Journal of the International Society for Respiratory Protection最新文献

Filtering facepiece respirators (FFRs) are manufactured in discrete sizes, with some models being limited in accommodating the fit of some sex and race combinations. This study presents the development of a custom-fit respiratory protective device (RPD) which conforms to a user's facial features and flexes and moves with facial movements during use. Our design also integrates a pressure-sensing network, which continuously monitors fit and will alert the user when the fit is compromised. In this Part II of the three-part series, we design and incorporate a continuous fit monitoring system in the RPD designed in Part I to enhance its role in protecting users from inhalation hazards in an effective manner during its use. The fit monitoring system comprises a fabric-based sensor network integrated into the RPD and an Android-based App designed to alert the user when the pressure at the faceseal falls below a given threshold established during the initial configuration of the RPD for the user. We also develop algorithms for the incorporation of the sensor slots and data buses into the custom-fit RPD using the Taxonomy of Landmarks defined in Part I. We enhance the structure developed in Part I to secure the sensor network during the use of the RPD. We develop algorithms for customizing a fastening hub to suit the head profiles of individuals to enable them to don the RPD quickly, easily, effectively, and in a repeatable manner. We demonstrate the successful application of the total design methodology by creating digital prototypes for three individuals with different facial profiles and make further advances to our goal of ensuring equitable respiratory protection for all including children, for whom RPDs are currently limited.

A manikin fit test method developed by the Center for Disease Control and Prevention's (CDC) National Institute of Occupational Safety and Health (NIOSH) has been proposed as an alternative to fit testing with human subjects. The advantages of a manikin fit test method over actual fit testing are that it does not require human subjects which can be resource intensive, and hence easier to implement. At the beginning of coronavirus 2019 (COVID-19) pandemic, although early studies showed that manikin fit can be maintained after several decontamination cycles, real world evidence obtained using human subjects revealed that the N95 respirators failed only after a few decontamination cycles. The goal of this article was to make modifications to the NIOSH's manikin fit-test method so it can mimic real world performance of N95 respirators better. After making modifications to this method, we then investigated the effect of long-term wear after donning of the respirators, repeated donning and doffing, as well as decontamination methods (i.e. autoclaving and microwave generated steam) on the fit factor. Averaging the overall manikin fit factor across all scenarios, our modified method overpredicted overall fit factor by only 7 % and 14 % compared to adult human subjects using a breathing routine that included simulated heavy breathing rates of 85, and 70 Liters/minute, respectively. In addition, a constant flow produced similar results as cyclic flow using a breathing simulator. The modified test method also offered the following additional insights into reuse of respirators during future pandemics - when reused within a single work shift, more than 5 donnings should be avoided; and microwave generated steam may be a more viable option for decontaminating N95 respirators compared to autoclaving for a single decontamination cycle.

Background: Coronavirus disease 2019 (COVID-19) has led to severe shortages of filtering facepiece respirators (FFRs). As a result, extended use, limited reuse, and FFR decontamination have been utilized to extend the life of single-use FFRs. Although some studies have raised concerns that reuse could affect the FFR's ability to form a seal, no comprehensive literature review of the effect of extended use or limited reuse on FFR seal exists.

Objective: The goal of this review was to assess the effect of extended use and reuse on respirator fit, with and without decontamination.

Methods: Searches of PubMed and Medrxiv yielded 24 papers that included assessment of fit after extended use or limited reuse on a human. One additional handpicked paper was added.

Results: Studies report a wide variation in the number of donnings and doffings before fit failure between different models of respirators. Additionally, while seal checks lack sufficient sensitivity to reliably detect fit failures, individuals who failed fit testing were often able to pass subsequent tests by re-positioning the respirator. Even with failure, respirators often maintained a substantially higher level of fit than a surgical mask, so they may still provide a level of protection in crisis settings.

Conclusion: Based on currently available data, this literature review was unable to establish a consensus regarding the amount of time a respirator can be worn or the number of uses before fit failure will occur. Furthermore, variations in reuses before fit failure between different models of N95 respirators limit the ability to offer a comprehensive recommendation of greater than one reuse or a specific amount of wear time.

During public health emergencies such as an influenza pandemic, disposable filtering facepiece respirator (FFR) shortages have a significant impact on the national response, affecting many types of workplaces that rely on respiratory protection. During the COVID-19 pandemic, severe FFR shortages led the CDC to publish strategies for optimizing the supply of N95 FFRs. These strategies included the extended use and limited reuse of FFRs, wearing decontaminated FFRs, wearing respirators that meet an international respirator standard, or wearing FFRs that were past their manufacturer-designated shelf life. An additional strategy to mitigate supply shortages that was highlighted during the COVID-19 pandemic was to wear reusable respirators, such as elastomeric half mask respirators (EHMRs), or powered air-purifying respirators, which can be cleaned, disinfected, and reused. A decade of nationwide initiatives to increase the utility of EHMRs in healthcare settings were realized during the COVID-19 pandemic as EHMRs became more well-known and were used in healthcare settings for respiratory protection. This expanded use of EHMRs led to an increase in federal procurement, research, guidance, and private sector research and development of innovative EHMR designs by manufacturers to respond to workers' needs for both respiratory protection and source control. This paper describes the role of reusable EHMRs before and during the COVID-19 pandemic, and reviews past and current research, to inform successful EHMR implementation in healthcare and first responder settings.

Reusable elastomeric half mask respirators (EHMRs) have been encouraged for use during conventional, contingency, and crisis capacity in healthcare delivery settings as an alternative to disposable N95 filtering facepiece respirators (FFRs). However, standard, operationalized guidelines for implementing EHMRs in healthcare and first responder settings are needed to facilitate such integration. Specifically, research is needed to identify and address specialized concerns in healthcare delivery settings beyond hospitals to understand the widespread barriers to EHMR use and how organizational culture can support or hinder EHMR adoption. The Strategic National Stockpile (SNS) requested support from the National Institute for Occupational Safety and Health (NIOSH) to develop its strategy to purchase and distribute EHMRs to interested health organizations. To support this SNS effort, NIOSH published a Federal Register Notice (FRN) to request formative input from the public on the nationwide distribution of EHMRs and provided the technical analysis of the responses. Twenty-two representatives from first responder organizations, healthcare and dental associations, manufacturers, higher education, medical/nursing societies, and a union provided comments for consideration. This feedback was qualitatively analyzed to identify themes among the comments. This paper discusses patterns that emerged in the feedback provided within the primary topics of perceived advantages and disadvantages of EHMRs and key considerations for a successful national deployment of EHMRs. This paper also discusses how the formative feedback received was critical to informing the SNS's strategy to purchase and deploy EHMRs for longitudinal demonstration projects with the goal to produce updated EHMR implementation guidelines and best practices.

This article is the third in a series of four articles on respirator history. This article continues to follow the history of respirator approval, use, and improvements in the US as discussed in our article entitled, History of U.S. Respirator Approval, published in the ISRP Journal, Vol. 35, No. 1, 2018 (Spelce. et. al.2018). In addition, a 1957 respirator decision logic diagram illustrates the U.S. Bureau of Mines (USBM) rules to follow for respirator selection (USBM 1957).

The U.S. CDC announced on 04/03/2020 that all citizens should wear face coverings when in public, potentially increasing demand for medical face masks from the public and exacerbating mask shortages for Covid-19 response staff. One solution is reuse after disinfection for the general public. Prior studies have shown that heating for 30 mins at 70°C or above effectively kills SARS, including SARS-CoV-2, and Influenza viruses on masks. Black carbon (BC) particles generated from a kerosene-lamp were used as a proxy for Coronavirus aerosols to test mask performance after disinfection given overlapping size distributions. We determined filtration efficiency (FE) measurements by comparing BC values on both sides of the respirators or masks (Moldex N95 and 3M N95 respirators, HSI surgical masks) placed under vacuum on mannequins. To obtain the maximum FE, each mask type was first measured while taped or modified to tightly fit a mannequin's face when new and after each heating cycle. No reduction in average FE was observed even after 10 disinfection cycles, with FE statistically greater than 95% for N95 respirators and 70% for surgical masks. In sharp contrast, the FE of all medical masks with no additional sealing decreased to ~ 40%, confirming the effectiveness of facial masks relies upon a tight fit. For solving this issue, we designed a method for making individualized custom nose clips to hold a mask tightly to face; FE of 3M N95 respirators and surgical masks remained above 95% and 80%, respectively. Surprisingly, the FE of three homemade thick cloth coverings (in normal use) were 55%. Though more work is still needed, this result supports the public announcements that the public could wear cloth coverings instead of N95 respirators or surgical masks in low-risk environments. When worn with a customized nose clip, N95 respirators and surgical masks have higher FE than the CDC design for cloth coverings.

During the current COVID-19 infectious disease pandemic, the demand for NIOSH-approved filtering facepiece respirators (FFR) has exceeded supplies and decontamination and reuse of FFRs has been implemented by various user groups. FFR decontamination and reuse is only intended to be implemented as a crisis capacity strategy. This paper provides a review of decontamination procedures in the published literature and calls attention to their benefits and limitations. In most cases, the data are limited to a few FFR models and a limited number of decontamination cycles. Institutions planning to implement a decontamination method must understand its limitations in terms of the degree of inactivation of the intended microorganisms and the treatment's effects on the fit and filtration of the device.

During epidemics and pandemics healthcare personnel (HCP) are on the front line of disease containment and mitigation. Personal protective equipment (PPE), such as NIOSH-approved N95 filtering facepiece respirators (FFRs), serve an important role in minimizing HCP risks and are in high demand during public health emergencies. Because PPE demand can exceed supply, various public health strategies have been developed to reduce the rate of PPE consumption as supply dwindles. Extended use and limited reuse of N95 FFRs are strategies advocated by many governmental agencies used to increase the number of times a device can be used. Increased use of respirators designed for reuse-such as powered air-purifying respirators (PAPRs) and elastomeric half-mask and full facepiece air-purifying respirators- is another option designed to reduce the continuous need for new devices as the daily need for respirator use increases. Together, these strategies are designed to reduce the number of PPE units that must be discarded daily and, therefore, extend the longevity of available supply. The purpose of this paper is to theoretically estimate the impact of extended use and limited reuse strategies for N95 FFRs and the increased use of reusable respirator options on PPE consumed. The results suggest that a considerable reduction in PPE consumption would result from extended use and limited reuse of N95 FFRs and the increased use of respirators designed for reuse; however, the practical benefits must be balanced with the risks and economic costs. In addition, extended use and reuse strategies must be accompanied by proper procedures to reduce risk. The study is designed to support epidemic and pandemic PPE supply and demand planning efforts.

During a public health emergency, respirator shortages can have a profound impact on the national response, such as for the current coronavirus disease 2019 (COVID-19) pandemic. Due to a severe shortage of respirators (particularly filtering facepiece respirators [FFRs]), there may be contexts in which understanding the performance of FFRs that are approved for use as part of a crisis capacity strategy is desired. This includes FFRs that are not covered under the National Institute for Occupational Safety and Health (NIOSH) Respirator Approval Program because they have been stored past their designated shelf life, have been decontaminated, or are approved by international certification bodies other than NIOSH. The purpose of this document is to provide a general framework to assess the performance of FFRs that are only being used as a crisis capacity strategy. The intended audience are those who are responsible for managing large amounts of FFRs. This framework includes a four-step process consisting of: 1) defining the population of FFRs to be sampled; 2) providing sampling strategy options; 3) inspecting and testing the sampled units; and 4) evaluating the results. In addition to the four-step process, we provide an example of how NIOSH recently evaluated the quality of FFRs sampled from ten U.S. stockpiles.