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1.
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 & distribução , 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 & distribução , Ventiladores Mecânicos/provisão & distribução
3.
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
4.
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
6.
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 Computadorizada com Tomografia por Emissão de Pósitrons/normas , Estudos Retrospectivos
7.
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 Computadorizada com Tomografia por Emissão de Pósitrons/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
9.
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 & distribução , Peru , Avaliação da Tecnologia Biomédica
11.
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
12.
Farm. hosp ; 44(supl.1): 21-23, 2020.
Artigo em Espanhol | IBECS | ID: ibc-190471

RESUMO

Los productos sanitarios se han convertido en imprescindibles en la prevención y control de la pandemia actual generada por COVID-19, tanto para el personal sanitario y pacientes, como para la ciudadanía en su totalidad. Los productos sanitarios cuentan con una legislación propia que es preciso conocer para su correcta gestión, distribución y control. El artículo 82 de la Ley 29/2006 de garantías y uso racional de los medicamentos y productos sanitarios establece que es responsabilidad de los servicios de farmacia hospitalaria “participar y coordinar la gestión de las compras de los productos sanitarios del hospital a efectos de asegurar la eficiencia de la misma y así contribuir al uso racional de los mismos”. Por este motivo, grupos de trabajo de expertos de la Sociedad Española de Farmacia Hospitalaria, junto a otras sociedades científicas, han desarrollado durante esta pandemia documentos técnicos y consensos para dar soporte técnico e informativo de forma actualizada en relación con las mascarillas, los equipos de protección individual y otros productos sanitarios. Por otro lado, los problemas de desabastecimiento secundarios a la elevada demanda han llevado a una producción y comercialización descontrolada de productos sanitarios. Este hecho, asociado a la comercialización fraudulenta de productos sanitarios en el mercado, ha generado la necesidad de una vigilancia exhaustiva, capaz de garantizar la eficacia y seguridad de los productos sanitarios en circulación. El uso racional, para asegurar la disponibilidad y seguridad de los productos sanitarios, es una responsabilidad multidisciplinar compleja. Para ello, es fundamental una formación específica como la del farmacéutico de hospital en aspectos técnicos de tenencia y uso que permite salva-guardar las garantías de eficacia, seguridad y calidad de los productos sanitarios. El conocimiento técnico y legal que requieren los productos sanitarios hace imprescindible la implicación del farmacéutico de hospital como uno de los profesionales sanitarios capacitado para la gestión integral de estos productos


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
Humanos , Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/transmissão , Equipamentos e Provisões/provisão & distribução , Equipamentos e Provisões/normas , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/transmissão , Equipamentos de Proteção/provisão & distribução , Serviço de Farmácia Hospitalar/organização & administração , Certificação , Ventiladores Mecânicos , Transmissão de Doença Infecciosa do Profissional para o Paciente/prevenção & controle , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Previsões , Fraude
13.
Am J Trop Med Hyg ; 101(6): 1373-1379, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31595864

RESUMO

Cutaneous leishmaniasis (CL), a neglected parasitic skin disease, is endemic in Pakistan, where Leishmania tropica and Leishmania major are the causative protozoan species. Standard treatment with antimonial injections is long, painful, and costly; has toxic side effects; and is not always available in public hospitals. Small pilot studies have previously evaluated a low-cost and noninvasive hand-held exothermic crystallization thermotherapy for cutaneous leishmaniasis (HECT-CL) device. We aimed to further establish the effectiveness, safety, and feasibility of HECT-CL in L. tropica. In a prospective observational study, patients with parasitological confirmation of CL were treated using the HECT-CL heat pack for 3 minutes with an initial temperature of 52-53°C for 7 consecutive days. Dried blood spot samples were taken for species identification by polymerase chain reaction (PCR). Effectiveness was assessed by using medical photographs and measurements of the lesion size at baseline and subsequent follow-up visits, for up to 180 days. We intended to enroll 317 patients. The HECT-CL treatment was easy to apply and well tolerated. Species identification demonstrated the presence of L. tropica. Interim analysis of 56 patients showed a failure rate of 91% at follow-up (median 45 days after treatment, interquartile range 30-60 days). Enrollment of patients was prematurely suspended because of futility. This study showed a high failure rate for HECT-CL thermotherapy in this setting. Leishmania tropica is known to be less sensitive to antileishmanial drugs, more temperature-resistant, and spontaneous healing is slower than that in L. major. More research is needed to identify low-cost, effective, and more patient-friendly treatment for L. tropica.


Assuntos
Término Precoce de Ensaios Clínicos , Equipamentos e Provisões/normas , Hipertermia Induzida/economia , Hipertermia Induzida/instrumentação , Leishmaniose Cutânea/terapia , Adolescente , Adulto , Criança , Custos e Análise de Custo , Feminino , Humanos , Leishmania tropica/genética , Leishmania tropica/patogenicidade , Leishmaniose Cutânea/parasitologia , Masculino , Paquistão , Estudos Prospectivos , Falha de Tratamento , Adulto Jovem
15.
Rev. Pesqui. (Univ. Fed. Estado Rio J., Online) ; 11(5): 1368-1375, out.-dez. 2019. il
Artigo em Inglês, Português | LILACS, BDENF - Enfermagem | ID: biblio-1021865

RESUMO

Objective: The study's main purpose has been to analyze the Brazilian scientific productions that used the Pediatric Evaluation of Disability Inventory (PEDI) in investigations focused on children diagnosed with disabilities. Methods: It is an integrative literature review which was carried out from July to August 2017 in the following data sources: MEDLINE (PubMed), Virtual Health Library (VHL) and Web of Science, in English, Portuguese and Spanish languages. Results: The use of PEDI contributed to the identification of individual disabilities and the most impaired functions in children, providing data that allows the planning of interventions for parents, professionals, and caregivers. Furthermore, it has revealed the benefits of physical activities for functional performance, as well as the effects of the guidelines transmitted by health professionals to children with developmental disorders. Conclusion: PEDI has been proved to be relevant as it contributes with evidence to the evolution of the child with disabilities, identifies the commitments and allows the redirection of the actions of professionals and caregivers


Objetivo: Analisar as produções científicas brasileiras que utilizaram o Inventário de Avaliação Pediátrica de Incapacidade (PEDI) em estudos voltados para crianças diagnosticadas com deficiência. Metodologia: Trata-se de revisão integrativa da literatura, realizada entre julho e agosto de 2017 nas seguintes fontes: MEDLINE (PubMed), Biblioteca virtual em saúde (BVS) e Web of sience nos idiomas inglês, português e espanhol. Resultados: A utilização do PEDI contribuiu para identificação de incapacidades individuais e das funções mais comprometidas em crianças, fornece dados que permitem o planejamento de intervenções para pais, profissionais e cuidadores. Além disso, permitiu revelar os benefícios das atividades físicas para o desempenho funcional assim como os efeitos das orientações realizadas por profissionais de saúde para crianças com desvios de desenvolvimento. Conclusão: O PEDI têm-se mostrado relevante por contribuir com evidências sobre a evolução da criança com incapacidades, identificar os comprometimentos e permitir redirecionamento das ações de profissionais e cuidadores


Objetivo: Analizar las producciones científicas brasileñas que utilizaron el Inventario deEvaluación Pediátrica de Discapacidad en estudios centrados en niños diagnosticados con discapacidad. Método: Se trata de una revisión integradora de la literatura, efectuada entre julio y agosto de 2017 en las siguientes fuentes: MEDLINE (PubMed), Biblioteca Virtual en Salud (BVS) y Web of Science enlos idiomas inglés, portugués y español. Resultados: La utilización del PEDI contribuyó a la identificación de discapacidades individuales y de las funciones más comprometidas en niños, suministra datos que permiten la planificación de intervenciones redireccionando las acciones de padres, profesionales y cuidadores, además de haber permitido revelar los beneficios de las actividades físicas para el desempeño funcional, así como los efectos de las orientaciones transmitidas por profesionales de salud para niños con desviaciones de desarrollo. Conclusión: El PEDI se ha mostrado relevante por contribuir con evidencias sobre la evolución del niño con discapacidades, identificar los compromisos y permitir la redirección de las acciones de profesionales y cuidadores


Assuntos
Humanos , Criança , Crianças com Deficiência/reabilitação , Crianças com Deficiência/estatística & dados numéricos , Equipamentos e Provisões/normas , Reabilitação/tendências
16.
Comput Inform Nurs ; 37(12): 615-627, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31498250

RESUMO

This qualitative study is part of a larger randomized prospective intervention study that examined the clinical and cost effectiveness of using sensor data from an environmentally embedded sensor system for early illness recognition. It explored the perceptions of older adults and family members on the sensor system's usefulness, impact on daily routine, privacy, and sharing of health information. This study was conducted in 13 assisted-living facilities in Missouri, and 55 older adults were interviewed. Data were collected over five points in time with a total of 188 interviews. From these five participant interview iterations, the following themes emerged: (1) understanding and purpose, (2) daily life and benefits, (3) impact on privacy, and (4) sharing of information. Three themes emerged from one round of family interviews: (1) benefits of bed sensors, (2) family involvement/staff interaction, and (3) privacy protection versus sensor benefits. The sensor suite was regarded as helpful in maintaining independence, health, and physical functioning. Responses suggest that the willingness to adopt the sensor suite was motivated by both a decline in functional status and a desire to remain independent. Participants were willing to share their health data with providers and select family members. Recommendations for future practice are provided.


Assuntos
Equipamentos e Provisões/normas , Materiais Inteligentes/normas , Acidentes por Quedas/prevenção & controle , Idoso , Moradias Assistidas/organização & administração , Moradias Assistidas/estatística & dados numéricos , Leitos/normas , Leitos/tendências , Formação de Conceito , Feminino , Humanos , Entrevistas como Assunto/métodos , Masculino , Missouri , Estudos Prospectivos , Pesquisa Qualitativa , Materiais Inteligentes/uso terapêutico
17.
Orthop Surg ; 11(5): 715-719, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31490619

RESUMO

Class III medical devices are defined as those which are implanted inside the human body and applied to maintain normal life and retain original tissue or organic functions. Because these devices are associated with high risk, their effectiveness and safety should be strictly monitored and clinically investigated. The aim of clinical investigation of these medical devices is to ensure the acceptability of their effectiveness and safety levels. On designing the clinical trial, the investigator should determine the indices to assess the effectiveness and safety of medical devices, select reasonable data-analyzing methods, and pay attention to several other issues. Although some guidelines on specific class III medical devices have illustrated those aspects in detail, there is still no comprehensive report that details all those principles and methodologies. This article aims to summarize the common features among the instruction principles and provide technological support for the clinical study of class III medical devices.


Assuntos
Ensaios Clínicos como Assunto , Segurança de Equipamentos , Equipamentos e Provisões/normas , Projetos de Pesquisa , China , Humanos
18.
Sanid. mil ; 75(3): 156-161, jul.-sept. 2019.
Artigo em Espanhol | IBECS | ID: ibc-187451

RESUMO

Se reseñan los medicamentos evaluados y con dictamen positivo por comisión de expertos de la Agencia Española de Medicamentos y Productos Sanitarios o de la Agencia Europea del Medicamento publicados en marzo y abril de 2018, considerados de mayor interés para el profesional sanitario. Se trata de opiniones técnicas positivas que son previas a la autorización y puesta en el mercado del medicamento


The drugs assessed by the Spanish Agency for Medicines and Health Products or European Medicines Agency made public in March, April and May of 2018, and considered of interest to the healthcare professional, are reviewed. These are positive technical reports prior to the authorization and placing on the market of the product


Assuntos
Humanos , Avaliação de Medicamentos/métodos , Equipamentos e Provisões/normas , Avaliação de Medicamentos/normas , Arginina/uso terapêutico , Buprenorfina/uso terapêutico , Antígenos CD34 , Cicloexanos , Lamivudina , Hidroxiureia , Toxinas Botulínicas Tipo A , Prestação Positiva de Saúde
20.
Ann Biol Clin (Paris) ; 77(5): 514-516, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31466939

RESUMO

In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.


Assuntos
Equipamentos e Provisões/normas , Indústria Manufatureira/legislação & jurisprudência , Legislação de Dispositivos Médicos , Documentação , Segurança de Equipamentos , Equipamentos e Provisões/economia , União Europeia/organização & administração , Fidelidade a Diretrizes/legislação & jurisprudência , Fidelidade a Diretrizes/organização & administração , Fidelidade a Diretrizes/normas , Humanos , Indústria Manufatureira/normas , Indústria Manufatureira/tendências , Legislação de Dispositivos Médicos/organização & administração , Legislação de Dispositivos Médicos/tendências , Segurança do Paciente
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