Measurement of inward leakage of full-face masks in EN and ISO standards: comparison of gas and aerosol test agents.

In Europe, respiratory protective devices must be certified before they can be marketed. Among the parameters of interest, inward leakage (IL) characterizes the tightness between the face seal and the face, to verify that the device is well-designed. European standard EN 13274-1 (2001) and International Organization for Standardization (ISO) standard ISO 16900-1 (2019) specify that IL should be measured using sodium chloride (NaCl) aerosol or sulfur hexafluoride (SF6) gas. For reusable masks made of nonporous materials, both test agents are considered equally acceptable. However, the few studies that have compared IL values measured with various aerosols and gases have come to divergent conclusions. This work then aimed to measure IL with the test agents recommended by the standards to determine whether they are really equivalent. Since krypton (Kr) is an interesting candidate for replacing SF6 in standard tests, IL was assessed with SF6 and Kr simultaneously, and with NaCl aerosol using various calculation methods. Tests were carried out on 5 models of full-face masks donned on a headform connected to a breathing machine simulating 3 sinusoidal breathing rates of various intensities. The respirator fit on the headform was evaluated using a controlled negative pressure method to determine a manikin fit factor. Four scenarios were then tested to represent very poor, bad, good, and excellent fit. Gas concentration was measured using a mass spectrometer, and IL was calculated for SF6 and Kr. A combination of 3 devices allowed the determination of the number-based concentration of particles with diameters between 20 nm and 2 µm, and IL was calculated for each of the 33 channels, as well as using a cumulative number concentration. In addition, to comply with standards, a conversion was carried out to calculate IL using a cumulative mass concentration. The results of this work evidenced that the IL values measured with NaCl were systematically lower than those determined with gases. IL was also shown to vary with particle size, with a maximum value exceeding that calculated with cumulative concentrations (in number or mass). As part of the revision of the standards, protocols for measuring inward leakage should be redefined. On the one hand, acceptability thresholds should be re-evaluated according to the nature of the test agent (gas or aerosol), as it is clear that the 2 options do not give the same results for a given configuration. On the other hand, the aerosol leakage measurement protocol needs to be reworked to enable the measurement of a well-defined, robust, and reproducible inward leakage value.

Respiratory protective device: One size to fit them all?

When exposed to hazardous or toxic substances, workers may be required to wear respiratory protective devices, selected in accordance with the pollutant, required protection level, individual characteristics, and work conditions. To emphasize the importance of the selection procedure, this study aimed to investigate the effects of the facial dimensions and breathing rate on the fit and the protection efficiency provided by full-face respirators. Manikin total efficiency measurements (mTEs) were then conducted on five head forms of various facial dimensions equipped with nine respirators of different models and sizes. A breathing machine simulating sinusoidal breathing rates was used to represent seven work rates, from rest to maximal intensity. For each experiment, the manikin fit factor (mFF), characterizing the respirator fit on the head form, was measured by a controlled negative pressure method. By varying the head form, respirator, breathing rate, and mFF, a total of 485 values of mTE were measured. Findings indicate that even if the respirator was equipped with a high-efficiency filter, mTE strongly decreases if the respirator does not fit the face of the wearer. In particular, it was highlighted that one given respirator cannot fit all facial dimensions and that the best match between the respirator size and facial dimensions is difficult to predict because respirator sizes are not standardized. Moreover, although the total efficiency of a well-fitted respirator naturally decreases when increasing the breathing rate due to filtration mechanisms, the reduction is more significant if the respirator does not fit well. To consider both the mTE and the breathing resistance, a quality factor value was determined for each tested combination of head form, respirator, and breathing rate. The maximum manikin fit factor mFFmax measured for each combination of head form and respirator was compared to that measured on nine human subjects with similar facial dimensions, providing encouraging results concerning the use of head forms during respirator testing.

Efficiency of Community Face Coverings and Surgical Masks to Limit the Spread of Aerosol.

In the current pandemic context of COVID-19, people wear different types of masks, particularly in their workplace, to limit the spread of the virus. Depending on their activity and work environment, employees are required to wear community face coverings, cloth masks with a transparent windows, surgical masks, reusable masks, or respirators. The objective of this study was to evaluate the efficiency as source control of these masks, i.e., when worn to protect the environment from the spread of particles emitted by the wearer. An experimental test bench including a dummy head and a breathing simulator associated with a DEHS droplet generator emitting 1 or 3 µm particles in the exhaled stream is used. Source control efficiency is calculated from the total flux of particles emitted in the test section without and with a mask. Seventeen models of masks are tested. Three breathing rate conditions were studied: from rest to heavy breathing, with average rates of 13, 27, and 45 L/min. Source control efficiencies vary from one mask to another. Among community face coverings (seven models) the values ranged from 15.6 to 33.8% for a medium intensity breath. The efficiencies of surgical masks (three models) ranged from 17.4 to 28.3% for the same breathing cycle. The community face coverings and the disposable surgical masks present equivalent values of source control efficiency, respectively, 25.9 and 24.1% at 1 µm and 31.5 and 23.2% at 3 µm. The respirators show higher source control efficiency than the other types of masks (76.7% at 1 µm and 82.5% at 3 µm). The statistical analysis of the data shows no effect of the breathing flow rate and an interaction effect between mask type and particle size. No differences in source control were found for the two particle sizes or the different experimental breathing rates for the respirators and the surgical masks. But the community face coverings and the cloth masks with transparent window present a source control efficiency which increases with the particle size. Varying levels of efficiency were measured with higher source control for respirators than for other types of masks. In the context of a respiratory protection programme, they can provide an effective barrier to the spread of the virus. But these results show also that no mask can stop all the particles emitted by its wearer. Regardless of the type of mask, other barrier measures (ventilation, social distancing, and hygiene) are then necessary.

Reuse of medical face masks in domestic and community settings without sacrificing safety: Ecological and economical lessons from the Covid-19 pandemic.

The need for personal protective equipment increased exponentially in response to the Covid-19 pandemic. To cope with the mask shortage during springtime 2020, a French consortium was created to find ways to reuse medical and respiratory masks in healthcare departments. The consortium addressed the complex context of the balance between cleaning medical masks in a way that maintains their safety and functionality for reuse, with the environmental advantage to manage medical disposable waste despite the current mask designation as single-use by the regulatory frameworks. We report a Workflow that provides a quantitative basis to determine the safety and efficacy of a medical mask that is decontaminated for reuse. The type IIR polypropylene medical masks can be washed up to 10 times, washed 5 times and autoclaved 5 times, or washed then sterilized with radiations or ethylene oxide, without any degradation of their filtration or breathability properties. There is loss of the anti-projection properties. The Workflow rendered the medical masks to comply to the AFNOR S76-001 standard as "type 1 non-sanitory usage masks". This qualification gives a legal status to the Workflow-treated masks and allows recommendation for the reuse of washed medical masks by the general population, with the significant public health advantage of providing better protection than cloth-tissue masks. Additionally, such a legal status provides a basis to perform a clinical trial to test the masks in real conditions, with full compliance with EN 14683 norm, for collective reuse. The rational reuse of medical mask and their end-of-life management is critical, particularly in pandemic periods when decisive turns can be taken. The reuse of masks in the general population, in industries, or in hospitals (but not for surgery) has significant advantages for the management of waste without degrading the safety of individuals wearing reused masks.

Workplace Respiratory Protection Factors during Asbestos Removal Operations.

Numerous changes have been made to the French labour regulations in recent years relating to the prevention of risks of exposure to asbestos fibres for operators removing asbestos-containing materials. These changes refer to the method used to count fibres, the collective and personal protective devices to be used on these worksites, and the occupational exposure limit value, which was reduced to 10 f.L-1 on 2 July 2015. In this context, this study assessed the level of respiratory protection afforded by supplied-air respirators and powered air-purifying respirators by monitoring exposure for several operators on nine worksites. The levels of dustiness measured in personal samples taken outside masks showed significant evidence of potential exposure during removal of asbestos-containing plaster or sprayed asbestos, and when using abrasive blasting to treat asbestos-containing materials. For these tasks outside concentration regularly exceeds 25000 f.L-1. Measurements inside masks were generally low, under 10 f.L-1, except in some situations involving the removal of asbestos-containing plaster. This partial penetration of fibres inside masks could be due to the high loading linked to this material. The distributions of Workplace Protection Factors obtained for the two types of respiratory protective devices studied were broad, and the fifth percentile values equal to 236 and 104, respectively, for supplied-air respirators and powered air-purifying respirators. This work highlights once again the need to prioritize collective protection when seeking to prevent asbestos-related risks.