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.

Effects of volume, velocity, and composition on the resistance to synthetic blood penetration of N95 filtering facepiece respirators and other head/facial personal protective equipment.

Surgical N95 filtering facepiece respirators (surgical N95 FFRs) are National Institute for Occupational Safety and Health-approved N95 filtering facepiece respirators (N95 FFRs) cleared by the Food and Drug Administration for resistance to liquid penetration and flammability. A recent study showed that several N95 FFR models performed as well as surgical N95 FFRs in synthetic blood penetration tests that evaluate resistance to penetration by horizontal projection. This aspect, in addition to the influence of other factors on liquid penetration, are not well studied. To address this issue, the effect of liquid volume (1 mL and 2 mL), spray velocity (450 cm/sec and 635 cm/sec), and liquid composition (synthetic blood and diluted synthetic blood) were evaluated. Four types of common protective devices were studied: N95 FFRs, surgical N95 FFRs, surgical masks, and powered air-purifying respirator (PAPR) hoods. For each protective device type, five models were analyzed using a protocol based on the F1862 ASTM International (2017) test method. Reduced liquid volume had a significant effect in only 3 of 20 models. Increased velocity had significantly greater penetration in 9 of 20 models. Diluted synthetic blood had significantly more penetration in 8 of 20 models. This last result was not expected because, in hydrostatic tests, surface tension of the diluted blood would be expected to reduce penetrability; however, across all models tested, data showed that the diluted spray was more penetrable. The study results suggest that fluid composition may be as important as velocity when considering liquid spray penetration. Furthermore, the penetrability of a spray may be inversely related to the penetrability through direct hydrostatic contact.

Evaluation of Rigidity of Surgical N95 Respirators Using a Manikin-System: A Pilot Study.

BACKGROUND: Surgical N95 respirators are devices certified by the National Institute for Occupational Safety and Health (NIOSH) and also cleared by the Food and Drug Administration (FDA) as a medical device. They are commonly used in healthcare settings to provide protection from infectious aerosols, as well as, bodily fluid sprays and splashes. It is hypothesized based on design, some models may change their shape significantly (i.e., collapse) during heavy breathing, which may allow the device to touch the wearer's face. Concerns have been raised that droplets of infectious biological fluids may reach the inner layer of surgical N95 respirators leading to the transfer of microorganisms to the oronasal facial region upon collapse. Unfortunately, little data currently exists on respirator rigidity testing or its relation to efficacy. The objective of this study was to develop and optimize a manikin-based test system to evaluate respirator rigidity. METHODS: Six surgical N95 models of three different designs (cup-shaped, flat fold and trifold) were tested at two different environmental conditions on the NIOSH medium headform. Rigidity evaluation was performed at 50% relative humidity (RH) and 22°C, and at ~100% RH and 33°C at 40, 50, and 60 L/min breathing flow rates. Facial contact secondary to shape change was assessed by coating the inner layer of the surgical N95 respirators with a fluorescent tracer and its transfer to the manikin face. RESULTS: The results showed that the cup-shaped models were rigid and resistant to shape change at both environmental conditions and all flow rates. In contrast, the flat fold models and trifold models showed significant changes with rigidity, at higher breathing flow rates and higher RH and temperature conditions. The flat fold models showed transfer of the fluorescent tracer to the manikin face at higher RH and breathing rates, confirming a change in rigidity. CONCLUSIONS: The results from the study suggest that the manikin-based test system designed for the purposes of this study can be used to evaluate respirator rigidity.

Flammability of Respirators and other Head and Facial Personal Protective Equipment.

BACKGROUND: Personal protective equipment (PPE) is worn by workers in surgical settings to protect them and patients. Food and Drug Administration (FDA) clears some PPE (e.g., surgical masks (SM)) as class II medical devices, and regulates some (e.g. surgical head cover) as class I exempt devices. For respiratory protection, National Institute for Occupational Safety and Health (NIOSH)-approved N95 filtering facepiece respirators (FFRs), and powered air-purifying respirators (PAPRs) are used. One type of PPE, "surgical N95 respirators", is a NIOSH-approved FFR that is also cleared by the FDA for use in medical settings. The surgical environment poses unique risks such as the potential for surgical fires. As part of its substantial equivalence determination process, FDA requests testing of flammability and other parameters for SM and surgical N95 respirators. A lack of data regarding flammability of PPE used in healthcare exists. We hypothesize that commonly used PPE, regardless of whether regulated and/or cleared by FDA or not, will pass an industry standard such as the 16 CFR 1610 flammability test. METHODS: Eleven N95 FFR models, eight surgical N95 respirator models, seven SM models, five surgical head cover models, and five PAPR hood models were evaluated for flammability with a 45 degree flammability tester using the 16 CFR 1610 method. Three common fabrics were included for comparison. RESULTS: All of the PPE samples regulated/and or cleared by FDA or not, passed the flammability test at class 1 (normal flammability), meaning they are less likely to burn. Only one of the three common fabrics, a cotton fabric at the lowest basis weight, was class 3 (high flammability). CONCLUSIONS: The results obtained in the study suggest that NIOSH-approved N95 FFRs would likely pass the 16 CFR 1610 flammability standard. Moreover, results suggest that NIOSH is capable of undertaking flammability testing using the 16 CFR 1610 standard as the flammability results NIOSH obtained for N95 FFRs were comparable to the results obtained by a third party independent laboratory.

A comparison of total inward leakage measured using sodium chloride (NaCl) and corn oil aerosol methods for air-purifying respirators.

The International Organization for Standardization (ISO) standard 16900-1:2014 specifies the use of sodium chloride (NaCl) and corn oil aerosols, and sulfur hexafluoride gas for measuring total inward leakage (TIL). However, a comparison of TIL between different agents is lacking. The objective of this study was to measure and compare TIL for respirators using corn oil and NaCl aerosols. TIL was measured with 10 subjects donning two models of filtering facepiece respirators (FFRs) including FFP1, N95, P100, and elastomeric half-mask respirators (ERs) in NaCl and corn oil aerosol test chambers, using continuous sampling methods. After fit testing with a PortaCount (TSI, Inc., St. Paul, MN) using the Occupational Safety and Health Administration (OSHA) protocol, five subjects were tested in the NaCl chamber first and then in the corn oil chamber, while other subjects tested in the reverse order. TIL was measured as a ratio of mass-based aerosol concentrations in-mask to the test chamber, while the subjects performed ISO 16900-1-defined exercises. The concentration of NaCl aerosol was measured using two flame photometers, and corn oil aerosol was measured with one light scattering photometer. The same instruments were used to measure filter penetration in both chambers using a Plexiglas setup. The size distribution of aerosols was determined using a scanning mobility particle sizer and charge was measured with an electrometer. Filter efficiency was measured using an 8130 Automated Filter Tester (TSI). Results showed the geometric mean TIL for corn oil aerosol for one model each of all respirator categories, except P100, were significantly (p < 0.05) greater than for NaCl aerosol. Filter penetration in the two test chambers showed a trend similar to TIL. The count median diameter was ∼82 nm for NaCl and ∼200 nm for corn oil aerosols. The net positive charge for NaCl aerosol was relatively larger. Both fit factor and filter efficiency influence TIL measurement. Overall, TIL determination with aerosols of different size distributions and charges using different methodologies may produce dissimilar results.

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.

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

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

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

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

Effect of multiple alcohol-based hand rub applications on the tensile properties of thirteen brands of medical exam nitrile and latex gloves.

Current CDC guidance for the disinfection of gloved hands during the doffing of personal protective equipment (PPE) following the care of a patient with Ebola recommends for multiple applications of alcohol-based hand rub (ABHR) on medical exam gloves. To evaluate possible effects of ABHR applications on glove integrity, thirteen brands of nitrile and latex medical exam gloves from five manufacturers and two different ABHRs were included in this study. A pair of gloves were worn by a test operator and the outside surfaces of the gloves were separately treated with an ABHR for 1-6 applications. Tensile strength and ultimate elongation of the gloves without any ABHR treatments (control gloves) and gloves after 1-6 ABHR applications were measured based on the ASTM D412 standard method. In general, tensile strength decreased with each ABHR application. ABHRs had more effect on the tensile strength of the tested nitrile than latex gloves, while ethanol-based ABHR (EBHR) resulted in lesser changes in tensile strength compared to isopropanol-based ABHR (IBHR). The results show that multiple EBHR applications on the latex gloves and some of the nitrile gloves tested should be safe for Ebola PPE doffing based on the CDC guidance. Appropriate hospital staff practice using ABHR treatment and doffing gloves is recommended to become more familiar with changes in glove properties.

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.

Inward leakage variability between respirator fit test panels - Part II. Probabilistic approach.

This study aimed to quantify the variability between different anthropometric panels in determining the inward leakage (IL) of N95 filtering facepiece respirators (FFRs) and elastomeric half-mask respirators (EHRs). We enrolled 144 experienced and non-experienced users as subjects in this study. Each subject was assigned five randomly selected FFRs and five EHRs, and performed quantitative fit tests to measure IL. Based on the NIOSH bivariate fit test panel, we randomly sampled 10,000 pairs of anthropometric 35 and 25 member panels without replacement from the 144 study subjects. For each pair of the sampled panels, a Chi-Square test was used to test the hypothesis that the passing rates for the two panels were not different. The probability of passing the IL test for each respirator was also determined from the 20,000 panels and by using binomial calculation. We also randomly sampled 500,000 panels with replacement to estimate the coefficient of variation (CV) for inter-panel variability. For both 35 and 25 member panels, the probability that passing rates were not significantly different between two randomly sampled pairs of panels was higher than 95% for all respirators. All efficient (passing rate ≥80%) and inefficient (passing rate ≤60%) respirators yielded consistent results (probability >90%) for two randomly sampled panels. Somewhat efficient respirators (passing rate between 60% and 80%) yielded inconsistent results. The passing probabilities and error rates were found to be significantly different between the simulation and binomial calculation. The CV for the 35-member panel was 16.7%, which was slightly lower than that for the 25-member panel (19.8%). Our results suggested that IL inter-panel variability exists, but is relatively small. The variability may be affected by passing level and passing rate. Facial dimension-based fit test panel stratification was also found to have significant impact on inter-panel variability, i.e., it can reduce alpha and beta errors, and inter-panel variability.

Temporal changes in filtering-facepiece respirator fit.

A three-year study examined changes in N95 filtering-facepiece respirator (FFR) fit at six-month intervals and the relationship between fit and changes in weight for 229 subjects. During each visit, subjects performed a total of nine fit tests using three samples of the same FFR model. Inward leakage and filter penetration were measured for each donned respirator to determine face seal leakage (FSL). A total of 195 subjects completed the second visit and 134 subjects completed all seven visits. Acceptable fit was defined as 90th percentile FSL ≤ 5% and at least one fit factor ≥ 100. An unacceptable fit was observed for 14, 10, 7, 12, 15, and 16% of subjects on Visits 2-7, respectively. The predicted risk of an unacceptable fit increased with increasing length of time between fit tests, from 10% at Year 1 to 20% at Year 2 and to 25% at Year 3. Twenty-four percent of subjects who lost ≥ 20 lb had an unacceptable fit; these percentages ranged from 7-17% for subjects with lower weight losses or any degree of weight gain. Results support the current OSHA requirement for annual fit testing and suggest that respirator users who lose more than 20 lb should be re-tested for respirator fit.

Flat fold and cup-shaped N95 filtering facepiece respirator face seal area and pressure determinations: a stereophotogrammetry study.

Twenty subjects underwent quantitative respirator fit testing with two styles (flat fold, cup-shaped) of N95 filtering facepiece respirators (N95 FFRs). Passing a fit test was followed by stereophotogrammetry to determine the face seal area and computation of seal pressure. There were significantly different seal pressures (p < 0.01) between standard size flat fold and cup-shaped N95 FFRs but no significant differences in face seal area. No significant differences were noted in fit factors, but more individuals passed fit testing wearing flat fold respirators. The ability of flat fold N95 FFRs, at lower seal pressures, to obtain similar fit factors as cup-shaped N95 FFR at higher seal pressures offers the possibility of enhanced facial comfort without a loss of protection. Stereophotogrammetry offers a relatively simple, non-invasive technology to evaluate various properties of N95 FFR fit.

Analysis of forces generated by n95 filtering facepiece respirator tethering devices: a pilot study.

The restorative forces of elasticized tethering devices on N95 filtering facepiece respirators (N95 FFR), that occur in response to the application of a load (applied force) during donning, create the requisite pressure to effectively seal the respirator against the face and prevent excessive inward migration of harmful elements. Many workers don and doff the same N95 FFR multiple times in the course of a single workday, yet little is known regarding the possible degradation of these restorative loads and, by implication, protection with multiple donnings. This laboratory pilot study evaluated the degradation in loads of tethering devices of three models of N95 FFRs subjected to the strain of five wear periods of 15 min interspersed with 15-min periods without wear. Data indicate that there were load degradations at each donning that differed significantly with the FFR model (p = <0.001), the greatest of which occurred with the first donning. The N95 FFR model with the lowest restorative loads was able to pass fit testing in a previous study, indicating that lower loads, perhaps coupled with FFR model-specific features, are sufficient to provide an adequate face/FFR interface seal. Tethering devices are importantly related to issues of comfort and protection afforded by N95 FFR and additional research is warranted.