Personal Interventions for Reducing Exposure and Risk for Outdoor Air Pollution: An Official American Thoracic Society Workshop Report.

Poor air quality affects the health and wellbeing of large populations around the globe. Although source controls are the most effective approaches for improving air quality and reducing health risks, individuals can also take actions to reduce their personal exposure by staying indoors, reducing physical activity, altering modes of transportation, filtering indoor air, and using respirators and other types of face masks. A synthesis of available evidence on the efficacy, effectiveness, and potential adverse effects or unintended consequences of personal interventions for air pollution is needed by clinicians to assist patients and the public in making informed decisions about use of these interventions. To address this need, the American Thoracic Society convened a workshop in May of 2018 to bring together a multidisciplinary group of international experts to review the current state of knowledge about personal interventions for air pollution and important considerations when helping patients and the general public to make decisions about how best to protect themselves. From these discussions, recommendations were made regarding when, where, how, and for whom to consider personal interventions. In addition to the efficacy and safety of the various interventions, the committee considered evidence regarding the identification of patients at greatest risk, the reliability of air quality indices, the communication challenges, and the ethical and equity considerations that arise when discussing personal interventions to reduce exposure and risk from outdoor air pollution.

Evaluación de la eficacia de las lengüetas en las tiras de la mascarilla autofiltrante para mejorar las técnicas de retirada adecuadas al mismo tiempo que se reduce la transmisión por contacto de los patógenos.

RESUMENLas mascarillas respiratorias autofiltrantes (filtering facepiece respirators, FFR) N95 certificadas por el Instituto Nacional de Seguridad y Salud Laborales (National Institute for Occupational Safety and Health, NIOSH) se utilizan en los centros de atención sanatoria como medida de control para mitigar las exposiciones a partículas atmosféricas infecciosas. Cuando la superficie externa de una FFR se contamina, supone un riesgo de transmisión para el usuario. La guía de los Centros para el Control y Prevención de Enfermedades (Centers for Disease Control and Prevention, CDC) recomienda que el personal sanitario retire las FFR agarrando las tiras en la parte posterior de la cabeza para evitar el contacto con la superficie posiblemente contaminada. Al parecer, la adherencia a la técnica de retirada adecuada es baja, debido a numerosos factores que incluyen la dificultad para ubicar y agarrar las tiras. En este estudio se compara el impacto de lengüetas ubicadas en las tiras de la FFR con el de mascarillas comparativas (sin lengüetas) sobre la retirada adecuada, la facilidad de uso, la comodidad y la reducción de la transmisión de la contaminación al usuario. El uso de un agente fluorescente como rastreador de contactos para explorar la contaminación de las FFR en manos y áreas de la cabeza de 20 sujetos humanos demostró que no hubo diferencia entre las tiras de la FFR con lengüetas y las mascarillas comparativas en el sentido de estimular la retirada adecuada de las mismas (p = 0.48), pero la hizo más fácil (p = 0.04), según indican siete de ocho sujetos que usaron las lengüetas. Siete de 20 sujetos opinaron que las FFR con lengüetas son más fáciles de retirar, mientras que solo dos de 20 sujetos indicaron que las FFR sin lengüetas son más fáciles de retirar. La incomodidad no fue un factor relevante para ninguno de los tipos de tiras de las FFR. Al retirar una FFR con las manos contaminadas, el uso de lengüetas redujo de forma importante la cantidad del rastreador de contactos transferida en comparación con las tiras sin lengüetas (p = 0.012). Las FFR con lengüetas en las tiras están asociadas con la facilidad de la retirada y una transferencia notablemente menor del rastreador de contactos fluorescente.

A Control Banding Framework for Protecting the US Workforce from Aerosol Transmissible Infectious Disease Outbreaks with High Public Health Consequences.

Recent high-profile infectious disease outbreaks illustrate the importance of selecting appropriate control measures to protect a wider range of employees, other than those in healthcare settings. In such settings, where routine exposure risks are often high, control measures may be more available, routinely implemented, and studied for effectiveness. In the absence of evidence-based guidelines or established best practices for selecting appropriate control measures, employers may unduly rely on personal protective equipment (PPE) because of its wide availability and pervasiveness as a control measure, circumventing other effective options for protection. Control banding is one approach that may be used to assign job tasks into risk categories and prioritize the application of controls. This article proposes an initial control banding framework for workers at all levels of risk and incorporates a range of control options, including PPE. Using the National Institutes of Health (NIH) risk groups as a surrogate for toxicity and combining the exposure duration with the exposure likelihood, we can generate the risk of a job task to the worker.

Healthcare personnel exposure in an emergency department during influenza season.

INTRODUCTION: Healthcare personnel are at high risk for exposure to influenza by direct and indirect contact, droplets and aerosols, and by aerosol generating procedures. Information on air and surface influenza contamination is needed to assist in developing guidance for proper prevention and control strategies. To understand the vulnerabilities of healthcare personnel, we measured influenza in the breathing zone of healthcare personnel, in air and on surfaces within a healthcare setting, and on filtering facepiece respirators worn by healthcare personnel when conducting patient care. METHODS: Thirty participants were recruited from an adult emergency department during the 2015 influenza season. Participants wore personal bioaerosol samplers for six hours of their work shift, submitted used filtering facepiece respirators and medical masks and completed questionnaires to assess frequency and types of interactions with potentially infected patients. Room air samples were collected using bioaerosol samplers, and surface swabs were collected from high-contact surfaces within the adult emergency department. Personal and room bioaerosol samples, surface swabs, and filtering facepiece respirators were analyzed for influenza A by polymerase chain reaction. RESULTS: Influenza was identified in 42% (53/125) of personal bioaerosol samples, 43% (28/ 96) of room bioaerosol samples, 76% (23/30) of pooled surface samples, and 25% (3/12) of the filtering facepiece respirators analyzed. Influenza copy numbers were greater in personal bioaerosol samples (17 to 631 copies) compared to room bioaerosol samples (16 to 323 copies). Regression analysis suggested that the amount of influenza in personal samples was approximately 2.3 times the amount in room samples (Wald χ2 = 16.21, p<0.001). CONCLUSIONS: Healthcare personnel may encounter increased concentrations of influenza virus when in close proximity to patients. Occupations that require contact with patients are at an increased risk for influenza exposure, which may occur throughout the influenza season. Filtering facepiece respirators may become contaminated with influenza when used during patient care.

Assessment of environmental and surgical mask contamination at a student health center - 2012-2013 influenza season.

Increased understanding of influenza transmission is critical for pandemic planning and selecting appropriate controls for healthcare personnel safety and health. The goals of this pilot study were to assess environmental contamination in different areas and at two time periods in the influenza season and to determine the feasibility of using surgical mask contamination to evaluate potential exposure to influenza virus. Bioaerosol samples were collected over 12 days (two 6-day sessions) at 12 locations within a student health center using portable two-stage bioaerosol samplers operating 8 hr each day. Surface samples were collected each morning and afternoon from common high-contact non-porous hard surfaces from rooms and locations where bioaerosol samplers were located. Surgical masks worn by participants while in contact with patients with influenza-like illness were collected. A questionnaire administered to each of the 12 participants at the end of each workday and another at the end of each workweek assessed influenza-like illness symptoms, estimated the number of influenza-like illness patient contacts, hand hygiene, and surgical mask usage. All samples were analyzed using qPCR. Over the 12 days of the study, three of the 127 (2.4%) bioaerosol samples, 2 of 483 (0.41%) surface samples, and 0 of 54 surgical masks were positive for influenza virus. For the duration of contact that occurred with an influenza patient on any of the 12 days, nurse practitioners and physicians reported contacts with influenza-like illness patients >60 min, medical assistants reported 15-44 min, and administrative staff reported <30 min. Given the limited number of bioaerosol and surface samples positive for influenza virus in the bioaerosol and surface samples, the absence of influenza virus on the surgical masks provides inconclusive evidence for the potential to use surgical masks to assess exposure to influenza viruses. Further studies are needed to determine feasibility of this approach in assessing healthcare personnel exposures. Information learned in this study can inform future field studies on influenza transmission.

Assessment of influenza virus exposure and recovery from contaminated surgical masks and N95 respirators.

Healthcare workers (HCWs) are at significantly higher risk of exposure to influenza virus during seasonal epidemics and global pandemics. During the 2009 influenza pandemic, some healthcare organizations recommended that HCWs wear respiratory protection such as filtering facepiece respirators, while others indicated that facemasks such as surgical masks (SMs) were sufficient. To assess the level of exposure a HCW may possibly encounter, the aim of this study was to (1.) evaluate if SMs and N95 respirators can serve as "personal bioaerosol samplers" for influenza virus and (2.) determine if SMs and N95 respirators contaminated by influenza laden aerosols can serve as a source of infectious virus for indirect contact transmission. This effort is part of a National Institute for Occupational Safety and Health 5-year multidisciplinary study to determine the routes of influenza transmission in healthcare settings. A coughing simulator was programmed to cough aerosol particles containing influenza virus over a wide concentration range into an aerosol exposure simulation chamber virus/L of exam room air), and a breathing simulator was used to collect virus on either a SM or N95 respirator. Extraction buffers containing nonionic and anionic detergents as well as various protein additives were used to recover influenza virus from the masks and respirators. The inclusion of 0.1% SDS resulted in maximal influenza RNA recovery (41.3%) but with a complete loss of infectivity whereas inclusion of 0.1% bovine serum albumin resulted in reduced RNA recovery (6.8%) but maximal retention of virus infectivity (17.9%). Our results show that a HCW's potential exposure to airborne influenza virus can be assessed in part through analysis of their SMs and N95 respirators, which can effectively serve as personal bioaerosol samplers.

Transfer of bacteriophage MS2 and fluorescein from N95 filtering facepiece respirators to hands: Measuring fomite potential.

Contact transmission of pathogens from personal protective equipment is a concern within the healthcare industry. During public health emergency outbreaks, resources become constrained and the reuse of personal protective equipment, such as N95 filtering facepiece respirators, may be needed. This study was designed to characterize the transfer of bacteriophage MS2 and fluorescein between filtering facepiece respirators and the wearer's hands during three simulated use scenarios. Filtering facepiece respirators were contaminated with MS2 and fluorescein in droplets or droplet nuclei. Thirteen test subjects performed filtering facepiece respirator use scenarios including improper doffing, proper doffing and reuse, and improper doffing and reuse. Fluorescein and MS2 contamination transfer were quantified. The average MS2 transfer from filtering facepiece respirators to the subjects' hands ranged from 7.6-15.4% and 2.2-2.7% for droplet and droplet nuclei derived contamination, respectively. Handling filtering facepiece respirators contaminated with droplets resulted in higher levels of MS2 transfer compared to droplet nuclei for all use scenarios (p = 0.007). MS2 transfer from droplet contaminated filtering facepiece respirators during improper doffing and reuse was greater than transfer during improper doffing (p = 0.008) and proper doffing and reuse (p = 0.042). Droplet contamination resulted in higher levels of fluorescein transfer compared to droplet nuclei contaminated filtering facepiece respirators for all use scenarios (p = 0.009). Fluorescein transfer was greater for improper doffing and reuse (p = 0.007) from droplet contaminated masks compared to droplet nuclei contaminated filtering facepiece respirators and for improper doffing and reuse when compared improper doffing (p = 0.017) and proper doffing and reuse (p = 0.018) for droplet contaminated filtering facepiece respirators. For droplet nuclei contaminated filtering facepiece respirators, the difference in MS2 and fluorescein transfer did not reach statistical significance when comparing any of the use scenarios. The findings suggest that the results of fluorescein and MS2 transfer were consistent and highly correlated across the conditions of study. The data supports CDC recommendations for using proper doffing techniques and discarding filtering facepiece respirators that are directly contaminated with secretions from a cough or sneeze.

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.

Speech intelligibility assessment of protective facemasks and air-purifying respirators.

Speech Intelligibility (SI) is the perceived quality of sound transmission. In healthcare settings, the ability to communicate clearly with coworkers, patients, etc., is crucial to quality patient care and safety. The objectives of this study were to: (1) assess the suitability of the Speech Transmission Index (STI) methods for testing reusable and disposable facial and respiratory personal protective equipment (protective facemasks [PF], N95 filtering facepiece respirators [N95 FFR], and elastomeric half-mask air-purifying respirators [EAPR]) commonly worn by healthcare workers; (2) quantify STI levels of these devices; and (3) contribute to the scientific body of knowledge in the area of SI. SI was assessed using the STI under two experimental conditions: (1) a modified version of the National Fire Protection Association 1981 Supplementary Voice Communications System Performance Test at a Signal to Noise Ratio (SNR) of -15 (66 dBA) and (2) STI measurements utilizing a range of modified pink noise levels (52.5 dBA (-2 SNR) - 72.5 dBA (+7 SNR)) in 5.0 dBA increments. The PF models (Kimberly Clark 49214 and 3 M 1818) had the least effect on SI interference, typically deviating from the STI baseline (no-mask condition) by 3% and 4% STI, respectively. The N95FFR (3 M 1870, 3 M 1860) had more effect on SI interference, typically differing from baseline by 13% and 17%, respectively, for models tested. The EAPR models (Scott Xcel and North 5500) had the most significant impact on SI, differing from baseline by 42% for models tested. This data offers insight into the performance of these apparatus with respect to STI and may serve as a reference point for future respirator design considerations, standards development, testing and certification activities.

The Respiratory Protection Effectiveness Clinical Trial (ResPECT): a cluster-randomized comparison of respirator and medical mask effectiveness against respiratory infections in healthcare personnel.

BACKGROUND: Although N95 filtering facepiece respirators and medical masks are commonly used for protection against respiratory infections in healthcare settings, more clinical evidence is needed to understand the optimal settings and exposure circumstances for healthcare personnel to use these devices. A lack of clinically germane research has led to equivocal, and occasionally conflicting, healthcare respiratory protection recommendations from public health organizations, professional societies, and experts. METHODS: The Respiratory Protection Effectiveness Clinical Trial (ResPECT) is a prospective comparison of respiratory protective equipment to be conducted at multiple U.S. study sites. Healthcare personnel who work in outpatient settings will be cluster-randomized to wear N95 respirators or medical masks for protection against infections during respiratory virus season. Outcome measures will include laboratory-confirmed viral respiratory infections, acute respiratory illness, and influenza-like illness. Participant exposures to patients, coworkers, and others with symptoms and signs of respiratory infection, both within and beyond the workplace, will be recorded in daily diaries. Adherence to study protocols will be monitored by the study team. DISCUSSION: ResPECT is designed to better understand the extent to which N95s and MMs reduce clinical illness among healthcare personnel. A fully successful study would produce clinically relevant results that help clinician-leaders make reasoned decisions about protection of healthcare personnel against occupationally acquired respiratory infections and prevention of spread within healthcare systems. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov, number NCT01249625 (11/29/2010).

Assessing the efficacy of tabs on filtering facepiece respirator straps to increase proper doffing techniques while reducing contact transmission of pathogens.

NIOSH-certified N95 filtering facepiece respirators (FFRs) are used in healthcare settings as a control measure to mitigate exposures to airborne infectious particles. When the outer surface of an FFR becomes contaminated, it presents a contact transmission risk to the wearer. The Centers for Disease Control and Prevention (CDC) guidance recommends that healthcare workers (HCWs) doff FFRs by grasping the straps at the back of the head to avoid contact with the potentially contaminated surface. Adherence to proper doffing technique is reportedly low due to numerous factors including difficulty in locating and grasping the straps. This study compares the impact of tabs placed on FFR straps to controls (without tabs) on proper doffing, ease of use and comfort, and reduction of transfer of contamination to the wearer. Utilizing a fluorescent agent as a tracer to track contamination from FFRs to hand and head areas of 20 human subjects demonstrated that there was no difference in tabbed FFR straps and controls with respect to promoting proper doffing (p = 0.48), but did make doffing easier (p = 0.04) as indicated by 7 of 8 subjects that used the tabs. Seven of the 20 subjects felt that FFRs with tabs were easier to remove, while only 2 of 20 indicated that FFRs without tabs were easier to remove. Discomfort was not a factor for either FFR strap type. When removing an FFR with contaminated hands, the use of the tabs significantly reduced the amount of tracer transfer compared to straps without tabs (p = 0.012). FFRs with tabs on the straps are associated with ease of doffing and significantly less transfer of the fluorescent tracer.

Capture of 0.1-µm aerosol particles containing viable H1N1 influenza virus by N95 filtering facepiece respirators.

Nosocomial infections pose an escalating threat to both patients and healthcare workers (HCWs). A widely recommended device for individual respiratory protection, the N95 filtering facepiece respirator (FFR) has been shown to provide efficient filtration of inert particles larger and smaller than the nominal most-penetrating particle size (MPPS) range, 0.03-0.3 µm. Humans generate respiratory aerosols in the MPPS range, suggesting that short-range disease transmission could occur via small infectious particles. Data presented here show that the N95 FFR will afford a significant measure of protection against infectious particles as small as a bare H1N1 influenza virion, and that the capture mechanism does not discriminate in favor of, or against, biological particles.

Pressure drop of filtering facepiece respirators: How low should we go?

INTRODUCTION: This study was undertaken to determine the mean peak filter resistance to airflow (Rfilter) encountered by subjects while wearing prototype filtering facepiece respirators (PRs) with low Rfilter during nasal and oral breathing at sedentary and low-moderate work rates. MATERIAL AND METHODS: In-line pressure transducer measurements of mean Rfilteracross PRs with nominal Rfilter of 29.4 Pa, 58.8 Pa and 88.2 Pa (measured at 85 l/min constant airflow) were obtained during nasal and oral breathing at sedentary and low-moderate work rates for 10 subjects. RESULTS: The mean Rfilter for the 29.4 PR was significantly lower than the other 2 PRs (p < 0.000), but there were no significant differences in mean Rfilter between the PRs with 58.8 and 88.2 Pa filter resistance (p > 0.05). The mean Rfilter was greater for oral versus nasal breathing and for exercise compared to sedentary activity (p < 0.001). CONCLUSIONS: Mean oral and nasal Rfilter for all 3 PRs was at, or below, the minimal threshold level for detection of inspiratory resistance (the 58.8-74.5 Pa/l×s-1), which may account for the previously-reported lack of significant subjective or physiological differences when wearing PRs with these low Rfilter. Lowering filtering facepiece respirator Rfilter below 88.2 Pa (measured at 85 l/min constant airflow) may not result in additional subjective or physiological benefit to the wearer.

Correlation of respirator fit measured on human subjects and a static advanced headform.

This study assessed the correlation of N95 filtering facepiece respirator (FFR) fit between a Static Advanced Headform (StAH) and 10 human test subjects. Quantitative fit evaluations were performed on test subjects who made three visits to the laboratory. On each visit, one fit evaluation was performed on eight different FFRs of various model/size variations. Additionally, subject breathing patterns were recorded. Each fit evaluation comprised three two-minute exercises: "Normal Breathing," "Deep Breathing," and again "Normal Breathing." The overall test fit factors (FF) for human tests were recorded. The same respirator samples were later mounted on the StAH and the overall test manikin fit factors (MFF) were assessed utilizing the recorded human breathing patterns. Linear regression was performed on the mean log10-transformed FF and MFF values to assess the relationship between the values obtained from humans and the StAH. This is the first study to report a positive correlation of respirator fit between a headform and test subjects. The linear regression by respirator resulted in R(2) = 0.95, indicating a strong linear correlation between FF and MFF. For all respirators the geometric mean (GM) FF values were consistently higher than those of the GM MFF. For 50% of respirators, GM FF and GM MFF values were significantly different between humans and the StAH. For data grouped by subject/respirator combinations, the linear regression resulted in R(2) = 0.49. A weaker correlation (R(2) = 0.11) was found using only data paired by subject/respirator combination where both the test subject and StAH had passed a real-time leak check before performing the fit evaluation. For six respirators, the difference in passing rates between the StAH and humans was < 20%, while two respirators showed a difference of 29% and 43%. For data by test subject, GM FF and GM MFF values were significantly different for 40% of the subjects. Overall, the advanced headform system has potential for assessing fit for some N95 FFR model/sizes.

Selecting models for a respiratory protection program: what can we learn from the scientific literature?

BACKGROUND: An unbiased source of comparable respirator performance data would be helpful in setting up a hospital respiratory protection program. METHODS: The scientific literature was examined to assess the extent to which performance data (respirator fit, comfort and usability) from N95 filtering facepiece respirator (FFR) models are available to assist with FFR model selection and procurement decisions. RESULTS: Ten studies were identified that met the search criteria for fit, whereas 5 studies met the criteria for comfort and usability. CONCLUSION: Analysis of these studies indicated that it is difficult to directly use the scientific literature to inform the FFR selection process because of differences in study populations, methodologies, and other factors. Although there does not appear to be a single best fitting FFR, studies demonstrate that fit testing programs can be designed to successfully fit nearly all workers with existing products. Comfort and usability are difficult to quantify. Among the studies found, no significant differences were noted.

Validation and application of models to predict facemask influenza contamination in healthcare settings.

Facemasks are part of the hierarchy of interventions used to reduce the transmission of respiratory pathogens by providing a barrier. Two types of facemasks used by healthcare workers are N95 filtering facepiece respirators (FFRs) and surgical masks (SMs). These can become contaminated with respiratory pathogens during use, thus serving as potential sources for transmission. However, because of the lack of field studies, the hazard associated with pathogen-exposed facemasks is unknown. A mathematical model was used to calculate the potential influenza contamination of facemasks from aerosol sources in various exposure scenarios. The aerosol model was validated with data from previous laboratory studies using facemasks mounted on headforms in a simulated healthcare room. The model was then used to estimate facemask contamination levels in three scenarios generated with input parameters from the literature. A second model estimated facemask contamination from a cough. It was determined that contamination levels from a single cough (≈19 viruses) were much less than likely levels from aerosols (4,473 viruses on FFRs and 3,476 viruses on SMs). For aerosol contamination, a range of input values from the literature resulted in wide variation in estimated facemask contamination levels (13-202,549 viruses), depending on the values selected. Overall, these models and estimates for facemask contamination levels can be used to inform infection control practice and research related to the development of better facemasks, to characterize airborne contamination levels, and to assist in assessment of risk from reaerosolization and fomite transfer because of handling and reuse of contaminated facemasks.

Considerations for recommending extended use and limited reuse of filtering facepiece respirators in health care settings.

Public health organizations, such as the Centers for Disease Control and Prevention (CDC), are increasingly recommending the use of N95 filtering facepiece respirators (FFRs) in health care settings. For infection control purposes, the usual practice is to discard FFRs after close contact with a patient ("single use"). However, in some situations, such as during contact with tuberculosis patients, limited FFR reuse (i.e., repeated donning and doffing of the same FFR by the same person) is practiced. A related practice, extended use, involves wearing the same FFR for multiple patient encounters without doffing. Extended use and limited FFR reuse have been recommended during infectious disease outbreaks and pandemics to conserve FFR supplies. This commentary examines CDC recommendations related to FFR extended use and limited reuse and analyzes available data from the literature to provide a relative estimate of the risks of these practices compared to single use. Analysis of the available data and the use of disease transmission models indicate that decisions regarding whether FFR extended use or reuse should be recommended should continue to be pathogen- and event-specific. Factors to be included in developing the recommendations are the potential for the pathogen to spread via contact transmission, the potential that the event could result in or is currently causing a FFR shortage, the protection provided by FFR use, human factors, potential for self-inoculation, the potential for secondary exposures, and government policies and regulations. While recent findings largely support the previous recommendations for extended use and limited reuse in certain situations, some new cautions and limitations should be considered before issuing recommendations in the future. In general, extended use of FFRs is preferred over limited FFR reuse. Limited FFR reuse would allow the user a brief respite from extended wear times, but increases the risk of self-inoculation and preliminary data from one study suggest that some FFR models may begin to lose effectiveness after multiple donnings.

Development of an advanced respirator fit-test headform.

Improved respirator test headforms are needed to measure the fit of N95 filtering facepiece respirators (FFRs) for protection studies against viable airborne particles. A Static (i.e., non-moving, non-speaking) Advanced Headform (StAH) was developed for evaluating the fit of N95 FFRs. The StAH was developed based on the anthropometric dimensions of a digital headform reported by the National Institute for Occupational Safety and Health (NIOSH) and has a silicone polymer skin with defined local tissue thicknesses. Quantitative fit factor evaluations were performed on seven N95 FFR models of various sizes and designs. Donnings were performed with and without a pre-test leak checking method. For each method, four replicate FFR samples of each of the seven models were tested with two donnings per replicate, resulting in a total of 56 tests per donning method. Each fit factor evaluation was comprised of three 86-sec exercises: "Normal Breathing" (NB, 11.2 liters per min (lpm)), "Deep Breathing" (DB, 20.4 lpm), then NB again. A fit factor for each exercise and an overall test fit factor were obtained. Analysis of variance methods were used to identify statistical differences among fit factors (analyzed as logarithms) for different FFR models, exercises, and testing methods. For each FFR model and for each testing method, the NB and DB fit factor data were not significantly different (P > 0.05). Significant differences were seen in the overall exercise fit factor data for the two donning methods among all FFR models (pooled data) and in the overall exercise fit factor data for the two testing methods within certain models. Utilization of the leak checking method improved the rate of obtaining overall exercise fit factors ≥100. The FFR models, which are expected to achieve overall fit factors ≥ 100 on human subjects, achieved overall exercise fit factors ≥ 100 on the StAH. Further research is needed to evaluate the correlation of FFRs fitted on the StAH to FFRs fitted on people. [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 file providing detailed information on the advanced head form design and fabrication process.].

Laboratory faceseal leakage evaluation of n95 filtering facepiece respirators against nanoparticles and "all size" particles.

National Institute for Occupational Safety and Health (NIOSH)-certified N95 filtering facepiece respirators (FFRs) are used for respiratory protection in some workplaces handling engineered nanomaterials. Previous NIOSH research has focused on filtration performance against nanoparticles. This article is the first NIOSH study using human test subjects to compare N95 FFR faceseal leakage (FSL) performance against nanoparticles and "all size" particles. In this study, estimates of FSL were obtained from fit factor (FF) measurements from nine test subjects who participated in previous fit-test studies. These data were analyzed to compare values obtained by: 1) using the PortaCount Plus (8020A, TSI, Inc., MN, USA) alone (measureable particle size range 20 nm to > 1,000 nm, hereby referred to as the "all size particles test"), and 2) using the PortaCount Plus with N95-Companion(TM) accessory (8095, TSI, Inc., Minn.) accessory (negatively charged particles, size range ∼40 to 60 nm, hereby referred to as the "nanoparticles test"). Log-transformed FF values were compared for the "all size particles test" and "nanoparticles test" using one-way analysis of variance tests (significant at P < 0.05). For individual FFR models, geometric mean (GM) FF using the "nanoparticles test" was the same or higher than the GM FFs using "all size particles test." For all three FFR models combined, GM FF using the "nanoparticles test" was significantly higher than the GM FF using "all size particles test" (P < 0.05). These data suggest that FSL for negatively charged ∼40-60 nm nanoparticles is not greater than the FSL for the larger distribution of charged and uncharged 20 to > 1,000 nm particles.

B95: a new respirator for health care personnel.

BACKGROUND: Respiratory protection relies heavily on user compliance to be effective, but compliance among health care personnel is less than ideal. METHODS: In 2008, the Department of Veterans Affairs formed the Project Better Respiratory Equipment using Advanced Technologies for Healthcare Employees (BREATHE) Working Group, composed of a variety of federal stakeholders, to discuss strategies for improving respirator compliance, including the need for more comfortable respirators. RESULTS: The Working Group developed 28 desirable performance characteristics that can be grouped into 4 key themes: (1) respirators should perform their intended function safely and effectively; (2) respirators should support, not interfere, with occupational activities; (3) respirators should be comfortable and tolerable for the duration of wear; and (4) respiratory protective programs should comply with federal/state standards and guidelines and local policies. As a necessary next step, the Working Group identified the need for a new class of respirators, to be called "B95," which would better address the unique needs of health care personnel. CONCLUSION: This article summarizes the outputs of the Project BREATHE Working Group and provides a national strategy to develop clinically validated respirator test methods, to promulgate B95 respirator standards, and to invent novel design features, which together will lead to commercialized B95 respirators.