Discrepancy of particle passage in 101 mask batches during the first year of the Covid-19 pandemic in Germany.

During the first wave of Covid-19 infections in Germany in April 2020, clinics reported a shortage of filtering face masks with aerosol retention> 94% (FFP2 & 3, KN95, N95). Companies all over the world increased their production capacities, but quality control of once-certified materials and masks came up short. To help identify falsely labeled masks and ensure safe protection equipment, we tested 101 different batches of masks in 993 measurements with a self-made setup based on DIN standards. An aerosol generator provided a NaCl test aerosol which was applied to the mask. A laser aerosol spectrometer measured the aerosol concentration in a range from 90 to 500 nm to quantify the masks' retention. Of 101 tested mask batches, only 31 batches kept what their label promised. Especially in the initial phase of the pandemic in Germany, we observed fluctuating mask qualities. Many batches show very high variability in aerosol retention. In addition, by measuring with a laser aerosol spectrometer, we were able to show that not all masks filter small and large particles equally well. In this study we demonstrate how important internal and independent quality controls are, especially in times of need and shortage of personal protection equipment.

Applying heat and humidity using stove boiled water for decontamination of N95 respirators in low resource settings.

Global shortages of N95 respirators have led to an urgent need of N95 decontamination and reuse methods that are scientifically validated and available world-wide. Although several large scale decontamination methods have been proposed (hydrogen peroxide vapor, UV-C); many of them are not applicable in remote and low-resource settings. Heat with humidity has been demonstrated as a promising decontamination approach, but care must be taken when implementing this method at a grassroots level. Here we present a simple, scalable method to provide controlled humidity and temperature for individual N95 respirators which is easily applicable in low-resource settings. N95 respirators were subjected to moist heat (>50% relative humidity, 65-80°C temperature) for over 30 minutes by placing them in a sealed container immersed in water that had been brought to a rolling boil and removed from heat, and then allowing the containers to sit for over 45 minutes. Filtration efficiency of 0.3-4.99 µm incense particles remained above 97% after 5 treatment cycles across all particle size sub-ranges. This method was then repeated at a higher ambient temperature and humidity in Mumbai, using standard utensils commonly found in South Asia. Similar temperature and humidity profiles were achieved with no degradation in filtration efficiencies after 6 cycles. Higher temperatures (>70°C) and longer treatment times (>40 minutes) were obtained by insulating the outer vessel. We also showed that the same method can be applied for the decontamination of surgical masks. This simple yet reliable method can be performed even without electricity access using any heat source to boil water, from open-flame stoves to solar heating, and provides a low-cost route for N95 decontamination globally applicable in resource-constrained settings.

Impact on the fitness of N95 masks with extended use/limited reuse and dry heat decontamination.

Substandard use of N95 masks, sometimes combined with dry heat decontamination, lacks safety data. We evaluated the impact of these practices on the fitness of N95 masks. This is a non-human subject research conducted from July to October 2020. 155 masks were used by 12 healthcare workers during 10-hour shifts. Masks were collected at the end of the shift and if the number of donnings/doffings was less than five ('modified extended use', ME) or whenever this number reached five ('limited reuse', LR), per the recommendation of the Centers for Disease Control and Prevention. Masks that passed an Occupational Safety and Health Administration qualitative fit test underwent a cycle (30 min, 75°C) of dry heat decontamination. After use, 84% (95% CI 77% to 90%) of the masks fit the users, 85% (95% CI 73% to 93%) in ME and 83% (95% CI 73% to 90%) in LR. After dry heat, 86% of the fitted masks (95% CI 78% to 91%) still fit, 93% (95% CI 80% to 98%) in ME and 82% (95% CI 70% to 89%) in LR. If a fit test was not done before decontamination, 72% (95% CI 64% to 79%) of the masks would fit, 79% (95% CI 66% to 88%) in ME and 68% (95% CI 57% to 77%) in LR. Common substandard use preserves fitness of N95 masks up to 85%. One cycle of dry heat decontamination preserves fitness of N95 masks up to 93% when donned/doffed less than five times and fitness is ensured before decontamination. If a fit test is not performed beforehand, dry heat decontamination cannot preserve the fitness of used N95 masks above 80%.

The COVID-19 pandemic and N95 masks: reusability and decontamination methods.

BACKGROUND: With the current SARS-CoV-2 pandemic, many healthcare facilities are lacking a steady supply of masks worldwide. This emergency situation warrants the taking of extraordinary measures to minimize the negative health impact from an insufficient supply of masks. The decontamination, and reuse of healthcare workers' N95/FFP2 masks is a promising solution which needs to overcome several pitfalls to become a reality. AIM: The overall aim of this article is to provide the reader with a quick overview of the various methods for decontamination and the potential issues to be taken into account when deciding to reuse masks. Ultraviolet germicidal irradiation (UVGI), hydrogen peroxide, steam, ozone, ethylene oxide, dry heat and moist heat have all been methods studied in the context of the pandemic. The article first focuses on the logistical implementation of a decontamination system in its entirety, and then aims to summarize and analyze the different available methods for decontamination. METHODS: In order to have a clear understanding of the research that has already been done, we conducted a systematic literature review for the questions: what are the tested methods for decontaminating N95/FFP2 masks, and what impact do those methods have on the microbiological contamination and physical integrity of the masks? We used the results of a systematic review on the methods of microbiological decontamination of masks to make sure we covered all of the recommended methods for mask reuse. To this systematic review we added articles and studies relevant to the subject, but that were outside the limits of the systematic review. These include a number of studies that performed important fit and function tests on the masks but took their microbiological outcomes from the existing literature and were thus excluded from the systematic review, but useful for this paper. We also used additional unpublished studies and internal communication from the University of Geneva Hospitals and partner institutions. RESULTS: This paper analyzes the acceptable methods for respirator decontamination and reuse, and scores them according to a number of variables that we have defined as being crucial (including cost, risk, complexity, time, etc.) to help healthcare facilities decide which method of decontamination is right for them. CONCLUSION: We provide a resource for healthcare institutions looking at making informed decisions about respirator decontamination. This informed decision making will help to improve infection prevention and control measures, and protect healthcare workers during this crucial time. The overall take home message is that institutions should not reuse respirators unless they have to. In the case of an emergency situation, there are some safe ways to decontaminate them.

Retracted: Facemasks in the COVID-19 era: A health hypothesis.

Many countries across the globe utilized medical and non-medical facemasks as non-pharmaceutical intervention for reducing the transmission and infectivity of coronavirus disease-2019 (COVID-19). Although, scientific evidence supporting facemasks' efficacy is lacking, adverse physiological, psychological and health effects are established. Is has been hypothesized that facemasks have compromised safety and efficacy profile and should be avoided from use. The current article comprehensively summarizes scientific evidences with respect to wearing facemasks in the COVID-19 era, providing prosper information for public health and decisions making.

Association of In-Ear Device Use With Communication Quality Among Individuals Wearing Personal Protective Equipment in a Simulated Operating Room.

Importance: The COVID-19 pandemic has brought forth new challenges for health care workers, such as the daily use of personal protective equipment, including reusable facial respirators. Poor communication while wearing respirators may have fatal complications for patients, and no solution has been proposed to date. Objective: To examine whether use of an in-ear communication device is associated with improved communication while wearing different personal protective equipment (N95 mask, half-face elastomeric respirator, and powered air-purifying respirator [PAPR]) in the operating room. Design, Setting, and Participants: This quality improvement study was conducted in June 2020. Surgical residents from the Department of Otolaryngology-Head and Neck Surgery at McGill University in Montreal, Quebec, Canada, were recruited. All participants had normal hearing, were fluent in English, and had access to the operating rooms at the Royal Victoria Hospital. Exposures: All participants performed the speech intelligibility tasks with and without an in-ear communication device. Main Outcomes and Measures: Speech intelligibility was measured using a word recognition task (Modified Rhyme Test) and a sentence recognition task (AzBio Sentence Test). A percentage correct score (0% to 100%) was obtained for each speech intelligibility test. Listening effort was assessed using the NASA Task Load Index. An overall workload score, ranging from 0 points (low workload) to 100 points (high workload), was obtained. Results: A total of 12 participants were included (mean [SD] age, 31.2 [1.9] years; 8 women [66.7%]). AzBio Sentence Test results revealed that, while wearing the N95 mask, the mean (SD) speech intelligibility was 98.8% (1.8%) without the in-ear device vs 94.3% (7.4%) with the device. While wearing the half-face elastomeric respirator, the mean speech intelligibility was 58.5% (12.4%) without the in-ear device vs 90.8% (8.9%) with the device. While wearing the PAPR, the mean speech intelligibility was 84.6% (9.8%) without the in-ear device vs 94.5% (5.5%) with the device. Use of the in-ear device was associated with a significant improvement in speech intelligibility while wearing the half-face elastomeric respirator (32.3%; 95% CI, 23.8%-40.7%; P < .001) and the PAPR (9.9%; 95% CI, 1.4%-18.3%; P = .01). Furthermore, use of the device was associated with decreased listening effort. The NASA Task Load Index results reveal that, while wearing the N95 mask, the mean (SD) overall workload score was 12.6 (10.6) points without the in-ear device vs 17.6 (9.2) points with the device. While wearing the half-face elastomeric respirator, the mean overall workload score was 67.7 (21.6) points without the in-ear device vs 29.3 (14.4) points with the in-ear device. While wearing the PAPR, the mean overall workload score was 42.2 (18.2) points without the in-ear device vs 23.8 (12.8) points with the in-ear device. Use of the in-ear device was associated with a significant decrease in overall workload score while wearing the half-face elastomeric respirator (38.4; 95% CI, 23.5-53.3; P < .001) and the PAPR (18.4; 95% CI, 0.4-36.4; P = .04). Conclusions and Relevance: This study found that among participants using facial respirators that impaired communication, a novel in-ear device was associated with improved communication and decreased listening effort. Such a device may be a feasible solution for protecting health care workers in the operating room while allowing them to communicate safely, especially during the COVID-19 pandemic.

Personal protective equipment for reducing the risk of COVID-19 infection among health care workers involved in emergency trauma surgery during the pandemic: An umbrella review.

BACKGROUND: Health care facilities in low- and middle-income countries are inadequately resourced to adhere to current COVID-19 prevention recommendations. Recommendations for surgical emergency trauma care measures need to be adequately informed by available evidence and adapt to particular settings. To inform future recommendations, we set to summarize the effects of different personal protective equipment (PPE) on the risk of COVID-19 infection in health personnel caring for trauma surgery patients. METHODS: We conducted an umbrella review using Living Overview of Evidence platform for COVID-19, which performs regular automated searches in MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and more than 30 other sources. Systematic reviews of experimental and observational studies assessing the efficacy of PPE were included. Indirect evidence from other health care settings was also considered. Risk of bias was assessed with the AMSTAR II tool (Assessing the Methodological Quality of Systematic Reviews, Ottawa, ON, Canada), and the Grading of Recommendations, Assessment, Development, and Evaluation approach for grading the certainty of the evidence is reported (registered in International Prospective Register of Systematic Reviews, CRD42020198267). RESULTS: Eighteen studies that fulfilled the selection criteria were included. There is high certainty that the use of N95 respirators and surgical masks is associated with a reduced risk of COVID-19 when compared with no mask use. In moderate- to high-risk environments, N95 respirators are associated with a further reduction in risk of COVID-19 infection compared with surgical masks. Eye protection also reduces the risk of contagion in this setting. Decontamination of masks and respirators with ultraviolet germicidal irradiation, vaporous hydrogen peroxide, or dry heat is effective and does not affect PPE performance or fit. CONCLUSION: The use of PPE drastically reduces the risk of COVID-19 compared with no mask use in health care workers. N95 and equivalent respirators provide more protection than surgical masks. Decontamination and reuse appear feasible to overcome PPE shortages and enhance the allocation of limited resources. These effects are applicable to emergency trauma care and should inform future recommendations. LEVEL OF EVIDENCE: Review, level II.

Evaluation of N95 respirators, modified snorkel masks and low-cost powered air-purifying respirators: a prospective observational cohort study in healthcare workers.

Disposable N95 respirator masks are the current standard for healthcare worker respiratory protection in the COVID-19 pandemic. In addition to shortages, qualitative fit testing can have low sensitivity for detecting poor fit, leading to inconsistent protection. Multiple groups have developed alternative solutions such as modified snorkel masks to overcome these limitations, but validation of these solutions has been lacking. We sought to determine if N95s and snorkel masks with attached high-efficiency filters provide consistent protection levels in healthcare workers and if the addition of positive pressure via an inexpensive powered-air purifying respirator to the snorkel mask would provide enhanced protection. Fifty-one healthcare workers who were qualitatively fitted with N95 masks underwent quantitative mask fit testing according to a simulated workplace exercise protocol. N95, snorkel masks with high-efficiency filters and snorkel masks with powered-air purifying respirators were tested. Respiratory filtration ratios were collected for each step and averaged to obtain an overall workplace protocol fit factor. Failure was defined as either an individual filtration ratio or an overall fit factor below 100. N95s and snorkel masks with high-efficiency filters failed one or more testing steps in 59% and 20% of participants, respectively, and 24% and 12% failed overall fit factors, respectively. The snorkel masks with powered-air purifying respirators had zero individual or overall failures. N95 and snorkel masks with high-efficiency filter respirators were found to provide inconsistent respiratory protection in healthcare workers.

Should emergency medical service stuff use respirators with filtered valve in COVID-19 pandemic?

Performing medical procedures with the use of personal protective equipment may reduce the efficiency of medical procedures performed, for example, as with the current use of respiratory protection devices, including N95 or surgical masks. Healthcare workers (HCWs) using N95 respirators or medical masks may experience discomfort associated with wearing a mask when performing medical procedures, in particular those associated with increased physical activity, causing increased respiratory effort.

Distribution of low quality filtering facepiece respirators during the COVID-19 pandemic: an independent analysis of the situation in Switzerland.

BACKGROUND: SARS-CoV-2 is a respiratory virus. Transmission occurs by droplets, contact and aerosols. In medical settings, filtering facepiece (FFP) respirators are recommended for use by personnel exposed to aerosol-generating procedures. During the COVID-19 pandemic, the demand for FFP respirators exceeded their supply worldwide and low-quality products appeared on the market, potentially putting healthcare workers at risk. AIMS: To raise awareness about variations in quality of imported FFP respirators in Switzerland during the COVID-19 pandemic, to draw attention to the current directives regulating the market launch of FFP respirators in Switzerland, to provide practical support in identifying suspicious products or documents and, finally, to offer strategies aimed at reducing the distribution of low-quality FFP respirators in the future. METHODS: Three Swiss laboratories, Spiez Laboratory and Unisanté in partnership with TOXpro SA individually set up testing procedures to evaluate aerosol penetration and fit testing of FFP respirators imported into Switzerland during COVID-19 pandemic. Additionally, Spiez Laboratory visually inspected the products, examined the certification documents and crosschecked the product information with international databases. RESULTS: Between 31 March and 15 June 2020, 151 FFP respirators were analysed. The initial assessment performed before testing allowed a reduction of up to 35% in the number of FFP respirators sent to Spiez Laboratory for evaluation, for which product information found to be faulty. After filtration efficiency evaluation and fit testing, 52% and 60% of all products tested by Spiez Laboratory and Unisanté-TOXpro SA, respectively, did not meet the minimum performance requirements established independently by the three Swiss laboratories. CONCLUSION: The demand for FFP respirators exceeded the supply capacity from established suppliers of the Swiss market. New production and import channels emerged, as did the number of poor-quality FFP respirators. FFP respirators remaining in stocks should be checked for conformity before being used, or eliminated and replaced if quality does not meet standards.

Comparing the fit of N95, KN95, surgical, and cloth face masks and assessing the accuracy of fit checking.

INTRODUCTION: The COVID-19 pandemic has made well-fitting face masks a critical piece of protective equipment for healthcare workers and civilians. While the importance of wearing face masks has been acknowledged, there remains a lack of understanding about the role of good fit in rendering protective equipment useful. In addition, supply chain constraints have caused some organizations to abandon traditional quantitative or/and qualitative fit testing, and instead, have implemented subjective fit checking. Our study seeks to quantitatively evaluate the level of fit offered by various types of masks, and most importantly, assess the accuracy of implementing fit checks by comparing fit check results to quantitative fit testing results. METHODS: Seven participants first evaluated N95 and KN95 respirators by performing a fit check. Participants then underwent quantitative fit testing wearing five N95 respirators, a KN95 respirator, a surgical mask, and fabric masks. RESULTS: N95 respirators offered higher degrees of protection than the other categories of masks tested; however, it should be noted that most N95 respirators failed to fit the participants adequately. Fit check responses had poor correlation with quantitative fit factor scores. KN95, surgical, and fabric masks achieved low fit factor scores, with little protective difference recorded between respiratory protection options. In addition, small facial differences were observed to have a significant impact on quantitative fit. CONCLUSION: Fit is critical to the level of protection offered by respirators. For an N95 respirator to provide the promised protection, it must fit the participant. Performing a fit check via NHS self-assessment guidelines was an unreliable way of determining fit.

Decontaminating N95 Respirators for Reuse in a Hospital Setting.

With the global outbreak of the COVID-19 pandemic, hospitals in Canada and around the world have been forced to consider conservation strategies to ensure continued availability of personal protective equipment (PPE) for healthcare providers. To mitigate critical PPE shortages, Sinai Health System (Sinai Health), a large academic healthcare institution in Canada, has developed and operationalized a standard operating procedure for the collection, decontamination and reuse of N95 respirators and other single-use PPE using a vaporized hydrogen peroxide decontamination method. Sinai Health has incorporated stringent quality assurance steps to ensure that the N95 respirators are successfully decontaminated without deformation and are safe to use.

KN95 filtering facepiece respirators distributed in South Africa fail safety testing protocols.

BACKGROUND: Given the global shortage of N95 filtering facepiece respirators (FFP2 in Europe) during the COVID-19 pandemic, KN95 masks (Chinese equivalent of the N95 and FFP2) were imported and distributed in South Africa (SA). However, there are hardly any published independent safety data on KN95 masks. OBJECTIVES: To evaluate the seal, fit and filtration efficiency of several brands of KN95 masks marketed for widespread use in SA healthcare facilities, using standardised testing protocols. METHODS: The verifiability of manufacturer and technical details was first ascertained, followed by evaluation of the number of layers comprising the mask material. The testing protocol involved a directly observed positive and negative pressure user seal check, which if passed was followed by qualitative fit testing (sodium saccharin) in healthy laboratory or healthcare workers. Quantitative fit testing (3M) was used to validate the qualitative fit testing method. The filtration efficacy and integrity of the mask filter material were evaluated using a particle counter-based testing rig utilising aerosolised saline (expressed as filtration efficacy of 0.3 µm particles). Halyard FLUIDSHIELD 3 N95 and 3M 1860 N95 masks were used as controls. RESULTS: Twelve KN95 mask brands (total of 36 masks) were evaluated in 7 participants. The mask type and manufacturing details were printed on only 2/12 brands (17%) as per National Institute of Occupational Safety and Health and European Union regulatory requirements. There was considerable variability in the number of KN95 mask layers (between 3 and 6 layers in the 12 brands evaluated). The seal check pass rate was significantly lower in KN95 compared with N95 masks (1/36 (3%) v. 12/12 (100%); p<0.0001). Modification of the KN95 ear-loop tension using head straps or staples, or improving the facial seal using Micropore 3M tape, enhanced seal test performance in 15/36 KN95 masks evaluated (42%). However, none of these 15 passed downstream qualitative fit testing compared with the control N95 masks (0/15 v. 12/12; p<0.0001). Only 4/8 (50%) of the KN95 brands tested passed the minimum filtration requirements for an N95 mask (suboptimal KN95 filtration efficacy varied from 12% to 78%, compared with 56% for a surgical mask and >99% for the N95 masks at the 0.3 µm particle size). CONCLUSIONS: The KN95 masks tested failed the stipulated safety thresholds associated with protection of healthcare workers against airborne pathogens such as SARS-CoV-2. These preliminary data have implications for the regulation of masks and their distribution to healthcare workers and facilities in SA.

Decontaminating N95 respirators during the COVID-19 pandemic: simple and practical approaches to increase decontamination capacity, speed, safety and ease of use.

BACKGROUND: The COVID-19 pandemic has caused a severe shortage of personal protective equipment (PPE), especially N95 respirators. Efficient, effective and economically feasible methods for large-scale PPE decontamination are urgently needed. AIMS: (1) to develop protocols for effectively decontaminating PPE using vaporized hydrogen peroxide (VHP); (2) to develop novel approaches that decrease set-up and take-down time while also increasing decontamination capacity; (3) to test decontamination efficiency for N95 respirators heavily contaminated by make-up or moisturizers. METHODS: We converted a decommissioned Biosafety Level 3 laboratory into a facility that could be used to decontaminate N95 respirators. N95 respirators were hung on metal racks, stacked in piles, placed in paper bags or covered with make-up or moisturizer. A VHP® VICTORY™ unit from STERIS was used to inject VHP into the facility. Biological and chemical indicators were used to validate the decontamination process. FINDINGS: N95 respirators individually hung on metal racks were successfully decontaminated using VHP. N95 respirators were also successfully decontaminated when placed in closed paper bags or if stacked in piles of up to six. Stacking reduced the time needed to arrange N95 respirators for decontamination by approximately two-thirds while almost tripling facility capacity. Make-up and moisturizer creams did not interfere with the decontamination process. CONCLUSIONS: Respirator stacking can reduce the hands-on time and increase decontamination capacity. When personalization is needed, respirators can be decontaminated in labelled paper bags. Make up or moisturizers do not appear to interfere with VHP decontamination.

Process for disinfection of N95 respirators during COVID-19 utilizing sterile processing department: A single center acute care hospital.

During the COVID-19 crisis, disposable N-95 filtering face piece respirators became a critical supply in many health care institutions. Infection preventionists nationwide struggled with ensuring their facilities had personal protective equipment available while utilizing crisis capacity strategies. Many facilities began using US Centers for Disease Control and Prevention and US Food and Drug Administration guidance to disinfect and reprocess N95 respirators for extended use. N95 respirators are collected for all clinical units on a scheduled basis by the sterile processing department (SPD) in individually labeled bins. Bins are checked into SPD and logged into electronic system to track mask volumes by unit. Masks are inspected by SPD team members, packaged in sterile peel packs on the decontamination side and sent to the clean side of the department. Masks are then reprocessed in the appropriate equipment based on the US Food and Drug Administration Emergency Use Authorization guidelines. The facility was able to provide a consistent method of N95 reprocessing throughout the facility. Utilizing an interdisciplinary team to include the operating room, infection preventionist, SPD, and nursing leadership to troubleshoot and identify barriers on a routine basis was key to making the program a success for the many months of the COVID-19 pandemic.