Comparison of performance of three different types of respiratory protection devices

Respiratory protection is offered to American workers in a variety of ways to guard against potential inhalation hazards. Two of the most common ways are elastomeric N95 respirators and N95 filtering-facepiece respirators. Some in the health care industry feel that surgical masks provide an acceptable level of protection in certain situations against particular hazards. This study compared the performance of these types of respiratory protection during a simulated workplace test that measured both filter penetration and face-seal leakage. A panel of 25 test subjects with varying face sizes tested 15 models of elastomeric N95 respirators, 15 models of N95 filtering-facepiece respirators, and 6 models of surgical masks. Simulated workplace testing was conducted using a TSI PORTACOUNT Plus model 8020, and consisted of a series of seven exercises. Six simulated workplace tests were performed with redonning of the respirator/mask occurring between each test. The results of these tests produced a simulated workplace protection factor (SWPF). The geometric mean (GM) and the 5th percentile values of the SWPFs were computed by category of respiratory protection using the six overall SWPF values. The level of protection provided by each of the three respiratory protection types was compared. The GM and 5th percentile SWPF values without fit testing were used for the comparison, as surgical masks were not intended to be fit tested. The GM values were 36 for elastomeric N95 respirators, 21 for N95 filtering-facepiece respirators, and 3 for surgical masks. An analysis of variance demonstrated a statistically significant difference between all three. Elastomeric N95 respirators had the highest 5th percentile SWPF of 7. N95 filtering-facepiece respirators and surgical masks had 5th percentile SWPFs of 3 and 1, respectively. A Fisher Exact Test revealed that the 5th percentile SWPFs for all three types of respiratory protection were statistically different. In addition, both qualitative (Bitrex and saccharin) and quantitative (N95-Companion) fit testing were performed on the N95 filtering- and elastomeric-facepiece respirators. It was found that passing a fit test generally improves the protection afforded the wearer. Passing the Bitrex fit test resulted in 5th percentile SWPFs of 11.1 and 7.9 for elastomeric and filtering-facepiece respirators, respectively. After passing the saccharin tests, the elastomeric respirators provided a 5th percentile of 11.7, and the filtering-facepiece respirators provided a 5th percentile of 11.0. The 5th percentiles after passing the N95-Companion were 13.0 for the elastomeric respirators and 20.5 for the filtering-facepiece respirators. The data supports fit testing as an essential element of a complete respiratory protection program.     

The effect of subject characteristics and respirator features on respirator fit

A recent study was conducted to compare five fit test methods for screening out poor-fitting N95 filtering-facepiece respirators. Eighteen models of NIOSH-certified, N95 filtering-facepiece respirators were used to assess the fit test methods by using a simulated workplace protection factor (SWPF) test. The purpose of this companion study was to investigate the effect of subject characteristics (gender and face dimensions) and respirator features on respirator fit. The respirator features studied were design style (folding and cup style) and number of sizes available (one size fits all, two sizes, and three sizes). Thirty-three subjects participated in this study. Each was measured for 12 face dimensions using traditional calipers and tape. From this group, 25 subjects with face size categories 1 to 10 tested each respirator. The SWPF test protocol entailed using the PortaCount Plus to determine a SWPF based on total penetration (face-seal leakage plus filter penetration) while the subject performed six simulated workplace movements. Six tests were conducted for each subject/respirator model combination with redonning between tests. The respirator design style (folding style and cup style) did not have a significant effect on respirator fit in this study. The number of respirator sizes available for a model had significant impact on respirator fit on the panel for cup-style respirators with one and two sizes available. There was no significant difference in the geometric mean fit factor between male and female subjects for 16 of the 18 respirator models. Subsets of one to six face dimensions were found to be significantly correlated with SWPFs (p < 0.05) in 16 of the 33 respirator model/respirator size combinations. Bigonial breadth, face width, face length, and nose protrusion appeared the most in subsets (five or six) of face dimensions and their multiple linear regression coefficients were significantly different from zero (p < 0.05). Lip length was found in only one subset. The use of face length and lip length as the criteria to define the current half-facepiece respirator fit test panel may need to be reconsidered when revising the panel. Based on the findings from this and previous studies, face length and face width are recommended measurements that should be used for defining the panel for half-facepiece respirators.     

Real-Time Fit of a Respirator during Simulated Health Care Tasks

Fit is an important but difficult-to-predict feature of respirator performance. This study examined a new approach to measuring respirator performance using two continuous direct-reading particle-counting instruments in a simulated health care workplace. A pilot test was conducted with eight experienced health care professionals who passed a traditional quantitative fit test before performing three randomized 10-min health care scenarios (patient assessment [PA], IV treatment [IV], and wound care [WC]). Two TSI Portacount Plus (Model 8020) with N95 Companion (Model 8095) instruments were used to continuously measure 1-sec ambient particle concentrations inside and outside the respirator facepiece. A simulated workplace protection factor (SWPF) was calculated by dividing outside by inside concentrations. Data were log transformed and examined using analysis of variance (ANOVA) between subjects, scenario types, and scenario order. The GM SWPF for the eight subjects, three scenarios per subject, ranged from 172 to 1073 (GSD 1.7 to 3.5) and was significantly different for each subject. A multi-way analysis of variance showed no difference between the three scenario types (PA, IV, WC). There were differences by the order in which scenarios were performed: the third scenario SWPF was significantly different and higher than that of the first and second scenarios. All subjects passed the initial quantitative fit test with a fit factor of at least 100. Five subjects had fit factors greater than 200 and GM scenario SWPFs greater than 400. Three participants with initial fit factors less than 200 had GM scenario SWPFs ranging from 132 to 326. This pilot test demonstrates that it is possible to evaluate instantaneous respirator fit using two quantitative fit test instruments in a simulated health care environment. Results suggest that an initial fit test may be predictive of fit during simulated tasks and that one scenario may be adequate for measuring a simulated workplace protection factor. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: a video for subject D activities overlaid with simulated workplace protection factor data.].     

Simulated workplace protection factors for half-facepiece respiratory protective devices

This study investigates two different methods (random effects model and 5th percentile) for determining the performance of three types of respiratory protective devices (elastomeric N95 respirators, N95 filtering-facepiece respirators, and surgical masks) during a simulated workplace test. This study recalculated the protection level of three types of respiratory protective devices using the random effects model, compared the two methods with each other and the APF of 10 for half-facepiece respirators, and determined the value of each of the fit test protocols in attaining the desired level of simulated workplace protection factor (SWPF). Twenty-five test subjects with varying face sizes tested 15 models of elastomeric N95 respirators, 15 models of N95 filtering-facepiece respirators, and 6 models of surgical masks. Simulated workplace testing was conducted using a TSI PORTACOUNT Plus model 8020 and consisted of a series of seven exercises. Six simulated workplace tests were performed with redonning of the respirator/mask occurring between each test. Each of the six tests produced an SWPF. To determine the level of protection provided by the respiratory protective devices, a 90% lower confidence limit for the simulated workplace protection factor (SWPF(LCL90%)) and the 5th percentile of simulated workplace protection factor were computed. The 5th percentile method values could be up to seven times higher than the SWPF(LCL90%) values. Without fit testing, all half-facepiece N95 respirators had a 5th percentile of 4.6 and an SWPF(LCL90%) value of 2.7. N95 filtering-facepiece respirators as a class had values of 3.3 and 2.0, respectively, whereas N95 elastomeric respirators had values of 7.3 and 4.6, respectively. Surgical masks did not provide any protection, with values of 1.2 and 1.4, respectively. Passing either the Bitrex, saccharin, or Companion fit test resulted in the respirators providing the expected level of protection with 5th percentiles greater than or equal to 10 except when passing the Bitrex test with N95 filtering-facepiece respirators, which resulted in a 5th percentile of only 7.9. No substantial difference was seen between the three fit tests. All of the SWPF(LCL90%) values after passing a fit test were less than 10. The random model method provides a more conservative estimate of the protection provided by a respirator because it takes into account both between- and within-wearer variability.     

Fitting characteristics of eighteen N95 filtering-facepiece respirators

Four performance measures were used to evaluate the fitting characteristics of 18 models of N95 filtering-facepiece respirators: (1) the 5th percentile simulated workplace protection factor (SWPF) value, (2) the shift average SWPF value, (3) the h-value, and (4) the assignment error. The effect of fit-testing on the level of protection provided by the respirators was also evaluated. The respirators were tested on a panel of 25 subjects with various face sizes. Simulated workplace protection factor values, determined from six total penetration (face-seal leakage plus filter penetration) tests with re-donning between each test, were used to indicate respirator performance. Five fit-tests were used: Bitrex, saccharin, generated aerosol corrected for filter penetration, PortaCount Plus corrected for filter penetration, and the PortaCount Plus with the N95-Companion accessory. Without fit-testing, the 5th percentile SWPF for all models combined was 2.9 with individual model values ranging from 1.3 to 48.0. Passing a fit-test generally resulted in an increase in protection. In addition, the h-value of each respirator was computed. The h-value has been determined to be the population fraction of individuals who will obtain an adequate level of protection (i.e., SWPF >/=10, which is the expected level of protection for half-facepiece respirators) when a respirator is selected and donned (including a user seal check) in accordance with the manufacturer's instructions without fit-testing. The h-value for all models combined was 0.74 (i.e., 74% of all donnings resulted in an adequate level of protection), with individual model h-values ranging from 0.31 to 0.99. Only three models had h-values above 0.95. Higher SWPF values were achieved by excluding SWPF values determined for test subject/respirator combinations that failed a fit-test. The improvement was greatest for respirator models with lower h-values. Using the concepts of shift average and assignment error to measure respirator performance yielded similar results. The highest level of protection was provided by passing a fit-test with a respirator having good fitting characteristics.     

Sensitivity and specificity of the user-seal-check in determining the fit of N95 respirators

N95 respirators are recommended by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) to prevent the inhalation of droplets which may transmit respiratory pathogens. The reliability of N95 respirators in preventing transmission depends on their fit to the wearer. Quantitative fit testing (QNFT) is the gold standard used to determine this fit objectively. The manufacturers of the respirators also recommend performing a self-reported user-seal-check to detect for leakage. This study aims to investigate the capability of the user-seal-check in determining the fit of N95 respirators by investigating the sensitivity and specificity of the user-seal-check compared with QNFT. A prospective and cross-sectional research design was used. A total of 204 local Chinese undergraduate nursing students were recruited to test two commonly used respirator models (3M 1860S and 3M 1862). The results of the user-seal-check were compared with the results of the gold standard QNFT using the Condensation Nucleus Counter Fit Tester System. The sensitivity and specificity of the user-seal-check results obtained with the respirators were calculated. The results indicated low sensitivity, accuracy and predictive value of the user-seal-check in determining the fit of the N95 respirators. The user-seal-check was not found to be reliable as a substitute for QNFT. The results also suggested that the user-seal-check may be unreliable for detecting gross leakage. We recommend that QNFT is used to determine the fit of N95 respirators.     

医务人员佩戴1860型微粒防护N95口罩的适合性及不适主观症状分析

目的检验N95防护口罩与中国医务人员面部的适合性及佩戴后的不适表现,为医务人员佩戴口罩提供科学依据。方法采用定性的方式检验3M公司提供的1860型微粒防护N95口罩中的杯罩式和折叠式VI罩对医务人员的适合程度。随访观察1个月,记录医务人员佩戴口罩出现的不适症状。结果共纳入研究对象1283人,其中198人仅参与了杯罩式口罩的适合性检测,826人仅参与了折叠式口罩的适合性检测,259人参与了上述两种口罩的适合性检测。杯罩式与折叠式口罩的适合性检测通过率分别为100％和98．9％。未通过折叠式口罩适合性检测的12名研究对象中有11名因脸形不合适,1名因感觉憋气不能完成检验。佩戴口罩的不适症状主要包括压迫面部（22．5％）、憋气（19．9％）和过敏（11．7％）。结论1860型微粒防护N95口罩适合大多数中国人脸形,普通医务人员在佩戴该型口罩前可以不进行适合性检验,但从事高危操作的医务人员必须进行适合性检验;长时间佩戴该型口罩可能引起较多的不适症状。     

Comparison of qualitative and quantitative fit-testing results for three commonly used respirators in the healthcare sector

N95 filtering facepiece respirators are used by healthcare workers when there is a risk of exposure to airborne hazards during aerosol-generating procedures. Respirator fit-testing is required prior to use to ensure that the selected respirator provides an adequate face seal. Two common fit-test methods can be employed: qualitative fit-test (QLFT) or quantitative fit-test (QNFT). Respiratory protection standards deem both fit-tests to be acceptable. However, previous studies have indicated that fit-test results may differ between QLFT and QNFT and that the outcomes may also be influenced by the type of respirator model. The aim of this study was to determine if there is a difference in fit-test outcomes with our suite of respirators, 3M - 1860S, 1860, AND 1870, and whether the model impacts the fit-test results.

Subjects were recruited from residential care facilities. Each participant was assigned a respirator and underwent sequential QLFT and QNFT fit-tests and the results (either pass or fail) were recorded. To ascertain the degree of agreement between the two fit-tests, a Kappa (Κ) statistic was conducted as per the American National Standards Institute (ANSI) respiratory protection standard. The pass-fail rates were stratified by respirator model and a Kappa statistic was calculated for each to determine effect of model on fit-test outcomes.

We had 619 participants and the aggregate Κ statistic for all respirators was 0.63 which is below the suggested ANSI threshold of 0.70. There was no statistically significant difference in results when stratified by respirator model.

QNFT and QLFT produced different fit-test outcomes for the three respirator models examined. The disagreement in outcomes between the two fit-test methods with our suite of N95 filtering facepiece respirators was approximately 12%. Our findings may benefit other healthcare organizations that use these three respirators.     

Evaluation of the benefit of the user seal check on N95 filtering facepiece respirator fit

The objective of this study was to better understand the benefit of the user seal check step for respirator test subjects in the N95 filtering facepiece respirator donning process. To qualify for the study, subjects were required to pass a standard quantitative fit test on at least one of the three N95 filtering facepiece respirator models: 3M 1860 (cup), 3M 1870 (flat-fold), and Kimberly Clark PFR95-270 (duckbill). Eleven subjects were enrolled and performed a series of abbreviated, quantitative fit tests where they were randomly asked either to perform or not perform a user seal check with 20 different respirator samples of each model. The experimental design included 3 respirator models × 10 subjects × 2 treatment levels with 10 replications. Geometric mean (GM) fit factors and percentages of times a fit factor ≥ 100 was achieved for a donning were compared for each subject with and without the user seal check across all models and for each model. Higher GM fit factors and smaller geometric standard deviations across all models were achieved for 10 of the 11 subjects when performing a user seal check compared with not performing a user seal check. Geometric mean fit factors of 148, 184, and 156, compared with 126, 187, and 115, respectively, were obtained for the 3M 1860, 3M 1870, and Kimberly Clark PFR95-270 models when the user seal check was performed vs. not performed. Differences in the GM fit factors for the 3M 1860 and Kimberly Clark PFR95-270 models were statistically significant (p < 0.05) when performing a user seal check vs. not performing a user seal check. These data suggest that there may be some benefit to performing the user seal check for at least some models during the filtering facepiece respirator donning process for workers who have previously passed a fit test for those respirator models. Additional research is needed with larger groups of subjects and respirator models/types.     

Evaluation of a quantitative fit testing method for N95 filtering facepiece respirators

A method for performing quantitative fit tests (QNFT) with N95 filtering facepiece respirators was developed by earlier investigators. The method employs a simple clamping device to allow the penetration of submicron aerosols through N95 filter media to be measured. The measured value is subtracted from total penetration, with the assumption that the remaining penetration represents faceseal leakage. The developers have used the clamp to assess respirator performance. This study evaluated the clamp's ability to measure filter penetration and determine fit factors. In Phase 1, subjects were quantitatively fit-tested with elastomeric half-facepiece respirators using both generated and ambient aerosols. QNFT were done with each aerosol with both P100 and N95 filters without disturbing the facepiece. In Phase 2 of the study elastomeric half facepieces were sealed to subjects' faces to eliminate faceseal leakage. Ambient aerosol QNFT were performed with P100 and N95 filters without disturbing the facepiece. In both phases the clamp was used to measure N95 filter penetration, which was then subtracted from total penetration for the N95 QNFT. It was hypothesized that N95 fit factors corrected for filter penetration would equal the P100 fit factors. Mean corrected N95 fit factors were significantly different from the P100 fit factors in each phase of the study. In addition, there was essentially no correlation between corrected N95 fit factors and P100 fit factors. It was concluded that the clamp method should not be used to fit-test N95 filtering facepieces or otherwise assess respirator performance.     

Errors associated with three methods of assessing respirator fit

Three fit test methods (Bitrex, saccharin, and TSI PortaCount Plus with the N95-Companion) were evaluated for their ability to identify wearers of respirators that do not provide adequate protection during a simulated workplace test. Thirty models of NIOSH-certified N95 half-facepiece respirators (15 filtering-facepiece models and 15 elastomeric models) were tested by a panel of 25 subjects using each of the three fit testing methods. Fit testing results were compared to 5th percentiles of simulated workplace protection factors. Alpha errors (the chance of failing a fit test in error) for all 30 respirators were 71% for the Bitrex method, 68% for the saccharin method, and 40% for the Companion method. Beta errors (the chance of passing a fit test in error) for all 30 respirator models combined were 8% for the Bitrex method, 8% for the saccharin method, and 9% for the Companion method. The three fit test methods had different error rates when assessed with filtering facepieces and when assessed with elastomeric respirators. For example, beta errors for the three fit test methods assessed with the 15 filtering facepiece respirators were < or = 5% but ranged from 14% to 21% when assessed with the 15 elastomeric respirators. To predict what happens in a realistic fit testing program, the data were also used to estimate the alpha and beta errors for a simulated respiratory protection program in which a wearer is given up to three trials with one respirator model to pass a fit test before moving onto another model. A subject passing with any of the three methods was considered to have passed the fit test program. The alpha and beta errors for the fit testing in this simulated respiratory protection program were 29% and 19%, respectively. Thus, it is estimated, under the conditions of the simulation, that roughly one in three respirator wearers receiving the expected reduction in exposure (with a particular model) will fail to pass (with that particular model), and that roughly one in five wearers receiving less reduction in exposure than expected will pass the fit testing program in error.     

Correlation of qualitative and quantitative results from testing respirator fit

Three qualitative respirator fit tests were evaluated for their ability to adequately measure respiratory protection. The evaluated methods were the negative pressure test, the isoamyl acetate test, and the irritant smoke test. Each test was performed concurrently with a single quantitative fit test, the dioctylphthalate (DOP) test, during 274 half-mask and 274 full facepiece wearings. The quantitative values of DOP penetration obtained after passing or failing each qualitative fit test were lognormally distributed. For each qualitative test performed on each mask type, the average log penetration values obtained after passing and failing each test were statistically different from each other. The mean of the log penetration values associated with the failed qualitative test was always larger than the mean of the log penetration values associated with passed qualitative tests for all three qualitative methods. Most (95%) of the tested study had adequately fitting respirators as determined by quantitative testing. Of these subjects, 96% to 100% passed the qualitative fit tests. Of the 5% of the study subjects with inadequately fitting half mask respirators, 93% to 100% of the inadequate fits were detected by qualitative methods. Twenty three to 46% of the poorly fitting full face masks were detected by qualitative methods. The probability of passing or failing a qualitative test with an inadequately fitting respirator can be estimated; however, the uncertainty associated with each estimate is large due to the small number of study subjects with poorly fitting respirators.     

Respiratory protection against Mycobacterium tuberculosis: quantitative fit test outcomes for five type N95 filtering-facepiece respirators

In preparing to fit test a large workforce, a respirator program manager needs to initially choose respirators that will fit the greatest proportion of employees and achieve the best fits. This article discusses our strategy in selecting respirators from an initial array of seven NIOSH-certified Type N95 filtering-facepiece devices for a respiratory protection program against Mycobacterium tuberculosis (M. tb) aerosol. The seven respirators were screened based on manufacturer-provided fit test data, comfort, and cost. From these 7 devices, 5 were chosen for quantitative fit testing on 40 subjects who were a convenience sample from a cohort of approximately 30,000 workers scheduled to undergo fit testing. Across the five brands, medium/regular-size respirators fit from 8% to 95% of the subjects; providing another size of the same brand improved the pass rates slightly. Gender was not found to significantly affect fit test pass rates for any respirator brand. Among test panel members, an Aearo Corporation respirator (TC 84A-2630) and a 3M Company respirator (TC 84A-0006) provided the highest overall pass rates of 98% and 90%, respectively. We selected these two brands for fit testing in the larger worker cohort. To date, these two respirators have provided overall pass rates of 98% (1793/1830) and 88% (50/57), respectively, which are similar to the test panel results. Among 1850 individuals who have been fit tested, 1843 (99.6%) have been successfully fitted with one or the other brand. In a separate analysis, we used the test panel pass rates to estimate the reduction in M. tb infection risk afforded by the medium/regular-size of five filtering-facepiece respirators. We posed a low-exposure versus a high-exposure scenario for health care workers and assumed that respirators could be assigned without conducting fit testing, as proposed by many hospital infection control practitioners. Among those who would pass versus fail the fit test, we assumed an average respirator penetration (primarily due to faceseal leakage) of .04 and 0.3, respectively. The respirator with the highest overall pass rate (95%) reduced M. tb infection risk by 95%, while the respirator with the lowest pass rate (8%) reduced M. tb infection risk by only 70%. To promote the marketing of respirators that will successfully fit the highest proportion of wearers, and to increase protection for workers who might use respirators without the benefit of being fit tested, we recommend that fit testing be part of the NIOSH certification process for negative-pressure air-purifying respirators with tightly fitting facepieces. At a minimum, we recommend that respirator manufacturers generate and provide pass rate data to assist in selecting candidate respirators. In any event, program managers can initially select candidate respirators by comparing quantitative fit tests for a representative sample of their employee population.     

Performance of dust respirators with facial seal leaks: II. Predictive model

A performance model for half-mask and single-use respirators is presented. It represents a possible alternative to field measurements of respirator performance. Experimental data on filter and leak performance given in Part I were used to develop a model that allows one to predict 1) the overall respirator penetration as a function of particle size for any work rate and 2) overall total mass penetration for any work rate and exposure aerosol-size distribution for a known respirator filter and facial seal leak condition. A simplified method based on general regression equations is presented that allows one to estimate these quantities based on QNFT (quantitative fit testing) measurements and a knowledge of the exposure aerosol-size distribution. Example calculations are given for a situation in which QNFT gives a fit factor of 50 for a half-mask with dust, fume and mist filter cartridges, but predicted protection factors for various use conditions range from 20 to 81 depending on exposure particle-size distribution and work rate of the wearer.     

The effects of strapped spectacles on the fit factors of three manufactured brands of full facepiece negative pressure respirators.

A study was conducted to determine the effects of strapped spectacles on the fit factors obtained during quantitative fit testing on three different brands of full facepiece negative pressure respirators. The three brands of respirators were evaluated with and without strapped spectacles worn by the test subjects. A total of 180 quantitative fit testing trials were conducted on ten male test subjects. For each test subject, three quantitative fit testing trials were performed with each brand of respirator with and without the spectacles. The average of the fit testing trials for each subject with each respirator was used for statistical analysis. The results demonstrated that the fit factor values were significantly lower during use of the spectacles (p < 0.05). The estimated percentage of test subjects who failed the American National Standards Institute pass/fail criteria for quantitative fit testing (1000) increased by 15-36% when spectacles were worn.     

Effective factors on not using the N95 respirators among health care workers: Application of Fuzzy Delphi and Fuzzy Analytic Hierarchy Process (FAHP)

Using respiratory protective equipment (RPE) including N95 respirators is one of the most important ways to protect health care workers (HCWs) against respiratory hazards. The aim of this study was to identify and prioritize the problems and obstacles in using N95 respirators among HCWs in Iran. In this cross‐sectional study, problems and obstacles in using N95 respirators were identified and ranked by experts, using Fuzzy Delphi and Fuzzy Analytic Hierarchy Process (FAHP). Additionally, HCWs were asked to give their opinions about obstacles in using N95 respirators in order to form an opinion. Of 15 important obstacles in using N95 respirators identified by Fuzzy Delphi method, 6 factors were entered into the FAHP model: heat around the face, inaccessibility to respirator, difficulty breathing, pressure on the nose, trouble communicating with patients and colleagues, and no one does it. Identified problems and obstacles in using N95 respirators could be controlled during the selection of respirators, as well as by training and administrative measures.     

Correlation between respirator fit and respirator fit test panel cells by respirator size

The National Institute for Occupational Safety and Health (NIOSH), recognizing the difficulties inherent in using old military data to define modern industrial respirator fit test panels, recently completed a study to develop an anthropometric database of the measurements of heads and faces of civilian respirator users. Based on the data collected, NIOSH researchers developed two new panels for fit testing half-facepiece and full-facepiece respirators. One of the new panels (NIOSH bivariate panel) uses face length and face width. The other panel is based on principal component analysis (PCA) to identify the linear combination of facial dimensions that best explains facial variations. The objective of this study was to investigate the correlation between respirator fit and the new NIOSH respirator fit test panel cells for various respirator sizes. This study was carried out on 30 subjects that were selected in part using the new NIOSH bivariate panel. Fit tests were conducted on the test subjects using a PORTACOUNT device and three exercises. Each subject was tested with three replications of four models of P-100 half-facepiece respirators in three sizes. This study found that respirator size significantly influenced fit within a given panel cell. Face size categories also matched the respirator sizing reasonably well, in that the small, medium, and large face size categories achieved the highest geometric mean fit factors in the small, medium, and large respirator sizes, respectively. The same pattern holds for fit test passing rate. Therefore, a correlation was found between respirator fit and the new NIOSH bivariate fit test panel cells for various respirator sizes. Face sizes classified by the PCA panel also followed a similar pattern with respirator fit although not quite as consistently. For the LANL panel, however, both small and medium faces achieved best fit in small size respirators, and large faces achieved best fit in medium respirators. These findings support the selection of the facial dimensions for developing the new NIOSH bivariate respirator fit test panel.     

Effect of Upper Strap Downward Displacement on N95 Filtering Facepiece Respirator Fit Factors: A Pilot Study

Fifteen subjects underwent three replicates of quantitative respirator fit-testing with N95 filtering facepiece respirators that were donned with the upper strap high on the occiput, as per the manufacturers’ donning instructions. Each fit-test was immediately followed by repeat fit-testing with the upper strap downwardly displaced to the level of the ear sulcus to determine any change in fit factors that might occur with upper strap downward slippage. A total of 35/45 (78%) initial fit-tests had a passing score (fit factor ≥100) with the top strap high on the occiput and 33/35 (94%) of these passed subsequent fit-testing after the top strap was displaced downward to the ear sulcus. Geometric mean fit factors for the initial passed fit-tests, and following downward strap displacement, were 217±1.6 and 207±1.9, respectively (p = 0.64). Downward displacement of the top strap did not significantly impact fit factors of N95 FFRs that had previously passed fit-testing.     

Determination of known exhalation valve damage using a negative pressure user seal check method on full facepiece respirators

A negative pressure user seal check (NPUSC) method was evaluated for its ability to adequately detect known exhalation valve leakage into a respirator. Three valves with different types of damage were included. Twenty-six test subjects, wearing full facepiece respirators, were asked to perform a NPUSC. Their responses as to whether they passed or failed the user seal check were compared to fit testing results from two quantitative fit test methods: ambient aerosol and controlled negative pressure. In addition, equipment developed at the University of Cincinnati was used to measure in-mask pressures that are generated during the performance of NPUSCs. This technique was employed to assess the ability of respirator wearers to properly conduct user seal checks. The data were analyzed to determine if the user seal check procedure is an effective method for detecting known exhalation valve damage. All test subjects reported passing the user seal check with the undamaged valve. With the warped valve installed, 95 percent of test subjects reported passing the user seal check. With the slit valve installed, 73 percent of test subjects reported passing. With the dirty valve installed, 65 percent reported passing. All fit factors, measured with the damaged valves, were below the Occupational Safety and Health Administration-recognized pass/fail criteria except one fit test with the respirator equipped with the slit valve. Results from the in-mask pressure measurements confirmed whether or not the subject properly conducted a user seal check, but did not detect respirator leakage. In conclusion, the performance of a NPUSC rarely helped to identify damaged exhalation valves. These results support the need for respirator inspection prior to donning with periodic fit testing and the performance of user seal checks as necessary components of an adequate respiratory protection program.     

Respiratory protection from isocyanate exposure in the autobody repair and refinishing industry

This study, part of the Survey of Painters and Repairers of Auto bodies by Yale (SPRAY), evaluated the effectiveness of respiratory protection against exposure to aliphatic polyisocyanates. A total of 36 shops were assessed for respiratory protection program completeness; 142 workers were measured for respirator fit factor (FF) using PortaCount Plus respirator fit tester. Twenty-two painters from 21 shops were sampled using NIOSH method 5525 to determine the workplace protection factor (WPF) of negative pressure, air-purifying half-facepiece respirators equipped with organic vapor cartridges and paint prefilters during spray-painting and priming activities. Only 11 shops (30%) had written respiratory protection programs. Eighty percent of all fit tested workers passed the test on the first try with FF >or= 100, and 92% passed the second test after respirator use training. Overall geometric mean (GM) FF was 1012 for all fit tested workers. Significant differences on pass rate (92% vs. 72%) and on FF (1990 vs. 736) were found between previously fit tested workers vs. nontested workers. Twenty-nine WPF samples were collected. The outside facepiece GM concentration of total isocyanate group (NCO) was 378.4 micro g NCO/m(3) with 96% concentrations exceeding the U.K. short-term exposure limit, 70 micro g NCO/m(3), but no in-facepiece concentrations exceeded the limit. The GM WPF of total NCO was 319 (GSD 4) and the 5th percentile was 54. WPF of total NCO was positively correlated with the duration of painting task. FF positively correlated with WPF when FF was 450. We conclude that negative pressure, air-purifying half-facepiece respirators equipped with organic vapor cartridges and paint prefilters provide effective protection against isocyanate exposure in spray and priming operations if workers are properly trained and fitted.