Simulated Workplace Protection Factor Research Articles

Simulated workplace protection factor study of a quarter-facepiece elastomeric respirator

The assigned protection factor (APF) for quarter-facepiece respirators is currently 5, based on fit test data from the 1970s with models no longer commercially available. The goal of this project was to evaluate the respirator fit capability of a NIOSH-approved N95 quarter-facepiece elastomeric respirator with a gel-based facial seal design (Envo Mask by Sleepnet Corporation). Human subjects were recruited from healthcare and the general population to satisfy a 25-member NIOSH bivariate panel. Subjects were fit tested with a fast fit protocol using a TSI Portacount Model 8038 in the N95 mode. Second-by-second measures of fit were then collected while subjects performed a 30-min series of simulated healthcare activities. Subjects completed a short comfort questionnaire. The median (5th, 95th percentile) fit factor was 188 (48, 201). Simulated workplace protection factors (SWPFs) had a median (5th, 95th percentile) of 181 (94, 199) (data truncated at 200) and 570 (153, 1508) (non-truncated data). Subjects ranked inhalation and exhalation as “easy” with average scores of 5.0/6.0 and 5.2/6.0, respectively. The facepiece was ranked between slightly comfortable and comfortable (4.8/6.0) and the harness as comfortable (5.0/6.0). Most users agreed (5.2/6.0) that the mask was stable on their faces. The 5th percentile SWPF of 95 supports an APF of at least 10 for this quarter-facepiece elastomeric respirator, similar to the APF for half-facepiece respirators. This study supports increasing the APF for quarter-facepiece respirators, a class that has been largely ignored by manufacturers for the past 40 years. A lightweight, low profile, reusable quarter-facepiece respirator is an effective option for healthcare and other worker protection during a pandemic and similar situations.

HALO CleanSpace PAPR evaluation: Communication, respiratory protection, and usability.

To evaluate a relatively new half-face-piece powered air-purifying respirator (PAPR) device called the HALO (CleanSpace). We assessed its communication performance, its degree of respiratory protection, and its usability and comfort level. This simulation study was conducted at the simulation center of the Royal Melbourne Hospital. In total, 8 voluntary healthcare workers participated in the study: 4 women and 4 men comprising 3 nursing staff and 5 medical staff. We performed the modified rhyme test, outlined by the National Institute for Occupational Safety and Health (NIOSH), for the communication assessment. We conducted quantitative fit test and simulated workplace protection factor studies to assess the degree of respiratory protection for participants at rest, during, and immediately after performing chest compression. We also invited the participants to complete a usability and comfort survey. The HALO PAPR met the NIOSH minimum standard for speech intelligibility, which was significantly improved with the addition of wireless communication headsets. The HALO provided consistent and adequate level of respiratory protection at rest, during and after chest compression regardless of the device power mode. It was rated favorably for its usability and comfort. However, participants criticized doffing difficulty and perceived communication interference. The HALO device can be considered as an alternative to a filtering face-piece respirator. Thorough doffing training and mitigation planning to improve the device communication performance are recommended. Further research is required to examine its clinical outcomes and barriers that may potentially affect patient or healthcare worker safety.

The protective effect of tight-fitting powered air-purifying respirators during chest compressions.

Airborne personal protective equipment is required for healthcare workers when performing aerosol-generating procedures on patients with infectious diseases. Chest compressions, one of the main components of cardiopulmonary resuscitation, require intense and dynamic movements of the upper body. We aimed to investigate the protective effect of tight-fitting powered air-purifying respirators (PAPRs) during chest compressions. This single-center simulation study was performed from February 2021 to March 2021. The simulated workplace protection factor (SWPF) is the concentration ratio of ambient particles and particles inside the PAPR mask; this value indicates the level of protection provided by a respirator when subjected to a simulated work environment. Participants performed continuous chest compressions three times for 2 min each time, with a 4-min break between each session. We measured the SWPF of the tight-fitting PAPR during chest compression in real-time mode. The primary outcome was the ratio of any failure of protection (SWPF <500) during the chest compression sessions. Fifty-four participants completed the simulation. Overall, 78% (n = 42) of the participants failed (the measured SWPF value was less than 500) at least one of the three sessions of chest compressions. The median value and interquartile range of the SWPF was 4304 (685-16,191). There were no reports of slipping down of the respirator or mechanical failure during chest compressions. Although the median SWPF value was high during chest compressions, the tight-fitting PAPR did not provide adequate protection.

The impact of extreme reuse and extended wear conditions on protection provided by a surgical-style N95 filtering facepiece respirator

Most respirators employed in health care settings, and often in first responder and industrial settings, are intended for single-use: the user dons the respirator, performs a work activity, and then doffs and discards the respirator. However, in the current COVID-19 pandemic, in the presence of persistent shortages of personal protective equipment, extended use and reuse of filtering facepiece respirators are routinely contemplated by many health care organizations. Further, there is considerable current effort to understand the effect of sterilization on the possibility of reuse, and some investigations of performance have been conducted. While the ability of such a respirator to continue to provide effective protection after repeated sanitization cycles is a critical component of implementing its reuse, of equal importance is an understanding of the impact that reusing the respirator multiple times in a day while performing work tasks, and even extending its wear over multiple days, has on the workplace protective performance. In this study, we subjected a stockpiled quantitatively fitted surgical style N95 filtering facepiece respirator device to extreme reuse and extended wear conditions (up to 19 uses over a duration of 5 days) and measured its protective performance at regular intervals, including simulated workplace protection factor measurements using total inward leakage. With this respirator, it was shown to be possible to maintain protection corresponding to an assigned protection factor greater than 10 under extreme usage conditions provided an individual is properly trained in the use of, and expertly fitted in, the respirator. Other factors such as hygiene and strap breakage are likely to place limits on reuse.

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.

Simulated workplace protection factors for respirators with N95 or higher filters for health care providers in an emergency medical centre: A randomized crossover study

Introduction:Health care providers in emergency medical centres often encounter infected sources during medical procedures; these sources can generate droplets. Wearing respirators could help to protect against infection risk. However, to the best of our knowledge, no previous study has reported the efficacy of N95 or higher respirators for health care providers in emergency medical centres.Methods:A randomized, crossover study of 26 health care providers was conducted to examine the protective performance of respirators. Quantitative fit tests with three types of respirators (cup type, fold type without valve and fold type with valve) were performed using seven exercises. Primary outcomes were the fit factors. Secondary outcomes included the percentage of fit factors above 100 and respirator preference.Results:After excluding one participant, data for 25 participants were analysed. The fit factors and the percentage of fit factors above 100 were higher when participants wore a fold-type respirator (200 fit factors [38.6–200], 100% [0–100]) relative to those for the cup-type respirator (114.0 fit factors [16.0–185.2], 60% [0–100]) and valve-type respirator (84.9 fit factors [14.2–170.8], 23.8 % [0–100]) in normal respiration. There was no clear preference regarding the type of respirator.Conclusion:The type of respirator could influence protective performance for health care providers. Health care providers in emergency medical centres should be aware of and wear the type of respirator that is well-fitted for them in advance.

Surgical Smoke Simulation Study: Physical Characterization and Respiratory Protection.

Exposure of operating room (OR) personnel to surgical smoke, a unique aerosol generated from the common use of electrocautery during surgical procedures, is an increasing health risk concern. The main objective of this simulation study was to characterize the surgical smoke exposure in terms of the particle number concentration and size distribution in a human breathing zone. Additionally, the performance of respiratory protective devices designed for ORs was examined using two commercially available N95 facepiece filtering respirators (FFRs) as well as the same FFRs modified with new faceseal technology. The tests were conducted in an OR-simulating exposure chamber with the surgical smoke generated by electrocautery equipment applied to animal tissue and measured in the breathing zone with four aerosol spectrometers. The simulated workplace protection factor of each tested respirator was determined for ten subjects by measuring the total aerosol concentrations inside and outside of a respirator. The peak of the particle size distribution was in a range of 60-150 nm. The concentration of particles generated during the simulated surgical procedure significantly exceeded the background concentration under all tested air exchange conditions. The data suggest that wearing N95 filtering facepiece respirators significantly decreased the human exposure to surgical smoke. The new faceseal technology provided significantly higher respiratory protection than the commercial N95 FFRs.

Performance of Facepiece Respirators and Surgical Masks Against Surgical Smoke: Simulated Workplace Protection Factor Study.

Objective:Surgical smoke generated during electrocautery contains toxins which may cause adverse health effects to operating room (OR) personnel. The objective of this study was to investigate the performance of surgical masks (SMs), which are routinely used in ORs, more efficient N95 surgical mask respirator (SMRs) and N100 filtering facepiece respirator (FFRs), against surgical smoke.Methods:Ten subjects were recruited to perform surgical dissections on animal tissue in a simulated OR chamber, using a standard electrocautery device, generating surgical smoke. Six respiratory protective devices (RPDs) were tested: two SMs, two SMRs, and two N100 FFRs [including a newly developed faceseal (FS) prototype]. Fit testing was conducted before the experiment. Each subject was then exposed to the surgical smoke while wearing an RPD under the tests. Concentrations inside (Cin) and outside (Cout) of the RPD were measured by a particle size spectrometer. The simulated workplace protection factor (SWPF) was determined by the ratio of Cout and Cin for each RPD-wearing subject.Results:For the SMs, the geometric means of SWPFtotal (based on the total aerosol concentration) were 1.49 and 1.76, indicating minimal protection. The SWPFtotal values of the SMRs and N100 FFRs were significantly higher than those of the SMs: for the two SMRs, the SWPFtotal were 208 and 263; for the two N100s, the SWPFtotal values were 1,089 and 2,199. No significant difference was observed between either the two SMs or the two SMRs. The SWPFtotal for the novel FS prototype N100 FFR was significantly higher than the conventional N100 FFR. The correlation between SWPFtotal and fit factor (FF) determined for two N95 SMRs was not significant.Conclusions:SMs do not provide measurable protection against surgical smoke. SMRs offer considerably improved protection versus SMs, while the N100 FFRs showed significant improvement over the SMRs. The FS prototype offered a higher level of protection than the standard N100 FFR, due to a tighter seal. While we acknowledge that conventional N100 FFRs (equipped with exhalation valves) are not practical for human OR use, the results obtained with the FS prototype demonstrate the potential of the new FS technology for implementation on various types of respirators.

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.

Protection of Firefighters Against Combustion Aerosol Particles: Simulated Workplace Protection Factor of a Half-Mask Respirator (Pilot Study)

The present pilot study investigated the penetration of ultrafine particles originated by combustion of different materials into elastomeric half-mask respirators equipped with two P100 filters. We determined the Simulated Workplace Protection Factor (SWPF) for 11 firefighters wearing elastomeric half-mask respirators and performing activities simulating those conducted during fire overhaul operations. The tests were performed in a controlled laboratory setting. A newly-developed battery-operated Portable Aerosol Mobility Spectrometer (PAMS) was used to measure size-resolved aerosol particle concentrations outside (Cout) and inside (Cin) of an air-purifying respirator donned on a firefighter, and the SWPF was calculated as Cout/Cin. Based on the total aerosol concentration, the “total” SWPF ranged from 4,222 (minimum) to 35,534 (maximum) with values falling primarily in a range from 11,171 (25 percentile) to 26,604 (75 percentile) and a median value being ≈15,000. This is consistent with the recently reported fit factor (FF) data base.(1) The size-resolved SWPF data revealed a dependency on the particle size. It was concluded that a portable device such as PAMS can be used on firefighters during overhaul operations (as well as on other workers wearing elastomeric half-mask respirators) to monitor the aerosol concentrations in real time and ultimately help prevent overexposure.

Respiratory Source Control Versus Receiver Protection: Impact of Facemask Fit

Placing a surgical mask on an infected patient (respiratory source control) may offer a health-care worker (HCW) more protection than donning an N95 respirator (receiver protection). This observation was made in an in vitro study that used hard, nondeformable faces, and the lack of proper N95 fit may have accounted for the observed results. In the present study, we test the effects of fit on respiratory source control protection, using a soft, deformable mannequin head. Resusci Anne CPR mannequin heads were placed in a chamber allowing 6 air exchanges/hr (14 cubic feet per minute), to simulate an infected patient (source) and an HCW (receiver). The heads were ventilated with a tidal breathing pattern. The source exhaled radioactive aerosols, and a filter was attached to the receiver to quantify inhaled exposure. N95 respirators and surgical masks were tested on both heads. The degree of protection was expressed by calculating the reduction in exposure expressed as a simulated workplace protection factor (sWPF; the ratio of exposure with mask to exposure without mask) compared statistically using confidence intervals. Use of the Resusci Anne heads resulted in improved fit, with higher sWPF than previously reported, for example, for source N95 mask combinations (7,174 vs. 317) as well as receiver (7.53 vs. 1.37). Masks placed on the receiver provided minimal exposure protection (sWPF range 0.99-7.53), except when sealed with Vaseline (sWPF 63.1). Any mask applied to the source mannequin resulted in significant reductions in exposure (sWPF range 214-17,038). Improved fit significantly enhanced the effects of source control protection. A Vaseline-sealed N95 respirator on the receiver offered less protection when compared with any mask on the source. Respiratory source control can offer more protection to HCW and potentially decrease the spread of aerosolized infections.

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.]

Quantifying exposure risk: Surgical masks and respirators

The interaction between the source of respiratory infectious aerosols and the receiver has not been investigated. Using a bench model, we measured the effects of filtration and deflection achieved with surgical masks and N95 respirators. We constructed a chamber designed to produce radiolabeled wet aerosols simulating contaminated particles exhaled during tidal breathing (source). Particles within the chamber were exposed to either 6 or 0 air exchanges/hr. Aerosols were defined by cascade impaction. Source aerosols were exhaled via a ventilated mannequin head suitable for mask protection. A similar ventilated head within the chamber assessed recipient exposure (receiver). A filter within the receiver quantified exposure. Two types of masks, an N95 respirator and surgical mask, were tested. Data were presented as percent of nebulized particles on the receiver filter (exposure) and simulated workplace protection factor (sWPF). In the presence of chamber air exchange, applying a mask on the source (primarily deflection) resulted in significant reduction in exposure to the receiver (sWPF170-320). Masks on receiver (filtration) did not significantly reduce exposure from that of no masks (sWPF1.37-2.21), except with a Vaseline seal (sWPF118). With 0 air exchanges/hr, only Vaseline seal was effective in reducing exposure (sWPF 16-101). In a ventilated space, deflection of exhaled particles with a mask worn at the source achieved far greater levels of protection than any mask on the receiver. Mask filtration at source or receiver did not play a significant role in reducing exposure.

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.

Integrated Unit Performance Testing of Powered, Air-Purifying Particulate Respirators Using a DOP Challenge Aerosol

Although workplace protection factor (WPF) and simulated workplace protection factor (SWPF) studies provide useful information regarding the performance capabilities of powered air-purifying respirators (PAPRs) under certain workplace or simulated workplace conditions, some fail to address the issue of total PAPR unit performance over extended time. PAPR unit performance over time is of paramount importance in protecting worker health over the course of a work shift or at least for the recommended service lifetime of the PAPR battery pack, whichever is shorter. The need for PAPR unit performance testing has become even more important with the inception of 42 CFR 84 and the recent introduction of electrostatic respirator filter media into the PAPR market. This study was conducted to learn how current PAPRs certified by the National Institute for Occupational Safety and Health would perform under an 8-hour unit performance test similar to the dioctyl phthalate (DOP) loading test described in 42 CFR 84 for R- and P-series filters for nonpowered, air-purifying particulate respirators. In this study, entire PAPR units, four with mechanical filters and one with an electrostatic filter, were tested using a TSI Model 8122 Automated Respirator Tester, with and without the built-in breathing machine. The two, tight-fitting PAPRs, both with mechanical filters, showed little effect on performance resulting from the breathing machine. The two loose-fitting helmet PAPRs indicate that unit performance testing without the breathing machine is a more stringent test than testing with the breathing machine under the conditions used. The PAPR with a loose-fitting hood gave inconclusive results as to which testing condition is more stringent. The PAPR unit equipped with electrostatic filters gave the highest maximum penetration values during unit performance testing.

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.

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 ≤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.

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.

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.