Decontamination Of Filtering Facepiece Respirators Research Articles

Filtration performance, fit test and side effects of respiratory personal protective equipment following decontamination: Observations for user safety and comfort.

While facing personal protective equipment (PPE) shortages during the COVID-19 pandemic, several institutions looked to PPE decontamination and reuse options. This study documents the effect of two hydrogen peroxide treatments on filtration efficiency and fit tests as well as the side effects for volunteers after the decontamination of N95 filtering facepiece respirators (FFRs). We also propose an efficient and large-scale treatment protocol that allows for the traceability of this protective equipment in hospitals during PPE shortages. The effects of low-temperature hydrogen peroxide sterilization and hydrogen peroxide vapor (HPV) on two FFR models (filtration, decontamination level, residual emanation) were evaluated. Ten volunteers reported comfort issues and side effects after wearing 1h FFRs worn and decontaminated up to five times. The decontamination process does not negatively affect FFR efficiency, but repeated use and handling tend to lead to damage, limiting the number of times FFRs can be reused. Moreover, the recommended 24-h post-treatment aeration does not sufficiently eliminate residual hydrogen peroxide. Prolonged aeration time increased user comfort when using decontaminated FFRs. HPV and low-temperature hydrogen peroxide sterilization seem to be appropriate treatments for FFR decontamination when the PPE is reused by the same user. PPE decontamination and reuse methods should be carefully considered as they are critical for the comfort and safety of healthcare workers.

Filtration performance of three models of N95 filtering facepiece respirators following clinical usage and vaporized hydrogen peroxide decontamination

N95 filtering facepiece respirators (FFRs) are essential personal protective equipment (PPE) for protecting healthcare workers from airborne pathogens. To perform the first large-scale evaluation of particulate filtration efficiency (PFE) of three models of N95 FFRs following clinical usage and vaporized hydrogen peroxide (VHP) decontamination. Three variables were assessed for effect on PFE following VHP decontamination: VHP sterilizer model, N95 respirator model, and prior N95 clinical usage. The VHP sterilizer model and N95 FFR model impacted PFE performance. Worn N95 FFRs had a 91% lower odds of exhibiting ≥95% PFE compared with the control. This work highlights the importance of validating any N95 FFR decontamination programme in its entirety, including prior clinical usage.

Kenneth Theodore Evans

<h3>Abstract</h3> N95 filtering facepiece respirators (FFRs) are essential for the protection of healthcare professionals and other high-risk groups against Coronavirus Disease of 2019 (COVID-19). In response to shortages in FFRs...

Effect of gamma irradiation on filtering facepiece respirators and SARS-CoV-2 detection

To cope with the shortage of filtering facepiece respirators (FFRs) during the coronavirus (COVID-19) pandemic, healthcare institutions were forced to reuse FFRs after applying different decontamination methods including gamma-irradiation (GIR). The aim of this study was to evaluate the effect of GIR on the filtration efficiency (FE) of FFRs and on SARS-CoV-2 detection. The FE of 2 FFRs types (KN95 and N95-3 M masks) was assessed at different particle sizes (0.3–5 µm) following GIR (0–15 kGy) delivered at either typical (1.65 kGy/h) or low (0.5088 kGy/h) dose rates. The detection of two SARS-CoV-2 RNA genes (E and RdRp4) following GIR (0–50 kGy) was carried out using RT-qPCR assay. Both masks showed an overall significant (P < 0.001) reduction in FE with increased GIR doses. No significant differences were observed between GIR dose rates on FE. The GIR exhibited significant increases (P ≤ 0.001) in the cycle threshold values (ΔCt) of both genes, with no detection following high doses. In conclusion, complete degradation of SARS-CoV-2 RNA can be achieved by high GIR (≥ 30 kGy), suggesting its potential use in FFRs decontamination. However, GIR exhibited adverse effects on FE in dose- and particle size-dependent manners, rendering its use to decontaminate FFRs debatable.

Evaluation of at-home methods for N95 filtering facepiece respirator decontamination

N95 filtering facepiece respirators (FFRs) are essential for the protection of healthcare professionals and other high-risk groups against Coronavirus Disease of 2019 (COVID-19). In response to shortages in FFRs during the ongoing COVID-19 pandemic, the Food and Drug Administration issued an Emergency Use Authorization permitting FFR decontamination and reuse. However, although industrial decontamination services are available at some large institutions, FFR decontamination is not widely accessible. To be effective, FFR decontamination must (1) inactivate the virus; (2) preserve FFR integrity, specifically fit and filtering capability; and (3) be non-toxic and safe. Here we identify and test at-home heat-based methods for FFR decontamination that meet these requirements using common household appliances. Our results identify potential protocols for simple and accessible FFR decontamination, while also highlighting unsuitable methods that may jeopardize FFR integrity.

Construction and validation of an ultraviolet germicidal irradiation system using locally available components.

Coronavirus disease (COVID-19), the disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, is responsible for a global pandemic characterized by high transmissibility and morbidity. Healthcare workers (HCWs) are at risk of contracting COVID-19, but this risk has been mitigated through the use of personal protective equipment such as N95 Filtering Facepiece Respirators (FFRs). At times the high demand for FFRs has exceeded supply, placing HCWs at increased exposure risk. Effective FFR decontamination of many FFR models using ultraviolet-C germicidal irradiation (UVGI) has been well-described, and could maintain respiratory protection for HCWs in the face of supply line shortages. Here, we detail the construction of an ultraviolet-C germicidal irradiation (UVGI) device using previously existing components available at our institution. We provide data on UV-C dosage delivered with our version of this device, provide information on how users can validate the UV-C dose delivered in similarly constructed systems, and describe a simple, novel methodology to test its germicidal effectiveness using in-house reagents and equipment. As similar components are readily available in many hospitals and industrial facilities, we provide recommendations on the local construction of these systems, as well as guidance and strategies towards successful institutional implementation of FFR decontamination.

A Practical Approach to Filtering Facepiece Respirator Decontamination and Reuse: Ultraviolet Germicidal Irradiation.

Purpose of reviewPrior outbreaks of respiratory viruses have demonstrated the need for adequate personal protective equipment (PPE) for healthcare workers, particularly filtering facepiece respirators (FFR). Due to shortfalls of PPE during the SARS CoV-2 pandemic, the need for FFR decontamination and reuse (FFR-DR) strategies is paramount. This paper aims to discuss primary decontamination strategies, with an in-depth analysis of ultraviolet germicidal irradiation (UVGI), arriving at the decontamination strategy utilized at the Nebraska Medical Center (NMC).MethodsReview of the primary literature in regard to FFR-DR as well as a synopsis of the current protocol for FFR-DR at NMC.Recent findingsUVGI demonstrates effective decontamination of multiple pathogens—including several human respiratory viruses—while maintaining mask integrity and filtering capacity. UVGI was associated with degradation of strap integrity at higher doses than that utilized for decontamination or with reuse beyond 20 times.SummaryUVGI effectively decontaminates N95 FFRs without significant reduction to fit or strap integrity and can be employed as a strategy for FFR-DR in times of emergency.

Heat and Humidity for Bioburden Reduction of N95 Filtering Facepiece Respirators.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has caused a global shortage of single-use N95 filtering facepiece respirators (FFRs). A combination of heat and humidity is a promising method for N95 FFR decontamination in crisis-capacity conditions; however, an understanding of its effect on viral inactivation and N95 respirator function is crucial to achieving effective decontamination. Objective: We reviewed the scientific literature on heat-based methods for decontamination of N95 FFRs contaminated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and viral analogues. We identified key parameters for SARS-CoV-2 bioburden reduction while preserving N95 fit and filtration, as well as methods that are likely ineffective. Key Findings: Viral inactivation by humid heat is highly sensitive to temperature, humidity, duration of exposure, and the local microenvironment (e.g., dried saliva). A process that achieves temperatures of 70-85°C and relative humidity >50% for at least 30 min is likely to inactivate SARS-CoV-2 (>3-log reduction) on N95 respirators while maintaining fit and filtration efficiency for three to five cycles. Dry heat is significantly less effective. Microwave-generated steam is another promising approach, although less studied, whereas 121°C autoclave treatments may damage some N95 FFRs. Humid heat will not inactivate all microorganisms, so reprocessed N95 respirators should be reused only by the original user. Conclusions: Effective bioburden reduction on N95 FFRs during the COVID-19 pandemic requires inactivation of SARS-CoV-2 and preservation of N95 fit and filtration. The literature suggests that humid heat protocols can achieve effective bioburden reduction. Proper industrial hygiene, biosafety controls, and clear protocols are required to reduce the risks of N95 reprocessing and reuse.

Comparative evaluation of four hydrogen peroxide-based systems to decontaminate N95 respirators.

Protocols designed to facilitate N95 filtering facepiece respirator (FFR) decontamination by commercial sterilization devices do not recommend that operators verify the device's performance against pathogens deposited on FFRs. Here, we compared the treatment efficacy of 4 hydrogen peroxide-based systems that were authorized for N95 decontamination during the COVID-19 pandemic. Suspensions prepared from S. aureus ATCC 29213 and 44300, B. subtilis ATCC 6633, a vancomycin-resistant E. faecium isolate (VRE), E. coli ATCC 25922, and P. aeruginosa ATCC 27853 colonies were inoculated onto nine 1-cm2 areas on a 3M 1805, 1860, 1860S, 1870+, 8210, 8110S, or 9105S FFR. Contaminated respirators were treated according to protocols recommended by the STERRAD 100NX, Bioquell Z-2, Sterizone VP4, or Clēan Works Mini systems. Decontamination efficacy was determined by comparing colony counts cultured from excised segments of treated and untreated FFR. All devices achieved a 6-log reduction in bacterial burden and met FDA sterilization criteria. The Bioquell Z-2 device demonstrated 100% efficacy against both gram-positive and gram-negative organisms with all FFRs tested. Colonies of S. aureus ATCC 29213 and 44300 and VRE were cultivable from up to 9 (100%) of 9 STERRAD 100NX- and Sterizone VP4-treated segments. Viable B. subtilis ATCC 6633 organisms were recovered from 76.0% of STERRAD 100NX-treated FFR segments. Variability in decontamination efficacy was noted across devices and FFR types. gram-positive organisms were more difficult to completely eliminate than were gram-negative organisms. Prior to initiating FFR decontamination practices, institutions should verify the effectiveness of their devices and the safety of treated FFR.

500. Novel Use of a Targeted Ultraviolet Light Device for the Decontamination of a Single-Use Filtering Facepiece Respirator

BackgroundThe use of disposable or single-use filtering facepiece respirators (FFRs), like N95s, are an important component of personal protective equipment for healthcare personnel in treating patients with a respiratory virus and not approved for reuse. The current pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the limited availability of respirators. As a result, the decontamination of FFRs is a potential solution for reuse in order to conserve supplies. However, the efficacy of disinfection for a contaminated FFR needs to be evaluated. This experiment examined the effectiveness of a targeted ultraviolet C (UVC) device for the decontamination of a single-use respirator.MethodsTo mimic an aerosolized droplet contaminating a cellulose based respirator, a 6 mm cotton disk was inoculated with a 10 μL aliquot of Bacillus subtilis endospores. The disks were placed directly under the UVC light with 6 inches between the bulb and disk. The samples were then exposed for 90 seconds, 3 minutes, 5 minutes, and 10 minutes, respectively. After specified exposure time, the disks were turned over, and the other side was exposed for the same time interval as the previous side. Disks were placed in a 10 mL nutrient broth and incubated at 30°C for 48 hours. Lastly, the serially diluted specimens were plated onto nutrient agar, incubated for 48 hours, and the log10 colony forming units (CFU) reductions were enumerated by comparing disks after decontamination versus untreated controls.ResultsThe log10 CFU reduction of B. subtilis spores over all time intervals were significant when compared to controls. The mean reduction of spores on the cotton disks were 2.5 log after 90 seconds, 4 log after 3 minutes, and >6 log for both 5 and 10 minutes with no measurable recovery of spores for the last two exposures.ConclusionThe use of targeted UVC was very successful in reducing the B. subtilis spores from a cotton disk within 90 seconds, and the 100% elimination of the spores after 5 minutes. Even though a pandemic virus was not used, the sporicidal efficacy suggests this device could be effective at inactivating SARS-CoV-2. Based upon these findings, a targeted UVC device could be utilized for the decontamination of a single-use respirator needed during times of shortages.Disclosures All Authors: No reported disclosures

Decontamination of SARS-CoV-2 contaminated N95 filtering facepiece respirators (FFRs) with moist heat generated by a multicooker.

Decontamination of N95 filtering facepiece respirators (FFRs) is a crisis capacity strategy allowed when there are known shortages of FFRs. The application of moist heat is one decontamination method that has shown promise and is the approach approved in the Steris Steam Emergency Use Authorization (EUA). This effort examines the use of multicookers to apply moist heat, as they are available in retail stores and more affordable than methods requiring more sophisticated equipment. Four of five multicooker models examined met the acceptance criteria for the test and one model was selected for inactivation testing. Tests were performed on four different FFR models with SARS‐CoV‐2 suspended in culture media, simulated saliva or simulated lung fluid. Moist heat treatment reduced recoverable titres of SARS‐CoV‐2 virus to levels below the limit of detection in all tests. Furthermore, these four FFR models showed no loss in collection efficiency, inhalation resistance or visual damage after up to 10 decontamination cycles. Two (2) FFR models showed a slight change in strap elasticity (<9%). These data show that moist heat treatment using a multicooker is a viable option for FFR decontamination in a crisis capacity strategy.

Evaluating an Ultraviolet C System for Use During SARS-CoV2 Pandemic and Personal Protective Equipment Shortage

PurposeThe supply of N95 masks and filtering facepiece respirators (FFRs) has been limited nationally owing to the coronavirus disease 2019 pandemic. Ultraviolet C (UVC) light has been suggested as a potential option for decontamination of FFRs by the Centers for Disease Control. There has been a lack of publications characterizing UVC dose distribution across FFRs. Methods and MaterialsA UVC light box and FFR rack system was assembled using low-pressure mercury lamps peaked at 254 nm and aluminum flashing to reduce shadowing effect. Dose was characterized with the use of ultraviolet (UV) intensity labels and an ultraviolet germicidal irradiation (UVGI) National Institute of Standards and Technology traceable meter. Ozone production was evaluated after extended bulb run time. ResultsCalibration of UV intensity labels was noted to have color-change saturation at 100 mJ/cm2. Dose measurements with the UV intensity labels on the FFR demonstrated symmetrical dose to all surfaces, but symmetry was not supported by measurements with the UVGI meter. There was substantial dose fall off on the lateral aspects of the FFR. No ozone production was noted in the UVC system. ConclusionsUV intensity labels for characterization of dose provided a false suggestion of symmetry compared with the UVGI meter. Estimates of appropriate exposure times to reach 1000 mJ/cm2 should be significantly increased to account for geometry of FFR and lateral dose fall off.

UV-C tower for point-of-care decontamination of filtering facepiece respirators

BackgroundFiltering facepiece respirators (FFR) are critical for protecting essential personnel and limiting the spread of disease. Due to the current COVID-19 pandemic, FFR supplies are dwindling in many health systems, necessitating re-use of potentially contaminated FFR. Multiple decontamination solutions have been developed to meet this pressing need, including systems designed for bulk decontamination of FFR using vaporous hydrogen peroxide or ultraviolet-C (UV-C) radiation. However, the large scale on which these devices operate may not be logistically practical for small or rural health care settings or for ad hoc use at points-of-care.MethodsHere, we present the Synchronous UV Decontamination System, a novel device for rapidly deployable, point-of-care decontamination using UV-C germicidal irradiation. We designed a compact, easy-to-use device capable of delivering over 2 J cm2 of UV-C radiation in one minute.ResultsWe experimentally tested Synchronous UV Decontamination System' microbicidal capacity and found that it eliminates near all virus from the surface of tested FFRs, with less efficacy against pathogens embedded in the inner layers of the masks.ConclusionsThis short decontamination time should enable care-providers to incorporate decontamination of FFR into a normal donning and doffing routine following patient encounters.

Decontamination of filtering facepiece respirators using a low-temperature-steam–2%-formaldehyde sterilization process during a pandemic: a safe alternative for re-use

BackgroundThe coronavirus disease 2019 pandemic has caused problems with respirator supplies. Re-use may minimize the impact of the shortage, but requires the availability of an efficient and safe decontamination method.AimTo determine whether low-temperature-steam–2%-formaldehyde (LTSF) sterilization is effective, preserves the properties of filtering facepiece (FFP) respirators and allows safe re-use.MethodsFourteen unused FFP2, FFP3 and N95 respirator models were subjected to two cycles of decontamination cycles. After the second cycle, each model was inspected visually and accumulated residual formaldehyde levels were analysed according to EN 14180. After one and two decontamination cycles, the fit factor (FF) of each model was tested, and penetration tests with sodium chloride aerosols were performed on five models.FindingsDecontamination physically altered three of the 14 models. All of the residual formaldehyde values were below the permissible threshold. Irregular decreases and increases in FF were observed after each decontamination cycle. In the sodium chloride aerosol penetration test, three models obtained equivalent or superior results to those of the FFP classification with which they were marketed, both at baseline and after one and two cycles of decontamination, and two models had lower filtering capacity.ConclusionOne and two decontamination cycles using LTSF did not alter the structure of most (11/14) respirators tested, and did not degrade the fit or filtration capacity of any of the analysed respirators. The residual formaldehyde levels complied with EN 14180. This reprocessing method could be used in times of shortage of personal protective equipment.

Decontamination and Reuse of N95 Filtering Facepiece Respirators: Where Do We Stand?

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.

UVC Germicidal Units: Determination of Dose Received and Parameters to be Considered for N95 Respirator Decontamination and Reuse.

The COVID‐19 pandemic has resulted in an international shortage of personal protective equipment including N95 filtering facepiece respirators (FFRs), resulting in many institutions using ultraviolet germicidal irradiation (UVGI) technology for N95 FFR decontamination. To ensure proper decontamination, it is crucial to determine the dose received by various parts of the FFR in this process. Recently, our group customized a UVGI unit for N95 decontamination. With experimental and theoretical approach, this manuscript discusses the minimum dose received by various parts of the N95 respirator after one complete decontamination cycle with this UVGI unit. The results demonstrate that all parts of the N95 FFR received at least 1 J cm−2 after one complete decontamination cycle with this unit. As there are a variety of UVGI devices and different types of FFRs, this study provides a model by which UVC dose received by different areas of the FFRs can be accurately assessed to ensure proper decontamination for the safety of healthcare providers.

Decontamination and reuse of surgical masks and N95 filtering facepiece respirators during the COVID-19 pandemic: A systematic review.

Surgical 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. We 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. Overall, 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. A 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.

Use of Silica Beads to Dry N95 Respirators During Storage.

The 2019 novel coronavirus, SARS-CoV-2, has caused an unprecedented use of personal protective equipment (PPE), especially the disposable filtering facepiece respirator (FFR), N95. The Centers for Disease Control and Prevention has provided crisis capacity strategies for FFR decontamination and reuse, including the drying of N95s in paper bags for 5 days to remove the moisture that could maintain virus viability. We tested the ability of food-grade silica bead packets to accelerate moisture removal from N95s during 24-hour time periods. Briefly, N95s sprayed with water were completely dehydrated by silica beads within 24 hours, as measured with a commercial moisture meter. Importantly, repeated wetting and drying (with silica) did not decrease the N95 ability to exclude the bitter taste of Bitrex during standard fit testing. We conclude that food-grade silica beads can desiccate wet N95s over 24 hours, removing moisture.

Should We or Should We Not Reuse Filtering Face Piece Masks? A Review.

Disposable filtering face piece respirators (FFRs) are usually not approved for routine practice of decontamination and reuse. However, such practice of decontamination and reuse may be needed only as a crisis capacity strategy to ensure continued availability. The current severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic would help us enlighten about more effective and efficient ways of decontamination and reuse. Based on the limited research available, ultraviolet irradiation, vapors of hydrogen peroxide, and moist heat showed the most promising potential methods to decontaminate FFRs. This article summarizes available research about decontamination of FFRs before reuse.How to cite this article: Singh R, Azim A, Singh N. Should We or Should We Not Reuse Filtering Face Piece Masks? A Review. Indian J Crit Care Med 2020;24(9):857–862.

Ultraviolet germicidal irradiation of influenza-contaminated N95 filtering facepiece respirators

Safe and effective decontamination and reuse of N95 filtering facepiece respirators (FFRs) has the potential to significantly extend FFR holdings, mitigating a potential shortage due to an influenza pandemic or other pandemic events. Ultraviolet germicidal irradiation (UVGI) has been shown to be effective for decontaminating influenza-contaminated FFRs. This study aims to build on past research by evaluating the UVGI decontamination efficiency of influenza-contaminated FFRs in the presence of soiling agents using an optimized UVGI dose. Twelve samples each of 15 N95 FFR models were contaminated with H1N1 influenza (facepiece and strap), then covered with a soiling agent-artificial saliva or artificial skin oil. For each soiling agent, 3 contaminated FFRs were treated with 1 J/cm2 UVGI for approximately 1 minute, whereas 3 other contaminated FFRs remained untreated. All contaminated surfaces were cut out and virus extracted. Viable influenza was quantified using a median tissue culture infectious dose assay. Significant reductions (≥3 log) in influenza viability for both soiling conditions were observed on facepieces from 12 of 15 FFR models and straps from 7 of 15 FFR models. These data suggest that FFR decontamination and reuse using UVGI can be effective. Implementation of a UVGI method will require careful consideration of FFR model, material type, and design.