A Review of Decontamination Methods for Filtering Facepiece Respirators.

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.

Preparing for an Influenza Pandemic: Hospital Acceptance Study of Filtering Facepiece Respirator Decontamination Using Ultraviolet Germicidal Irradiation.

OBJECTIVES: Predictions estimate supplies of filtering facepiece respirators (FFRs) would be limited in the event of a severe influenza pandemic. Ultraviolet decontamination and reuse (UVDR) is a potential approach to mitigate an FFR shortage. A field study sought to understand healthcare workers' perspectives and potential logistics issues related to implementation of UVDR methods for FFRs in hospitals. METHODS: Data were collected at three hospitals using a structured guide to conduct 19 individual interviews, 103 focus group interviews, and 285 individual surveys. Data were then evaluated using thematic analysis to reveal key themes. RESULTS: Data revealed noteworthy variation in FFR use across the sample, along with preferences and requirements for the use of UVDR, unit design, and FFR reuse. Based on a scale of 1 (low) to 10 (high), the mean perception of safety in a high mortality pandemic wearing no FFR was 1.25 of 10, wearing an FFR for an extended period without decontamination was 4.20 of 10, and using UVDR was 7.72 of 10. CONCLUSIONS: In addition to technical design and development, preparation and training will be essential to successful implementation of a UVDR program. Ultraviolet decontamination and reuse program design and implementation must account for actual clinical practice, compliance with regulations, and practical financial considerations to be successfully adopted so that it can mitigate potential FFR shortages in a pandemic.

Ultraviolet germicidal irradiation of influenza-contaminated N95 filtering facepiece respirators.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Assessment of half-mask elastomeric respirator and powered air-purifying respirator reprocessing for an influenza pandemic.

BACKGROUND: Health care facilities are considering the use of reusable respiratory protective devices (RPDs) to mitigate a potential N95 filtering facepiece respirator shortage caused by an influenza pandemic. US regulators are also considering stockpiling reusable RPDs for pandemic preparedness, but limited data exist on the effectiveness of cleaning and disinfection of these devices. This study defines reprocessing protocols and evaluates their effectiveness against a pandemic influenza strain in a laboratory setting. METHODS: Five half-mask elastomeric respirator models and 3 powered air-purifying respirator models were contaminated with influenza virus and artificial skin oil on multiple surfaces. RPDs were then manually treated with 1 of 2 methods: cleaned or cleaned and disinfected. Presence of viable influenza was determined via swab sampling and a median tissue culture infectious dose assay. RESULTS: Across 41 RPD surfaces, a mean log reduction in viable influenza of 4.54 ± 0.97 log10 median tissue culture infectious dose was achieved for all treated surfaces, which included both cleaned and cleaned and disinfected surfaces. CONCLUSIONS: The methods defined as part of this study are effective for eliminating viable influenza in the presence of artificial skin oil on most of the RPD surfaces tested. Material type and RPD design should be considered when implementing RPD reprocessing protocols.

Bioaerosol exposure to personnel in a clinical environment absent patients.

Nosocomial infections pose a significant and escalating threat to both patients and healthcare workers (HCWs). By their nature, hospitals induce antibiotic resistance in virulent and commensal strains, leading to increasingly severe hospital-acquired infections. This study measured environmental exposure experienced by domestic staff cleaning vacated patient rooms of a community hospital to bacteria in ambient bioaerosols. While they cleaned the room, participants wore an N95 filtering facepiece respirator (FFR), from which coupons were cut and bacteria were extracted, cultured and enumerated. Extrapolation to the full area of the respirator yielded measured exposures of 0.2-1.4 × 10(4) colony-forming units/hour, of which ∼97% collected on the front layer of the N95, suggesting a possible role for minimal respiratory protection in nonpatient environments. Random resistance testing of 1.6% of the isolates showed that ∼70% of both Gram-positive and Gram-negative organisms exhibited resistance to oxacillin and ∼9% of the Gram-positives displayed resistance to vancomycin. These data provide an estimate for mask bioaerosol loading that can be used in risk modeling and to refine strategies for reuse of FFRs during critical shortages.

Capture of 0.1-µm aerosol particles containing viable H1N1 influenza virus by N95 filtering facepiece respirators.

Nosocomial infections pose an escalating threat to both patients and healthcare workers (HCWs). A widely recommended device for individual respiratory protection, the N95 filtering facepiece respirator (FFR) has been shown to provide efficient filtration of inert particles larger and smaller than the nominal most-penetrating particle size (MPPS) range, 0.03-0.3 µm. Humans generate respiratory aerosols in the MPPS range, suggesting that short-range disease transmission could occur via small infectious particles. Data presented here show that the N95 FFR will afford a significant measure of protection against infectious particles as small as a bare H1N1 influenza virion, and that the capture mechanism does not discriminate in favor of, or against, biological particles.

Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress.

BACKGROUND: Sterilized packaging systems are designed to maintain the sterility of surgical instruments and devices from the time of sterilization until use. This study evaluated the effectiveness of rigid containers versus wrapped instrument trays, sterilized using North American sterilization protocols, to maintain a sterile internal environment poststerilization when challenged with aerosolized bacteria under dynamic environmental conditions. METHODS: Using a custom aerosol chamber, 111 rigid containers of various durations of use (unused, used <5 years, used 5-9 years) and 161 wrapped trays using 3 grades of sterilization wrap were challenged with ~10(2) colony-forming units per liter of air containing aerosolized Micrococcus luteus with a count median particle size of 1 µm, while simultaneously experiencing air volume exchanges due to vacuum cycles-two 1-psi cycles, three 0.7-psi cycles, and three 0.4-psi cycles-to simulate air exchange events occurring during the sterilization, transportation, and storage of sterilized instrument trays in health care facilities. RESULTS: Of 111 rigid containers tested, 97 (87%) demonstrated bacterial ingress into the container. Of 161 wrapped trays, 0 (0%) demonstrated bacterial ingress into the tray. Contamination rates of rigid containers increased significantly with increasing duration of use. CONCLUSIONS: In this study using a dynamic bacterial aerosol challenge, sterilized wrapped trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria.

Correlation of respirator fit measured on human subjects and a static advanced headform.

This study assessed the correlation of N95 filtering facepiece respirator (FFR) fit between a Static Advanced Headform (StAH) and 10 human test subjects. Quantitative fit evaluations were performed on test subjects who made three visits to the laboratory. On each visit, one fit evaluation was performed on eight different FFRs of various model/size variations. Additionally, subject breathing patterns were recorded. Each fit evaluation comprised three two-minute exercises: "Normal Breathing," "Deep Breathing," and again "Normal Breathing." The overall test fit factors (FF) for human tests were recorded. The same respirator samples were later mounted on the StAH and the overall test manikin fit factors (MFF) were assessed utilizing the recorded human breathing patterns. Linear regression was performed on the mean log10-transformed FF and MFF values to assess the relationship between the values obtained from humans and the StAH. This is the first study to report a positive correlation of respirator fit between a headform and test subjects. The linear regression by respirator resulted in R(2) = 0.95, indicating a strong linear correlation between FF and MFF. For all respirators the geometric mean (GM) FF values were consistently higher than those of the GM MFF. For 50% of respirators, GM FF and GM MFF values were significantly different between humans and the StAH. For data grouped by subject/respirator combinations, the linear regression resulted in R(2) = 0.49. A weaker correlation (R(2) = 0.11) was found using only data paired by subject/respirator combination where both the test subject and StAH had passed a real-time leak check before performing the fit evaluation. For six respirators, the difference in passing rates between the StAH and humans was < 20%, while two respirators showed a difference of 29% and 43%. For data by test subject, GM FF and GM MFF values were significantly different for 40% of the subjects. Overall, the advanced headform system has potential for assessing fit for some N95 FFR model/sizes.

Cleaning of filtering facepiece respirators contaminated with mucin and Staphylococcus aureus.

BACKGROUND: Decontamination, cleaning, and reuse of filtering facepiece respirators (FFRs) has been proposed to mitigate an acute FFR shortage during a public health emergency. Our study evaluates the ability of commercially available wipe products to clean FFRs contaminated with either infectious or noninfectious aerosols. METHODS: Three models of surgical N95 FFRs were contaminated with aerosols of mucin or viable Staphylococcus aureus then cleaned with hypochlorite, benzalkonium chloride, or nonantimicrobial wipes. After cleaning, FFRs were separated into components (nose pad, fabrics, and perforated strip), and contaminants were extracted and quantified. Filtration performance was assessed for cleaned FFRs. RESULTS: Mucin removal was <1 log for all wipe products on all components. Inert wipes achieved ∼1-log attenuation in viable S aureus on fabrics from all FFR models--removal was less effective from nose pads and perforated edges. Both antimicrobial wipes achieved 3-5-log attenuation on most components, with smaller reductions on nose pads and greater reductions on perforated strips. Particle penetration following cleaning yielded mean values <5%. The highest penetrations were observed in FFRs cleaned with benzalkonium chloride wipes. CONCLUSIONS: FFRs can be disinfected using antimicrobial wipe products, but not effectively cleaned with the wipes evaluated in this study. This study provides informative data for the development of better FFRs and applicable cleaning products.

Development of an advanced respirator fit-test headform.

Improved respirator test headforms are needed to measure the fit of N95 filtering facepiece respirators (FFRs) for protection studies against viable airborne particles. A Static (i.e., non-moving, non-speaking) Advanced Headform (StAH) was developed for evaluating the fit of N95 FFRs. The StAH was developed based on the anthropometric dimensions of a digital headform reported by the National Institute for Occupational Safety and Health (NIOSH) and has a silicone polymer skin with defined local tissue thicknesses. Quantitative fit factor evaluations were performed on seven N95 FFR models of various sizes and designs. Donnings were performed with and without a pre-test leak checking method. For each method, four replicate FFR samples of each of the seven models were tested with two donnings per replicate, resulting in a total of 56 tests per donning method. Each fit factor evaluation was comprised of three 86-sec exercises: "Normal Breathing" (NB, 11.2 liters per min (lpm)), "Deep Breathing" (DB, 20.4 lpm), then NB again. A fit factor for each exercise and an overall test fit factor were obtained. Analysis of variance methods were used to identify statistical differences among fit factors (analyzed as logarithms) for different FFR models, exercises, and testing methods. For each FFR model and for each testing method, the NB and DB fit factor data were not significantly different (P > 0.05). Significant differences were seen in the overall exercise fit factor data for the two donning methods among all FFR models (pooled data) and in the overall exercise fit factor data for the two testing methods within certain models. Utilization of the leak checking method improved the rate of obtaining overall exercise fit factors ≥100. The FFR models, which are expected to achieve overall fit factors ≥ 100 on human subjects, achieved overall exercise fit factors ≥ 100 on the StAH. Further research is needed to evaluate the correlation of FFRs fitted on the StAH to FFRs fitted on people. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: a file providing detailed information on the advanced head form design and fabrication process.].

Challenge of N95 filtering facepiece respirators with viable H1N1 influenza aerosols.

OBJECTIVE. Specification of appropriate personal protective equipment for respiratory protection against influenza is somewhat controversial. In a clinical environment, N95 filtering facepiece respirators (FFRs) are often recommended for respiratory protection against infectious aerosols. This study evaluates the ability of N95 FFRs to capture viable H1N1 influenza aerosols. METHODs. Five N95 FFR models were challenged with aerosolized viable H1N1 influenza and inert polystyrene latex particles at continuous flow rates of 85 and 170 liters per minute. Virus was assayed using Madin-Darby canine kidney cells to determine the median tissue culture infective dose (TCID50). Aerosols were generated using a Collison nebulizer containing H1N1 influenza virus at 1 x 10(8) TCID50/mL. To determine filtration efficiency, viable sampling was performed upstream and downstream of the FFR. RESULTS. N95 FFRs filtered 0.8-µm particles of both H1N1 influenza and inert origins with more than 95% efficiency. With the exception of 1 model, no statistically significant difference in filtration performance was observed between influenza and inert particles of similar size. Although statistically significant differences were observed for 2 models when comparing the 2 flow rates, the differences have no significance to protection. CONCLUSIONS. This study empirically demonstrates that a National Institute for Occupational Safety and Health-approved N95 FFR captures viable H1N1 influenza aerosols as well as or better than its N95 rating, suggesting that a properly fitted FFR reduces inhalation exposure to airborne influenza virus. This study also provides evidence that filtration efficiency is based primarily on particle size rather than the nature of the particle's origin.

Effectiveness of three decontamination treatments against influenza virus applied to filtering facepiece respirators.

Filtering facepiece respirators (FFRs) are recommended for use as precautions against airborne pathogenic microorganisms; however, during pandemics demand for FFRs may far exceed availability. Reuse of FFRs following decontamination has been proposed but few reported studies have addressed the feasibility. Concerns regarding biocidal efficacy, respirator performance post decontamination, decontamination cost, and user safety have impeded adoption of reuse measures. This study examined the effectiveness of three energetic decontamination methods [ultraviolet germicidal irradiation (UVGI), microwave-generated steam, and moist heat] on two National Institute for Occupational Safety and Health-certified N95 FFRs (3M models 1860s and 1870) contaminated with H5N1. An aerosol settling chamber was used to apply virus-laden droplets to FFRs in a method designed to simulate respiratory deposition of droplets onto surfaces. When FFRs were examined post decontamination by viral culture, all three decontamination methods were effective, reducing virus load by > 4 log median tissue culture infective dose. Analysis of treated FFRs using a quantitative molecular amplification assay (quantitative real-time polymerase chain reaction) indicated that UVGI decontamination resulted in lower levels of detectable viral RNA than the other two methods. Filter performance was evaluated before and after decontamination using a 1% NaCl aerosol. As all FFRs displayed <5% penetration by 300-nm particles, no profound reduction in filtration performance was caused in the FFRs tested by exposure to virus and subsequent decontamination by the methods used. These findings indicate that, when properly implemented, these methods effectively decontaminate H5N1 on the two FFR models tested and do not drastically affect their filtering function; however, other considerations may influence decisions to reuse FFRs.

A pandemic influenza preparedness study: use of energetic methods to decontaminate filtering facepiece respirators contaminated with H1N1 aerosols and droplets.

BACKGROUND: A major concern among health care experts is a projected shortage of N95 filtering facepiece respirators (FFRs) during an influenza pandemic. One option for mitigating an FFR shortage is to decontaminate and reuse the devices. Many parameters, including biocidal efficacy, filtration performance, pressure drop, fit, and residual toxicity, must be evaluated to verify the effectiveness of this strategy. The focus of this research effort was on evaluating the ability of microwave-generated steam, warm moist heat, and ultraviolet germicidal irradiation at 254 nm to decontaminate H1N1 influenza virus. METHODS: Six commercially available FFR models were contaminated with H1N1 influenza virus as aerosols or droplets that are representative of human respiratory secretions. A subset of the FFRs was treated with the aforementioned decontamination technologies, whereas the remaining FFRs were used to evaluate the H1N1 challenge applied to the devices. RESULTS: All 3 decontamination technologies provided >4-log reduction of viable H1N1 virus. In 93% of our experiments, the virus was reduced to levels below the limit of detection of the method used. CONCLUSIONS: These data are encouraging and may contribute to the evolution of effective strategies for the decontamination and reuse of FFRs.

Method for contamination of filtering facepiece respirators by deposition of MS2 viral aerosols.

A droplet/aerosol loading chamber was designed to deliver uniform droplets/aerosols onto substrates. An ultrasonic nebulizer was used to produce virus-containing droplets from artificial saliva to emulate those from coughing and sneezing. The operating conditions were determined by adjusting various parameters to achieve loading density and uniformity requirements. The count median diameter and mass median diameter were 0.5-2 and 3-4 µm, respectively, around the loading location when 35% relative humidity was applied. The average loading density was ∼2×103 plaque-forming units/cm2 for 5-min loading time with a virus titer of 107 plaque-forming units/mL. Six different filtering facepiece respirators from commercial sources were loaded to evaluate uniform distribution. For each of the six FFRs, the virus loading uniformity within a sample and across numerous samples was 19.21% and 12.20%, respectively. This system supports a standard method for loading viable bioaerosols onto specimen surfaces when different decontamination techniques are to be compared.