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1.
Medicine (Baltimore) ; 100(38): e27245, 2021 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-34559126

RESUMO

ABSTRACT: When developing a new medical device, it is essential to assess the usability of such a device through various stakeholders.This study assessed the usability of pain medical devices through a Delphi survey administered to physiatrists and physiotherapists.A Delphi survey was conducted on the problems and improvements in hardware and software for a panel consisting of 10 physiatrists and 10 physiotherapists. A total of 3 rounds of surveys were conducted, and the third round of survey was confirmed through a Likert scale (1 = strongly agree to 5 = strongly disagree).The 2 groups generally had a common perception of the problems and improvements in pain medical devices. However, the physiatrist group mostly identified problems such as linking patient information, whereas the physiotherapist group deemed hardware problems such as device weight or connection cables as being more important (mean [standard deviation]; physiatrist, hardware 2.90 [0.93], software 2.28 [0.91] / physiotherapist, hardware 3.04 [0.84], software 3.03 [1.13]).To date, analysis has not been conducted by dividing the focus of various stakeholders using pain medical devices. The difference in view of the usability of these 2 stakeholder groups should be considered when improving the hardware or software of pain medical devices in the future. Further research is warranted to investigate other stakeholders such as patients and device developers to improve the devices.


Assuntos
Desenho de Equipamento/normas , Manejo da Dor/instrumentação , Design Centrado no Usuário , Adulto , Técnica Delfos , Desenho de Equipamento/estatística & dados numéricos , Feminino , Humanos , Masculino , Manejo da Dor/normas , Manejo da Dor/tendências , Fisiatras/tendências , Fisioterapeutas/tendências , República da Coreia , Estatísticas não Paramétricas , Inquéritos e Questionários
2.
Nat Commun ; 12(1): 4880, 2021 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-34385444

RESUMO

Accurate and imperceptible monitoring of electrophysiological signals is of primary importance for wearable healthcare. Stiff and bulky pregelled electrodes are now commonly used in clinical diagnosis, causing severe discomfort to users for long-time using as well as artifact signals in motion. Here, we report a ~100 nm ultra-thin dry epidermal electrode that is able to conformably adhere to skin and accurately measure electrophysiological signals. It showed low sheet resistance (~24 Ω/sq, 4142 S/cm), high transparency, and mechano-electrical stability. The enhanced optoelectronic performance was due to the synergistic effect between graphene and poly (3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), which induced a high degree of molecular ordering on PEDOT and charge transfer on graphene by strong π-π interaction. Together with ultra-thin nature, this dry epidermal electrode is able to accurately monitor electrophysiological signals such as facial skin and brain activity with low-motion artifact, enabling human-machine interfacing and long-time mental/physical health monitoring.


Assuntos
Eletrodos , Eletrofisiologia/métodos , Epiderme/fisiologia , Desenho de Equipamento/métodos , Monitorização Fisiológica/métodos , Dispositivos Eletrônicos Vestíveis , Artefatos , Compostos Bicíclicos Heterocíclicos com Pontes/química , Condutividade Elétrica , Eletrofisiologia/instrumentação , Eletrofisiologia/normas , Desenho de Equipamento/normas , Grafite/química , Humanos , Estrutura Molecular , Monitorização Fisiológica/instrumentação , Monitorização Fisiológica/normas , Movimento (Física) , Polímeros/química , Poliestirenos/química , Pele
5.
A A Pract ; 15(4): e01449, 2021 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-33905378

RESUMO

Snorkel masks have become an option for personal protective equipment (PPE) due to the shortage of air filtration at least 95% of airborne particle (N95) masks as a result of the coronavirus disease 2019 (COVID-19) pandemic. We developed a 3D design of a triheaded adapter that connects a snorkel mask to 3 different National Institute for Occupational Safety and Health (NIOSH)-approved air filtration at least 99% of airborne particles (N99) filters with the aim of improving wearer comfort. We measured the resistance of the new triheaded adapter to be one-third the resistance of the single adapter. Interdepartmental survey of anesthesiologists showed an improvement in perceived comfort when using the triheaded adapter as compared to the single adapter.


Assuntos
Anestesiologistas/tendências , COVID-19/prevenção & controle , Desenho de Equipamento/tendências , Máscaras/tendências , Exposição Ocupacional/prevenção & controle , Equipamento de Proteção Individual/tendências , Anestesiologistas/normas , COVID-19/epidemiologia , Desenho de Equipamento/normas , Humanos , Máscaras/normas , Equipamento de Proteção Individual/normas
7.
Clin Neurophysiol ; 132(3): 723-729, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33578337

RESUMO

OBJECTIVE: The presence of a cochlear implant is being considered an absolute contraindication for experiments and/or treatments. We aimed to verify TMS (Transcranial Magnetic Stimulation) compatibility of a new generation of cochlear implants. METHODS: In a series of experiments, we test if MED-EL cochlear implants -compatible with stable fields of magnetic resonance imaging scanning- are fully resistant even to rapidly varying magnetic fields as those generated by single pulses and low and high-frequency trains of repetitive TMS (rTMS) applied with a figure of eight coil and different magnetic stimulators. RESULTS: With a TMS intensity equal or below 2.2 Tesla (T) the cochlear implant and all its electronic components remain fully functional, even when the combination of frequency, intensity and number of pulses exceeds the currently available safety guidelines. Induced forces on the implant are negligible. With higher magnetic fields (i.e., 3.2 T), one device was corrupted. CONCLUSIONS: Results exclude the risk of electronic damaging, demagnetizing or displacements of the studied cochlear implants when exposed to magnetic fields of up to 2.2 T delivered through a focal coil. SIGNIFICANCE: They open the way to use focal rTMS protocols with the aim of promoting neural plasticity in auditory networks, possibly helping the post-implant recovery of speech perception performance.


Assuntos
Implante Coclear/instrumentação , Implante Coclear/tendências , Implantes Cocleares/tendências , Desenho de Equipamento/tendências , Estimulação Magnética Transcraniana/tendências , Implante Coclear/normas , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Estudos de Viabilidade , Perda Auditiva/diagnóstico , Perda Auditiva/fisiopatologia , Perda Auditiva/cirurgia , Humanos , Plasticidade Neuronal/fisiologia , Estimulação Magnética Transcraniana/métodos
8.
Medicine (Baltimore) ; 100(3): e24370, 2021 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-33546074

RESUMO

ABSTRACT: Robotic surgical systems have evolved over time. The da Vinci Xi system was developed in 2014 and was expected to solve the shortcomings of the previous S system. Therefore, we conducted this study to compare these 2 systems and identify if the Xi system truly improves surgical outcomes.In this retrospective study, a total of 86 patients with unilateral papillary thyroid carcinoma without central lymph node involvement underwent gasless transaxillary hemithyroidectomy using 2 robotic systems, the da Vinci S and Xi. Forty patients were in the da Vinci S group and 46 patients were in the da Vinci Xi group. All surgeries were performed by 1 surgeon (YWC). All surgery video files were analyzed to compare the duration of each surgical step.The total operation time was significantly shorter in the Xi group than in the S group (153.0 minutes vs 105.7 minutes, P < .01). Time for robot docking was shorter in the Xi group (19.8 minutes vs 10.6 minutes, P < .01), and all procedures performed in the console also required a shorter time in this group. The overall complication rate did not differ significantly (P = .464).The da Vinci Xi system made robotic thyroidectomy easier and faster without increasing the complication rate. It is a safe and valuable system for robotic thyroidectomy.


Assuntos
Desenho de Equipamento/normas , Procedimentos Cirúrgicos Robóticos/instrumentação , Procedimentos Cirúrgicos Robóticos/normas , Tireoidectomia/instrumentação , Adulto , Distribuição de Qui-Quadrado , Desenho de Equipamento/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/métodos , Tireoidectomia/métodos , Tireoidectomia/normas , Resultado do Tratamento
9.
J Acoust Soc Am ; 149(1): 66, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33514153

RESUMO

During the COVID-19 outbreak, the auscultation of heart and lung sounds has played an important role in the comprehensive diagnosis and real-time monitoring of confirmed cases. With clinicians wearing protective clothing in isolation wards, a potato chip tube stethoscope, which is a secure and flexible substitute for a conventional stethoscope, has been used by Chinese medical workers in the first-line treatment of COVID-19. In this study, an optimal design for this simple cylindrical stethoscope is proposed based on the fundamental theory of acoustic waveguides. Analyses of the cutoff frequency, sound power transmission coefficient, and sound wave propagation in the uniform lossless tube provide theoretical guidance for selecting the geometric parameters for this simple cylindrical stethoscope. A basic investigation into the auscultatory performances of the original tube and the optimal tube with proposed dimensions was conducted both in a semi-anechoic chamber and in a quiet laboratory. Both experimental results and front-line doctors' clinical feedback endorse the proposed theoretical optimization.


Assuntos
Acústica , Auscultação/normas , COVID-19/diagnóstico , Desenho de Equipamento/normas , Estetoscópios/normas , Acústica/instrumentação , Auscultação/instrumentação , Auscultação/métodos , COVID-19/epidemiologia , COVID-19/fisiopatologia , Desenho de Equipamento/instrumentação , Desenho de Equipamento/métodos , Humanos , Sons Respiratórios/fisiologia , Sons Respiratórios/fisiopatologia
10.
Anaesthesia ; 76(5): 617-622, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33470422

RESUMO

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.


Assuntos
COVID-19/prevenção & controle , Análise Custo-Benefício/normas , Pessoal de Saúde/normas , Máscaras/normas , Respiradores N95/normas , Adulto , COVID-19/economia , Estudos de Coortes , Desenho de Equipamento/economia , Desenho de Equipamento/normas , Feminino , Pessoal de Saúde/economia , Humanos , Masculino , Máscaras/economia , Pessoa de Meia-Idade , Respiradores N95/economia , Exposição Ocupacional/economia , Exposição Ocupacional/prevenção & controle , Equipamento de Proteção Individual/economia , Equipamento de Proteção Individual/normas , Estudos Prospectivos , Reprodutibilidade dos Testes
11.
Int J Qual Health Care ; 33(Supplement_1): 4-10, 2021 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-32780821

RESUMO

BACKGROUND: This paper describes a rapid response project from the Chartered Institute of Ergonomics & Human Factors (CIEHF) to support the design, development, usability testing and operation of new ventilators as part of the UK response during the COVID-19 pandemic. METHOD: A five-step approach was taken to (1) assess the COVID-19 situation and decide to formulate a response; (2) mobilise and coordinate Human Factors/Ergonomics (HFE) specialists; (3) ideate, with HFE specialists collaborating to identify, analyse the issues and opportunities, and develop strategies, plans and processes; (4) generate outputs and solutions; and (5) respond to the COVID-19 situation via targeted support and guidance. RESULTS: The response for the rapidly manufactured ventilator systems (RMVS) has been used to influence both strategy and practice to address concerns about changing safety standards and the detailed design procedure with RMVS manufacturers. CONCLUSION: The documents are part of a wider collection of HFE advice which is available on the CIEHF COVID-19 website (https://covid19.ergonomics.org.uk/).


Assuntos
COVID-19 , Ergonomia/métodos , Ventiladores Mecânicos/normas , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Ergonomia/normas , Humanos , Segurança do Paciente/normas , Reino Unido
13.
BMJ Mil Health ; 167(3): 147-152, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32094217

RESUMO

INTRODUCTION: Side plates are worn by UK Armed Forces as part of the VIRTUS body armour and load carriage systems to protect the thorax and abdomen from high-velocity threats. The VIRTUS project has provided the impetus to objectively demonstrate the anatomical coverage provided by side plates. METHOD: CT scans of 120 male UK Armed Forces personnel were analysed to ascertain the vertical distance between the anterior axillary fold and iliac crest, and horizontal distance between anterior and posterior borders of the liver, delineating the boundaries of essential medical coverage from the side aspects. The percentage of shot-lines intersected by the existing Enhanced Combat Body Armour (ECBA) plates as well as an optimised plate based on the maximum potential dimensions of essential coverage was determined in the Coverage of Armour Tool. RESULTS: ECBA plates were 101 mm shorter and 4 mm narrower than a plate with dimensions providing essential medical coverage for the 50th percentile subject (157×315 mm). Coverage increased by 35% when using two ECBA plates as side coverage in addition to using the front and rear OSPREY plates in the VIRTUS vest. Two side plates with dimensions providing essential medical coverage for the 50th percentile increased anatomical coverage by a further 16%. CONCLUSIONS: This analysis has provided strong evidence that ECBA plates are already optimised for side protection, despite not being originally designed for this purpose. They are correctly positioned within the VIRTUS soft body armour vest and the width of the ECBA plate is only 3% less than what would be optimum size for the 50th percentile. Although the height of the plate could be increased to further enhance the anatomical coverage, it is unlikely that this would be acceptable in terms of the human factors, equipment integration or additional mass.


Assuntos
Axila/lesões , Desenho de Equipamento/métodos , Roupa de Proteção/tendências , Traumatismos Torácicos/prevenção & controle , Traumatismos por Explosões/prevenção & controle , Desenho de Equipamento/normas , Humanos , Roupa de Proteção/normas , Roupa de Proteção/provisão & distribuição , Traumatismos Torácicos/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Tomografia Computadorizada por Raios X/estatística & dados numéricos , Ferimentos por Arma de Fogo/prevenção & controle
14.
BMJ Mil Health ; 167(2): 75-79, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32086262

RESUMO

INTRODUCTION: There is a need for a military tourniquet to control catastrophic haemorrhage in a chemical, biological, radiological or nuclear (CBRN) threat environment. No published data exist as to the efficacy of tourniquets while wearing British military CBRN individual protective equipment (IPE). METHODS: 12 volunteers from the counter CBRN instructors' course allowed testing on 24 legs. A Combat Application Tourniquet (C-A-T) was applied to all volunteers at the level of the midthigh. 12 legs were tested while wearing CBRN IPE (both operator and simulated casualty), and the control group of 12 legs was tested while wearing conventional combat dress state (both operator and simulated casualty). The order of leg laterality and dress state were sequenced according to a prerandomised system. Efficacy was measured via use of an ultrasound probe at the popliteal artery. Tourniquets were considered effective if arterial flow was completely occluded on ultrasound imaging. Data were collected on time to successful application, failure of tourniquets and pain scores as rated by the visual analogue scale (1-10). RESULTS: There were no failures of tourniquet application in the CBRN group, and two failures (17%) in the control group. Failures were pain threshold exceeded (n=1) and tourniquet internal strap failure (n=1). The mean application time for the CBRN group was 28.5 s (SD 11.7) and 23.7 s (SD 9.8) for the conventional combat group. There was no statistically significant difference (p=0.27). The median CBRN pain score was 2.0 (IQR 2.0-3.5). The median control pain score was 4.0 (IQR 3-6). This was a statistically significant difference (p=0.002). CONCLUSION: C-A-Ts applied to simulated casualties in CBRN IPE at the midthigh are at least as efficacious as those applied to the midthigh in a conventional combat dress state. The pain experienced was less in CBRN IPE than when in a conventional combat dress state.


Assuntos
Derramamento de Material Biológico/tendências , Vazamento de Resíduos Químicos/tendências , Desenho de Equipamento/normas , Liberação Nociva de Radioativos/tendências , Torniquetes/normas , Adulto , Estudos Cross-Over , Desenho de Equipamento/métodos , Humanos , Masculino , Medicina Militar/instrumentação , Medicina Militar/métodos , Medicina Militar/estatística & dados numéricos , Militares/estatística & dados numéricos , Estudos Prospectivos , Torniquetes/tendências
15.
J Neurointerv Surg ; 13(3): 272-277, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32601259

RESUMO

BACKGROUND: With the recent advent of advanced technologies in the field, treatment of neurovascular diseases using endovascular techniques is rapidly evolving. Here we describe our experience with pre-surgical simulation using the Biomodex EVIAS patient-specific 3D-printed models to plan aneurysm treatment using endovascular robotics and novel flow diverter devices. METHODS: Pre-procedural rehearsals with 3D-printed patient-specific models of eight cases harboring brain aneurysms were performed before the first in-human experiences. To assess the reliability of the experimental model, the characteristics of the aneurysms were compared between the patient and 3D models. The rehearsals were used to define the patient treatment plan, including technique, device sizing, and operative working projections. RESULTS: The study included eight patients with their respective EVIAS 3D aneurysm models. Pre-operative simulation was performed for the first in-human robotic-assisted neurovascular interventions (n=2) and new generation flow-diverter stents (n=6). Aneurysms were located in both the anterior (n=5) and posterior (n=3) circulation and were on average 11.0±6.5 mm in size. We found reliable reproduction of the aneurysm features and similar dimensions of the parent vessel anatomy between the 3D models and patient anatomy. Information learned from pre-surgical in vitro simulation are described in detail, including an improved patient treatment plan, which contributed to successful first in-world procedures with no intraprocedural complications. CONCLUSIONS: Pre-procedural rehearsal using patient-specific 3D models provides precise procedure planning, which can potentially lead to greater operator confidence, decreased radiation dose and improvements in patient safety, particularly in first in-human experiences.


Assuntos
Procedimentos Endovasculares/métodos , Desenho de Equipamento/métodos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Impressão Tridimensional , Procedimentos Cirúrgicos Robóticos/métodos , Idoso , Procedimentos Endovasculares/normas , Desenho de Equipamento/normas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Impressão Tridimensional/normas , Reprodutibilidade dos Testes , Procedimentos Cirúrgicos Robóticos/normas , Stents Metálicos Autoexpansíveis/normas , Resultado do Tratamento
16.
Am J Infect Control ; 49(2): 274-275, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-32682016

RESUMO

The use of surgical sterilization wrap for respirator masks during the COVID-19 crisis has become a popularized personal protective equipment alternative option due to claims supporting its ability to meet N95 standards. This study sought to assess these claims using standardized filter testing. The tested material failed to meet N95 standards and suggests its use may place medical personnel at increased risk of harm when managing COVID-19 patients.


Assuntos
COVID-19/prevenção & controle , Desenho de Equipamento/efeitos adversos , Máscaras/virologia , Teste de Materiais/estatística & dados numéricos , Dispositivos de Proteção Respiratória/virologia , SARS-CoV-2/isolamento & purificação , Aerossóis/isolamento & purificação , COVID-19/virologia , Desenho de Equipamento/normas , Pessoal de Saúde , Humanos , Máscaras/normas , Dispositivos de Proteção Respiratória/normas , Esterilização
18.
Otolaryngol Clin North Am ; 54(1): 11-23, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33243372

RESUMO

A new era of surgical visualization and magnification is poised to disrupt the field of otology and neurotology. The once revolutionary benefits of the binocular microscope now are shared with rigid endoscopes and exoscopes. These 2 modalities are complementary. The endoscope improves visualization of the hidden recesses through the external auditory canal or canal-up mastoidectomy. The exoscope provides an immersive visual experience and superior ergonomics compared with binocular microscopy. Endoscopes and exoscopes are poised to disrupt the standard of care for surgical visualization and magnification in otology and neurotology.


Assuntos
COVID-19 , Endoscópios/normas , Endoscopia/instrumentação , Neuro-Otologia/instrumentação , Otolaringologia/instrumentação , Pandemias , Meato Acústico Externo/cirurgia , Endoscopia/normas , Desenho de Equipamento/normas , Humanos , Mastoidectomia/instrumentação , Microcirurgia/instrumentação , Procedimentos Cirúrgicos Minimamente Invasivos/instrumentação , Procedimentos Neurocirúrgicos/instrumentação , Neuro-Otologia/normas , Otolaringologia/normas , Padrão de Cuidado/normas , Estados Unidos
19.
Rev Sci Instrum ; 91(11): 114101, 2020 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-33261462

RESUMO

The SARS-CoV-2 global pandemic has produced widespread shortages of certified air-filtering personal protection equipment and an acute need for rapid evaluation of breathability and filtration efficiency of proposed alternative solutions. Here, we describe experimental efforts to nondestructively quantify three vital characteristics of mask approaches: breathability, material filtration effectiveness, and sensitivity to fit. We focus on protection against aqueous aerosols >0.3 µm using off-the-shelf particle, flow, and pressure sensors, permitting rapid comparative evaluation of these three properties. We present and discuss both the pressure drop and the particle penetration as a function of flow to permit comparison of relative protection for a set of proposed filter and mask designs. The design considerations of the testing apparatus can be reproduced by university laboratories and medical facilities and used for rapid local quality control of respirator masks that are of uncertified origin, monitoring the long-term effects of various disinfection schemes and evaluating improvised products not designed or marketed for filtration.


Assuntos
COVID-19/prevenção & controle , Máscaras , Pandemias/prevenção & controle , Dispositivos de Proteção Respiratória , SARS-CoV-2 , Aerossóis , Microbiologia do Ar , Movimentos do Ar , Pressão do Ar , COVID-19/transmissão , Desenho de Equipamento/normas , Face , Filtração/instrumentação , Humanos , Máscaras/normas , Teste de Materiais/instrumentação , Teste de Materiais/normas , Respiradores N95/normas , Tamanho da Partícula , Dispositivos de Proteção Respiratória/normas
20.
S Afr Med J ; 0(0): 13162, 2020 12 09.
Artigo em Inglês | MEDLINE | ID: mdl-33334390

RESUMO

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.


Assuntos
COVID-19 , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Teste de Materiais/métodos , Respiradores N95/normas , Exposição Ocupacional/prevenção & controle , COVID-19/epidemiologia , COVID-19/prevenção & controle , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Análise de Falha de Equipamento , Humanos , SARS-CoV-2/isolamento & purificação , Gestão da Segurança/organização & administração , África do Sul/epidemiologia
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