Extended use or reuse of N95 respirators during COVID-19 pandemic: An overview of national regulatory authority recommendations.
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ABSTRACT:
SUBMITTER: Kobayashi LM
PROVIDER: S-EPMC7200848 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
Publications
Extended use or reuse of N95 respirators during COVID-19 pandemic: An overview of national regulatory authority recommendations.
Kobayashi Leticia Mitiko LM Marins Bianca Ramos BR Costa Patrícia Cristina Dos Santos PCDS Perazzo Hugo H Castro Rodolfo R
Infection control and hospital epidemiology 20200422 11
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Project description: Not available
| S-EPMC7318975 | biostudies-literature
Project description:The coronavirus disease 2019 (COVID-19) pandemic created an extraordinary demand for N95 and similarly rated filtering facepiece respirators (FFR) that remains unmet due to limited stock, production constraints, and logistics. Interest in decontamination and reuse of FFR, a product class designed for single use in health care settings, has undergone a parallel surge due to shortages. A worthwhile decontamination method must provide effective inactivation of the targeted pathogen(s), and preserve particle filtration, mask fit, and safety for a subsequent user. This discussion reviews the background of the current shortage, classification, structure, and functional aspects of FFR, and potentially effective decontamination methods along with reference websites for those seeking updated information and guidance. The most promising techniques utilize heat, hydrogen peroxide, microwave-generated steam, or ultraviolet light. Many require special or repurposed equipment and a detailed operational roadmap specific to each setting. While limited, research is growing. There is significant variation between models with regard to the ability to withstand decontamination yet remain protective. The number of times an individual respirator can be reused is often limited by its ability to maintain a tight fit after multiple uses rather than by the decontamination method itself. There is no single solution for all settings; each individual or institution must choose according to their need, capability, and available resources. As the current pandemic is expected to continue for months to years, and the possibility of future airborne biologic threats persists, the need for plentiful, effective respiratory protection is stimulating research and innovation.
| S-EPMC7571614 | biostudies-literature
Project description: Not available
| S-EPMC7971774 | biostudies-literature
Project description:ObjectivesSurgical masks and N95 filtering facepiece respirators (FFRs) prevent the spread of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection and protect medical personnel. Increased demands for surgical masks and N95 FFRs during the coronavirus disease 2019 (COVID-19) pandemic has resulted in the shortage crisis. However, there is no standard protocol for safe reuse of the N95 FFRs. In this systematic review, we aimed to evaluate the effectiveness of existing decontamination methods of surgical masks and N95 FFRs and provide evidence-based recommendations for selecting an appropriate decontamination method.MethodsWe performed systematic searches of Ovid MEDLINE and Ovid EMBASE electronic databases. The last search was performed April 11, 2020. Any trials studying surgical masks and/or N95 FFRs decontamination were included. Outcomes were disinfections of virus and bacteria, restoration of the filtration efficiency, and maintenance of the physical structure of the mask.ResultsOverall, 15 studies and 14 decontamination methods were identified. A low level of evidence supported 4 decontamination methods: ultraviolet (UV) germicidal irradiation (9 studies), moist heat (5 studies), microwave-generated steam (4 studies), and hydrogen peroxide vapor (4 studies). Therefore, we recommended these 4 methods, and we recommended against use were given for the other 10 methods.ConclusionsA low level of evidence supported the use of UV germicidal irradiation, moist heat, microwave-generated steam, and hydrogen peroxide vapor for decontamination and reuse of N95 FFRs. These decontamination methods were effective for viral and bacterial disinfection as well as restoration of the filtration efficiency, and the physical structure of the FFRs.
| S-EPMC7438629 | biostudies-literature
Project description: Not available
| S-EPMC11581496 | biostudies-literature
Project description:BackgroundIn response to supply shortages during the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs or "masks"), which are typically single-use devices in healthcare settings, are routinely being used for prolonged periods and in some cases decontaminated under "reuse" and "extended use" policies. However, the reusability of N95 masks is often limited by degradation or breakage of elastic head bands and issues with mask fit after repeated use. The purpose of this study was to develop a frame for N95 masks, using readily available materials and 3D printing, which could replace defective or broken bands and improve fit.ResultsAn iterative design process yielded a mask frame consisting of two 3D-printed side pieces, malleable wire links that users press against their face, and cut lengths of elastic material that go around the head to hold the frame and mask in place. Volunteers (n= 41; average BMI= 25.5), of whom 31 were women, underwent qualitative fit with and without mask frames and one or more of four different brands of FFRs conforming to US N95 or Chinese KN95 standards. Masks passed qualitative fit testing in the absence of a frame at rates varying from 48 - 92% (depending on mask model and tester). For individuals for whom a mask passed testing, 75-100% (average = 86%) also passed testing with a frame holding the mask in place. Among users for whom a mask failed in initial fit testing, 41% passed using a frame. Success varied with mask model and across individuals.ConclusionsThe use of mask frames can prolong the lifespan of N95 and KN95 masks by serving as a substitute for broken or defective bands without adversely affecting fit. Frames also have the potential to improve fit for some individuals who cannot fit existing masks. Frames therefore represent a simple and inexpensive way of extending the life and utility of PPE in short supply. For clinicians and institutions interested in mask frames, designs and specifications are provided without restriction for use or modification. To ensure adequate performance in clinical settings, qualitative fit testing with user-specific masks and frames is required.
| S-EPMC7386530 | biostudies-literature
Project description:BackgroundIn response to supply shortages caused by the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs or "masks"), which are typically single-use devices in healthcare settings, are routinely being used for prolonged periods and in some cases decontaminated under "reuse" and "extended use" policies. However, the reusability of N95 masks is limited by degradation of fit. Possible substitutes, such as KN95 masks meeting Chinese standards, frequently fail fit testing even when new. The purpose of this study was to develop an inexpensive frame for damaged and poorly fitting masks using readily available materials and 3D printing.ResultsAn iterative design process yielded a mask frame consisting of two 3D printed side pieces, malleable wire links that users press against their face, and cut lengths of elastic material that go around the head to hold the frame and mask in place. Volunteers (n = 45; average BMI = 25.4), underwent qualitative fit testing with and without mask frames wearing one or more of four different brands of FFRs conforming to US N95 or Chinese KN95 standards. Masks passed qualitative fit testing in the absence of a frame at rates varying from 48 to 94 % (depending on mask model). For individuals who underwent testing using respirators with broken or defective straps, 80-100 % (average 85 %) passed fit testing with mask frames. Among individuals who failed fit testing with a KN95, ~ 50 % passed testing by using a frame.ConclusionsOur study suggests that mask frames can prolong the lifespan of N95 and KN95 masks by serving as a substitute for broken or defective bands without adversely affecting fit. Use of frames made it possible for ~ 73 % of the test population to achieve a good fit based on qualitative and quantitative testing criteria, approaching the 85-90 % success rate observed for intact N95 masks. Frames therefore represent a simple and inexpensive way of expanding access to PPE and extending their useful life. For clinicians and institutions interested in mask frames, designs and specifications are provided without restriction for use or modification. To ensure adequate performance in clinical settings, fit testing with user-specific masks and PanFab frames is required.
| S-EPMC8182357 | biostudies-literature
Project description:BackgroundCoronavirus 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.ObjectiveThe goal of this review was to assess the effect of extended use and reuse on respirator fit, with and without decontamination.MethodsSearches 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.ResultsStudies 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.ConclusionBased 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.
| S-EPMC10191141 | biostudies-literature
Project description:BackgroundThere is global shortage of Personal Protective Equipment due to COVID-19 pandemic. N95 Filtering Facepiece Respirators (N95-FFRs) provide respiratory protection against respiratory pathogens including SARS-CoV-2. There is scant literature on reprocessing methods which can enable reuse of N95-FFRs.AimWe conducted this study to evaluate research done, prior to COVID-19 pandemic, on various decontamination methods for reprocessing of N95-FFRs.MethodsWe searched 5 electronic databases (Pubmed, Google Scholar, Crossref, Ovid, ScienceDirect) and 1 Grey literature database (OpenGrey). We included original studies, published prior to year 2020, which had evaluated any decontamination method on FFRs. Studies had evaluated a reprocessing method against parameters namely physical changes, user acceptability, respirator fit, filter efficiency, microbicidal efficacy and presence of chemical residues post-reprocessing.Findings and conclusionsOverall, we found 7887 records amongst which 17 original research articles were finally included for qualitative analysis. Overall, 21 different types of decontamination or reprocessing methods for N95-FFRs were evaluated. Most commonly evaluated method for reprocessing of FFRs was Ultraviolet (Type-C) irradiation (UVGI) which was evaluated in 13/17 (76%) studies. We found published literature was scant on this topic despite warning signs of pandemic of a respiratory illness over the years. Promising technologies requiring expeditious evaluation are UVGI, Microwave generated steam (MGS) and based on Hydrogen peroxide vapor. Global presence of technologies, which have been given Emergency use authorisation for N95-FFR reprocessing, is extremely limited. Reprocessing of N95-FFRs by MGS should be considered for emergency implementation in resource limited settings to tackle shortage of N95-FFRs.Systematic review identifierPROSPERO, PROSPERO ID: CRD42020189684, (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020189684).
| S-EPMC7678983 | biostudies-literature
Project description:IntroductionThe COVID-19 pandemic has unveiled widespread shortages of personal protective equipment including N95 respirators. Several centers are developing reusable stop-gap respirators as alternatives to disposable N95 respirators during public health emergencies, using techniques such as 3D-printing, silicone moulding and plastic extrusion. Effective sealing of the mask, combined with respiratory filters should achieve 95% or greater filtration of particles less than 1um. Quantitative fit-testing (QNFT) data from these stop-gap devices has not been published to date. Our team developed one such device, the "SSM", and evaluated it using QNFT.MethodsDevice prototypes were iteratively evaluated for comfort, breathability and communication, by team members wearing them for 15-30min. The fit and seal were assessed by positive and negative pressure user seal checks. The final design was then formally tested by QNFT, according to CSA standard Z94.4-18 in 40 volunteer healthcare providers. An overall fit-factor >100 is the passing threshold. Volunteers were also tested by QNFT on disposable N95 masks which had passed qualitative fit testing (QLFT) by institutional Occupational Health and Safety Department.ResultsThe SSM scored 3.5/5 and 4/5 for comfort and breathability. The median overall harmonic mean fit-factors of disposable N95 and SSM were 137.9 and 6316.7 respectively. SSM scored significantly higher than disposable respirators in fit-test runs and overall fit-factors (p <0.0001). Overall passing rates in disposable and SSM respirators on QNFT were 65% and 100%. During dynamic runs, passing rates in disposable and SSM respirators were 68.1% and 99.4%; harmonic means were 73.7 and 1643.ConclusionsWe present the design and validation of a reusable N95 stop-gap filtering facepiece respirator that can match existent commercial respirators. This sets a precedence for adoption of novel stop-gap N95 respirators in emergency situations.
| S-EPMC7665821 | biostudies-literature