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1.
Medicine (Baltimore) ; 100(3): e23941, 2021 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-33545969

RESUMO

ABSTRACT: This study aimed to compare the effectiveness and safety of reduced-port laparoscopic surgery (RPLS) and conventional multi-port laparoscopic (CMPLS) surgery in the treatment of gastric diseases.The PubMed, Embase, Cochrane Library, Web of Science, and Chinese Biomedical Literature databases were systematically searched for randomized controlled trials, cohort studies, and case control studies on the use of RPLS vs conventional multi-port laparoscopic surgery in treating gastric diseases from their inception until March 10, 2019. The evaluated outcomes were the operative time, blood loss, length of hospital stay, number of dissected lymph nodes, postoperative complications, and conversions. All of these were compared using Stata software version 12.0.A total of 18 studies were included, which involved 2938 patients. In studies referring to the comparison between RPLS and CMPLS in treating gastric diseases, the former showed significantly inferior in terms of operative time (P = .011) and number of dissected lymph nodes (P = .031); but superior results in terms of the estimated blood loss (P = .000) and length of hospital stay (P = .001) than the latter did; however, the rates of postoperative complications (P = .830) and conversions (P = .102) were not statistically significant between the 2 groups.RPLS and CMPLS showed comparable effectiveness and safety in the treatment of gastric diseases in our meta-analysis. Based on the current evidence, we believe that RPLS is an efficacious surgical alternative to CMPLS in the management of gastric diseases because of the shorter hospital stay and reduced blood loss. However, large-scale, well-designed, multicenter studies are needed to further confirm the results of this study.


Assuntos
Equipamentos e Provisões/normas , Laparoscopia/instrumentação , Laparoscopia/normas , Gastropatias/cirurgia , Resultado do Tratamento , Equipamentos e Provisões/efeitos adversos , Humanos , Laparoscopia/métodos , Tempo de Internação/tendências , Duração da Cirurgia , Complicações Pós-Operatórias/etiologia , Gastropatias/complicações
2.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(6): 545-548, 2020 Dec 08.
Artigo em Chinês | MEDLINE | ID: mdl-33314866

RESUMO

OBJECTIVE: By introducing the Medical Device Reporting (MDR) system and related inspection practice of the US, this paper puts forward some suggestions on implementing reporting responsibility of manufactures in China. METHODS: The MDR system and the related inspection system in the US were systematically analyzed. RESULTS: The US had established a sound system for discovering and reporting MDR, and a mechanism for inspecting the implementing of manufactures, forming an effective post-market surveillance system. CONCLUSIONS: By learning from the experience of the US, we can carry out the post-market surveillance of medical devices adverse events in China from the aspects of implementing the existing system, strengthening the reporting ability and perfecting the inspection mechanism.


Assuntos
Equipamentos e Provisões/normas , Vigilância de Produtos Comercializados , China
3.
J Diabetes Sci Technol ; 14(6): 1035-1064, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32985262

RESUMO

This article is the work product of the Continuous Glucose Monitor and Automated Insulin Dosing Systems in the Hospital Consensus Guideline Panel, which was organized by Diabetes Technology Society and met virtually on April 23, 2020. The guideline panel consisted of 24 international experts in the use of continuous glucose monitors (CGMs) and automated insulin dosing (AID) systems representing adult endocrinology, pediatric endocrinology, obstetrics and gynecology, advanced practice nursing, diabetes care and education, clinical chemistry, bioengineering, and product liability law. The panelists reviewed the medical literature pertaining to five topics: (1) continuation of home CGMs after hospitalization, (2) initiation of CGMs in the hospital, (3) continuation of AID systems in the hospital, (4) logistics and hands-on care of hospitalized patients using CGMs and AID systems, and (5) data management of CGMs and AID systems in the hospital. The panelists then developed three types of recommendations for each topic, including clinical practice (to use the technology optimally), research (to improve the safety and effectiveness of the technology), and hospital policies (to build an environment for facilitating use of these devices) for each of the five topics. The panelists voted on 78 proposed recommendations. Based on the panel vote, 77 recommendations were classified as either strong or mild. One recommendation failed to reach consensus. Additional research is needed on CGMs and AID systems in the hospital setting regarding device accuracy, practices for deployment, data management, and achievable outcomes. This guideline is intended to support these technologies for the management of hospitalized patients with diabetes.


Assuntos
Glicemia/análise , Equipamentos e Provisões , Hospitalização , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Monitorização Fisiológica/instrumentação , Adulto , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Automonitorização da Glicemia/normas , Criança , Consenso , Infecções por Coronavirus/sangue , Infecções por Coronavirus/complicações , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Complicações do Diabetes/sangue , Complicações do Diabetes/epidemiologia , Complicações do Diabetes/terapia , Diabetes Mellitus/sangue , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/terapia , Cálculos da Dosagem de Medicamento , Equipamentos e Provisões/normas , Feminino , Hospitais/normas , Humanos , Sistemas de Infusão de Insulina/normas , Monitorização Fisiológica/métodos , Monitorização Fisiológica/normas , Pandemias , Pneumonia Viral/sangue , Pneumonia Viral/complicações , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Gravidez
4.
PLoS One ; 15(7): e0235068, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32645015

RESUMO

Advances in digital health technologies have revolutionised home medical care. Yet many home medical devices (HMEDs, which includes devices referred to as 'life support equipment') rely upon a stable and resilient electricity supply. For users of HMEDs, interruptions to electricity supply can compromise treatment, well-being or survival. This paper addresses a challenge critical to the continued innovation in digital health technologies: the reliable supply of electricity. We bridge the current gap between electricity networks and digital health technologies through a novel method for the remote detection of the phase (that is, which part of the network that each house is connected to), in order to eliminate avoidable interruptions to supply for HMED users. We present an unsupervised phase identification algorithm capable of remote phase detection at scale, and without transformer data. This method translates data insights into actionable energy provision for HMED users and other vulnerable customers, enables more accurate management and planning, and improves electricity reliability which is critical for HMED users and the continued advances in digital health technologies.


Assuntos
Eletricidade , Equipamentos e Provisões , Serviços de Assistência Domiciliar , Algoritmos , Equipamentos e Provisões/normas , Serviços de Assistência Domiciliar/normas , Humanos
5.
Farm Hosp ; 44(7): 21-23, 2020 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-32533664

RESUMO

Medical devices have become essential to the prevention and control of the  COVID-19 pandemic, being crucial for health professionals and patients in  particular, and the population in general. It is important to be aware of the laws  that regulate the management, distribution, and control of medical devices.  Article 82 of the Spanish Law 29/2006 on Guarantees and Rational Use of  Medicines and Medical Devices establishes that it is the responsibility of Hospital  Pharmacy Services "to participate in and coordinate the purchase of medicines and medical devices in the hospital to ensure an efficient acquisition  and rational use of medical devices". For this reason, working groups of the Spanish Society of Hospital Pharmacy and other scientific societies have issued technical guidelines and consensus statements to provide technical support and updated information on the use of masks, individual  protection equipments and other medical devices. In addition, the shortage of  medical devices caused by the high demand has resulted in the uncontrolled  production and distribution of medical devices. This phenomenon, added to the  fraudulent selling of medical devices, highlights the need for a closer surveillance of the market to guarantee the efficacy and safety of available medical devices. A rational use of medical devices is necessary to ensure the availability and safety of these products, which requires the involvement of  different stakeholders, including hospital pharmacists. Thus, it is essential that  hospital pharmacists receive specific training in technical aspects concerning the possession and use of medical devices. This will help guarantee an effective and safe use of medical products. The acquisition and use of medical  devices requires a keen understanding of the technical and legal aspects  concerning these products, which makes hospital pharmacists essential for the  integral management of medical devices.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Equipamentos e Provisões , Pandemias , Serviço de Farmácia Hospitalar , Pneumonia Viral , Equipamentos de Proteção , Certificação , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Aprovação de Equipamentos , Equipamentos e Provisões/normas , Equipamentos e Provisões/provisão & distribuição , Previsões , Fraude , Necessidades e Demandas de Serviços de Saúde , Humanos , Controle de Infecções/instrumentação , Controle de Infecções/métodos , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Transmissão de Doença Infecciosa do Profissional para o Paciente/prevenção & controle , Pandemias/prevenção & controle , Serviço de Farmácia Hospitalar/organização & administração , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Equipamentos de Proteção/provisão & distribuição , Ventiladores Mecânicos/provisão & distribuição
7.
Washington; Organización Panamericana de la Salud; mayo 14, 2020. 26 p.
Não convencional em Espanhol | LILACS | ID: biblio-1096910

RESUMO

El IMDRF es un grupo voluntario de reguladores de dispositivos médicos de todo el mundo que se han unido con el objetivo de acelerar la armonización y convergencia reguladora internacional de dispositivos médicos. Los miembros actuales son Australia, Brasil, Canadá, China, la Unión Europea, Japón, Rusia, Singapur, Corea del Sur y Estados Unidos de América quienes cuentan con sistemas regulatorios consolidados para dispositivos médicos


Assuntos
Pneumonia Viral/prevenção & controle , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/epidemiologia , Equipamentos e Provisões/normas , Pandemias/prevenção & controle , Legislação de Dispositivos Médicos/normas , Betacoronavirus
8.
Eur J Nucl Med Mol Imaging ; 47(7): 1649-1656, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32342191

RESUMO

AIM: To illustrate the [18F]FDG-PET/CT findings in patients affected by cancer with clinical diagnosis of Covid-19 METHODS: We retrospectively reviewed the cases of patients who showed pulmonary involvement unrelated to cancer metastases on March 13 and 16 2020. We reviewed the scans, collected medical history, and exposure information. RESULTS: Among the 13 scans, we identified 5 cases with imaging findings suspicious for viral infection. Peripheral lung consolidations and/or ground-glass opacities in two or more lobes were found. Lung abnormalities displayed increased [18F]FDG uptake (SUVmax 4.3-11.3). All the patients on the day of PET/CT acquisition were asymptomatic, and they did not have fever or cough. In view of the PET/CT findings, home isolation, symptom surveillance, and treatment (in 3/5 patients) were indicated. At 1-week follow-up, 2/5 patients experienced the onset of mild respiratory symptoms. CONCLUSIONS: The [18F]FDG-PET/CT can identify probable Covid-19 disease in the absence or before symptoms onset and can guide patient management. Nuclear medicine staff needs to be aware of the possibility of contact with patients affected by the SARS-CoV-2 infection even if they do not present any symptom. Therefore, safety measures need to be adopted for other patients and hospital staff in order to block the spread of infection.


Assuntos
Infecções por Coronavirus/diagnóstico por imagem , Pulmão/diagnóstico por imagem , Pneumonia Viral/diagnóstico por imagem , Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Equipamentos e Provisões/normas , Fluordesoxiglucose F18 , Humanos , Itália , Pandemias/prevenção & controle , Segurança do Paciente/normas , Pneumonia Viral/prevenção & controle , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/normas , Estudos Retrospectivos
9.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(1): 88-91, 2020 Jan 08.
Artigo em Chinês | MEDLINE | ID: mdl-32343076

RESUMO

By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.


Assuntos
Ensaios Clínicos como Assunto , Equipamentos e Provisões/normas , Indicadores e Reagentes/normas , Projetos de Pesquisa/normas , Reprodutibilidade dos Testes
10.
Eur J Nucl Med Mol Imaging ; 47(7): 1620-1622, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32296884

RESUMO

In the global pandemic COVID-19, it is important for everyone including nuclear medicine personnel to know how to stop transmission and contain and prevent the spread of COVID-19. Here, we summarize our American College of Nuclear Medicine members' experiences from Wuhan, China; Singapore; and the USA, so to provide advice to the nuclear medicine personnel for their clinical practice and management strategies in responding to COVID-19.


Assuntos
Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/normas , Betacoronavirus , China , Infecções por Coronavirus/prevenção & controle , Equipamentos e Provisões/normas , Humanos , Medicina Nuclear/métodos , Pandemias/prevenção & controle , Segurança do Paciente/normas , Recursos Humanos em Hospital , Pneumonia Viral/prevenção & controle , Serviço Hospitalar de Radiologia/normas , Singapura , Estados Unidos
14.
Lima; IETSI; mar. 2020. ilus.
Não convencional em Espanhol | LILACS, BRISA/RedTESA | ID: biblio-1095412

RESUMO

OBJETIVOS DEL DOCUMENTO: o Disminuir el riesgo de COVID-19 en el personal de salud asistencial que participa en la atención de casos sospechosos, probables o confirmados de esta enfermedad y en el personal de limpieza que realiza labores en áreas destinadas a la atención de estos pacientes. Brindar lineamientos sobre los procedimientos a seguir para el correcto uso del equipo de protección personal (EPP), lo cual involucra conocer el tipo de equipo a utilizar, los procedimientos para colocarse correctamente el EPP, para quitarse correctamente el EPP, y sobre el reúso o eliminación de dichos equipos. MÉTODOS: Búsqueda y selección de protocolos, guías de práctica clínica y documentos técnicos prévios. El 24 de marzo de 2020 se buscaron protocolos de manejo, guías de práctica clínica, y documentos técnicos que aborden los procedimientos a seguir para el uso de EPP por el personal de salud asistencial ante casos sospechosos, probables o confirmados de COVID-19, cuya versión a texto completo se encuentre en español o inglés. Los detalles de la búsqueda y selección de los documento. Producto de la evaluación y selección, no se identificaron documentos que cumplan con todos los criterios de selección. Sin embargo, se consideró tomar como principal fuente de información a aquellos documentos que describieron ampliamente los procedimientos a seguir para el uso de EPP por personal de salud asistencial ante casos sospechosos, probables o confirmados de COVID-19. RECOMENDACIONES DURANTE EL CONTACTO CON EL PACIENTE: Intente que la menor cantidad de personal de salud esté cerca al paciente. Cerciórese que el paciente tenga una mascarilla quirúrgica puesta. Si el paciente tiene que usar una mascarilla de oxígeno, cerciórese que la mascarilla está correctamente colocada. Evite tocarse el respirador.Si necesita retirarse el respirador por algún motivo, hágalo fuera de la zona de atención del paciente. RECOMENDACIONES LUEGO DEL CONTACTO CON EL PACIENTE: Diríjase a una zona destinada para el retiro del EPP, luego asegúrese que haya recipientes para desechos biocontaminados (bolsa roja) y un contenedor para los componentes reutilizables en la zona de retiro del EPP. Seguidamente, defina qué componente del EPP se va a reusar y qué se va a descarta. RECOMENDACIONES PARA LA LIMPIEZA Y REÚSO DE EPP Y EQUIPO UTILIZADO PARA LA ATENCIÓN DEL PACIENTE: Respiradores: Cuando se retire el respirador envuélvalo en una toalla desechable, guárdelo en una bolsa de papel con su nombre, impidiendo que éste se aplaste y deforme. Almacénelo en un lugar limpio y seco. No use bolsa plástica ya que retiene la humedad. Los respiradores pueden utilizarse hasta un máximo de 3 días consecutivos o 7 días cuando hay uso alterno (días no consecutivos). Protector ocular: Para reusar el equipo de protección ocular, es necesario realizar dos procedimientos: Limpieza: se deberá limpiar el protector ocular luego de quitárselo. Descontaminación: adicionalmente a la limpieza, se deberá descontaminar cuando se haya realizado un procedimiento generador de aerosoles o cuando haya signos evidentes de contaminación. Equipo utilizado para la atención del paciente: No olvidar limpiar, descontaminar o desechar el equipo usado (estetoscopio, tensiómetro, pulsioxímetro, entre otros) según los lineamientos locales.


Assuntos
Humanos , Pessoal de Saúde/normas , Infecções por Coronavirus/prevenção & controle , Equipamentos e Provisões/normas , Máscaras/provisão & distribuição , Peru , Avaliação da Tecnologia Biomédica
15.
Emerg Med J ; 37(3): 170-171, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32098795

RESUMO

A short-cut systematic review was carried out to establish if strategies to reduce greenhouse gas emissions in the ED could succeed while maintaining comparable care standards. Of 2914 papers found in the searches, 40 were selected for full-text review and none were eligible for inclusion. The main reason for exclusion was article type. Given the wide-ranging proposals for reducing greenhouse gas emissions in healthcare, there is a dramatic paucity of evidence on the pragmatic effects on patient care.


Assuntos
Pegada de Carbono/normas , Serviço Hospitalar de Emergência/normas , Equipamentos e Provisões/normas , Aquecimento Global/prevenção & controle , Serviço Hospitalar de Emergência/organização & administração , Equipamentos e Provisões/efeitos adversos , Humanos
16.
Artigo em Inglês | MEDLINE | ID: mdl-32024065

RESUMO

Background: Large technical developments in avalanche transceivers as well as in ski-shoe-binding units should make backcountry skiing a safer sport and as a consequence, yield to a decrease in the number and severity of mountain emergency events. Methods: From 2009-2018, a total of 3044 mountain emergencies (953 females and 2091 males) were identified from the SAC (Swiss Alpine Club) central registry while backcountry skiing. These were classified descriptively by cause, whereby the severity of the mountain emergency was quantified with a NACA-Score (National Advisory Committee for Aeronautics Score). Results: A total of 1357 falls (44.6%), 558 emergencies caused by avalanches (18.3%), 408 cases of blocking (13.4%), 214 cases of illnesses (7.0%), 202 cases of losing way (6.6%), 138 cases of a crevasse accident (4.5%), and material failure in 30 cases (1%) were registered. For the remaining 137 cases (4.5%), no classification or rare forms were detected. No substantial sex differences were found in severity of injury, however looking at the two endpoints of the observed time frame, a significant increase in NACA-Score from 2009 to 2018 (2.1 ± 1.8 up to 2.6 ± 2.1, p < 0.01) was detected. Conclusions: The increase in the severity of mountain emergencies while backcountry skiing in the last decade might be due to the fact that too many inexperienced absolve backcountry tours. The tendency might be promoted by the improved material in the way that it seems easier to absolve a tour while underestimating potential hazards.


Assuntos
Equipamentos e Provisões , Esqui , Acidentes por Quedas/estatística & dados numéricos , Traumatismos em Atletas/prevenção & controle , Avalanches/estatística & dados numéricos , Equipamentos e Provisões/normas , Feminino , Humanos , Masculino , Montanhismo/estatística & dados numéricos , Esqui/estatística & dados numéricos , Suíça , Índices de Gravidade do Trauma
17.
J Nepal Health Res Counc ; 17(4): 431-436, 2020 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-32001844

RESUMO

BACKGROUND: Newborn service readiness is facility's observed capacity to provide newborn services and a pre-requisite for quality. Newborn services are priority program of government and efforts are focused on infrastructure and supplies at peripheral health facilities. Study describes health facility readiness for newborn services in four domains of general requirements, equipment, medicines and commodities, and staffing and guidelines. METHODS: Convergent parallel mixed method using concurrent triangulation was done in public health facilities providing institutional deliveries of two randomly selected districts- Taplejung and Solukhumbu of Eastern Mountain Region of Nepal. Face to face interview and observation of facilities were done using structured questionnaire and checklist; in-depth interviews were done using interview guideline from November 2016 to January 2017. Ethical clearance was taken. Descriptive analysis and deductive thematic analysis were done. RESULTS: Mean score of newborn service readiness was 68.7±7.1 with range from 53.3 to 81.4 out of 100. Domains of general requirement, equipment, medicine and commodity, supervision, staffing and guideline were assessed. The gaps identified in general requirements were availability of uninterrupted power supply, means of communication and referral vehicle. Clean wrappers and heater for room temperature maintenance were identified during interviews to be part of the readiness. All health facilities had trained staff while retention of skill was of concern. There was felt need of enforcing adequate training coverage to suffice the need of human resources in remote. CONCLUSIONS: Efforts of improving transportation, heater for room temperature maintenance, trainings with skill retention strategy, utilization of guidelines, availability of skilled birth attendance could result increased and improved newborn service readiness.


Assuntos
Assistência Perinatal/organização & administração , Qualidade da Assistência à Saúde/organização & administração , Comunicação , Medicamentos Essenciais/normas , Medicamentos Essenciais/provisão & distribuição , Fontes de Energia Elétrica/provisão & distribuição , Equipamentos e Provisões/normas , Equipamentos e Provisões/provisão & distribuição , Fidelidade a Diretrizes , Pesquisas sobre Serviços de Saúde , Acesso aos Serviços de Saúde/organização & administração , Calefação/normas , Humanos , Recém-Nascido , Assistência Perinatal/normas , Admissão e Escalonamento de Pessoal/normas , Guias de Prática Clínica como Assunto , Qualidade da Assistência à Saúde/normas
20.
Drug Saf ; 43(2): 83-93, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31845212

RESUMO

We propose the following definition of a medical device: "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional." Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorporate medicines should be required to meet the same regulatory standards as medicinal products. This would remove the anomaly that some delivery systems that incorporate medicines are classified as devices while other similar systems that deliver the same medicines are classified as medicinal products. Some improvements might also result from more widespread use of registries, such as those used for prosthetic joint replacements. Registries would allow both a prospective examination of the performance of high-risk devices and a retrospective analysis when signals from other sources of information suggest problems. Those who apply for a marketing authorization for a new device should have to assure regulators of its quality of manufacture, safety, and efficacy before licensing. Even the most straightforward device should be shown to be useable in practice. Trials on patients, or at least simulations of use in the real world, should be practicable for most devices.


Assuntos
Equipamentos e Provisões/classificação , Equipamentos e Provisões/normas , Segurança de Equipamentos , União Europeia , Humanos , Legislação de Dispositivos Médicos , Estados Unidos
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