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1.
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
2.
Farm. hosp ; 44(1): 26-31, ene.-feb. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-187489

RESUMO

El desarrollo y la comercialización de medicamentos de terapia celular con células T con receptor de antígeno quimérico (CAR-T) suponen un nuevo reto para la farmacia hospitalaria en España. El objetivo de este artículo es revisar los aspectos clave de estos medicamentos y describir el papel del farmacéutico oncohematológico dentro del equipo clínico multidisciplinar en las diferentes fases del proceso transversal que implica el tratamiento con medicamentos CAR-T, desde la indicación hasta el seguimiento a corto y largo plazo de los pacientes tratados con este tipo de terapias, con una importante mención al manejo de sus principales efectos adversos. La terapia tipo CAR-T ofrece al farmacéutico hospitalario la oportunidad de trabajar en estrecha colaboración con el resto de los profesionales clínicos implicados en el proceso, permitiendo su contribución en el desarrollo de procedimientos, guías de práctica clínica de abordaje global y estableciendo puntos de partida para afrontar tratamientos futuros de complejidad similar e incluso mejorar procesos base anteriormente establecidos


The development and commercialization of cell therapy drugs with chimeric antigen receptor T cells (CAR-T) represent a new challenge for Spain's hospital pharmacy. The aim of this article is to review the key aspects of these medicines and to describe the oncohematological pharmacist's role within the multidisciplinary clinical team. This includes the different phases in the transversal process that involves a therapy with CAR-T medicines, ranging from indication to short and long term follow-up of patients treated with this type of therapy, and emphasizing on the management of its main adverse effects. CAR-T therapy offers the hospital pharmacist the opportunity to work closely with the rest of the clinical professionals involved in the process, allowing their contribution to the development of procedures, clinical practice guidelines of global approach, and establishing starting points when facing future therapies of similar complexity -and even improving previously established basic processes


Assuntos
Humanos , Farmacêuticos/organização & administração , Farmacêuticos/normas , Imunoterapia Adotiva/métodos , Serviço de Farmácia Hospitalar , Imunoterapia Adotiva/normas , Legislação de Dispositivos Médicos/normas , Farmacovigilância
5.
Curr Opin Urol ; 29(4): 414-418, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30950866

RESUMO

PURPOSE OF REVIEW: Advancements in biomedical engineering and advanced therapies including tissue engineering products necessitate revisions to the regulation and governance of their production and use to ensure patient safety. In this review, the current regulations and recent improvements on the governance of biomedical devices are reviewed. RECENT FINDINGS: Current regulations on approval of biomedical devices failed to address some important aspects related to the definition of biocompatibility of medical implants. The main issue was that the failure to establish design requirements for a specific application - in this case, the pelvic floor. Another issue was the lack of knowledge on disease mechanisms leading to an inability to define clear targets for surgical treatment. A clear example of this is the recent vaginal mesh scandal. SUMMARY: Surgical innovations are inherently challenging. It is no surprise that the regulatory landscape lags behind advancements in biomedical technologies. Very recent modifications to the available regulations particularly in Europe aim to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures patient safety while supporting innovation.


Assuntos
Equipamentos e Provisões/efeitos adversos , Invenções/legislação & jurisprudência , Legislação de Dispositivos Médicos/tendências , Segurança do Paciente/legislação & jurisprudência , Próteses e Implantes/efeitos adversos , Telas Cirúrgicas/efeitos adversos , Tecnologia Biomédica/legislação & jurisprudência , Difusão de Inovações , Europa (Continente) , Humanos , Legislação de Dispositivos Médicos/normas , Prolapso de Órgão Pélvico/cirurgia , Incontinência Urinária por Estresse/cirurgia
9.
Cont Lens Anterior Eye ; 42(2): 136-146, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30446241

RESUMO

Medical devices are under strict regulatory oversight worldwide and such regulations prioritise patient safety and efficacy over anything else. Contact lenses fall under the medical device category - a result of direct contact with the eye. Equally regulated are the contact lens care product solutions, which include cleaning and maintenance solutions and lubricating and rewetting drops. In the USA, it is the FDA Centre for Devices and Radiological Health (CDRH) overseeing the regulations of medical devices, since 1976. In the European Union, it is the EU Commission responsible for regulating devices in Member States. The categorisation of contact lenses into medical devices is based on their inherent risk to the wearer. Contact lenses are subject to crucial regulatory oversight from concept to clinical evaluation, clinical investigations through to the finished lens product, and finally, strict conditions associated with their marketing approval including post-marketing surveillance. The physiochemical and manufacturing testing, such as biocompatibility testing alongside pre-clinical stability, sterility and microbiological testing are just some of the essential testing lenses must endure. Only through understanding the inherent risks and potential complications that can arise from contact lens wear, can one truly appreciate the need to adhere to strict regulations. The challenge however, lies in the need for more standardised regulations and flexible approaches, ensuring innovative device technologies reach patients in a timely manner without compromising public health and safety. This review highlights some key requirement, differences and similarities between the FDA and EU administrations in the approval of contact lenses.


Assuntos
Soluções para Lentes de Contato , Lentes de Contato , Internacionalidade/legislação & jurisprudência , Legislação de Dispositivos Médicos/normas , Aprovação de Equipamentos , Aprovação de Drogas , Humanos , Marketing de Serviços de Saúde
10.
J Clin Hypertens (Greenwich) ; 20(7): 1092-1095, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-30003703

RESUMO

The accuracy of blood pressure (BP) measuring devices is fundamental to good practice and scientific research. International guidelines on BP measurement are provided for clinicians who diagnose and treat patients with hypertension, clinical researchers who conduct trials on the efficacy of BP lowering drugs and interventional strategies, epidemiologists who conduct population surveys to determine the demographic consequences of hypertension on society, and researchers who perform meta-analyses on published research to further influence the practice of medicine and the provision of resources. Although the outcomes of the endeavors of all these groups are dependent on the accuracy of BP measurements, the equipment is often of doubtful accuracy and the methodology of measurement is often poorly described and frequently not standardized. Thus, the fundamental element of hypertension evaluation has been largely ignored by both clinical practitioners and scientific researchers. Here, the authors briefly review the development of efforts to improve and validate the accuracy of BP measuring devices and highlight the deficiencies that persist. We conclude that, to protect the public from the serious consequences of inaccurate BP measurements, the following steps are required: (1) regulatory requirement for mandatory independent validation of all BP measuring devices using a universal protocol; (2) accreditation of laboratories for the performance of BP device validations; (3) online evaluation of validation studies with detection of protocol violations prior to publication of results; and (4) establishment of an independent scientific forum for the listing of accurate BP measuring devices.


Assuntos
Determinação da Pressão Arterial/instrumentação , Monitorização Ambulatorial da Pressão Arterial/normas , Pressão Sanguínea/fisiologia , Hipertensão/fisiopatologia , Anti-Hipertensivos/uso terapêutico , Monitorização Ambulatorial da Pressão Arterial/métodos , Desenho de Equipamento , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Legislação de Dispositivos Médicos/normas , Guias de Prática Clínica como Assunto , Reprodutibilidade dos Testes
13.
J Biomed Mater Res B Appl Biomater ; 106(6): 2093-2100, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29080388

RESUMO

The 4th US-China Joint Workshop on Regulation, Standards and Innovation of Biomaterials was held during the Annual Meeting of the Society for Biomaterials on April 5, 2017 at Minneapolis, MN. This series of joint workshops have become a unique platform for both the US and China to discuss and update what is new in the field of biomaterials and medical devices in terms of regulation, standards and innovation since 2013. China Food and Drug Administration and its affiliated agencies such as Center for Medical Device Evaluation presented at each of the workshop. With the implementation of Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council of the People's Republic of China, No. 650) since June 1, 2014, the regulatory changes and reform for medical devices in China have been hot topics in the workshops. This report captures the key information presented during the workshops, which includes major changes of the Chinese medical device regulation systems, reform of the review and approval system for medical devices in China, and the special procedures of review and approval for innovative medical devices. The market growth of medical devices along with demands for innovative technologies brings the ongoing regulatory changes and reform in China, which will certainly create positive impact on both the development of the Chinese healthcare system and the innovation of medical devices in China. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 2093-2100, 2018.


Assuntos
Aprovação de Equipamentos/normas , Equipamentos e Provisões/normas , Legislação de Dispositivos Médicos/normas , China , Congressos como Assunto , Humanos
15.
Rev Panam Salud Publica ; 39(5): 238-244, 2016 May.
Artigo em Espanhol | MEDLINE | ID: mdl-27706400

RESUMO

Objective To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.


Assuntos
Órgãos Governamentais , Legislação de Dispositivos Médicos/normas , América , Humanos , Legislação de Dispositivos Médicos/estatística & dados numéricos
16.
Rev Panam Salud Publica ; 39(5): 294-298, 2016 May.
Artigo em Espanhol | MEDLINE | ID: mdl-27706406

RESUMO

Health technology regulation and quality assurance are critical to the development of national pharmaceutical policies, and implementing these actions is the responsibility of national regulatory authorities, whose level of development and maturity affect the quality, safety, and effectiveness of the products made available to the public. On the initiative of the regulatory authorities themselves, together with the Pan American Health Organization, the Region of the Americas promotes the strengthening of health regulation through an evaluation and certification process that allows for the designation of regulatory authorities of regional reference for drugs and biological products. Over the period from its implementation to the present, six authorities have been certified and one is in the process of obtaining certification. These authorities work jointly and promote dialogue and regulatory convergence, information-sharing to facilitate regulatory decision making, and regional cooperation to support the establishment of other authorities in the Region--actions having direct impact on access to effective and quality-assured health technologies. Their combined efforts have led to the recognition of this process of evaluation and certification by the World Health Organization (WHO). Among the actions resulting from the International Consultation on Regulatory Systems Strengthening, WHO recommended taking a close look at this model to assess its potential scale-up at the global level.


Assuntos
Certificação/normas , Legislação de Medicamentos/normas , Legislação de Dispositivos Médicos/normas , Garantia da Qualidade dos Cuidados de Saúde , América , Humanos , Organização Pan-Americana da Saúde , Organização Mundial da Saúde
17.
Rev Panam Salud Publica ; 39(5): 281-287, 2016 May.
Artigo em Português | MEDLINE | ID: mdl-27706413

RESUMO

The present article describes the changing relationship among healthcare regulatory authorities in various international settings, with special emphasis on the Americas. As other sectors, healthcare also faces the need to regulate international practices, while at the same time taking into consideration the specific realities of each country. Regulatory convergence - a movement towards technical alignment to enable the adoption of local regulatory mechanisms that take into account internationally recognized standards and principles to promote a single sanitary goal - has emerged as a means to address this challenge. Organizations that already use this tool, such as the International Conference of Drug Regulatory Authorities (ICDRA), Pan American Network for Drug Regulatory Harmonization (PANDRH), International Generic Drug Regulators Programme (IGDRP), and the International Medical Device Regulators Forum (IMDRF), among others, are currently working to gather knowledge, data, and specialists from different countries to build an international technical and scientific standard that can be used for decision-making by local regulators. This would ensure convergence of national regulations despite the need to adapt international standards to local needs, structure, and capacities. The most recent resolutions issued by the World Health Organization recognize the need to bring regulatory systems closer to the reality of national healthcare systems, and underscore the advantages of using existing local guidelines as input for cooperation with regulatory authorities.


Assuntos
Assistência à Saúde/legislação & jurisprudência , Regulamentação Governamental , Internacionalidade , América , Assistência à Saúde/normas , Humanos , Legislação de Medicamentos/normas , Legislação de Dispositivos Médicos/normas , Organizações , Organização Mundial da Saúde
19.
Expert Rev Med Devices ; 13(6): 533-43, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27136699

RESUMO

INTRODUCTION: With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes. AREAS COVERED: The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.


Assuntos
Equipamentos e Provisões/normas , Legislação de Dispositivos Médicos/organização & administração , Legislação de Dispositivos Médicos/normas , Legislação de Dispositivos Médicos/tendências , Ásia , Humanos
20.
Rev. panam. salud pública ; 39(5): 238-244, may. 2016. tab, graf
Artigo em Espanhol | LILACS | ID: lil-795356

RESUMO

RESUMEN Objetivo Describir y analizar la situación actual y los desafíos de la regulación de dispositivos médicos en la Región de las Américas, así como presentar los resultados del Mapeo Regional, los avances en la construcción de indicadores avanzados de evaluación y los logros obtenidos por el Grupo de Trabajo Regional. Métodos Elaborar un perfil regional sobre la regulación de dispositivos médicos en las Américas es una prioridad del Grupo de Trabajo. Para ello, se desarrolló una herramienta de evaluación integrada por 45 preguntas organizadas en seis secciones, que se distribuyó en 15 países para su autoevaluación (la tasa de participación fue 100%). A partir de los datos recibidos se establecieron nueve indicadores básicos y se acordó el desarrollo de indicadores avanzados para medir el nivel de implementación de los programas regulatorios de dispositivos médicos. Resultados El 93% de 15 países cuenta con una institución responsable de la regulación de dispositivos médicos. Al analizar el desempeño por país, se observa variabilidad: desde países que cumplen todos los indicadores, hasta aquellos que únicamente cumplen 11%. El mapeo también permitió generar información sobre alianzas colaborativas, capacitación y reglamentación. Conclusiones Los resultados muestran una heterogeneidad significativa a nivel regional. La implementación de indicadores avanzados contribuirá a identificar áreas de oportunidad y fortalezas para la creación del perfil regulatorio. Aunque se ha avanzado en el fortalecimiento de los programas regulatorios de dispositivos médicos, aún hay brechas que deben reducirse mediante estrategias e iniciativas que serán lideradas por el Grupo de Trabajo.


ABSTRACT Objective To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.


Assuntos
Equipamentos e Provisões/provisão & distribução , Legislação de Dispositivos Médicos/normas , América
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