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1.
Zhongguo Yi Liao Qi Xie Za Zhi ; 45(1): 62-66, 2021 Feb 08.
Artigo em Chinês | MEDLINE | ID: mdl-33522179

RESUMO

IMDRF revised the Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices (hereinafter referred to as "EP"), which further promoted the unification of medical device safety and effectiveness internationally. In order to strengthen the scientific review of medical device and deepen the understanding of EP, we introduce EP, focus on the role of EP and the connection with the construction of quality management systems, risk and benefit determination, and registration, analyze the problems and reasons in the process of medical device registration, and give suggestions to promote the application of EP.


Assuntos
Equipamentos e Provisões , Segurança de Equipamentos
2.
Zhongguo Yi Liao Qi Xie Za Zhi ; 45(1): 90-95, 2021 Feb 08.
Artigo em Chinês | MEDLINE | ID: mdl-33522185

RESUMO

ISO/TS 10974 is a general international technical specification (TS) which concentrates on the safety assessment of magnetic resonance imaging (MRI) for active implantable medical devices. ISO/TS 10974 Ed.2 was published in 2018 with substantial revision to Ed.1. To provide a guideline for adopting this recently revised TS in practice, this paper summarized the major changes and analyzed the technical improvements in Ed.2. Moreover, we also discussed current and emerging challenges to MRI safety evaluation remaining in Ed.2. The study revealed the consistency between these two editions with respect to classification of potential patient hazards and testing strategies, whereas Ed.2 has many methodological improvements over Ed.1 in testing methods for RF-induced heating, gradient-induced malfunction, and combined field testing, etc. However, it is still necessary to expand the scope of applicability and to adopt latest research findings into this TS to keep pace with the rapid developments in industry, making it a better guidance in the future.


Assuntos
Segurança de Equipamentos , Imagem por Ressonância Magnética , Humanos , Próteses e Implantes
3.
Texto & contexto enferm ; 29: e20180371, Jan.-Dec. 2020. tab, graf
Artigo em Inglês | LILACS, BDENF - Enfermagem | ID: biblio-1059139

RESUMO

ABSTRACT Objective: to identify factors associated with medical-device-related pressure injury. Method: an integrative review of published articles on the subject related to the adult population in the databases of PUBMED, Scopus, MEDLINE, Latin American and Caribbean Health Sciences Literature (Literatura Latino-Americana e do Caribe em Ciências da Saúde, LILACS), Web of Science and Nursing Database (Banco de Dados em Enfermagem, BDENF), between 2013 and 2018. Results: medical-device-related pressure injuries were common in adults, especially in the elderly, due to capillary fragility, among other changes. Other observed factors were length of stay, critically ill patients or those requiring any type of medical device. Numerous medical devices have been associated with skin lesions; among the most frequent were breathing, feeding, and orthopedic devices, tubes, oximeters, neck collars, patches and nasogastric tubes. Conclusion: the first step towards prevention is exploration in terms of identifying the types of injury-causing devices and evidence-based interventions, and disseminating information to the entire multidisciplinary team.


RESUMEN Objetivo: identificar factores asociados con las lesiones por presión relacionadas a dispositivos médicos. Método: revisión integradora de artículos publicados sobre el tema relacionado a la población adultas en las siguientes bases de datos: PUBMED, Scopus, MEDLINE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Web of Science y Banco de Dados em Enfermagem (BDENF), entre 2013 y 2018. Resultados: las lesiones por presión relacionadas con dispositivos médicos fueron comunes en adultos, principalmente en ancianos, debido a la fragilidad capilar, entre otras alteraciones. También se observaron otros factores como tiempo de permanencia, pacientes críticos o que necesitaban cualquier tipo de dispositivo médico. Se asoció un sinnúmero de dispositivos médicos a las lesiones de piel; entre los más frecuentes se pueden mencionar los dispositivos respiratorios, de alimentación y ortopédicos, los tubos, los oxímetros, los collares cervicales, los adhesivos y las sondas nasogástricas. Conclusión: el primer paso para la prevención es la exploración, en términos de identificar los tipos de dispositivos que causan la lesión y las intervenciones basadas en evidencias científicas, además de divulgar la información a todo el equipo multiprofesional.


RESUMO Objetivo: identificar fatores associados à lesão por pressão relacionada a dispositivo médico. Método: revisão integrativa de artigos publicados sobre o tema relacionado à população adulta nas bases de dados da PUBMED, Scopus, MEDLINE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Web of Science e Banco de Dados em Enfermagem (BDENF), entre 2013 e 2018. Resultados: lesões por pressão relacionadas a dispositivo médico foram comuns em adultos, principalmente em idosos, devido à fragilidade capilar, entre outras alterações. Outros fatores observados foram tempo de permanência, pacientes críticos ou que necessitassem de qualquer tipo de dispositivo médico. Inúmeros dispositivos médicos foram associados às lesões de pele; entre os mais frequentes estiveram dispositivos respiratórios, de alimentação, ortopédicos, tubos, oxímetros, colares cervicais, adesivos e sondas nasogástricas. Conclusão: o primeiro passo para a prevenção é a exploração, em termos de identificação dos tipos de dispositivos que causam a lesão e intervenções baseadas em evidências científicas, além da divulgação das informações para toda a equipe multiprofissional.


Assuntos
Humanos , Adulto , Ferimentos e Lesões , Lesão por Pressão , Enfermagem , Adulto , Equipamentos e Provisões , Segurança de Equipamentos
4.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(6): 532-536, 2020 Dec 08.
Artigo em Chinês | MEDLINE | ID: mdl-33314863

RESUMO

This paper analyzed the current reform of review and approval mechanism for medical devices and discussed the method for technical review process extending to product quality controllable direction and found the measures and suggestions to strengthen technical review for quality management system with the help with complementary relationship between the technical review and the quality management system assessment of the pre-market registration. Nowadays, because of the demand of eRPS, MAH and the amendment of regulation, the integration of technical review and quality management system is more important, necessary and scientific. Scientific and systematic evaluation should be carried out to strengthen the pre-market approval of medical devices and ensure the safety and effectiveness of medical products.


Assuntos
Aprovação de Equipamentos , Segurança de Equipamentos , Projetos de Pesquisa
5.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(6): 549-552, 2020 Dec 08.
Artigo em Chinês | MEDLINE | ID: mdl-33314867

RESUMO

OBJECTIVE: An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests. METHODS: According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed. RESULTS: After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard. There was no significant difference between the two methods when the dose of 60 U and 30 U were tested, but there was significant difference when the dose of 1 U was tested. CONCLUSIONS: Both methods can be used to evaluate dose accuracy, however, the method proposed in this paper can reduce the usage of drugs by 2/3, so it can reduce cost of supervised test.


Assuntos
Equipamentos Descartáveis/normas , Injeções Intradérmicas/instrumentação , Segurança de Equipamentos , Seringas
6.
Ann Biol Clin (Paris) ; 78(6): 609-616, 2020 Dec 01.
Artigo em Francês | MEDLINE | ID: mdl-33361015

RESUMO

Confronted with the COVID-19 crisis, healthcare professionals have had to tackle an epidemic crisis of a huge magnitude for which they were not prepared. Medical laboratories have been on the front line, from collecting samples to performing the analysis required to diagnose this new pathology. Responding to the needs and to the urgency of the situation, the authorities relied on the network of private laboratories. In France, private laboratory medicine represents 70% of overall activity, and with a network of more than 4,000 local laboratories, private laboratory medicine has been the cornerstone of the « screen-trace-isolate ¼ strategy. This article gives feedback from private laboratory medicine professionals, directly involved in the reorganization carried out at the pre-analytical, analytical and post-analytical stages, during the crisis from March to October 2020.


Assuntos
/epidemiologia , Serviços de Laboratório Clínico/organização & administração , Pandemias , Setor Privado/organização & administração , Manejo de Espécimes/normas , /diagnóstico , Serviços de Laboratório Clínico/normas , Técnicas de Laboratório Clínico/instrumentação , Técnicas de Laboratório Clínico/métodos , Técnicas de Laboratório Clínico/normas , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/prevenção & controle , Segurança de Equipamentos/métodos , Segurança de Equipamentos/normas , França/epidemiologia , Unidades Hospitalares/organização & administração , Humanos , Colaboração Intersetorial , Corpo Clínico/organização & administração , Corpo Clínico/normas , Segurança do Paciente/normas , Fase Pré-Analítica/métodos , Fase Pré-Analítica/normas , Setor Privado/normas , Manejo de Espécimes/métodos
7.
Rev. SOBECC ; 25(4): 247-252, 21-12-2020.
Artigo em Português | LILACS, BDENF - Enfermagem | ID: biblio-1141403

RESUMO

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.


Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.


Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.


Assuntos
Humanos , Reutilização de Equipamento , Equipamentos Descartáveis , Segurança do Paciente , Reutilização de Equipamento/normas , Equipamentos Descartáveis/normas , Segurança de Equipamentos , Serviços de Saúde
8.
PLoS One ; 15(11): e0242474, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33216795

RESUMO

BACKGROUND: There is global shortage of Personal Protective Equipment due to COVID-19 pandemic. N95 Filtering Facepiece Respirators (N95-FFRs) provide respiratory protection against respiratory pathogens including SARS-CoV-2. There is scant literature on reprocessing methods which can enable reuse of N95-FFRs. AIM: We conducted this study to evaluate research done, prior to COVID-19 pandemic, on various decontamination methods for reprocessing of N95-FFRs. METHODS: We searched 5 electronic databases (Pubmed, Google Scholar, Crossref, Ovid, ScienceDirect) and 1 Grey literature database (OpenGrey). We included original studies, published prior to year 2020, which had evaluated any decontamination method on FFRs. Studies had evaluated a reprocessing method against parameters namely physical changes, user acceptability, respirator fit, filter efficiency, microbicidal efficacy and presence of chemical residues post-reprocessing. FINDINGS AND CONCLUSIONS: Overall, we found 7887 records amongst which 17 original research articles were finally included for qualitative analysis. Overall, 21 different types of decontamination or reprocessing methods for N95-FFRs were evaluated. Most commonly evaluated method for reprocessing of FFRs was Ultraviolet (Type-C) irradiation (UVGI) which was evaluated in 13/17 (76%) studies. We found published literature was scant on this topic despite warning signs of pandemic of a respiratory illness over the years. Promising technologies requiring expeditious evaluation are UVGI, Microwave generated steam (MGS) and based on Hydrogen peroxide vapor. Global presence of technologies, which have been given Emergency use authorisation for N95-FFR reprocessing, is extremely limited. Reprocessing of N95-FFRs by MGS should be considered for emergency implementation in resource limited settings to tackle shortage of N95-FFRs. SYSTEMATIC REVIEW IDENTIFIER: PROSPERO, PROSPERO ID: CRD42020189684, (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020189684).


Assuntos
Descontaminação/métodos , Desinfecção/métodos , Reutilização de Equipamento , Máscaras , Dispositivos de Proteção Respiratória , Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Segurança de Equipamentos , Humanos , Peróxido de Hidrogênio , Micro-Ondas , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vapor , Raios Ultravioleta
9.
PLoS One ; 15(10): e0240499, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33048980

RESUMO

During the current SARS-CoV-2 pandemic there is unprecedented demand for personal protective equipment (PPE), especially N95 respirators and surgical masks. The ability of SARS-CoV-2 to be transmitted via respiratory droplets from asymptomatic individuals has necessitated increased usage of both N95 respirators in the healthcare setting and masks (both surgical and homemade) in public spaces. These precautions rely on two fundamental principles of transmission prevention: particle filtration and droplet containment. The former is the focus of NIOSH N95 testing guidelines, and the latter is an FDA guideline for respirators and surgical masks. While studies have investigated droplet containment to provide guidance for homemade mask production, limited work has been done to characterize the filtration efficiency (FE) of materials used in home mask making. In this work, we demonstrate the low-cost (<$300) conversion of standard equipment used to fit-test respirators in hospital and industrial settings into a setup that measures quantitative FEs of materials based on NIOSH N95 guidelines, and subsequently measure FEs of materials found in healthcare and consumer spaces. These materials demonstrate significant variability in filtration characteristics, even for visually similar materials. We demonstrate a FE of 96.49% and pressure drop of 25.4 mmH20 for a double-layer of sterilization wrap used in surgical suites and a FE of 90.37% for a combination of consumer-grade materials. The excellent filtration characteristics of the former demonstrate potential utility for emergent situations when N95 respirators are not available, while those of the latter demonstrate that a high FE can be achieved using publicly available materials.


Assuntos
Filtros de Ar/normas , Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Segurança de Equipamentos/métodos , Máscaras/normas , Teste de Materiais/métodos , Pandemias/prevenção & controle , Equipamento de Proteção Individual/normas , Pneumonia Viral/prevenção & controle , Dispositivos de Proteção Respiratória/normas , Aerossóis , Infecções por Coronavirus/virologia , Segurança de Equipamentos/instrumentação , Pessoal de Saúde , Humanos , Teste de Materiais/instrumentação , Exposição Ocupacional/prevenção & controle , Pneumonia Viral/virologia
10.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 5089-5092, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-33019131

RESUMO

Safety alerts are published by manufacturers of medical devices when unforeseen hazards are identified in the post-market phase of a device's lifecycle. Multiple problems were identified in 2017 with Lower Mainland Biomedical Engineering's process for identifying, assessing and actioning safety alerts. A quality improvement (QI) project utilizing "The Model for Improvement" methodology, was carried out to improve the process. The original process was centralized and relied on a single individual to carry out all alert management responsibilities. A new hybrid process was developed which involves both centralized and decentralized components with responsibilities shared across multiple stakeholders. The QI project resulted in the closure time for assessing and actioning high priority alerts to improve from 200 days in 2017 to 14 days in 2019.


Assuntos
Melhoria de Qualidade , Segurança de Equipamentos
11.
Indian J Ophthalmol ; 68(11): 2486-2489, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33120649

RESUMO

Since the emergence of COVID pandemic, health workers have been facing major challenges every day. Ophthalmology practice has encountered countless modifications in the practice pattern not to jeopardize patient care and at the same time maintain all safety measures to reduce transmission. One such modification we made was the Safe Slit-Lamp Shield (SSS) which has been found to be extremely protective in differentiation to other available shield. Although SSS has a larger surface area when compared to already available shields, it won't compromise the comfort of the clinician at the same time gives satisfactory protection.


Assuntos
Betacoronavirus , Infecções por Coronavirus/transmissão , Segurança de Equipamentos , Ergonomia , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Pneumonia Viral/transmissão , Equipamentos de Proteção , Microscopia com Lâmpada de Fenda/instrumentação , Resinas Acrílicas , Aerossóis , Desenho de Equipamento , Humanos , Pandemias , Lâmpada de Fenda
12.
Niger J Clin Pract ; 23(8): 1044-1047, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32788479

RESUMO

Introduction: Delivery of accurate volumes of fluid in surgical neonates and children is crucial for the good outcome of treatment. But how accurate are the calibrations on the fluid delivery devices? Aims: This study seeks to verify the accuracy of these devices in common use in our practice. Materials and Methods: This is a cross-sectional experimental study carried out in our center; a tertiary health facility in Southern Nigeria in May 2019. Fluid delivery devices (FDDs) used in the course of treatment of our pediatric patients were randomly included in the study. The number of drops per ml of each device was obtained by counting while the fluid dropped until a 1 ml volume was delivered. The data was then collated and analyzed. Results: A total of 215 FDDs were included in this study. They comprised infusion giving set, Soluset (Burette) giving set, and blood giving set. The rate of delivery was 20 drops/ml (infusion giving sets), 60 drops/min (Burette/Soluset), and 15 drops/ml (Blood giving set). They were all in keeping with the labeled/assumed calibration in each of the types of FDDs P < 0.05. Therefore, the mean, median, and mode were the same. Conclusion: This study has demonstrated that the FDDs used our center are accurately calibrated and safe as they deliver volumes of fluid as labeled. The findings in this study reassure us of the dependability and accuracy of delivery of the FDDs we use in children in our center.


Assuntos
Segurança de Equipamentos/normas , Hidratação/instrumentação , Bombas de Infusão/normas , Administração Oral , Criança , Estudos Transversais , Feminino , Hidratação/métodos , Humanos , Recém-Nascido , Nigéria
14.
BMJ Open ; 10(8): e039454, 2020 08 04.
Artigo em Inglês | MEDLINE | ID: mdl-32753454

RESUMO

OBJECTIVE: There are widespread shortages of personal protective equipment as a result of the COVID-19 pandemic. Reprocessing filtering facepiece particle (FFP)-type respirators may provide an alternative solution in keeping healthcare professionals safe. DESIGN: Prospective, bench-to-bedside. SETTING: A primary care-based study using FFP-2 respirators without exhalation valve (3M Aura 1862+ (20 samples), Maco Pharma ZZM002 (14 samples)), FFP-2 respirators with valve (3M Aura 9322+ (six samples) and San Huei 2920V (16 samples)) and valved FFP type 3 respirators (Safe Worker 1016 (10 samples)). INTERVENTIONS: All masks were reprocessed using a medical autoclave (17 min at 121°C with 34 min total cycle time) and subsequently tested up to three times whether these respirators retained their integrity (seal check and pressure drop) and ability to filter small particles (0.3-5.0 µm) in the laboratory using a particle penetration test. RESULTS: We tested 33 respirators and 66 samples for filter capacity. All FFP-2 respirators retained their shape, whereas half of the decontaminated FFP-3 respirators showed deformities and failed the seal check. The filtering capacity of the 3M Aura 1862 was best retained after one, two and three decontamination cycles (0.3 µm: 99.3%±0.3% (new) vs 97.0±1.3, 94.2±1.3% or 94.4±1.6; p<0.001). Of the other FFP-2 respirators, the San Huei 2920 V had 95.5%±0.7% at baseline vs 92.3%±1.7% vs 90.0±0.7 after one-time and two-time decontaminations, respectively (p<0.001). The tested FFP-3 respirator (Safe Worker 1016) had a filter capacity of 96.5%±0.7% at baseline and 60.3%±5.7% after one-time decontamination (p<0.001). Breathing and pressure resistance tests indicated no relevant pressure changes between respirators that were used once, twice or thrice. CONCLUSION: This small single-centre study shows that selected FFP-2 respirators may be reprocessed for use in primary care, as the tested masks retain their shape, ability to retain particles and breathing comfort after decontamination using a medical autoclave.


Assuntos
Infecções por Coronavirus , Descontaminação/métodos , Reutilização de Equipamento , Segurança de Equipamentos , Máscaras/normas , Exposição Ocupacional/prevenção & controle , Pandemias , Pneumonia Viral , Dispositivos de Proteção Respiratória/normas , Filtros de Ar , Betacoronavirus , Infecções por Coronavirus/virologia , Pessoal de Saúde , Humanos , Tamanho da Partícula , Equipamento de Proteção Individual/normas , Pneumonia Viral/virologia , Atenção Primária à Saúde , Estudos Prospectivos , Ventiladores Mecânicos
15.
J Occup Environ Med ; 62(10): 781-782, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32769798

RESUMO

OBJECTIVE: The proliferation of improvised masks during the COVID-19 pandemic has raised questions regarding filter effectiveness and safety. We sought to compare the effectiveness of commonly used improvised filter materials against N95 industry standards. METHODS: Six different filter materials commonly used in the community were tested using both single- and multi-layer configurations with the TSI 8130 automated filter tester in accordance with National Institute for Occupational Safety and Health (NIOSH) standards for N95 respirators. RESULTS: Only three of the tested filter material configurations met N95 parameters with regard to filtration efficiency and pressure drop across the filter material-the: True-high-efficiency particulate air (HEPA) filter, four-layer MERV 13 and 14 HVAC filters. CONCLUSIONS: Many proposed filter materials for improvised masks do not meet current industry standards and may pose safety and efficacy concerns. Care should be taken when selecting materials for this critical respirator component, particularly for health care workers or others at high risk for pathogen exposure.


Assuntos
Infecções por Coronavirus/prevenção & controle , Exposição por Inalação/prevenção & controle , Máscaras/normas , Exposição Ocupacional/prevenção & controle , Saúde do Trabalhador , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Poluentes Ocupacionais do Ar/análise , Infecções por Coronavirus/epidemiologia , Desenho de Equipamento , Segurança de Equipamentos , Feminino , Saúde Global , Pessoal de Saúde/estatística & dados numéricos , Humanos , Masculino , Teste de Materiais , National Institute for Occupational Safety and Health, U.S./normas , Pandemias/estatística & dados numéricos , Tamanho da Partícula , Pneumonia Viral/epidemiologia , Garantia da Qualidade dos Cuidados de Saúde/normas , Estados Unidos
18.
J Agric Saf Health ; 26(2): 61-65, 2020 Jun 17.
Artigo em Inglês | MEDLINE | ID: mdl-32727168

RESUMO

In 2006, Cole et al. (2006) reported on tractor overturn-related injuries in Kentucky from a random sample of farmers that numbered 6,063 respondents. The highest number of people who experienced tractor overturns were operators 16 to 20 years old. In 2007, at a National Institute for Occupational Safety and Health (NIOSH) Tractor Safety Initiative meeting in Colorado, John Myers of NIOSH presented a map of the states with the highest overturn fatality rates: Tennessee, Kentucky, West Virginia, Ohio, Pennsylvania, and Illinois. Significantly, four of these states, including Kentucky, overlap the Appalachian region (Cole, 2007; Hard and Myers, 2001). In Kentucky, this region involves farming on slopes, as examined by Saman et al. (2012), who found a high-risk cluster of tractor overturns among ten Kentucky counties in the Appalachian region, with a 97% increased risk of overturn as compared to other Kentucky counties. In 1971, James Arndt of Deere & Company presented a 50-year review of rollover protective structures (ROPS) at a Society of Automotive Engineers (SAE) conference. Arndt (1971) estimated that, over the previous 50 years, 30,000 operators had been killed when crushed by tractor overturns in agriculture and construction work. Since then, ROPS have been recognized as an effective device to prevent death in the event of a tractor overturn (Reynolds and Groves, 2000). Nevertheless, the epidemic of tractor-related deaths has continued into the modern era, and the cost of ROPS has been found to be a significant barrier to retrofitting tractors that lack ROPS (Myers et al., 1998). To provide a low-cost alternative, NIOSH safety engineers have designed, tested, and provided instructions for building and fitting cost-effective ROPS (CROPS) onto pre-ROPS tractors (i.e., tractors built before 1968) (Hard et al., 2016).


Assuntos
Acidentes de Trabalho/prevenção & controle , Agricultura , Segurança de Equipamentos , Equipamentos de Proteção , Humanos , Estados Unidos
19.
PLoS One ; 15(7): e0235287, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32667931

RESUMO

OBJECTIVE: Noise in the neonatal intensive care unit can be detrimental to the health of the hospitalized infant. Means of reducing that noise include staff training, warning lights, and ear coverings, all of which have had limited success. Single family rooms, while an improvement, also expose the hospitalized infant to the same device alarms and mechanical noises found in open bay units. METHODS: We evaluated a non-contact incubator-based active noise control device (Neoasis™, Invictus Medical, San Antonio, Texas) in a simulated neonatal intensive care unit (NICU) setting to determine whether it could effectively reduce the noise exposure of infants within an incubator. In the NICU simulation center, we generated a series of clinically appropriate sound sequences with bedside medical devices such as a patient monitor and fluid infusion devices, hospital air handling systems, and device mechanical sounds. A microphone-equipped infant mannequin was oriented within an incubator. Measurements were made with the microphones with the Neoasis™ deactivated and activated. RESULTS: The active noise control device decreased sound pressure levels for certain alarm sounds by as much as 14.4 dB (a 5.2-fold reduction in sound pressure) at the alarm tone's primary frequency. Frequencies below the 2 kHz octave band were more effectively attenuated than frequencies at or above the 2 kHz octave band. Background noise levels below 40 dBA were essentially not impacted by the active noise control device. CONCLUSIONS: The active noise control device further reduces noise inside infant incubators. Device safety and potential health benefits of the quieter environment should be verified in a clinical setting.


Assuntos
Desenvolvimento Infantil/fisiologia , Incubadoras para Lactentes , Recém-Nascido Prematuro/fisiologia , Unidades de Terapia Intensiva Neonatal , Ruído/efeitos adversos , Segurança de Equipamentos , Humanos , Saúde do Lactente , Recém-Nascido , Manequins , Texas
20.
J Am Acad Orthop Surg ; 28(14): e604-e611, 2020 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-32692096

RESUMO

Physicians offer unique contributions to the orthopaedic implant design process by providing creative ideas and insightful clinical expertise. This article provides a brief overview of the pertinent considerations of transforming a concept into an orthopaedic implant and bringing it to the market. Implant concept choice should consider medical or surgical necessity, regional variability, market characteristics, cost of goods sold, and average selling price. Implant development requires adherence to regulatory requirements and device classification. Implant production incorporates design specifications, mechanical testing, sterilization, packaging, and marketing and sales. Orthopaedic implant company agreements determine physician compensation through royalties and/or the purchase of intellectual property. After rollout, physicians participate in monitoring for device safety. Bringing an orthopaedic implant from a concept to the market can be lengthy and complicated, but innovation is essential for advancing patient care and well-being.


Assuntos
Comércio/economia , Marketing/economia , Marketing/métodos , Procedimentos Ortopédicos , Médicos/economia , Próteses e Implantes/economia , Desenho de Prótese/economia , Compensação e Reparação , Segurança de Equipamentos , Humanos , Propriedade Intelectual
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