Evaluation of the effects of wiping decontamination for filter cartridges of elastomeric half-mask respirators (EHMRs).

BACKGROUND: A major concern among health care experts is a shortage of N95 filtering facepiece respirators during a pandemic. If the supply of N95 filtering facepiece respirators becomes limited, reusable elastomeric half-mask respirators (EHMRs) may be used to protect health care workers. The focus of this study was to evaluate the effects on the filter performance of wiping decontamination for EHMR P100 filter cartridges. METHODS: The filter cartridge exterior of EHMR Honeywell, Moldex, and Mine Safety Appliance (MSA) models was wiped using quaternary ammonium and sodium hypochlorite wipes. These filter cartridge properties were assessed including observational analysis and filter performance tests. These wiping and assessing procedures were repeated after each set of wiping cycles (50, 100, 150, 200, and 400 cycles) to determine the effects of wiping decontamination. RESULTS: For sodium hypochlorite wipes, Honeywell, Moldex, and MSA models passed the National Institute for Occupational Safety and Health (NIOSH) liquid particulate penetration criteria for all wiping cycles from 50 to 400 (penetrations<0.014%). For quaternary ammonium wipes, filter penetrations of Moldex failed (penetrations>0.03%) after 150 cycles, while the filter penetrations of Honeywell and MSA passed for all wiping cycles (penetrations ≤0.013%). CONCLUSIONS: Wiping decontamination methods using sodium hypochlorite and quaternary ammonium wipes could be considered promising decontamination candidates for Honeywell, Moldex, and MSA reuse, except for the wiping number selection for Moldex (<150 cycles) when using the quaternary ammonium wipe.

Total outward leakage of half-mask respirators and surgical masks used for source control.

Both respirators and surgical masks (SM) are used as source control devices. During the COVID-19 pandemic, there was much interest in understanding the extent of particle total outward leakage (TOL) from these devices. The objective of this study was to quantify the TOL for five categories of devices: SMs, National Institute for Occupational Safety and Health (NIOSH) Approved N95 filtering facepiece respirators (FFRs) without exhalation valves, NIOSH Approved N95 FFRs with exhalation valves (N95 FFRV), NIOSH Approved elastomeric half-mask respirators (EHMRs) with exhalation valves, and NIOSH Approved EHMRs with an SM covering the exhalation valve (EHMRSM). A benchtop test system was designed to test two models of each device category. Each device was mounted on a headform at three faceseal levels (0% faceseal, 50% faceseal, and 100% faceseal). At each faceseal level, the TOL was assessed at three flow rates of minute ventilations of 17, 28, and 39 L/min. The experimental design was a split-split-plot configuration. Device type, faceseal level, flow rate, and the interaction of device type and faceseal level were found to have a significant effect (p-value < 0.05) on the TOL. This study found that the N95 FFRs without exhalation valves had the lowest mean TOL. The SMs had about three times higher TOL than the N95 FFRs without exhalation valves. The TOL of the N95 FFRV was comparable to that of the SM at 0% and 50% faceseal on average overall conditions, but the N95 FFRV had a significantly higher TOL than the SM at a 100% faceseal. The EHMRs had the highest TOL because of the exhalation valve. Using an SM to cover the exhalation valve did not improve the EHMRs' efficiency in mitigating the TOL. Caution should be exercised when using N95 FFRVs as a source control measure against respiratory activities with heavy work rates, such as performing CPR. Results of this study showed that reduced faceseal leakage for N95 FFRs and SMs improves source control.

Fit evaluation of NIOSH approved N95 filtering facepiece respirators with various skin protectants: A pilot study.

Widespread disease outbreaks can result in prolonged wear times of National Institute for Occupational Safety and Health Approved N95 filtering facepiece respirators by healthcare personnel. Prolonged wear times of these devices can cause the development of various adverse facial skin conditions. Healthcare personnel have been reported to apply "skin protectants" to the face to reduce the pressure and friction of respirators. Because tight-fitting respirators rely on a good face seal to protect the wearer, it is important to understand if the fit is affected when skin protectants are used. This laboratory pilot study included 10 volunteers who performed quantitative fit tests to evaluate respirator fit while wearing skin protectants. Three N95 filtering facepiece respirator models and three skin protectants were evaluated. Three replicate fit tests were performed for each combination of subject, skin protectant (including a control condition of no protectant), and respirator model. Fit Factor (FF) was affected differently by the combination of the protectant type and respirator model. The main effects of the protectant type and respirator model were both significant (p < 0.001); additionally, their interaction was significant (p = 0.02), indicating FF is affected by the combined effects of the protectant type and respirator model. Compared to the control condition, using a bandage-type or surgical tape skin protectant decreased the odds of passing the fit test. Using a barrier cream skin protectant also decreased the odds of passing the fit test across all models compared to the control condition; however, the probability of passing a fit test was not statistically significantly different from the control condition (p = 0.174). These results imply that all three skin protectants reduced mean fit factors for all N95 filtering facepiece respirator models tested. The bandage-type and surgical tape skin protectants both reduced fit factors and passing rates to a greater degree than the barrier cream. Respirator users should follow respirator manufacturers' guidance on the use of skin protectants. If a skin protectant is to be worn with a tight-fitting respirator, the fit of the respirator should be evaluated with the skin protectant applied before use in the workplace.

A manikin-based assessment of loose-fitting powered air-purifying respirator performance at variable flow rates and work rates.

Loose-fitting powered air-purifying respirators (PAPRs) are used in healthcare settings, although barriers to routine, everyday usage remain, including usability concerns and potential interference with work activities. Loose-fitting PAPRs are approved by the National Institute for Occupational Safety and Health (NIOSH) and must meet minimum performance requirements, including a minimum airflow requirement of 170 L/min. One course of action to address usability concerns is to allow for the use of PAPRs designed with reduced airflow rates. The primary objective of this study was to assess the effect of PAPR flow rate and user work rate on PAPR performance, using a manikin-based assessment method. PAPR performance was quantified using the "Manikin Fit Factor" (mFF), a ratio of the challenge aerosol concentration to the in-facepiece concentration. Flow rates from 50-215 L/min and low, moderate, and high work rates were tested. Two models of NIOSH Approved loose-fitting facepiece PAPRs were tested, both having an Occupational Safety and Health Administration Assigned Protection Factor (APF) or expected level of protection, of 25. A two-way analysis of variance with an effect size model was run for each PAPR model to analyze the effects of work rate and flow rate on PAPR performance. Flow rate and work rate were found to be significant variables impacting PAPR performance. At low and moderate work rates and flow rates below the NIOSH minimum of 170 L/min, mFF was greater than or equal to 250, which is 10 times the OSHA APF of 25 for loose-fitting facepiece PAPRs. At high work rates and flow rates below 170 L/min, mFF was not greater than or equal to 250. These results suggest that some loose-fitting facepiece PAPRs designed with a flow rate lower than the current NIOSH requirement of 170 L/min may provide respirator users with expected protection at low and moderate work rates. However, when used at high work rates, some loose-fitting facepiece PAPRs designed with lower flow rates may not provide the expected level of protection.

Laboratory assessment of bacterial contamination of a sterile environment when using respirators not traditionally used in a sterile field environment.

OBJECTIVE: During infectious disease outbreaks or pandemics, an increased demand for surgical N95s that create shortages and necessitate the use of alternative National Institute for Occupational Safety and Health (NIOSH)-approved respirators that do not meet the Food and Drug Administration (FDA) additional requirements. The objective of this research was to quantify the level of bacterial contamination resulting from wearing NIOSH-approved respirators lacking the additional protections afforded by surgical N95s. METHODS: Participants performed simulated healthcare tasks while wearing 5 different respirators approved by the NIOSH. Sterile field contamination resulting from use of a surgical mask cleared by the FDA served as a baseline for comparison with the NIOSH-approved respirators. RESULTS: The bacterial contamination produced by participants wearing the N95 filtering facepiece respirators (FFRs) without an exhalation valve, the powered air-purifying respirators (PAPRs) with an assigned protection factor of 25 or 1,000 was not significantly different compared to the contamination resulting from wearing the surgical mask. The bacterial contamination resulting from wearing the N95 FFR with an exhalation valve and elastomeric half-mask respirator (EHMR) with an exhalation valve was found to be statistically significantly higher than the bacterial contamination resulting from wearing the surgical mask. CONCLUSIONS: Overall, NIOSH-approved respirators without exhalation valves maintain a sterile field as well as a surgical mask. These findings inform respiratory guidance on the selection of respirators where sterile fields are needed during shortages of surgical N95 FFRs.

Evaluation of total inward leakage for NIOSH-approved elastomeric half-facepiece, full-facepiece, and powered air-purifying respirators using sodium chloride and corn oil aerosols.

Recently, total inward leakage (TIL) for filtering facepiece and elastomeric half-mask respirators (EHRs) was measured according to the International Organization for Standardization (ISO) test method standard 16900-1:2014 that showed larger TIL for corn oil aerosol than for NaCl aerosol. Comparison of TIL measured for different aerosols for higher protection level respirators is lacking. The objective of this study was to determine TIL for EHRs, full-facepiece respirators, and loose-fitting and tight-fitting powered air-purifying respirators (PAPRs) using NaCl and corn oil aerosols to compare. TIL was measured for two models each of EHRs, full-facepiece respirators, and loose-fitting and tight-fitting PAPRs. After fit testing with a PortaCount (TSI, St. Paul, MN) using the Occupational Safety and Health Administration (OSHA) protocol, eight subjects were tested in the NaCl aerosol chamber first and then in the corn oil aerosol chamber, while another eight subjects tested in the reverse order. Subjects were randomly assigned to one of the two groups. TIL was measured as a ratio of mass-based aerosol concentrations inside the mask to the test chamber while the subjects performed ISO 16900-1-defined exercises using continuous sampling methods. The concentration of corn oil aerosol was measured with one light scattering photometer, alternately, and NaCl aerosol was measured using two flame photometers. Results showed the geometric mean TIL for EHR was significantly (p < 0.05) larger for corn oil aerosol than for NaCl aerosol. EHR models equipped with P100 filters showed relatively smaller TIL values than the same models with N95 filters showing that TIL was inversely related to filter efficiency. Interestingly, TIL was significantly (p < 0.05) larger for NaCl aerosol than for corn oil aerosol for PAPRs, but not for full-facepiece respirators. TIL was inversely related to fit factors of respirator types. Overall, filter efficiency and faceseal leakage determine TIL. The relative trends in TIL for the two aerosols' test methods differ between respirator types indicating that generalization of TIL for respirator types may not be appropriate when using different test agents.

New technique to evaluate decontamination methods for filtering facepiece respirators.

BACKGROUND: A major concern among health care experts is a shortage of N95 filtering facepiece respirators (FFRs) during a pandemic. One option for mitigating an FFR shortage is to decontaminate and reuse the devices. The focus of this study was to develop a new evaluation technique based on 3 major decontamination requirements: (1) inactivating viruses, (2) not altering the respirator properties, and (3) not leaving any toxic byproduct on the FFR. METHODS: Hydrophilic and hydrophobic FFRs were contaminated with MS2 virus. In the solution-based deposition, the virus-containing liquid droplets were spiked directly onto FFRs, while in the vapor-based and aerosol-based depositions, the viral particles were loaded onto FFRs using a bio-aerosol testing system. Ultraviolet germicidal irradiation (UVGI) and moist heat (MH) decontamination methods were used for inactivation of viruses applied to FFRs. RESULTS: Both UVGI and MH methods inactivated viruses (>5-log reduction of MS2 virus; in 92% of both method experiments, the virus was reduced to levels below the detection limit), did not alter the respirator properties, and did not leave any toxic byproduct on the FFRs. CONCLUSIONS: Both UVGI and MH methods could be considered as promising decontamination candidates for inactivation of viruses for respirator reuse during shortages.

Speech intelligibility test methodology applied to powered air-purifying respirators used in healthcare.

Powered air-purifying respirators (PAPRs) are worn to protect workers from hazardous respiratory exposures in a wide range of workplaces, including healthcare. However, PAPRs may diminish the ability of wearers to correctly hear words spoken by others, potentially interfering with safe performance of healthcare duties. Accordingly, the impact of PAPRs during healthcare use on speech intelligibility (SI) and consequently on user safety, usability, and patient care is not well studied. The objectives of this study were to (1) determine a listener's ability to comprehend single-syllable words spoken by a PAPR wearer; (2) determine a PAPR wearer's ability to intelligibly hear and identify single-syllable words spoken by a PAPR wearer; (3) to assess the variability between speakers, listeners, and PAPR models; (4) to investigate the effects of PAPR design features on SI; and (5) inform a SI requirement for certifying future PAPRs for use in healthcare. This study utilized a Modified Rhyme Test to assess SI for PAPRs. The current National Institute for Occupational Safety and Health (NIOSH) methods for assessing SI are limited to the recently introduced PAPR100 respirator class and the class of respirators claiming chemical, biological, radiological, and nuclear (CBRN) protections. Four NIOSH-approved PAPRs were evaluated using four human subjects. Four experimental conditions were examined:(1) Speaker and Listener with no PAPR; (2) Speaker and Listener both wearing PAPRs; (3) Speaker with a PAPR, Listener without a PAPR; and (4) Speaker without a PAPR, Listener with a PAPR resulted in a total of 144 experiments. Statistical analysis showed that the SI performance ratings were not significantly different among the PAPR models, but experimental conditions had significant impact on SI. The pattern of SI across the conditions of the experiment also showed a significant difference depending on PAPR model. The SI performance rating for all PAPRs could meet the current NIOSH CBRN certification requirement for speech intelligibility.

New respirator performance monitor (RePM) for powered air-purifying respirators.

Powered air-purifying respirators (PAPRs) that offer protection from particulates are deployed in different workplace environments. Usage of PAPRs by healthcare workers is rapidly increasing; these respirators are often considered the best option in healthcare settings, particularly during public health emergency situations, such as outbreaks of pandemic diseases. At the same time, lack of user training and certain vigorous work activities may lead to a decrease in a respirator's performance. There is a critical need for real-time performance monitoring of respiratory protective devices, including PAPRs. In this effort, a new robust and low-cost real-time performance monitor (RePM) capable of evaluating the protection offered by a PAPR against aerosol particles at a workplace was developed. The new device was evaluated on a manikin and on human subjects against a pair of condensation nuclei counters (P-Trak) used as the reference protection measurement system. The outcome was expressed as a manikin-based protection factor (mPF) and a Simulated Workplace Protection Factor (SWPF) determined while testing on subjects. For the manikin-based testing, the data points collected by the two methods were plotted against each other; a near-perfect correlation was observed with a correlation coefficient of 0.997. This high correlation is particularly remarkable since RePM and condensation particle counter (CPC) measure in different particle size ranges. The data variability increased with increasing mPF. The evaluation on human subjects demonstrated that RePM prototype provided an excellent Sensitivity (96.3% measured on human subjects at a response time of 60 sec) and a Specificity of 100%. The device is believed to be the first of its kind to quantitatively monitor PAPR performance while the wearer is working; it is small, lightweight, and does not interfere with job functions.

A technique to measure respirator protection factors against aerosol particles in simulated workplace settings using portable instruments.

The aim of this study was to develop a new method to measure respirator protection factors for aerosol particles using portable instruments while workers conduct their normal work. The portable instruments, including a set of two handheld condensation particle counters (CPCs) and two portable aerosol mobility spectrometers (PAMSs), were evaluated with a set of two reference scanning mobility particle sizers (SMPSs). The portable instruments were mounted to a tactical load-bearing vest or backpack and worn by the test subject while conducting their simulated workplace activities. Simulated workplace protection factors (SWPFs) were measured using human subjects exposed to sodium chloride aerosols at three different steady state concentration levels: low (8x103 particles/cm3), medium (5x104 particles/cm3), and high (1x105 particles/cm3). Eight subjects were required to pass a quantitative fit test before beginning a SWPF test for the respirators. Each SWPF test was performed using a protocol of five exercises for 3 min each: (1) normal breathing while standing; (2) bending at the waist; (3) a simulated laboratory-vessel cleaning motion; (4) slow walking in place; and (5) deep breathing. Two instrument sets (one portable instrument {CPC or PAMS} and one reference SMPS for each set) were used to simultaneously measure the aerosol concentrations outside and inside the respirator. The SWPF was calculated as a ratio of the outside and inside particles. Generally, the overall SWPFs measured with the handheld CPCs had a relatively good agreement with those measured with the reference SMPSs, followed by the PAMSs. Under simulated workplace activities, all handheld CPCs, PAMSs, and the reference SMPSs showed a similar GM SWPF trend, and their GM SWPFs decreased when simulated workplace movements increased. This study demonstrated that the new design of mounting two handheld CPCs in the tactical load-bearing vest or mounting one PAMS unit in the backpack permitted subjects to wear it while performing the simulated workplace activities. The CPC shows potential for measuring SWPFs based on its light weight and lack of major instrument malfunctions.

A pilot study of minimum operational flow for loose-fitting powered air-purifying respirators used in healthcare cleaning services.

The objective of this pilot study was to determine the minimum operational flow for loose-fitting powered air-purifying respirators (PAPR) used in healthcare cleaning services. An innovative respiratory flow recording device was worn by nine healthcare workers to obtain the minute volume (MV, L/min), mean inhalation flow (MIF, L/min), and peak inhalation flow (PIF, L/min) while performing "isolation unit work" (cleaning and disinfecting) of a patient room within 30 min. The MV and PIF were compared with the theoretical values obtained from an empirical formula. The correlations of MV, MIF, and PIF with subjects' age, weight, height, body surface area (ADu), and body mass index (BMI) were analyzed. The average MV, MIF, and PIF were 33, 74, and 107 L/min, with maximal airflow rates of 41, 97, and 145 L/min, respectively, which are all below the current 170 L/min minimum operational flow for NIOSH certified loose-fitting PAPRs.

Numerical Simulations of Exhaled Particles from Wearers of Powered Air Purifying Respirators.

In surgical settings, infectious particulate wound contamination is a recognized cause of post-operative infections. Powered air purifying respirators (PAPRs) are worn by healthcare workers for personal protection against contaminated aerosols. Healthcare infection preventionists have expressed concern about the possibility that infectious particles expelled from PAPR exhalation channels could lead to healthcare-associated disease, especially in operative settings where sterile procedural technique is essential. This study used computational fluid dynamics (CFD) modeling to simulate and visualize the distribution of particles exhaled by PAPR wearers. Using CFD simulations, the PAPR inside to outside ratio of particle concentrations was estimated. Also, the effects of particle sizes, supplied-air flow rates, and breathing work rates on outward leakage were evaluated. This simulation study reconstructed a geometrical model of a static median headform wearing a loose-fitting PAPR by capturing a 3D image. We defined a mathematical model for the headform and PAPR system and ran simulations with four particle sizes, three breathing workloads and two supplied-air flow rates (a total 24 configurations; 4×3×2=24) applied on the digital model of the headform and PAPR system. This model accounts for exhaled particles, but not ambient particles. Computed distributions of particles inside and outside the PAPR are displayed. The outward concentration leakage was low at surgical setting, e.g., it was about 9% for a particle size of 0.1 and 1 µm at light breathing and a 205 L/min supplied-air flow rate. The supplied-air flow rates, particle sizes, and breathing workloads had effects on the outward concentration leakage, as the outward concentration leakage increased as particle size decreased, breathing workload increased, and the supplied-air flow rate decreased. The CFD simulations can help to optimize the supplied-air flow rates. When the loose-fitting PAPR is used, exhaled particles with small size (below 1µm), or heavy breathing workloads, may generate a great risk to the sterile field and should be avoided.

COMPUTATIONAL FLUID DYNAMICS SIMULATION OF FLOW OF EXHALED PARTICLES FROM POWERED-AIR PURIFYING RESPIRATORS.

In surgical settings, infectious particulate wound contamination is a recognized cause of post-operative infections. Powered air-purifying respirators (PAPRs) are widely used by healthcare workers personal protection against infectious aerosols. Healthcare infection preventionists have expressed concern about the possibility that infectious particles expelled from PAPR exhalation channels could lead to healthcare associated infections, especially in operative settings where sterile procedural technique is emphasized. This study used computational fluid dynamics (CFD) modeling to simulate and visualize the distribution of particles exhaled by the PAPR wearer. In CFD simulations, the outward release of the exhaled particles, i.e., ratio of exhaled particle concentration outside the PAPR to that of inside the PAPR, was determined. This study also evaluated the effect of particle sizes, supplied air flow rates, and breathing work rates on outward leakage. This simulation study for the headform and loose-fitting PAPR system included the following four main steps: (1) preprocessing (establishing a geometrical model of a headform wearing a loose-fitting PAPR by capturing a 3D image), (2) defining a mathematical model for the headform and PAPR system, and (3) running a total 24 simulations with four particle sizes, three breathing workloads and two supplied-air flow rates (4×3×2=24) applied on the digital model of the headform and PAPR system, and (4) post-processing the simulation results to visually display the distribution of exhaled particles inside the PAPR and determine the particle concentration of outside the PAPR compared with the concentration inside. We assume that there was no ambient particle, and only exhaled particles existed. The results showed that the ratio of the exhaled particle concentration outside to inside the PAPR were influenced by exhaled particle sizes, breathing workloads, and supplied-air flow rates. We found that outward concentration leakage from PAPR wearers was approximately 9% with a particle size of 0.1 and 1 µm at the light breathing and 205 L/min supplied-air flow rates, which is similar to the respiratory physiology of a health care worker in operative settings, The range of the ratio of exhaled particle concentration leaking outside the PAPR to the exhaled particle concentration inside the PAPR is from 7.6% to 49. We found that supplied air flow rates and work rates have significant impact on outward leakage, the outward concentration leakage increased as particle size decreased, breathing workload increased, and supplied-air flow rate decreased. The results of our simulation study should help provide a foundation for future clinical studies.

Validation of Computational Fluid Dynamics Models for Evaluating Loose-Fitting Powered Air-Purifying Respirators.

Loose-fitting powered air-purifying respirators (PAPRs) are used in healthcare settings to reduce exposure to high-risk respiratory pathogens. Innovative computational fluid dynamics (CFD) models were developed for evaluating loose-fitting PAPR performance. However, the computational results of the CFD models have not been validated using actual experimental data. Experimental testing to evaluate particle facepiece leakage was performed in a test laboratory using two models of loose-fitting PAPRs. Each model was mounted on a static (non-moving) advanced headform placed in a sodium chloride (NaCl) aerosol test chamber. The headform performed cyclic breathing via connection to a breathing machine. High-efficiency particulate air (HEPA)-filtered air was supplied directly to the PAPR facepiece using laboratory compressed supplied-air regulated with a mass-flow controller. One model was evaluated with six supplied-air flowrates from 50-215 L/min (Lpm) and the other model with six flowrates from 50-205 Lpm. Three different workrates (minute volumes) were evaluated: low (25 Lpm), moderate 46 (Lpm), and high 88 (Lpm). Manikin penetration factor (mPF) was calculated as the ratio of chamber particle concentration to the in-facepiece concentration. Overall, data analyses indicated that the mPF results from the simulations were well correlated with the experimental laboratory data for all data combined (r = 0.88). For data at the three different workrates (high, moderate, low) for both models combined, the r-values were 0.96, 0.97, and 0.77, respectively. The CFD models of the two PAPR models were validated and may be utilized for further research.

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.

Performance Comparison of Field Portable Instruments to the Scanning Mobility Particle Sizer Using Monodispersed and Polydispersed Sodium Chloride Aerosols.

This study compared the performance of the following field portable aerosol instrument sets to performance of the reference Scanning Mobility Particle Sizer (SMPS): the handheld CPC-3007, the portable aerosol mobility spectrometer (PAMS), the NanoScan scanning mobility particle sizer (NanoScan SMPS) combined with an optical particle sizer (OPS). Tests were conducted with monodispersed and polydispersed aerosols. Monodispersed aerosols were controlled at the approximate concentration of 1 × 105 particles cm-3 and four monodispersed particle sizes of 30, 60, 100, and 300 nm were selected and classified for the monodispersed aerosol test, while three different steady-state concentration levels (low, medium, and high: ~8 × 103, 5 × 104, and 1 × 105 particles cm-3, respectively) were selected for the polydispersed aerosol test. For all four monodispersed aerosol sizes, particle concentrations measured with the NanoScan SMPS were within 13% of those measured with the reference SMPS. Particle concentrations measured with the PAMS were within 25% of those measured with the reference SMPS. Concentrations measured with the handheld condensation particle counter were within 30% of those measured with the reference SMPS. For the polydispersed aerosols, the particle sizes and concentrations measured with the NanoScan-OPS compared most favorably with those measured with the reference SMPS for three different concentration levels of low, medium, and high (concentration deviations ≤10% for all three concentration levels; deviations of particle size ≤4%). Although the particle-size comparability between the PAMS and the reference SMPS was quite reasonable with the deviations within 10%, the polydispersed particle concentrations measured with the PAMS were within 36% of those measured with the reference SMPS. The results of this evaluation will be useful for selecting a suitable portable device for our next workplace study phase of respiratory protection assessment. This study also provided the advantages and limitations of each individual portable instrument and therefore results from this study can be used by industrial hygienists and safety professionals, with appropriate caution, when selecting a suitable portable instrument for aerosol particle measurement in nanotechnology workplaces.

Assessment of Two Personal Breathing Recording Devices in a Simulated Healthcare Environment.

BACKGROUND: In the field of respiratory protection for healthcare workers (HCWs), few data are available on respiratory airflow rate when HCWs are performing their work activities. The objective of this study was to assess the performance of two wearable breathing recording devices in a simulated healthcare environment. METHODS: Breathing recording devices from two different manufactures "A" and "B" were assessed using 15 subjects while performing a series of simulated healthcare work activities (patient assessment; vitals; IV treatment; changing linen; carrying weight while walking; normal breathing while standing). The minute volume (MV, L/min), mean inhalation flow (MIF, L/min), peak inhalation flow (PIF, L/min), breathing frequency (f, breaths/min), and tidal volume (TV, L/min) measured by each device were analyzed. Bland-Altman method was applied to explore the variability of devices A and B. Duncan's multiple range test was used to investigate the differences among activity-specific inspiratory flow rates. RESULTS: The average MV, MIF and PIF reported by device A were 23, 54, and 82 L/min with 95% upper confidence intervals (CIs) of 25, 60 and 92 L/min; the mean differences of MV, MIF and PIF presented by the two units of device A were 0.9, 1.3, and 2.8 L/min, respectively. The average values and mean differences of MV, MIF and PIF found with device B were significantly higher than device A (P<0.05), showing a high variability. During non-speech activities, the PIF/MV and MIF/MV ratios were >3.14 and >2, while with speech, the ratios increased to >6 and >3. The f during speech (15 breaths/min) was significantly lower than non-speech activities (20-25 breaths/min). Among different simulated work activities, the PIF of "patient assessment" was the highest. CONCLUSIONS: This study demonstrated a novel approach to characterize respiratory flow for healthcare workers using an innovative wearable flow recording device. Data from this investigation could be useful in the development of future respirator test standards.

Recommended test methods and pass/fail criteria for a respirator fit capability test of half-mask air-purifying respirators.

This study assessed key test parameters and pass/fail criteria options for developing a respirator fit capability (RFC) test for half-mask air-purifying particulate respirators. Using a 25-subject test panel, benchmark RFC data were collected for 101 National Institute for Occupational Safety and Health-certified respirator models. These models were further grouped into 61 one-, two-, or three-size families. Fit testing was done using a PortaCount® Plus with N95-Companion accessory and an Occupational Safety and Health Administration-accepted quantitative fit test protocol. Three repeated tests (donnings) per subject/respirator model combination were performed. The panel passing rate (PPR) (number or percentage of the 25-subject panel achieving acceptable fit) was determined for each model using five different alternative criteria for determining acceptable fit. When the 101 models are evaluated individually (i.e., not grouped by families), the percentages of models capable of fitting >75% (19/25 subjects) of the panel were 29% and 32% for subjects achieving a fit factor ≥100 for at least one of the first two donnings and at least one of three donnings, respectively. When the models are evaluated grouped into families and using >75% of panel subjects achieving a fit factor ≥100 for at least one of two donnings as the PPR pass/fail criterion, 48% of all models can pass. When >50% (13/25 subjects) of panel subjects was the PPR criterion, the percentage of passing models increased to 70%. Testing respirators grouped into families and evaluating the first two donnings for each of two respirator sizes provided the best balance between meeting end user expectations and creating a performance bar for manufacturers. Specifying the test criterion for a subject obtaining acceptable fit as achieving a fit factor ≥100 on at least one out of the two donnings is reasonable because a majority of existing respirator families can achieve an PPR of >50% using this criterion. The different test criteria can be considered by standards development organizations when developing standards.

Project BREATHE - Prototype Respirator Evaluation Utilizing Newly Proposed Respirator Test Criteria.

Machine and human subject testing of four prototype filtering facepiece respirators (FFR) and two commercial FFR was carried out utilizing recently proposed respirator test criteria that address healthcare worker-identified comfort and tolerance issues. Overall, two FFR (one prototype, one commercial model) were able to pass all eight criteria and three FFR (two prototypes, one commercial model) were able to pass seven of eight criteria. One prototype FFR was not tested against the criteria due to an inability to obtain satisfactory results on human subject quantitative respirator fit testing. Future studies, testing different models and styles of FFR against the proposed criteria, will be required to gauge the overall utility and effectiveness of the criteria in determining FFR comfort and tolerance issues that may impact user compliance and, by extension, protection.

Development of a Manikin-Based Performance Evaluation Method for Loose-Fitting Powered Air-Purifying Respirators.

OBJECTIVE: Loose-fitting powered air-purifying respirators (PAPRs) are increasingly being used in healthcare. NIOSH has previously used advanced manikin headforms to develop methods to evaluate filtering facepiece respirator fit; research has now begun to develop methods to evaluate PAPR performance using headforms. This preliminary study investigated the performance of PAPRs at different work rates to support development of a manikin-based test method. METHODS: Manikin penetration factors (mPF) of three models of loose-fitting PAPRs were measured at four different work rates (REST: 11 Lpm, LOW: 25 Lpm, MODERATE: 48 Lpm, and HIGH: 88 Lpm) using a medium-sized NIOSH static advanced headform mounted onto a torso. In-mask differential pressure was monitored throughout each test. Two condensation particle counters were used to measure the sodium chloride aerosol concentrations in the test chamber and also inside the PAPR facepiece over a 2-minute sample period. Two test system configurations were evaluated for returning air to the headform in the exhalation cycle (filtered and unfiltered). Geometric mean (GM) and 5th percentile mPFs for each model/work rate combination were computed. Analysis of variance tests were used to assess the variables affecting mPF. RESULTS: PAPR model, work rate, and test configuration significantly affected PAPR performance. PAPR airflow rates for the three models were approximately 185, 210, and 235 Lpm. All models achieved GM mPFs and 5th percentile mPFs greater than their designated Occupational Safety and Health Administration assigned protection factors despite negative minimum pressures observed for some work rate/model combinations. CONCLUSIONS: PAPR model, work rate, and test configuration affect PAPR performance. Advanced headforms have potential for assessing PAPR performance once test methods can be matured. A manikin-based inward leakage test method for PAPRs can be further developed using the knowledge gained from this study. Future studies should vary PAPR airflow rate to better understand the effects on performance. Additional future research is needed to evaluate the correlation of PAPR performance using advanced headforms to the performance measured with human subjects.