Qualitative Fit Testing Research Articles

Impact of Hydrocolloid Dressing and Moisturizing Cream as Facial Skin Protectants Among Health Care Workers.

During the novel coronavirus disease 2019 pandemic, health care workers experienced facial problems from prolonged use of N95 masks, including skin irritation, pigmentation changes, and contact dermatitis. We assessed the use of hydrocolloid dressing versus dimethicone cream to prevent skin breakdown among military health care workers while wearing an N95. Participants were recruited using convenience and snowball sampling in this nonblinded, randomized, cross-over study with 2 active treatments, hydrocolloid dressing and dimethicone cream, across 3 time points. The skin was assessed using photographs and subepidermal moisture scanner (SEM). N95 seal integrity was assessed using qualitative fit test. Institutional review board approval was obtained from the Madigan Army Medical Center Institutional Review Board. Among the 73 participants, wearing an N95 alone versus with dimethicone cream or hydrocolloid dressing caused more adverse skin reactions. There were no significant differences in qualitative fit test failure rate between groups. Participants experienced minimal to no dizziness, loss of energy/tiredness/fatigue, claustrophobia, shortness of breath, difficulty breathing, and dry or itchy eyes. For all interventions, wearing an N95 did not interfere with participants' concentration, verbal communication, hearing, vision, and, importantly, delivery of care. Using a skin protectant with an N95 may prevent adverse skin reactions while preserving health care workers' ability to safely and competently care for patients in routine and pandemic conditions.

Incidence of Fit Test Failure During N95 Respirator Reuse and Extended Use

The COVID-19 pandemic resulted in a widespread acute shortage of N95 respirators, prompting the Centers for Disease Control and Prevention to develop guidelines for extended use and limited reuse of N95s for health care workers (HCWs). While HCWs followed these guidelines to conserve N95s, evidence from clinical settings regarding the safety of reuse and extended use is limited. To measure the incidence of fit test failure during N95 reuse and compare the incidence between N95 types. This prospective cohort study, conducted from April 2, 2021, to July 15, 2022, at 6 US emergency departments (EDs), included HCWs who practiced N95 reuse for more than half of their clinical shift. Those who were unwilling to wear an N95 for most of their shift, repeatedly failed baseline fit testing, were pregnant, or had facial hair or jewelry that interfered with the N95 face seal were excluded. Wearing the same N95 for more than half of each clinical shift and for up to 5 consecutive shifts. Participants chose an N95 model available at their institution; models were categorized into 3 types: dome (3M 1860R, 1860S, and 8210), trifold (3M 1870+ and 9205+), and duckbill (Halyard 46727, 46767, and 46827). Participants underwent 2 rounds of testing using a different mask of the same type for each round. The primary outcome was Occupational Safety and Health Administration-approved qualitative fit test failure. Trained coordinators conducted fit tests after clinical shifts and recorded pass or fail based on participants tasting a bitter solution. A total of 412 HCWs and 824 N95s were fit tested at baseline; 21 N95s (2.5%) were withdrawn. Participants' median age was 34.5 years (IQR, 29.5-41.8 years); 252 (61.2%) were female, and 205 (49.8%) were physicians. The overall cumulative incidence of fit failure after 1 shift was 38.7% (95% CI, 35.4%-42.1%), which differed by N95 type: dome, 25.8% (95% CI, 21.2%-30.6%); duckbill, 28.3% (95% CI, 22.2%-34.7%); and trifold, 61.3% (95% CI, 55.3%-67.3%). The risk of fit failure was significantly higher for trifold than dome N95s (adjusted hazard ratio, 1.75; 95% CI, 1.46-2.10). In this cohort study of ED HCWs practicing N95 reuse, fit failure occurred in 38.7% of masks after 1 shift. Trifold N95s had higher incidence of fit failure compared with dome N95s. These results may inform pandemic preparedness, specifically policies related to N95 selection and reuse practices.

Respiratory protective equipment fit tests for researchers at the national synchrotron radiation research center

Researchers at the National Synchrotron Radiation Research Center should use respiratory protective equipment to prevent respiratory damage caused by gases, steam, solvents, chemicals, materials containing toxic substances, and oxygen-deficient environments. Those working with organic matter and certain chemical substances and those exposed to occupation dust should use respiratory protective gear to ensure their health. This study conducted qualitative and quantitative fit tests for various mask brands and sizes, namely 3M-9042, N95-9211, P95-8576, and 3M-6200 masks. The gear worn by all 18 participants in the qualitative fit test passed. By contrast, the gear worn by 12 of the 15 participants in the quantitative test passed; the failure of the remaining gear was due to differences in face shape. The N95-9211 mask can be used in three-piece protective gear because it exhibited a tight fit. Additionally, the 3M-6200 negative-pressure half-face mask exhibited the most satisfactory fit and can be used in protective gear.

SIR Flat CAP (Safety In Radiology - Flat-Packed Compact Airborne Precaution): A Low-Cost, Portable, Negative-Pressure Isolation Barrier Shield for Protecting Frontline Healthcare Workers.

Introduction Multiple barrier shields have been described since the start of the COVID-19 pandemic. Most of these are bulky and designed for use in the main anesthetic or radiology departments. We developed a portable, negative-pressure barrier shield designed specifically for portable ultrasound examinations.A novel supine cough generation model was developed together with a reverse qualitative fit test to simulate real-world aerosol droplet generation and dispersion for evaluating the effectiveness of the barrier shield.We report the technical specifications of this design, named "SIR Flat CAP" from Safety In Radiology - Flat-packed Compact Airborne Precaution, as well as its performance in reducing the spread of droplets and aerosols. Methods The barrier shield was constructed using 1 mm acrylic panels, clear packing tape, foam double-sided tape, and surgical drapes. Negative pressure was provided via hospital wall suction. A supine cough generation model was developed to simulate cough droplet dispersal. A reverse qualitative fit test was used to assess for airborne transmission of microdroplets. Results The supine cough generation model was able to replicate similar results to previously reported supine human cough generation dispersion. The use of the barrier shield with negative-pressure suction prevented the escape of visible droplets, and no airborne microdroplets were detected by reverse qualitative fit testing from the containment area. Conclusions The barrier shield significantly reduces the escape of visible and airborne droplets from the containment area, providing an additional layer of protection to front-line sonographers.

Moist heat as a promising method to decontaminate N95 masks: A large scale clinical study comparing four decontamination modalities—moist heat, steam, ultraviolet-C irradiation, and hydrogen peroxide plasma

BackgroundEarly in the COVID-19 pandemic, there was a global shortage of masks. Although mask reprocessing was practiced, no clinical study has assessed systematically the impact of repeated cycles of wear and decontamination on the integrity of N95 filtering facepiece respirators (FFRs). MethodsWe evaluated mask fit assessed by qualitative respirator fit test (QRFT) after each cycle of wear and decontamination, as well as four measures of mask integrity—bacterial filtration efficacy, particle filtration efficacy, differential pressure, and splash resistance through five cycles of wear and decontamination using one of the four modalities (moist heat, steam, ultraviolet-C irradiation, and hydrogen peroxide plasma). ResultsA total of 60.6% (hydrogen peroxide plasma) to 77.5% (moist heat) of the FFRs passed five cycles of wear and decontamination, as assessed by the wearers passing QRFT all five times. Moist heat-decontaminated FFRs retained all technical measures of integrity through all five cycles. ConclusionsThis is the first large-scale study to assess systematically the impact (clinically and quantitatively) on N95 FFR integrity of repeated cycles of wearing followed by decontamination.Our results suggest that moist heat is a promising method for decontaminating N95 FFRs. Performing QRFT after every cycle of wear and decontamination ensures wearer safety. Although there is currently no mask shortage, reprocessing may reduce medical waste and improve sustainability.

SG-APSIC1056: Finding the right fit: Our experience in quantitative N95 respirator fit-testing

Objectives: Following a cluster of COVID-19 cases in a Singapore public hospital in April 2021, the local health authority mandated the use of N95 respirators in all inpatient wards. This increased the demand for N95 mask fit-testing to ensure that healthcare workers were donning respirators that fit their facial characteristics and hence provided protection through a good facial seal. The demand for fit-testing during the pandemic highlighted the scarcity of manpower and ergonomics concern, such as carpel tunnel syndrome experienced in long hours of qualitative fit-testing sessions. We evaluated the operational efficiency, cost-effectiveness, and difference in passing rate after the introduction of the quantitative method. Methods: Conventional qualitative fit-testing was conducted using manual pumping of a challenge agent, enabling the user to determine the fit of the respirator. The quantitative fit-testing protocol used a condensation particle counter (CPC) to measure the concentration of particles inside the mask and the atmosphere to determine the fit of respirator. The Occupational Safety and Health Administration (OSHA)–approved minimum fit factor of 100 was used as the criterion for a successful N95 respirator fit. Tubes used during quantitative fit-testing were reprocessed using thermal disinfection. Results: Quantitative mask fit-testing provided an objective numerical measure to assess adequate fit of N95 respirator, which provided users with confidence in the respirator fit. It addressed a manpower limitation issue because it did not require qualified trainers to conduct the test, and automation also prevented any potential occupational hazard from repeated actions required in qualitative fit-testing. An increase in the passing rate for N95 fit-testing from 94.5% to 95.5% was observed. However, the high cost of equipment, annual recalibration, and consumables must be considered. Conclusions: Quantitative N95 fit-testing, when adopted with careful consideration of its cost, is an approach to consider for hospital-wide fit-testing.

Development of a Customized Mask Frame Using a Three-Dimensional Facial Scan for an Airtight Seal for Disposable Surgical Face Masks

Abstract Disposable surgical face masks are designed to block the airborne transmission of infectious viruses between patients and healthcare personnel; however, there are limitations to a surgical mask's ability to prevent transmissions because the mask does not provide an airtight seal around the face. This study focuses on the design and development of a custom mask frame, using individuals' three-dimensional (3D) facial scans, to improve the seal of the existing surgical masks. Three participants' facial scans with a wide range of facial dimensions were collected using a 3D hand-held scanner. During design, the contact area between the custom frame and the wearer's skin was determined based on the individual's 3D facial shape. To evaluate the effectiveness of the airtight seal, a qualitative fit (smell/taste) test kit and thermal imaging camera were utilized. When the participants wore the surgical masks without the customized mask frames, the participants smelled the saccharine scent from the test kit. However, while wearing the surgical masks fitted with the custom mask frame that held the mask in place, none of the participants could smell the scent. In addition, thermal images showed ambient temperature changes in the surgical mask suggesting air leakage around the boundary of the mask while the subject was inhaling and exhaling. With the mask frame, thermal images confirmed the effectiveness of the custom frame to block the inflow/outflow of air potentially carrying the virus. The results indicate that the custom-built mask frames are effective in providing a proper and much improved seal compared to a surgical mask without the frame. The developed custom mask frame will be particularly beneficial for frontline medical staff members who treat patients with infectious viruses transmitted through aerosols as part of their PPE.

The need for systematic quality controls in implementing N95 reprocessing and sterilization

Due to increased requirement for personal protective equipment during the coronavirus disease 2019 pandemic, many medical centres utilized sterilization systems approved under Food and Drug Administration Emergency Use Authorization for single-use N95 mask re-use. However, few studies have examined the real-world clinical challenges and the role of ongoing quality control measures in successful implementation. To demonstrate successful implementation of quality control measures in mask reprocessing, and the importance of continued quality assurance. A prospective quality improvement study was conducted at a tertiary care medical centre. In total, 982 3M 1860 masks and Kimberly-Clark Tecnol PFR95 masks worn by healthcare workers underwent sterilization using a vaporized hydrogen peroxide gas plasma-based reprocessing system. Post-processing qualitative fit testing (QFT) was performed on 265 masks. Mannequin testing at the National Institute for Occupational Safety and Health (NIOSH) laboratory was used to evaluate the impact of repeated sterilization on mask filtration efficacy and fit. A locally designed platform evaluated the filtration efficiency of clinically used and reprocessed masks. In total, 255 N95 masks underwent QFT. Of these, 240 masks underwent post-processing analysis: 205 were 3M 1860 masks and 35 were PFR95 masks. Twenty-five (12.2%) of the 3M masks and 10 (28.5%) of the PFR95 masks failed post-processing QFT. Characteristics of the failed masks included mask deformation (N=3, all 3M masks), soiled masks (N=3), weakened elastic bands (N=5, three PFR95 masks), and concern about mask shrinkage (N=3, two 3M masks). NIOSH testing demonstrated that while filter efficiency remained >98% after two cycles, mask strap elasticity decreased by 5.6% after reprocessing. This study demonstrated successful quality control implementation for N95 mask disinfection, and highlights the importance of real-world clinical testing beyond laboratory conditions.

Development of a qualitative respirator fit testing program for BSN students

The COVID-19 pandemic has impacted the nursing student clinical experience. At the time of this project, hospitals hosting students for clinical experiences had a high population of COVID-19 positive patients. University and hospital policies at the time prohibited students from caring for COVID-19 patients due to the inability to safely ensure that students could access the proper protective equipment (PPE) necessary when caring for patients in airborne precautions. Infection control guidelines for patients in airborne precautions require a N95 respirator to be always worn by healthcare providers. These respirators require yearly fit test following OSHA (Occupational Safety and Health Administration) standards. Hospitals do have the resources to complete N95 fit tests for nursing students. The solution was to provide qualitative N95 mask fit testing, performed by university faculty, staff, and students using OSHA guidelines and standards. Within 3 months, over 50% of the student population had been fit tested, which increased the clinical opportunities for the students.

External nasal dilator decreases N95 respirator-related respiratory effort and symptoms in gastrointestinal endoscopy unit staff.

Background and study aims N95-filtering facepiece respirators (FFR) use is associated with physiological changes and symptoms due to impaired nasal airflow and increased breathing resistance. We prospectively studied the effect of using an external nasal dilator (END) in gastroenterology laboratory (gastrointestinal lab) staff using N95FFR. Patients and methods N95FFR qualitative saccharine fit testing was performed on study participants with and without an END. Prospective data collection and comparisons included: 1) survey of perceived symptoms and difficulty of performing one day of gastrointestinal procedures with N95FFR and 1 day of gastrointestinal procedures with END plus N95FFR in random sequence; and 2) vitals and respiratory belt plethysmography in ten gastroenterologists performing simulated colonoscopy while wearing a surgical mask (SM), N95FFR plus SM, END plus N95FFR plus SM for 20 minutes each in random sequence and rapid succession. Results Twenty-nine of 31 participants passed the N95FFR and the END plus N95FFR fit test. Twenty-two participants (12 physicians; 11 males; mean age 44.1 years, range 31–61) performed 1 day of gastrointestinal procedures with an N95FFR and 1 day of gastrointestinal procedures with an END plus N95FFR. Significantly less difficulty with nasal breathing and severity of symptoms including breathing difficulty, headache, fatigue and frustration, occurred while using an END plus N95FFR. Respiratory plethysmography peak-to-trough measurement showed an increase during the N95FFR stage compared to the END plus N95FFR stage and the SM stage. Conclusions N95FFR related respiratory changes and symptom development may be mitigated by END use.

Aerosolized Hydrogen Peroxide Decontamination of N95 Respirators, with Fit-Testing and Viral Inactivation, Demonstrates Feasibility for Reuse during the COVID-19 Pandemic.

ABSTRACTIn response to the demand for N95 respirators by health care workers during the COVID-19 pandemic, we evaluated decontamination of N95 respirators using an aerosolized hydrogen peroxide (aHP) system. This system is designed to dispense a consistent atomized spray of aerosolized, 7% hydrogen peroxide (H2O2) solution over a treatment cycle. Multiple N95 respirator models were subjected to 10 or more cycles of respirator decontamination, with a select number periodically assessed for qualitative and quantitative fit testing. In parallel, we assessed the ability of aHP treatment to inactivate multiple viruses absorbed onto respirators, including phi6 bacteriophage, herpes simplex virus 1 (HSV-1), coxsackievirus B3 (CVB3), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). For pathogens transmitted via respiratory droplets and aerosols, it is critical to address respirator safety for reuse. This study provided experimental validation of an aHP treatment process that decontaminates the respirators while maintaining N95 function. External National Institute for Occupational Safety & Health (NIOSH) certification verified respirator structural integrity and filtration efficiency after 10 rounds of aHP treatment. Virus inactivation by aHP was comparable to the decontamination of commercial spore-based biological indicators. These data demonstrate that the aHP process is effective, with successful fit-testing of respirators after multiple aHP cycles, effective decontamination of multiple virus species, including SARS-CoV-2, successful decontamination of bacterial spores, and filtration efficiency maintained at or greater than 95%. While this study did not include extended or clinical use of N95 respirators between aHP cycles, these data provide proof of concept for aHP decontamination of N95 respirators before reuse in a crisis-capacity scenario.IMPORTANCE The COVID-19 pandemic led to unprecedented pressure on health care and research facilities to provide personal protective equipment. The respiratory nature of the SARS-CoV2 pathogen makes respirator facepieces a critical protective measure to limit inhalation of this virus. While respirator facepieces were designed for single use and disposal, the pandemic increased overall demand for N95 respirators, and corresponding manufacturing and supply chain limitations necessitated the safe reuse of respirators when necessary. In this study, we repurposed an aerosolized hydrogen peroxide (aHP) system that is regularly utilized to decontaminate materials in a biosafety level 3 (BSL3) facility, to develop a method for decontamination of N95 respirators. Results from viral inactivation, biological indicators, respirator fit testing, and filtration efficiency testing all indicated that the process was effective at rendering N95 respirators safe for reuse. This proof-of-concept study establishes baseline data for future testing of aHP in crisis-capacity respirator-reuse scenarios.

Development of respirator design for children using bamboo-based activated carbon filter and bipolar ionization

This paper proposes a respirator for children integrated with bamboo-based activated carbon filters and bipolar ionization as the sterilizer to increase protection from Covid-19 and other pathogens. The respirator, named as Bion-Kids, was designed based on the children's head-and-face anthropometry from direct measurement. The duration of sterilization process is controlled based on the activities, which are classified using the Recurrent Neural Network (RNN) model with dataset acquired from the accelerometer. Manufacturing process of the main body prototype comprises heat bending and 3D printing. The bamboo-based activated carbon filter was synthesized by applying heat and pressure at the strewed activated carbon particles on the N95 filter. Observation using scanning electron microscope showed the ability of the bamboo-based activated carbon filter to adsorb and trap the particles. Result of the qualitative fit test and questionnaire survey indicated that Bion-Kids is suitable and comfortable for the children's face. The result of filtration and bipolar ionization sterilization system analysis have also met the ISO14698 standard by not showing any infiltration of microorganisms on the blood agar media. This device may become an early-stage personal protective equipment against the transmission of Covid-19 and other pathogens.

The effect of plastic tape seal to reduce face seal leak in respirator N-95 type 1860

The risk of face seal leak while using N-95 respirators is experienced by health workers and thus failing fit test are quite common. Finding solutions to overcome face seal leaks is crucial; one of which is by sealing the N-95 respirator. The seal used in this research was Tegaderm® a transparent film dressing or a plastic tape which is known to have the advantages of strong adhesion, high level of pore density and standardized medical grade. This study tries to determine the effectiveness of plastic tape adhesive on the N-95 type 1860 respirator in overcoming face seal leak qualitative fit test using Bitrex immediately after being worn and after 4 h of using it. The study used a quantitative approach with an incidence study design conducted pre and post experimental without comparison to see the effectiveness of plastic tape sealing. The subjects for the research were 81 health workers in the CMH environment who were at risk of being exposed to COVID-19. The study found a significant difference in the Bitrex fit test immediately after sealing the N-95 type 1860 respirator with plastic tape; 100% passed the fit test immediately after sealing, and 64.2% passed the fit test after 4 h of working. The effectiveness of sealing using plastic tape is considered to be quite good to overcome face seal leak on the N-95 type 1860 respirator. Health care workers need to be more vigilance to ensure better face seal.

Improving the fit of filtering facepiece respirators.

Aims To assess the effectiveness and acceptability of smartphone customised frame technology to improve the fit of disposable filtering facepiece class 3 (FFP3) respirators for dental staff who previously failed fit testing.Method In total, 20 volunteers who previously failed FFP3 fit testing were recruited to use smartphone technology (Bellus3D FaceApp) to have a 3D-printed bespoke face frame produced for them. They underwent qualitative fit testing with and without the frame with two freely available disposable FFP3 respirator designs (mask A: GVS F31000 Segre folded model; mask B: Valmy Spireor). The order of testing was random. Ease of use of the smartphone technology and the comfort of the frame were determined by questionnaire.Results Fit test passes increased from 5% without the frame to 70% and 95%, respectively, for masks A and B with the frame (p <0.01). Very few participants reported using the technology as difficult (n = 1/20) or the frame uncomfortable (n = 3/20) or difficult to wear (n = 0/20).Conclusion Customised frames produced using smartphone technology improved qualitative fit test pass rates for two commonly available FFP3 respirators. Using smartphone technology for frame design, wearing a frame and frame comfort levels were all acceptable to the majority of participants.

Qualitative fit test outcomes for N95 filtering facepiece respirators in health care workers

BackgroundWe analyzed the qualitative fit test results of the filtering facepiece respirators (FFRs) used at our institution to determine their performance and utility. MethodsWe retrospectively analyzed 12,582 qualitative fit testing results for several FFR models among 8,809 health care workers (HCWs). ResultsThe overall failure rate for HCWs was 15.2%. Nearly one-third (2933/8809, 33.3%) had multiple FFRs fit tested. HCW sex was a statistically significant indicator of fit testing failure (χ2 = 29.9, df = 1, P < .001), with women having a 44% higher likelihood (OR, 1.4; 95% CI: 1.27–1.65) than men. There were statistically significant differences in the failure rate across FFRs (Fig 4, F[5, 12475] = 8.4, P < .001). Fluidshield 46867S had a significantly higher failure rate (49%) than the 3M 1860 (P = .012), 3M 1860S (P < .001), 3M 8210 (P < .001), and Safelife (P < .001) FFRs. ConclusionsThere was a large degree of variation in fit testing results for the FFRs tested. Although we were unable to find an FFR that fit more than 95% of the HCWs successfully, we identified poorly functioning FFRs that can help our institution with decision-making and budgeting for acquisition and stocking appropriate FFRs.

Face mask fit hacks: Improving the fit of KN95 masks and surgical masks with fit alteration techniques.

During the course of the COVID-19 pandemic, there have been suggestions that various techniques could be employed to improve the fit and, therefore, the effectiveness of face masks. It is well recognized that improving fit tends to improve mask effectiveness, but whether these fit modifiers are reliable remains unexplored. In this study, we assess a range of common "fit hacks" to determine their ability to improve mask performance. Between July and September 2020, qualitative fit testing was performed in an indoor living space. We used quantitative fit testing to assess the fit of both surgical masks and KN95 masks, with and without 'fit hacks', on four participants. Seven fit hacks were evaluated to assess impact on fit. Additionally, one participant applied each fit hack multiple times to assess how reliable hacks were when reapplied. A convenience of four participants took part in the study, three females and one male with a head circumference range of 54 to 60 centimetres. The use of pantyhose, tape, and rubber bands were effective for most participants. A pantyhose overlayer was observed to be the most effective hack. High degrees of variation were noted between participants. However, little variation was noted within participants, with hacks generally showing similar benefit each time they were applied on a single participant. An inspection of the fit hacks once applied showed that individual facial features may have a significant impact on fit, especially the nose bridge. Fit hacks can be used to effectively improve the fit of surgical and KN95 masks, enhancing the protection provided to the wearer. However, many of the most effective hacks are very uncomfortable and unlikely to be tolerated for extended periods of time. The development of effective fit-improvement solutions remains a critical issue in need of further development.

Adequacy of a Novel Qualitative Fit Test Kit and Protocol during the COVID-19 Pandemic.

To develop our own qualitative fit test kit and protocol for respirators and validate this against the manufacturer-issued kit. This is a crossover study of 50 healthcare workers in a tertiary government hospital. Some healthcare workers were tested multiple times according to the number of respirators they want tested. Qualitative fit testing was done according to manufacturer protocol for the commercial kits or according to our own protocol for the novel kits. A total of 63 fit tests were analyzed. This novel kit was determined to be noninferior to manufacturer-issued kits in detecting leaks among worn respirators (p=0.005). A fit test kit can be successfully created from readily available household and hospital materials. Fit tests with these novel kits using our validated protocol are shown to be noninferior to commercial test kits. This can greatly aid in qualitative fit testing of respirators in a logistically constrained pandemic setting.

A position statement and practical guide to the use of particulate filtering facepiece respirators (N95, FFP2, or equivalent) for South African health workers exposed to respiratory pathogens including Mycobacterium tuberculosis and SARS-CoV-2

Summary Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is transmitted mainly by aerosol in particles &lt;10 µm that can remain suspended for hours before being inhaled. Because particulate filtering facepiece respirators (‘respirators’; e.g. N95 masks) are more effective than surgical masks against bio-aerosols, many international organisations now recommend that health workers (HWs) wear a respirator when caring for individuals who may have COVID-19. In South Africa (SA), however, surgical masks are still recommended for the routine care of individuals with possible or confirmed COVID-19, with respirators reserved for so-called aerosol-generating procedures. In contrast, SA guidelines do recommend respirators for routine care of individuals with possible or confirmed tuberculosis (TB), which is also transmitted via aerosol. In health facilities in SA, distinguishing between TB and COVID-19 is challenging without examination and investigation, both of which may expose HWs to potentially infectious individuals. Symptom-based triage has limited utility in defining risk. Indeed, significant proportions of individuals with COVID-19 and/or pulmonary TB may not have symptoms and/or test negative. The prevalence of undiagnosed respiratory disease is therefore likely significant in many general clinical areas (e.g. waiting areas). Moreover, a proportion of HWs are HIV-positive and are at increased risk of severe COVID-19 and death. Recommendations Sustained improvements in infection prevention and control (IPC) require reorganisation of systems to prioritise HW and patient safety. While this will take time, it is unacceptable to leave HWs exposed until such changes are made. We propose that the SA health system adopts a target of ‘zero harm’, aiming to eliminate transmission of respiratory pathogens to all individuals in every healthcare setting. Accordingly, we recommend: 1. the use of respirators by all staff (clinical and non-clinical) during activities that involve contact or sharing air in indoor spaces with individuals who: (i) have not yet been clinically evaluated; or (ii) are thought or known to have TB and/or COVID-19 or other potentially harmful respiratory infections; 2. the use of respirators that meet national and international manufacturing standards; 3. evaluation of all respirators, at the least, by qualitative fit testing; and 4. the use of respirators as part of a ‘package of care’ in line with international IPC recommendations. We recognise that this will be challenging, not least due to global and national shortages of personal protective equipment (PPE). SA national policy around respiratory protective equipment enables a robust framework for manufacture and quality control and has been supported by local manufacturers and the Department of Trade, Industry and Competition. Respirator manufacturers should explore adaptations to improve comfort and reduce barriers to communication. Structural changes are needed urgently to improve the safety of health facilities: persistent advocacy and research around potential systems change remain essential.

A feasible route for the design and manufacture of customised respiratory protection through digital facial capture

The World Health Organisation has called for a 40% increase in personal protective equipment manufacturing worldwide, recognising that frontline workers need effective protection during the COVID-19 pandemic. Current devices suffer from high fit-failure rates leaving significant proportions of users exposed to risk of viral infection. Driven by non-contact, portable, and widely available 3D scanning technologies, a workflow is presented whereby a user’s face is rapidly categorised using relevant facial parameters. Device design is then directed down either a semi-customised or fully-customised route. Semi-customised designs use the extracted eye-to-chin distance to categorise users in to pre-determined size brackets established via a cohort of 200 participants encompassing 87.5% of the cohort. The user’s nasal profile is approximated to a Gaussian curve to further refine the selection in to one of three subsets. Flexible silicone provides the facial interface accommodating minor mismatches between true nasal profile and the approximation, maintaining a good seal in this challenging region. Critically, users with outlying facial parameters are flagged for the fully-customised route whereby the silicone interface is mapped to 3D scan data. These two approaches allow for large scale manufacture of a limited number of design variations, currently nine through the semi-customised approach, whilst ensuring effective device fit. Furthermore, labour-intensive fully-customised designs are targeted as those users who will most greatly benefit. By encompassing both approaches, the presented workflow balances manufacturing scale-up feasibility with the diverse range of users to provide well-fitting devices as widely as possible. Novel flow visualisation on a model face is presented alongside qualitative fit-testing of prototype devices to support the workflow methodology.

A position statement and practical guide to the use of particulate filtering facepiece respirators (N95, FFP2, or equivalent) for South African health workers exposed to respiratory pathogens including Mycobacterium tuberculosis and SARS-CoV-2.

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is transmitted mainly by aerosol in particles <10 µm that can remain suspended for hours before being inhaled. Because particulate filtering facepiece respirators ('respirators'; e.g. N95 masks) are more effective than surgical masks against bio-aerosols, many international organisations now recommend that health workers (HWs) wear a respirator when caring for individuals who may have COVID-19. In South Africa (SA), however, surgical masks are still recommended for the routine care of individuals with possible or confirmed COVID-19, with respirators reserved for so-called aerosol-generating procedures. In contrast, SA guidelines do recommend respirators for routine care of individuals with possible or confirmed tuberculosis (TB), which is also transmitted via aerosol. In health facilities in SA, distinguishing between TB and COVID-19 is challenging without examination and investigation, both of which may expose HWs to potentially infectious individuals. Symptom-based triage has limited utility in defining risk. Indeed, significant proportions of individuals with COVID-19 and/or pulmonary TB may not have symptoms and/or test negative. The prevalence of undiagnosed respiratory disease is therefore likely significant in many general clinical areas (e.g. waiting areas). Moreover, a proportion of HWs are HIV-positive and are at increased risk of severe COVID-19 and death. Sustained improvements in infection prevention and control (IPC) require reorganisation of systems to prioritise HW and patient safety. While this will take time, it is unacceptable to leave HWs exposed until such changes are made. We propose that the SA health system adopts a target of 'zero harm', aiming to eliminate transmission of respiratory pathogens to all individuals in every healthcare setting. Accordingly, we recommend: the use of respirators by all staff (clinical and non-clinical) during activities that involve contact or sharing air in indoor spaces with individuals who: (i) have not yet been clinically evaluated; or (ii) are thought or known to have TB and/or COVID-19 or other potentially harmful respiratory infections;the use of respirators that meet national and international manufacturing standards;evaluation of all respirators, at the least, by qualitative fit testing; andthe use of respirators as part of a 'package of care' in line with international IPC recommendations. We recognise that this will be challenging, not least due to global and national shortages of personal protective equipment (PPE). SA national policy around respiratory protective equipment enables a robust framework for manufacture and quality control and has been supported by local manufacturers and the Department of Trade, Industry and Competition. Respirator manufacturers should explore adaptations to improve comfort and reduce barriers to communication. Structural changes are needed urgently to improve the safety of health facilities: persistent advocacy and research around potential systems change remain essential.