Reducing respirator fit test errors: a multi-donning approach.

As a continuation of recent studies to assess the accuracy of existing fit test methods, a multi-donning approach to fit testing is presented. As an example of that approach, a multi-donning quantitative fit test for filtering-facepiece respirators is presented and analyzed by comparing its error rates with those of the single-donning approach of current fit test methods. That analysis indicates the multi-donning fit test has the potential to reduce both the alpha error and the beta error to half that of single-donning fit tests. The alpha error is the error of failing a respirator that should pass; the beta error is the error of passing a respirator that should fail. Lowering fit test error rates for filtering-facepiece respirators is important because fit testing is an essential means of helping assure that an individual has selected an adequately fitting respirator. To reduce the alpha and beta error inherent in current fit test methods, the proposed fit test for filtering-facepiece respirators incorporates five donnings of the facepiece, unlike the single donning of existing fit test methods. The analysis presented here indicates that the multiple-donning approach reduces the element of chance in the fit test result and thereby increases the consistency and accuracy of the fit tests. The time to conduct the multi-donning test can approximate the time for current, single-donning tests by shortening the time the respirator is worn after each donning to about 10 sec. And, unlike current fit tests for filtering-facepieces that measure only faceseal leakage, the example multiple-donning fit test considered here is based on a measurement of total leakage (faceseal plus filter). Utilizing total respirator leakage can result in simpler quantitative fit test instrumentation and a fit test that is more relevant to the workplace. Further trials with human subjects are recommended in order to validate the proposed multi-donning approach.

Respiratory protection as a function of respirator fitting characteristics and fit-test accuracy.

The fitting characteristics of particulate respirators are no longer assessed in the National Institute for Occupational Safety and Health respirator certification program. It is important for respirator program administrators to understand the implications of that change and the additional burden it may impose. To address that issue, a typical respirator fit-testing program is analyzed using a mathematical model that describes the effectiveness of a fit-testing program as a function of the fitting characteristics of the respirator and the accuracy of the fittesting method. The model is used to estimate (1) the respirator assignment error, the percentage of respirator wearers mistakenly assigned an ill-fitting respirator; (2) the number of fit-test trials necessary to qualify a group of workers for respirator use; and (3) the number of workers who will fail the fit-test with any candidate respirator model and thereby fail to qualify for respirator use. Using data from previous studies, the model predicts respirator assignment errors ranging from 0 to 20%, depending on the fitting characteristics of the respirator models selected and the fit-testing method used. This analysis indicates that when respirators do not necessarily have good fitting characteristics, respirator program administrators should exercise increased care in the selection of respirator models and increased care in fit-testing. Also presented are ways to assess the fitting characteristics of candidate respirator models by monitoring the first-time fit-testing results. The model demonstrates that significant public health and economic benefits can result when only respirators having good fitting characteristics are purchased and respirators are assigned to workers using highly accurate fit-testing methods.

Simulated workplace performance of N95 respirators.

During July 1995 the National Institute for Occupational Safety and Health (NIOSH) began to certify nine new classes of particulate respirators. To determine the level of performance of these respirators, NIOSH researchers conducted a study to (1) measure the simulated workplace performance of 21 N95 respirator models, (2) determine whether fit-testing affected the performance, and (3) investigate the effect of varying fit-test pass/fail criteria on respirator performance. The performance of each respirator model was measured by conducting 100 total penetration tests. The performance of each respirator model was then estimated by determining the 95th percentile of the total penetration through the respirator (i.e., 95% of wearers of that respirator can expect to have a total penetration value below the 95th percentile penetration value). The 95th percentile of total penetrations for each respirator without fit-testing ranged from 6 to 88%. The 95th percentile of total penetrations for all the respirators combined was 33%, which exceeds the amount of total penetration (10%) normally expected of a half-mask respirator. When a surrogate fit test (1% criterion) was applied to the data, the 95th percentile of total penetrations for each respirator decreased to 1 to 16%. The 95th percentile of total penetrations for all the respirators combined was only 4%. Therefore, fit-testing of N95 respirators is necessary to ensure that the user receives the expected level of protection. The study also found that respirator performance was dependent on the value of the pass/fail criterion used in the surrogate fit-test.

Comparison of six respirator fit-test methods with an actual measurement of exposure in a simulated health care environment: Part III--Validation.

This article, the last in a series of three, describes the validation phase of a study conducted to test the correlation of respirator fit factors to the subject's actual exposure using biological sampling. The study consisted of three phases: protocol development, method comparison testing, and validation. Six quantitative fit-test methods were evaluated in the method comparison testing phase. The two fit methods with the highest correlation with the wearers' measured exposure were a corn oil method (R2 = 0.81) and an ambient aerosol method (R2 = 0.78). Because the ambient aerosol method is more commonly used in the workplace, it was selected for further analysis. In this validation phase, the fit factors measured during the ambient aerosol fit-test were used to calculate the exposures to Freon-113 by using the model determined in the method comparison testing phase of the study. The actual Freon-113 exposures were then measured and compared with the predicted exposures. The results verified that the ambient aerosol method fit factors are highly correlated to the total Freon-113 exposure dose and thus that the model had a predictive ability.

Comparison of six respirator fit-test methods with an actual measurement of exposure in a simulated health care environment: Part I--Protocol development.

Quantitative fit tests (QNFT) have been assumed to be predictive of the protection respirators would provide to a wearer in the workplace. Workplace studies have consistently found no correlation between quantitative fit factors and workplace protection factors. This article is the first in a series of three describing a study designed to compare the fit factors from six QNFT methods against the actual dose of 1,1,2 trichloro-1,2,2 trifluoroethane (Freon-113) received under the same laboratory conditions. Five preliminary studies conducted to develop the protocol to assess the respirator wearer's dose through end-exhaled air analysis are described in this article: (1) chamber characterization, (2) end-exhaled air sampling, (3) skin absorption testing, (4) pharmacokinetic modeling, and (5) subject characterization. It was established that the concentration of corn oil aerosol and Freon-113 could be generated simultaneously in the chamber. It was ascertained that the optimum time to sample the exhaled breath was 30 minutes after the subject exited the chamber. It was also found that in a chamber concentration of 500 ppm, without any respiratory exposure, Freon-113 was still present in the end-exhaled air. This was attributed to skin absorption. The end-exhaled air of subjects exposed to 0.5, 3, 5, 25, 50, and 100 ppm (30 minute time-weighted average) of Freon-113 was evaluated at 30 minutes postexposure. This characterization was then used to predict the actual dose of Freon-113 received during the method comparison and validation testing to be described in subsequent articles.

Comparison of six respirator fit-test methods with an actual measurement of exposure in a simulated health care environment: Part II--Method comparison testing.

This article, the second in a series of three, describes the method comparison testing portion of a study conducted to compare the fit factors from six quantitative fit-tests (QNFT) with a measure of a respirator wearer's actual exposure assessed by end-exhaled air analysis for 1,1,2-trichloro-1,2,2-trifluoroethane (Freon-113) under the same conditions. The six QNFT methods were (1) continuous low flow, flush probe; (2) continuous high flow, deep probe (CHD); (3) exhalation valve discharge (EVD); (4) controlled negative pressure; (5) 10-minute Ambient Aerosol 1 (AA1); and (6) 30-minute Ambient Aerosol 2. The first three methods utilized corn oil and a forward light scattering photometer. The last two methods used the TSI Portacount. Respirators used in the study were both disposable and elastomeric organic vapor/high efficiency half-masks. The characterization equations from the preliminary research (described previously) were used to determine the actual exposure to Freon-113 during the method comparison testing. The fit factors resulting from the QNFT methods were then individually correlated with the Freon-113 exposures using the coefficient of determination, R2. The lowest R2 value, 0.20, was found with the EVD method. The highest R2 values, 0.81 and 0.78, were associated, respectively, with the CHD and AA1 methods. This study suggests that some QNFT methods may be used to estimate actual respirator performance under laboratory conditions.

Performance of N95 respirators: filtration efficiency for airborne microbial and inert particles.

In 1995 the National Institute for Occupational Safety and Health issued new regulations for nonpowered particulate respirators (42 CFR Part 84). A new filter certification system also was created. Among the new particulate respirators that have entered the market, the N95 respirator is the most commonly used in industrial and health care environments. The filtration efficiencies of unloaded N95 particulate respirators have been compared with those of dust/mist (DM) and dust/fume/mist (DFM) respirators certified under the former regulations (30 CFR Part 11). Through laboratory tests with NaCl certification aerosols and measurements with particle-size spectrometers, N95 respirators were found to have higher filtration efficiencies than DM and DFM respirators and noncertified surgical masks. N95 respirators made by different companies were found to have different filtration efficiencies for the most penetrating particle size (0.1 to 0.3 micron), but all were at least 95% efficient at that size for NaCl particles. Above the most penetrating particle size the filtration efficiency increases with size; it reaches approximately 99.5% or higher at about 0.75 micron. Tests with bacteria of size and shape similar to Mycobacterium tuberculosis also showed filtration efficiencies of 99.5% or higher. Experimental data were used to calculate the aerosol mass concentrations inside the respirator when worn in representative work environments. The penetrated mass fractions, in the absence of face leakage, ranged from 0.02% for large particle distributions to 1.8% for submicrometer-size welding fumes. Thus, N95 respirators provide excellent protection against airborne particles when there is a good face seal.

The role of respiratory protective devices in the control of tuberculosis.

In this comprehensive review, the authors describe various types of respirators and the major issues in their application to TB control, including the degree of protection they offer and cost. Recent recommendations regarding the use of respiratory protective devices also are discussed.