as the most destructive California wildfires during this period. Visits to this page increased by four-fold (3,985 to 16,764) from October 2018 to November 2018 at the same time as the Camp, Woolsey, and Hill fires.

Conclusions: Wildfire activity in the U.S. is projected to increase and, with it, the demand for respiratory protection information for workers, employers, and the general public. NPPTL continues to develop respiratory protection resources in response to these events and is working with manufacturers as well as state and federal government entities to streamline communication efforts.

Speaker: Lee Greenawald

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Background: Emergency responders rely on respiratory protection in the event of an intentional or unintentional release of a chemical, biological, radiological, or nuclear (CBRN) hazard. The National Institute for Occupational Safety and Health (NIOSH) evaluates CBRN air-purifying respiratory protective devices (RPDs) by challenging the canister filter media with 11 test representative agent (TRA) chemicals from seven chemical families. The NIOSH TRAs were selected in 2001 and are still used today. CBRN hazards are constantly evolving in type, usage, and dissemination and it is critical that these hazards are purposefully identified and reviewed to ensure RPDs remain protective.

Objective: The objective of this study was to determine if NIOSH-approved CBRN air-purifying RPD systems continue to provide adequate protection from newly emerging chemical and radiological hazards by evaluating NIOSH’s current TRAs and ensuring they continue to represent each chemical family.

Methods: NIOSH and its federal partners conducted a chemical/radiological hazard assessment, which included 1) compiling a comprehensive list of chemical and radiological hazards relevant to emergency responders; 2) assessing chemical and physical properties; 3) categorizing each hazard into a current NIOSH chemical family; and 4) developing a decision logic process to systematically compare each identified hazard to a current TRA.

Conclusions: Over 230 contemporary chemical and radiological hazards were identified. Upon evaluation, it was determined that NIOSH’s current 11 TRAs remain representative of all identified potential hazards to emergency responders at this time. Six chemicals were identified for further testing, where various NIOSH-approved commercial canister models were evaluated. The decision logic criteria can be used in the future to systematically review emerging hazards and evaluate individual chemicals against the current TRAs.

Speaker: Maryann Gruden

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The following two posters, Occupational Health Nurses and Respiratory Protection Competency and Respiratory Protection Competencies for Occupational Health Nurses, provide background on the development of respiratory protection (RP) competencies for occupational health nurses. The impetus for the development of these competencies was from the 2011 Institute of Medicine’s (IOM) Report: Occupational Health Nurses (OHNs) and Respiratory Protection: Improving Education and Training. There were seven recommendations in the report to improve OHN competency in RP and educate nurses at all levels about RP. The IOM Letter Report was a result of letter from NIOSH NPPTL requesting that the IOM examine existing RP curricula in OHN training programs and to develop recommendations to improve education and training on the selection, use, care, and maintenance of respirators.

In December, 2011 a national Advisory Committee was convened by the Association of Occupational Health Nurses (AAOHN) with representatives from the:

• Association of Occupational Health Professionals in Healthcare (AOHP)
• American Board of Occupational Health Nurses (ABON), the certifying body for OHNs
• American Nurses Association IOM Standing Committee on Personal Protective Equipment in Workplace Safety and Health, which is now a National Academies of Science Medicine and Engineering committee and Representatives from NIOSH and NPPTL

The advisory group’s mission was to address two of the seven recommendations in the IOM report. The first was to conduct a national survey of OHNs related to RP and two, develop RP educational materials.

Speaker: Stella Hines

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Background: Respiratory protection programs (RPPs) in healthcare settings are likely to function optimally when safety culture is prioritized.

Methods: Healthcare workers (HCWs) enrolled in RPPs in a medical system where three different forms of respiratory protective devices (RPDs) were in use were surveyed. These included elastomeric half face respirators (EHFRs), powered air-purifying respirators (PAPRs) and N95 respirators (N95s). Participants completed an online questionnaire that addressed several domains including safety culture beliefs.

Results: Of 1152 total participants, 53% currently used N95s, 24% used EHFRs and 23% used PAPRs. Respondents included 48% nurses, 19% providers, 6% respiratory therapists, and 28% all others. 72% of respondents worked at an urban academic medical center, with the remainder from 4 community hospitals or an outpatient facility. 19% agreed that using respiratory protection interferes with patient care, while 81% disagreed or were neutral. 32% agreed that it is inconvenient to use recommended personal protective equipment when taking care of patients on airborne precautions, while 17% were neutral and 51% disagreed. 82% agreed that use of a respirator is as important as responding to a patient emergency and 92% agreed that correct use of respirators is as important as proper medication administration.

Conclusion: Most respondents report safety culture beliefs that support the importance of respiratory protection. It is unclear whether the type of RPD influences perceptions of safety culture. Future analyses will compare safety culture beliefs among different respirator user and occupational groups and evaluate safety culture beliefs associated with compliance with expected use.

Speaker: Leshan Jones Kimbrough

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OSHA recognizes two quantitative fit test methods: ambient aerosol count, such as the TSI PortaCount^® and controlled negative pressure, such as the OHD Quantifit^®. The Portacount^® measures particle migration while the Quantifit^® measures direct leakage. Previous studies compared results obtained from Quantifit^® and Portacount^® instruments using the OSHA approved eight-exercise protocol. Overall, the Quantifit^® was more sensitive at identifying leakage. OSHA recently approved an additional protocol (REDON) for the Quantifit^® consisting of three exercises and two redonnings. Due to different fit factors (FF) obtained by the Portacount^® versus Quantifit^® there is concern an individual could pass a fit test with one instrument and fail with the other. This study extended the comparison between the Portacount^® and Quantifit^® using different protocols. The hypothesis was an individual who fails to pass a fit test using the Portacount^® (eight exercise protocol) will also fail to pass a fit test using the Quantifit^® (REDON protocol). Fit test were conducted on nine subjects wearing 3M 6000 series half- and full-facepiece respirators. There was no correlation between the Quantifit^® FF and the Portacount^® FF for half- or full-face respirators (r=0.12, p=0.781 and r=0.15, p=0.699). The Quantifit^® FF was significantly lower than the Portacount^® FF for both half- and full-face respirators (t=2.51, p=0.04 and t=5.48, p<0.001). Nonetheless, all individuals who passed using the Portacount^® also passed using the Quantifit^® (pass level: ≥100 for half- and ≥500 for full-face). Although the Quantifit^® is more sensitive in detecting leaks, both instruments yielded the same conclusion (Pass/Fail) in this study.

Speaker: Bill King

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For evaluating breathing resistance of respiratory protective devices (RPD) in the U.S., NIOSH uses constant flow +/-85 L/min (which as peak flow corresponds to a ventilation rate, VE = 27 L/min) for all air-purifying respirators (APR), tight-fitting powered APR (blower off) and supplied-air respirators (SAR) (at required air-line supply flow). Breathing resistance requirements (pressure limits) in 42 CFR Part 84 vary with certain design aspects (e.g. APR design and filter type).

ISO published a dynamic method for recording pressure-volume (P-V) data during sinusoidal flow and proposed volume-averaged, peak pressure and elastance limits for all RPD (any design) and ventilation rates (10 to 135 L/min). To compare results and requirements, both methods were applied to available as-received APR and SAR (53 largely U.S. NIOSH-approved configurations).

All APR (seven full-facepiece, 38 half-mask, and nine powered) and SAR (three self-contained and six airline) met both U.S. NIOSH and proposed ISO requirements at ISO work rate 1 (35 L/min). With U.S. NIOSH considered across all designs, maximum inspiration limits were comparable whereas U.S. NIOSH expiration limits were lower than proposed ISO limits.

At ISO work rate 2 (65 L/min) six full-facepiece APR with combination filters (high efficiency particulate/chemical sorbent) exceeded ISO inspiration limits. At ISO work rate 3 (105 L/min) these were joined by two (of eleven) elastomeric half-mask APR with high efficiency particulate filters and one (of three) tight-fitting PAPR with similar results at ISO work rate 4 (135 L/min). Filtering-facepiece, hooded powered APR, self-contained pressure-demand SAR met requirements at all work rates. Airline SAR exceeded ISO limit(s): two (of four) constant flow at work rate 2; one at work rate 3; two constant flow, two pressure demand at work rate 4.

Overall APR constant flow inhalation resistance correlated with ISO pressure(s) at all work rates. However, pressures over the flow range showed distinctly different first and second order flow-dependence for each design with both coefficients for full facepiece > elastomeric half-mask > filtering-facepiece APR.

Speaker: Heidi Sewchok

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In order to streamline and harmonize the regulatory activities regarding the approval of N95 filtering facepiece respirators for use in healthcare settings a Memorandum of Understanding (MOU) was created between the U. S. Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH). The MOU led to the creation of a new respirator protection classification to encompass the NIOSH and FDA requirements for N95 filtering facepiece respirators. Respirators approved by NIOSH under the MOU will be approved with the protection of N95-F. NIOSH administers the respirator approval program through the National Personal Protective Technology Laboratory (NPPTL). In order to be used in occupational settings in the United States, a respirator must have NIOSH approval, as required by the Occupational Safety and Health Administration (OSHA) under 29 CFR 1910.134. The Food and Drug Administration (FDA) administers the 510(k) premarket notification program through the Center for Devices and Radiological Health (CDRH). If a respirator is to be used in a healthcare setting, it is considered a medical device and must gain clearance through the FDA’s 510(k) process, as required the Federal Food, Drug, and Cosmetic Act (FD&C Act). Respirators that meet the specifications outlined in the MOU can be submitted for NIOSH approval at the new N95-F protection level. In order to be NIOSH approved as N95-F respirators, devices must meet the requirements in 42 CFR Part 84 Subpart K and, in addition, must also meet the requirements of medical devices outlined by the FDA in the FD&C Act.

Speakers: Susan Xu, Bill King, and Caitlin McClain

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Background: National Institute for Occupational Safety and Health (NIOSH) methods and requirements for air-purifying respirator (APRs) breathing resistance (BR) in 42 CFR Part 84 do not include work of breathing (WOB). The International Organization for Standardization (ISO) SC15 utilized WOB to evaluate airflow resistance for all classes of respiratory protective devices (RPDs) as part of their development of performance standards for RPDs. This study evaluated the relationship between ISO WOB measurements and NIOSH BR test results; provided scientific basis for standard development organizations (SDO) to decide if WOB should be adopted; established regression equations for manufacturers and test laboratories to estimate WOB measurements using BR data.

Methods: A total of 43 respirators were tested for WOB in minute ventilation at five work rates: 10, 35, 65, 105, and 135 liters per minute (l/min). WOB determination followed ISO Standards 16900-5 for methods, 169000-12 for procedures, and 16976-4 for data calculations. NIOSH BR obtained at a constant flow rate of 85l/min was correlated to each of the parameters obtained from the WOB test.

Results: The WOB and NIOSH BR were found to be strongly and positively correlated at work rate 35 and 65l/m for inhalation and exhalation. Linear, nonlinear and multiple regression models were also established to estimate WOB using BR.

Conclusions: NIOSH BR does reasonably predict WOB for APRs. The results of our study may be considered by SDOs for the development and modification of new RPD standards. The results may also be used by manufacturers for product development and evaluation.