Filtering Facepiece Respirators Models Research Articles

Using the Number of N95® Filtering Facepiece Respirator Models as an Indicator of Supply Chain Stability in a US Health-Care System.

Personal protective equipment (PPE) supply chain disruptions force US health-care entities to adopt conservation strategies such as procurement from different respirator manufacturers. This research seeks to better understand how the number of respirator models on hand can serve as an indicator of N95 filtering facepiece respirator (FFR) supply chain stability or disruption. Researchers looked at differences in the mean number of N95 FFR models, averaged weekly, from 10 hospitals in a health-care system over 15 wk from June 1 to September 10, 2020. Participating hospitals entered near-daily PPE inventory data by manufacturer and model number. A linear mixed effect model was run in SPSS v. 26 using a random intercept for hospitals, with week as a fixed predictor and mean number of respirator models (averaged weekly) on hand as the dependent variable. Each week showed a small but significant effect compared with the past week (P < 0.001), where the average weekly number of respirator models on hand decreased. The limited data may indicate a resolution of supply chain disruptions and warrant further investigation. Consequently, the number of respirator models may be applicable as an indicator of supply chain stability and be more easily ascertained and tracked by health-care entities.

The effect of N95 designs on respirator fit and its associations with gender and facial dimensions.

This study examined the association of various brands of NIOSH-certified N95 filtering face-piece respirators (FFR) fit with facial dimensions and gender. One hundred and thirty-five participants (77 females and 58 males) were recruited from the previous facial anthropometry study among Malaysians in 2020. Quantitative respirator fit testing of six FFR were performed using the TSI Portacount Pro+ 8038 which comprised of four exercises (bending over, talking, up-down head movement, and side to side head movement). An overall fit factor (FF) of ≥ 100 was considered a pass for each FFR. Analysis was done using T-test, Pearson's correlations, and generalised linear regression. The passing rates for the six FFR were 36.3% (Cup B), 50.4% (Trifold A), 54.1% (Duckbill A), 57.0% (Cup A), 74.1% (Trifold B), and 83.7% (Duckbill B). Both Duckbill B and Trifold B had the highest passing rates for both genders. However, certain FFR models (Cup B, Trifold A, Trifold B, and Duckbill A) fit better for participants with large facial size who were mostly males, while others (Cup A and Duckbill B) specifically fit better for those with small facial size, who were mostly females. This study showed significant positive effect of nose protrusion, nasal root and subnasale-sellion and the negative effect of menton-sellion, bigonial breadth and nose breadth on fit factors of various FFR. The results of this study emphasized the importance of choosing and designing FFR based on local anthropometry data, with careful consideration on the dimensions that affect the respirator fit. Since N95 are commonly used in the healthcare settings to prevent airborne transmission, the practice of respirator fit testing and selecting N95 with high passing rates for healthcare workers need to be emphasized.

Filtration performance, fit test and side effects of respiratory personal protective equipment following decontamination: Observations for user safety and comfort.

While facing personal protective equipment (PPE) shortages during the COVID-19 pandemic, several institutions looked to PPE decontamination and reuse options. This study documents the effect of two hydrogen peroxide treatments on filtration efficiency and fit tests as well as the side effects for volunteers after the decontamination of N95 filtering facepiece respirators (FFRs). We also propose an efficient and large-scale treatment protocol that allows for the traceability of this protective equipment in hospitals during PPE shortages. The effects of low-temperature hydrogen peroxide sterilization and hydrogen peroxide vapor (HPV) on two FFR models (filtration, decontamination level, residual emanation) were evaluated. Ten volunteers reported comfort issues and side effects after wearing 1h FFRs worn and decontaminated up to five times. The decontamination process does not negatively affect FFR efficiency, but repeated use and handling tend to lead to damage, limiting the number of times FFRs can be reused. Moreover, the recommended 24-h post-treatment aeration does not sufficiently eliminate residual hydrogen peroxide. Prolonged aeration time increased user comfort when using decontaminated FFRs. HPV and low-temperature hydrogen peroxide sterilization seem to be appropriate treatments for FFR decontamination when the PPE is reused by the same user. PPE decontamination and reuse methods should be carefully considered as they are critical for the comfort and safety of healthcare workers.

Filtration performance of three models of N95 filtering facepiece respirators following clinical usage and vaporized hydrogen peroxide decontamination

N95 filtering facepiece respirators (FFRs) are essential personal protective equipment (PPE) for protecting healthcare workers from airborne pathogens. To perform the first large-scale evaluation of particulate filtration efficiency (PFE) of three models of N95 FFRs following clinical usage and vaporized hydrogen peroxide (VHP) decontamination. Three variables were assessed for effect on PFE following VHP decontamination: VHP sterilizer model, N95 respirator model, and prior N95 clinical usage. The VHP sterilizer model and N95 FFR model impacted PFE performance. Worn N95 FFRs had a 91% lower odds of exhibiting ≥95% PFE compared with the control. This work highlights the importance of validating any N95 FFR decontamination programme in its entirety, including prior clinical usage.

Effectiveness of a Low-cost UVGI Chamber for Decontaminating Filtering Facepiece Respirators to Extend Reuse

ABSTRACT In emergencies like the COVID-19 pandemic, reuse or reprocessing of filtering facepiece respirators (FFRs) may be required to mitigate exposure risk. Research gap: Only a few studies evaluated decontamination effectiveness against SARS-CoV-2 that are practical for low-resource settings. This study aimed to determine the effectiveness of a relatively inexpensive ultraviolet germicidal irradiation chamber to decontaminate FFRs contaminated with SARS-CoV-2. A custom design UVGI chamber was constructed to determine the ability to decontaminate seven FFR models including N95s, KN95 and FFP2s inoculated with SARS-CoV-2. Vflex was excluded due to design folds/pleats and UVGI shadowing inside the chamber. Structural and functional integrity tolerated by each FFR model on repeated decontamination cycles was assessed. Twenty-seven participants were fit tested over 30 cycles for each model and passed if the fit factor was ≥100. Of the FFR models included for testing, only the KN95 model failed filtration. The 3M™ 3M 1860 and Halyard™ duckbill 46727 (formerly Kimberly Clark) models performed better on fit testing than other models for both pre-and-post decontaminations. Fewer participants (0.3 and 0.7%, respectively) passed fit testing for Makrite 9500 N95 and Greenline 5200 FFP2 and only two for the KN95 model post decontamination. Fit testing appeared to be more affected by donning & doffing, as some passed with adjustment and repeat fit testing. A ≥ 3 log reduction of SARS-CoV-2 was achieved for worn-in FFRs namely Greenline 5200 FFP2. Conclusion: The study showed that not all FFRs tested could withstand 30 cycles of UVGI decontamination without diminishing filtration efficiency or facial fit. In addition, SARS-CoV-2 log reduction varied across the FFRs, implying that the decontamination efficacy largely depends on the decontamination protocol and selection of FFRs. We demonstrated the effectiveness of a low-cost and scalable decontamination method for SARS-CoV-2 and the effect on fit testing using people instead of manikins. It is recognised that extensive experimental evidence for the reuse of decontaminated FFRs is lacking, and thus this study would be relevant and of interest in crisis-capacity settings, particularly in low-resource facilities.

Assessing the Fit of N95 Filtering Facepiece Respirators Fitted with an Ear Loop Strap System: A Pilot Study.

Throughout the COVID-19 pandemic, hundreds of millions of people worldwide have become new users of respiratory protective devices. Facemasks and KN95 respirators utilizing an ear loop straps system (ELSS) have recently become popular among occupational and non-occupational populations. Part of this popularity is due to the ease of wearability as compared with traditional devices utilizing two headbands, one worn over the head and the other behind the neck—a universal strap system used in NIOSH-certified N95 filtering facepiece respirators (FFRs). Some users convert the two-strap configuration to an adjustable ELSS. The first objective of this pilot study was to quantitatively characterize how such a conversion impacts the respirator fit. Additionally, a novel faceseal (NFS) technology, which has been previously demonstrated to enhance the fit of N95 FFRs, was deployed to modify the ELSS-converted N95 FFRs. The second objective of this study was to quantify the fit improvement that results from adding the NFS to the ELSS. The study was conducted by performing the Occupational Safety and Health Administration (OSHA)-approved quantitative fit testing (QNFT) on 16 human subjects featuring different facial shapes and dimensions. Three models of cup-shaped N95 FFRs were tested in three versions: the standard version with manufacturer’s strap system, the ELSS-converted, and the ELSS-converted version modified by adding the NFS. QNFT demonstrated that the fit of an N95 FFR featuring the traditional/standard headbands strap system is negatively impacted when this system is converted to an ELSS. The fit of an ELSS-converted respirator can be significantly improved by the addition of the NFS. We found that the FFR model and the strap system version are significant factors affecting the QNFT-determined respirator fit factor (FF), as well as the OSHA QNFT pass rate (FF ≥100). The findings suggest that the current NFS, if further improved, has a potential for developing a ‘universally fitting’ ELSS-equipped N95 FFR that can be used by the general public, the vast majority of whom do not have access to OSHA fit requirements.

Effect of UV-C germicidal irradiation (UVGI) on the structural integrity of N95 and KN95 respirators

This study focuses on reprocessing a group of filtering facepiece respirators (FFR) using ultraviolet germicidal irradiation (UVGI). The aim is to explore the possibility of disinfecting selected KN95 FFRs, in comparison with the N95 FFRs, and assess their viability for reusage. For this purpose, five models of unused N95 and KN95 FFR models obtained from the hospital were exposed to UV-C light using a customized UVGI chamber. The material integrity of treated FFRs was examined in terms of particle penetration and strap tension. The surface morphology of all models is inspected to determine the visible changes of each FFR upon exposure to 1–100 cycles (1 cycle is equivalent to 1 J/cm2 UV dose). The penetration test results indicate that the physical properties of the KN95 and N95 FFRs remain within permissible limits despite being reprocessed by up to 100 cycles (100 J/cm2). Using a microscope, the physical observations also reveal that no visible damage can be seen even after 100 J/cm2 exposure. Apart from the filter bodies, the tension of each strap was also found to not be significantly affected by UV radiation by at least 10 disinfection cycles (10 J/cm2). This confirms that KN95, as well as N95 FFRs, can be subjected to UV treatment as a means of disinfection.

Qualitative fit test outcomes for N95 filtering facepiece respirators in health care workers

BackgroundWe analyzed the qualitative fit test results of the filtering facepiece respirators (FFRs) used at our institution to determine their performance and utility. MethodsWe retrospectively analyzed 12,582 qualitative fit testing results for several FFR models among 8,809 health care workers (HCWs). ResultsThe overall failure rate for HCWs was 15.2%. Nearly one-third (2933/8809, 33.3%) had multiple FFRs fit tested. HCW sex was a statistically significant indicator of fit testing failure (χ2 = 29.9, df = 1, P < .001), with women having a 44% higher likelihood (OR, 1.4; 95% CI: 1.27–1.65) than men. There were statistically significant differences in the failure rate across FFRs (Fig 4, F[5, 12475] = 8.4, P < .001). Fluidshield 46867S had a significantly higher failure rate (49%) than the 3M 1860 (P = .012), 3M 1860S (P < .001), 3M 8210 (P < .001), and Safelife (P < .001) FFRs. ConclusionsThere was a large degree of variation in fit testing results for the FFRs tested. Although we were unable to find an FFR that fit more than 95% of the HCWs successfully, we identified poorly functioning FFRs that can help our institution with decision-making and budgeting for acquisition and stocking appropriate FFRs.

Persistence of SARS-Co-V-2 on N95 filtering facepiece respirators: implications for reuse

In response to the shortage of N95 filtering facepiece respirators for healthcare workers during the COVID-19 pandemic, the Centers for Disease Control and Prevention issued guidance for extended use and limited reuse of N95 FFRs to conserve supply. Previously worn N95 filtering facepiece respirators can serve as a source of pathogens, which can be transferred to the wearer while doffing and donning a respirator when practicing reuse. When practicing limited filtering facepiece respirators reuse, to reduce the risk of self-contamination, the Centers for Disease Control and Prevention recommends storing filtering facepiece respirators for five days between uses to allow for the decay of viable pathogens including SARS-CoV-2. This study assesses the persistence of the SARS-CoV-2 strain USA-WA1/2020 on N95 filtering facepiece respirators under controlled storage conditions for up to 5 days to inform the Centers for Disease Control and Prevention guidance. Coupons excised from six N95 filtering facepiece respirator models and glass slide coverslips were inoculated with the virus in a defined culture medium and in human saliva and stored at 20 °C and 20%, 45%, and 75% relative humidity. Statistically significant differences in SARS-CoV-2 half-lives were measured among the tested humidity levels with half-lives decreasing from an average of approximately 30 hr at 20% relative humidity to approximately 2 hr at 75% relative humidity. Significant differences in virus half-lives were also observed between the culture medium and saliva suspension media at 20% and 45% relative humidity with half lives up to 2.9 times greater when the virus was suspended in cell culture medium. The 5-day storage strategy, assessed in this study, resulted in a minimum of 93.4% reduction in viable virus for the most challenging condition (20% relative humidity, cell culture medium) and exceeding 99% reduction in virus at all other conditions.

Construction and validation of an ultraviolet germicidal irradiation system using locally available components.

Coronavirus disease (COVID-19), the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, is responsible for a global pandemic characterized by high transmissibility and morbidity. Healthcare workers (HCWs) are at risk of contracting COVID-19, but this risk has been mitigated through the use of personal protective equipment such as N95 Filtering Facepiece Respirators (FFRs). At times the high demand for FFRs has exceeded supply, placing HCWs at increased exposure risk. Effective FFR decontamination of many FFR models using ultraviolet-C germicidal irradiation (UVGI) has been well-described, and could maintain respiratory protection for HCWs in the face of supply line shortages. Here, we detail the construction of an ultraviolet-C germicidal irradiation (UVGI) device using previously existing components available at our institution. We provide data on UV-C dosage delivered with our version of this device, provide information on how users can validate the UV-C dose delivered in similarly constructed systems, and describe a simple, novel methodology to test its germicidal effectiveness using in-house reagents and equipment. As similar components are readily available in many hospitals and industrial facilities, we provide recommendations on the local construction of these systems, as well as guidance and strategies towards successful institutional implementation of FFR decontamination.

Assessing the impact of multiple ultraviolet disinfection cycles on N95 filtering facepiece respirator integrity

During the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs) were recommended to protect healthcare workers when providing care to infected patients. Despite their single-use disposable nature, the need to disinfect and repurpose FFRs is paramount during this global emergency. The objectives of this study were to (1) determine if UV treatment has an observable impact on respirator integrity; (2) test the impact of UV treatment on N95 FFR user fit; and (3) test the impact of UV treatment on FFR integrity. Ultraviolet (UV) disinfection was assessed in maintaining N95 FFR integrity. Two models of FFRs were exposed to UV fluences ranging from 0 to 10,000 mJ cm−2 per side and subsequently tested for fit, respirator integrity, and airflow. Inspection of N95 FFRs before and after UV treatment via microscopy methods showed no observable or tactile abnormalities in the integrity of respirator material or straps. Tensile loading tests on UV-treated and untreated respirator straps also demonstrated no impact on breaking strength. Standardized fit test methods showed no compromise in user fit following UV treatment. Evaluation of particle penetration and airflow through N95 FFRs showed no impact on integrity, and average filtration efficiency did not fall below 95% for any of the respirator types or fluence levels. This work provides evidence that UV disinfection does not compromise N95 FFR integrity at UV fluences up to 10,000 mJ cm−2. UV disinfection is a viable treatment option to support healthcare professionals in their strategy against the spread of COVID-19.

Decontamination of SARS-CoV-2 contaminated N95 filtering facepiece respirators (FFRs) with moist heat generated by a multicooker.

Decontamination of N95 filtering facepiece respirators (FFRs) is a crisis capacity strategy allowed when there are known shortages of FFRs. The application of moist heat is one decontamination method that has shown promise and is the approach approved in the Steris Steam Emergency Use Authorization (EUA). This effort examines the use of multicookers to apply moist heat, as they are available in retail stores and more affordable than methods requiring more sophisticated equipment. Four of five multicooker models examined met the acceptance criteria for the test and one model was selected for inactivation testing. Tests were performed on four different FFR models with SARS‐CoV‐2 suspended in culture media, simulated saliva or simulated lung fluid. Moist heat treatment reduced recoverable titres of SARS‐CoV‐2 virus to levels below the limit of detection in all tests. Furthermore, these four FFR models showed no loss in collection efficiency, inhalation resistance or visual damage after up to 10 decontamination cycles. Two (2) FFR models showed a slight change in strap elasticity (<9%). These data show that moist heat treatment using a multicooker is a viable option for FFR decontamination in a crisis capacity strategy.

Hydrogen Peroxide Methods for Decontaminating N95 Filtering Facepiece Respirators.

Introduction: During a pandemic, when the supply of N95 filtering facepiece respirators (FFRs) is limited, FFRs may be decontaminated by methods that inactivate pathogens as long as they do not damage FFR function. Hydrogen peroxide (H2O2) is widely used for decontamination in medical settings. Objective: To review the literature on the use of H2O2 to decontaminate N95 FFRs and identify methods that inactivate virus and preserve FFR filtration efficiency and fit. Methods: The literature was searched for studies evaluating H2O2 decontamination methods on inactivating SARS-CoV-2 and other viruses and microorganisms inoculated on N95 FFRs and the effects on respirator filtration efficiency and fit. Current U.S. Federal guidelines are also presented. Results: Findings from relevant laboratory studies (N = 24) are summarized in tables. Commercially available H2O2 decontamination systems differ on how H2O2 is delivered, the temperature, the duration of treatment, and other factors that can impact N95 FFR filtration efficiency and fit. Some methods inactivate SARS-CoV-2 virus-contaminated N95 FFRs with >3 log attenuation, whereas other methods are yet to be evaluated. Discussion and Conclusion: Most of the H2O2 methods reviewed effectively decontaminate N95 FFRs without damaging FFR function. However, some methods adversely impact N95 fit or filtration efficiency, which could go undetected by the end user and compromise their protection from pathogen inhalation. When making decisions about H2O2 decontamination of respirators, it is important to understand differences in methods, effects on different FFR models, and potential hazards to workers who manage the decontamination process.

The effect of ultraviolet C radiation against different N95 respirators inoculated with SARS-CoV-2

ObjectivesThere are currently no studies that have examined whether one dosage can be uniformly applied to different respirator types to effectively decontaminate SARS-CoV-2 on N95 filtering facepiece respirators (FFRs). Health care workers have been using this disinfection method during the pandemic. Our objective was to determine the effect of UVC on SARS-CoV-2 inoculated N95 respirators and whether this was respirator material/model type dependent. MethodsFour different locations (facepiece and strap) on five different N95 FFR models (3M 1860, 8210, 8511, 9211; Moldex 1511) were inoculated with a 10 μL drop of SARS-CoV-2 viral stock (8 × 107 TCID50/mL). The outside-facing and wearer-facing surfaces of the respirators were each irradiated with a dose of 1.5 J/cm2 UVC (254 nm). Viable SARS-CoV-2 was quantified by a median tissue culture infectious dose assay (TCID50). ResultsUVC delivered using a dose of 1.5 J/cm2, to each side, was an effective method of decontamination for the facepieces of 3M 1860 and Moldex 1511, and for the straps of 3M 8210 and the Moldex 1511. ConclusionThis dose is an appropriate decontamination method to facilitate the reuse of respirators for healthcare personnel when applied to specific models/materials. Also, some straps may require additional disinfection to maximize the safety of frontline workers. Implementation of widespread UVC decontamination methods requires careful consideration of model, material type, design, and fit-testing following irradiation.

Multicycle Autoclave Decontamination of N95 Filtering Facepiece Respirators.

Introduction:During pandemic situations like the one caused by the emergent coronavirus SARS-CoV-2, healthcare systems face the challenge of limited personal protective equipment and impaired supply chains. This problem poses a threat to healthcare workers, first responders, and the public, which demands solutions that can span the gap between institutional shortages and resupplies.Objectives:To examine the efficacy of autoclave-based decontamination for the reuse of single-use surgical masks and N95 filtering facepiece respirators (FFRs). This method is the most readily available form of decontamination in the hospital and laboratory settings.Methods:Three models of N95 FFRs and two procedural masks were evaluated in this study. A moist heat autoclave using four different autoclave cycles: 115°C for one hour, 121.1°C for 30 minutes, 130°C for two minutes, and 130°C for four minutes was used. After the autoclave process, the FFRs were NIOSH fit tested and particle counting was performed for both coarse particles of 5 micrometers (µM) and fine particles from 0.1µM to 1.0µM.Results:We observed negligible alterations in the functionality and integrity of 3M 1805 and 3M 1870/1870+ N95 FFRs after three autoclave cycles. Surgical masks also showed minimal changes in functionality and integrity. The 3M 1860 FFR failed fit test after a single autoclave decontamination cycle.Discussion and Conclusion:The study finds that specific surgical masks and N95 FFR models can withstand autoclave decontamination for up to three cycles. Additionally, the autoclave cycles tested were those that could be readily achieved by both clinical and research institutions.

A comparison of total inward leakage measured using sodium chloride (NaCl) and corn oil aerosol methods for air-purifying respirators

The International Organization for Standardization (ISO) standard 16900-1:2014 specifies the use of sodium chloride (NaCl) and corn oil aerosols, and sulfur hexafluoride gas for measuring total inward leakage (TIL). However, a comparison of TIL between different agents is lacking. The objective of this study was to measure and compare TIL for respirators using corn oil and NaCl aerosols. TIL was measured with 10 subjects donning two models of filtering facepiece respirators (FFRs) including FFP1, N95, P100, and elastomeric half-mask respirators (ERs) in NaCl and corn oil aerosol test chambers, using continuous sampling methods. After fit testing with a PortaCount (TSI, Inc., St. Paul, MN) using the Occupational Safety and Health Administration (OSHA) protocol, five subjects were tested in the NaCl chamber first and then in the corn oil chamber, while other subjects tested in the reverse order. TIL was measured as a ratio of mass-based aerosol concentrations in-mask to the test chamber, while the subjects performed ISO 16900-1-defined exercises. The concentration of NaCl aerosol was measured using two flame photometers, and corn oil aerosol was measured with one light scattering photometer. The same instruments were used to measure filter penetration in both chambers using a Plexiglas setup. The size distribution of aerosols was determined using a scanning mobility particle sizer and charge was measured with an electrometer. Filter efficiency was measured using an 8130 Automated Filter Tester (TSI). Results showed the geometric mean TIL for corn oil aerosol for one model each of all respirator categories, except P100, were significantly (p < 0.05) greater than for NaCl aerosol. Filter penetration in the two test chambers showed a trend similar to TIL. The count median diameter was ∼82 nm for NaCl and ∼200 nm for corn oil aerosols. The net positive charge for NaCl aerosol was relatively larger. Both fit factor and filter efficiency influence TIL measurement. Overall, TIL determination with aerosols of different size distributions and charges using different methodologies may produce dissimilar results.

Ultraviolet germicidal irradiation of influenza-contaminated N95 filtering facepiece respirators

Safe and effective decontamination and reuse of N95 filtering facepiece respirators (FFRs) has the potential to significantly extend FFR holdings, mitigating a potential shortage due to an influenza pandemic or other pandemic events. Ultraviolet germicidal irradiation (UVGI) has been shown to be effective for decontaminating influenza-contaminated FFRs. This study aims to build on past research by evaluating the UVGI decontamination efficiency of influenza-contaminated FFRs in the presence of soiling agents using an optimized UVGI dose. Twelve samples each of 15 N95 FFR models were contaminated with H1N1 influenza (facepiece and strap), then covered with a soiling agent-artificial saliva or artificial skin oil. For each soiling agent, 3 contaminated FFRs were treated with 1 J/cm2 UVGI for approximately 1 minute, whereas 3 other contaminated FFRs remained untreated. All contaminated surfaces were cut out and virus extracted. Viable influenza was quantified using a median tissue culture infectious dose assay. Significant reductions (≥3 log) in influenza viability for both soiling conditions were observed on facepieces from 12 of 15 FFR models and straps from 7 of 15 FFR models. These data suggest that FFR decontamination and reuse using UVGI can be effective. Implementation of a UVGI method will require careful consideration of FFR model, material type, and design.

Manikin-based size-resolved penetrations of CE-marked filtering facepiece respirators

ABSTRACTThe purpose of this manikin-based study was to determine the percentage penetrations of nine CE-marked filtering facepiece respirator models (two samples from each) from filtering classes FFP1, FFP2, and FFP3 and to demonstrate by an independent measurement method the disadvantages and shortcomings of the currently valid European Norm (EN 149:2001) for filtering facepieces. All of the filtering facepieces were evaluated size-selectively in an experimental chamber using charge-neutralized monodisperse ammonium sulfate in 9 sizes ranging from 20–400 nm of count median diameter (CMD) under flowrate of 95 L/min. The results were then compared to the previous study concerning penetrations of 47-mm diameter filters cut from the filtering material of identical filtering facepieces. Although these two experimental methods for measuring penetrations of filtering materials from filtering facepieces are in good agreement (R2 = 0.91), the results show within-respirator variations in all three filtering classes (5.5–19.3% for all FFRs in FFP1, 2.8–8.5% in FFP2, and 0.1–2.8% in FFP3). The most penetrating particle size (MPPS) in this study was found to be in the range of 25–65 nm (CMD), which is in agreement with the range of 30–60 nm found in the previous study. Moreover, 7 out of 9 FFR models reached higher penetrations from manikin-based respirator measurements than during measurements of filters from the respective respirators. Furthermore, penetration levels increased up to ∼50% when the respirator was not sealed around the face of the manikin, indicating that the real protection level provided by these filtering facepieces may be even lower if the respirator does not fit perfectly. Considering that poor filtration efficiency and poor fit may increase under real work conditions, the particle penetration is even higher than was found in this study. Therefore, the CE-marked respirators examined in this study may not be efficient in providing the expected level of protection for workers exposed to nanoparticles.

Resistance to synthetic blood penetration of National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators and surgical N95 respirators

BackgroundSurgical N95 filtering facepiece respirators (FFRs), certified by the National Institute for Occupational Safety and Health (NIOSH) as a respirator and cleared by the Food and Drug Administration (FDA) as a surgical mask, are often used to protect from the inhalation of infectious aerosols and from splashes/sprays of body fluids in health care facilities. A shortage of respirators can be expected during a pandemic. The availability of surgical N95 FFRs can potentially be increased by incorporating FDA clearance requirements in the NIOSH respirator approval process.MethodsFluid resistance of NIOSH-approved N95 FFRs, and FDA-cleared surgical N95 FFRs and surgical masks was tested using the ASTM F1862 method at 450 and 635 cm/sec velocities and compared with the results from a third-party independent laboratory. Blood penetration through different layers of filter media of masks were also analyzed visually.ResultsFour N95 FFR models showed no test failures at both velocities. The penetration results obtained in the NIOSH laboratory were comparable to those from the third-party independent laboratory. The number of respirator samples failing the test increased with increasing test velocity.ConclusionsThe results indicate that several NIOSH-approved N95 FFR models would likely pass FDA clearance requirements for resistance to synthetic blood penetration.

Comparison of Simulated Workplace Protection Factors Offered by N95 and P100 Filtering Facepiece and Elastomeric Half-Mask Respirators against Particles of 10 to 400 nm.

This study compared the simulated workplace protection factors (SWPFs) between NIOSH-approved N95 respirators and P100 respirators, including two models of filtering facepiece respirator (FFR) and two models of elastomeric half-mask respirator (EHR), against sodium chloride particles (NaCl) in a range of 10 to 400 nm.Twenty-five human test subjects performed modified OSHA fit test exercises in a controlled laboratory environment with the N95 respirators (two FFR models and two EHR models) and the P100 respirators (two FFRs and two EHRs). Two Scanning Mobility Particle Sizers (SMPS) were used to measure aerosol concentrations (in the 10–400 nm size range) inside (Cin) and outside (Cout) of the respirator, simultaneously. SWPF was calculated as the ratio of Cout to Cin. The SWPF values obtained from the N95 respirators were then compared to those of the P100 respirators.SWPFs were found to be significantly different (P<0.05) between N95 and P100 class respirators. The 10th, 25th, 50th, 75th and 90th percentiles of the SWPFs for the N95 respirators were much lower than those for the P100 models. The N95 respirators had 5th percentiles of the SWPFs > 10. In contrast, the P100 class was able to generate 5th percentiles SWPFs > 100. No significant difference was found in the SWPFs when tested against nano-size (10 to 100 nm) and large-size (100 to 400 nm) particles.Overall, the findings suggest that the two FFRs and two EHRs with P100 class filters provide better performance than those with N95 filters against particles from 10 to 400 nm, supporting current OSHA and NIOSH recommendations.