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6.
Rev Assoc Med Bras (1992) ; 65(3): 410-418, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30994841

RESUMO

INTRODUCTION: There is a worldwide increase in the number of invasive aesthetic procedures, and there is a general apprehension in medical societies towards the assurance of patient safety, that is dependent on the quality and certification of providers, of the materials and substances used, and where they take place.It is the main objective of this study to determine the perception of the gravity of non-authorized substances for clinical use in invasive aesthetic procedures among Portuguese plastic surgeons and its variation by the clinical sector of practice. METHODS: We proceeded to an inquiry by using a questionnaire, measured in a Linkert scale, and the collected data were statistically treated with a non-parametric Kruskal-Wallis test. RESULTS: We obtained a 41,4% answer rate and a global perception that this is a serious problem - a median of 8,00 and mean of 7,45 points on a 1 to 10 scale. 70% of the plastic surgeons that answered the questionnaire work both in the private and public sector, 19% exclusively in the public sector and 11% only in private practice. The perception of the problem was most serious among those that work exclusively in the private sector (statistically significant difference). CONCLUSION: The causes of the observed difference may reside in various reasons: the higher number of patients submitted to invasive aesthetic procedures exclusively in private practice; the higher perception of regulatory deficits in the private sector; scarce specific health politics for procedures outside the traditional boundaries of medicine; the difficulty for independent regulatory agencies to adopt effective measures.


Assuntos
Padrões de Prática Médica/estatística & dados numéricos , Procedimentos Cirúrgicos Reconstrutivos/efeitos adversos , Medicamentos Fora do Padrão/efeitos adversos , Cirurgiões/estatística & dados numéricos , Regulamentação Governamental , Humanos , Legislação de Dispositivos Médicos , Portugal , Padrões de Prática Médica/legislação & jurisprudência , Setor Privado/estatística & dados numéricos , Setor Público/estatística & dados numéricos , Procedimentos Cirúrgicos Reconstrutivos/instrumentação , Procedimentos Cirúrgicos Reconstrutivos/estatística & dados numéricos , Estatísticas não Paramétricas , Cirurgia Plástica/efeitos adversos , Cirurgia Plástica/estatística & dados numéricos , Inquéritos e Questionários
8.
Toxicol Pathol ; 47(3): 264-279, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30832552

RESUMO

The design, production, and preclinical testing of neurothrombectomy devices is in a burgeoning phase as the demand escalates for safe and reliable treatment options following neurovascular stroke. Currently, there is a paucity of published data describing the development of iatrogenic vascular lesions occurring secondary to neurothrombectomy procedures. In an effort to test new devices, demonstrate device safety, satisfy regulatory requirements, and develop an understanding of the potential for associated vascular pathology, investigators are establishing appropriate methodology in suitable animal models. Significant challenges exist in identifying a single animal species that can be consistently utilized in all phases of device development. These aforementioned challenges are underscored by the intricacies of neurovascular pathology, thrombovascular interactions, and vascular responses to injury.


Assuntos
Artérias Cerebrais , Segurança de Equipamentos/normas , Acidente Vascular Cerebral/cirurgia , Trombectomia/instrumentação , Dispositivos de Acesso Vascular/normas , Animais , Artérias Cerebrais/lesões , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Legislação de Dispositivos Médicos , Estados Unidos , United States Food and Drug Administration , Dispositivos de Acesso Vascular/efeitos adversos
9.
Medicina (Ribeiräo Preto) ; 52(1)jan.-mar.,2019.
Artigo em Português | LILACS | ID: biblio-1024829

RESUMO

RESUMO Introdução: O Núcleo Interno de Regulação (NIR) é uma das estratégias de gestão criadas pela Política Nacional de Atenção Hospitalar do Ministério da Saúde em 2013. Visa a organização do acesso à consultas, serviços diagnósticos e terapêuticos e aos leitos de internação, sendo fundamental o conhecimento do perfil epidemiológico e ajuste de seus processos de trabalho de modo a garantir o fluxo no sistema de saúde. Como as normas para implantação só foram realizadas em 2018, vários serviços implantaram o NIR sem diretrizes e há necessidade de se avaliar o grau de implantação. Objetivo: Avaliar o nível de implantação do NIR em duas unidades de um complexo hospitalar público terciário. Metodologia: Estudo de avaliação, exploratório, descritivo e longitudinal, realizado em duas unidades de internação hospitalar público terciário implantadas no primeiro semestre de 2016 (Unidade de Emergência) e no primeiro semestre de 2017 (Unidade Campus). Resultados: Devido à natureza de sua vocação (eletivo ou urgência), observou-se perfil epidemiológico distinto nas unidades, embora tenha sido possível a construção de processo e análise de SWOT integrada para efeitos de tomada de decisão e planejamento. De acordo com os pilares propostos pelo Manual, ambas em maior ou menor grau apresentam iniciativas recomendadas. Mas, por outro lado, os entrevistados reforçam a necessidade de maior investimento para aprimorar o processo. Conclusão: É necessário o estabelecimento de uma política de implantação dos NIR's com referenciais objetivos que possam ser pontuados e permitam o acompanhamento temporal do seu desenvolvimento. (AU)


ABSTRACT Introduction: The Internal Regulation Committee (IRC) is one of the management strategies created by the National Health Care Policy of the Ministry of Health in 2013. It aims to organize the access to consultations, diagnostic and therapeutic services and to hospital beds. It is necessary to know the epidemiological profile to adjust its processes to guarantee the flow in the healthcare system. As the standards for implementation were only established in 2018, several services implemented the ICR without guidelines, and there is a need to evaluate the degree of implementation. Objective: To evaluate the level of NIR implantation in two units of a public tertiary hospital complex. Methodology: Exploratory, descriptive and longitudinal study, carried out in two tertiary public hospitalization units implanted in the first half of 2016 (Emergency Unit) and the first half of 2017 (Campus Unit). Results:Due to the nature of their vocation (elective or emergency), a distinct epidemiological profile was observed, although it was possible to construct an integrated SWOT process and analysis for decision--making and planning purposes. According to the principles proposed by the Manual, both presented recommended initiatives to a greater or lesser degree. However, on the other hand, the units inter-viewed reinforce the need for more investment to improve the process. Conclusion: It is necessary to establish a policy for the implementation of NIRs with objective checklists that can be set and allow the temporal monitoring of their development (AU)


Assuntos
Gestão em Saúde , Sistemas Nacionais de Saúde , Legislação de Dispositivos Médicos , Administração Hospitalar
10.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(1): 43-47, 2019 Jan 30.
Artigo em Chinês | MEDLINE | ID: mdl-30770690

RESUMO

The traditional regulation mode on medical devices has invalid and negative effect problems. In order to more effectively ensure safety and efficacy of medical devices, promote healthy industrial development, this paper puts forward the innovative concept of smart regulation on the basis of problem orientation. Compared with traditional regulatory mode, smart regulation focus on effectiveness, and pays attention to relationship between effective regulation with self-discipline and industrial development, has characteristics of improving pertinence, effectiveness, accuracy, speed and efficiency of regulation. This paper further elaborates implementation approaches and attentions of smart regulation, by the ways of strengthening credit management, intelligent regulation, professional regulation, promoting self-discipline and encouraging innovation.


Assuntos
Legislação de Dispositivos Médicos , Humanos
12.
Plast Surg Nurs ; 39(1): 5-9, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30801491

RESUMO

The medical device industry is an incredibly profitable and rapidly growing sector of health care. In plastic surgery, the nonsurgical medical aesthetic device industry presents ongoing ethical challenges, specifically related to the principles of nonmaleficence and respect for autonomy. The purpose of this article is to increase awareness of the ethical challenges the nonsurgical medical aesthetic device industry presents, including use of deceptive or misleading language in advertising, limited evidence of efficacy, and lack of public and professional understanding of the U.S. Food and Drug Administration regulation of medical devices. Practical application of ethics is presented through the lens of the Code of Ethics for Nurses With Interpretive Statements () and the Code of Ethics of the American Society for Aesthetic Plastic Surgery ().


Assuntos
Técnicas Cosméticas/ética , Ética em Enfermagem , Legislação de Dispositivos Médicos , Cirurgia Plástica/ética , /normas , Estética , Humanos
16.
Toxicol Pathol ; 47(3): 250-263, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30599801

RESUMO

Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must be familiar with the regulatory framework affecting device development, biocompatibility and safety determinants impacting nervous tissue responses, and appropriate study design, including the use of appropriate animal models, group design, device localization, euthanasia time points, tissue examination, sampling and processing, histochemistry and immunohistochemistry, and reporting. This overview contextualizes these features of neurologic medical devices for pathologists engaged in device evaluations.


Assuntos
Desenho de Equipamento/normas , Segurança de Equipamentos/normas , Equipamentos e Provisões/normas , Sistema Nervoso/patologia , Patologistas , Animais , Materiais Biocompatíveis/normas , Humanos , Teste de Materiais/métodos , Legislação de Dispositivos Médicos
17.
Therapie ; 74(1): 73-85, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30598315

RESUMO

The European regulation governing the placing on the market of medical devices (MD) provides for the gradual and mandatory phasing-in, within the European Union, of a unique device identification (UDI) system and a European database (EUDAMED) aimed at improving traceability and transparency of the market. The deployment of these tools will have a significant impact on the stakeholders of the medical device world (companies, health institutions, healthcare professionals, competent authorities, etc.). A strengths/weaknesses/opportunities/threats (SWOT) analysis conducted among the think tank participants shows real support for the objectives but also distinguishes a great deal of issues relating to the implementation of these tools. An inventory of the current traceability tools and databases used in France was then carried out to measure the gaps between the requirements of the European regulation and the current situation revealing that EUDAMED and the UDI system will ultimately have to slot into a complex and poorly interoperable ecosystem. An essential first step to facilitate this integration will be to increase the number of educational, awareness-raising and information initiatives for the stakeholders concerned. Several other recommendations were put forward to support the implementation of EUDAMED and the UDI system in France and thus enable their promises to crystallise in the future.


Assuntos
Legislação de Dispositivos Médicos/tendências , Bases de Dados Factuais , União Europeia , Previsões , França , Setor de Assistência à Saúde , Humanos , Terminologia como Assunto
18.
Toxicol Pathol ; 47(3): 344-357, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30392453

RESUMO

The development of biomaterials, medical device components, finished medical products, and 3-D printed and regenerative medicine products is governed by a variety of international and country-specific standards and guidelines. Of greatest importance to planning, executing, and reporting biocompatibility, safety and efficacy studies for most biomaterials and medical components or products are the International Organization for Standardization guidelines, U.S. Pharmacopeial Convention, ASTM International, and Conformité Européenne (European Conformity) marking. The International Medical Device Regulators Forum publishes harmonized standards similar to the International Council for Harmonization. Good Laboratory Practices are applicable and guidance documents for the development of drugs and biologics can also be relevant to biomaterials, medical device components, and medical products and more recently to products produced by 3-D printing or additive manufacturing. Regenerative products may have medical device-based scaffolding and may be treated as biologics, reflecting the cell and tissue components. This compilation of international standards and guidelines provides toxicologic pathologists, toxicologists, bioengineers, and allied professionals with an overview of and source for important regulatory documents that may apply to the nonclinical development of their products.


Assuntos
Materiais Biocompatíveis/normas , Equipamentos e Provisões/normas , Cooperação Internacional , Teste de Materiais/normas , Legislação de Dispositivos Médicos , Tecidos Suporte/normas , Animais , Humanos , Cooperação Internacional/legislação & jurisprudência , Impressão Tridimensional , Medicina Regenerativa/legislação & jurisprudência , Medicina Regenerativa/normas
19.
Ther Innov Regul Sci ; 53(1): 120-127, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-29756484

RESUMO

Regarding the widespread and ever-increasing applications of biomaterials in different medical fields, their accurate assessment is of great importance. Hence the safety and efficacy of biomaterials is confirmed only through the evaluation process, the way it is done has direct effects on public health. Although every biomaterial undergoes rigorous premarket evaluation, the regulatory agencies receive a considerable number of complications and adverse event reports annually. The main factors that challenge the process of biomaterials evaluation are dissimilar regulations, asynchrony of biomaterials evaluation and biomaterials development, inherent biases of postmarketing data, and cost and timing issues. Several pieces of evidence indicate that current medical device regulations need to be improved so that they can be used more effectively in the evaluation of biomaterials. This article provides suggested conceptual refinements and practical reforms to increase the efficiency and effectiveness of the existing regulations. The main focus of the article is on strategies for evaluating biomaterials in US, and then in EU.


Assuntos
Materiais Biocompatíveis , Segurança de Equipamentos , Materiais Biocompatíveis/classificação , Bases de Dados Factuais , União Europeia , Legislação de Dispositivos Médicos , Vigilância de Produtos Comercializados , Estados Unidos
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