43 research outputs found

    El Análisis del Impacto Regulatorio en el momento de la pandemia: un ejercicio práctico en el contexto del COVID - 19

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    This study aims to demonstrate the potential use of problem identification and analysis, one of the Regulatory Impact Assessment (RIA) stages, as an alternative to drive critical, rational, and logic thinking while formulating regulatory policies and actions to face COVID-19. The theoretical foundation included an outlook on regulation, RIA and problem identification and analysis. The authors performed a descriptive study with a qualitative approach to report on the results of the didactic-pedagogical workshop, related to problem identification and analysis on a COVID-19 situation. Seven federal workers and ond trainee from the regulatory quality improvement area in Anvisa participated in the workshop. "SARS-COV-2 coronavirus dissemination, as a little- know, untreated and highly contagious virus" was the main problem identified. Ten problem- related consequences were pinpointed, including the worsening of wokshop participants. One of the investigated problem causes was the low population adherence to prevention and control measures. According to the workshop participants, 30 affected stakeholders were identified in the workshop, such as the high - risk population (elderly and people with comorbidities). Thus, this study aims to contribute to the COVID-19 coping in Brazil, as well as to other future public health emergencies.Este estudo objetivou demonstrar o potencial uso da análise e definição de problemas, uma das fases da Análise de Impacto Regulatório (AIR), como uma alternativa em direcionar um pensamento crítico, racional e lógico para a formulação de políticas regulatórias e ações para o enfrentamento da COVID-19. A fundamentação teórica envolveu um panorama sobre regulação, AIR e análise e definição do problema. Recorreu-se a um estudo descritivo com abordagem qualitativa para relatar os resultados da oficina virtual, de caráter didático-pedagógico, sobre análise e definição do problema principal no contexto da COVID-19. Participaram da oficina sete servidores e um estagiário que atuam na unidade de melhoria da qualidade regulatória na Anvisa. O problema principal definido foi “Disseminação do coronavírus SARS-COV-2, pouco conhecido, sem tratamento e com alta taxa de contágio”. Foram identificadas 10 consequências relacionadas ao problema, sendo o agravamento de problemas ligados à saúde mental uma delas. A título ilustrativo, o estudo destacou cinco das 20 causas elencadas pelos participantes. A baixa adesão da população às medidas de prevenção e controle foi considerada uma das causas do problema. A população de grupos de risco, como idosos e pessoas com comorbidades, foi um dos 30 agentes afetados pelo problema identificados na oficina. Este estudo é uma contribuição ao enfretamento da COVID-19, bem como a outras futuras emergências em saúde pública.Este estudio tuvo como objetivo demostrar el uso potencial del análisis y la definición de problemas, una de las fases del Análisis de Impacto Regulatorio (AIR), como una alternativa para dirigir el pensamiento crítico, racional y lógico para la formulación de políticas y acciones regulatorias para enfrentar el COVID-19. La base teórica implicaba una visión general de la regulación, el AIR y el análisis y la definición del problema. Se utilizó un estudio descriptivo con un enfoque cualitativo para informar los resultados del taller virtual sobre análisis y definición del problema principal en el contexto de COVID-19. Siete empleados y un interno que trabajan en la unidad de mejora de la calidad reguladora en Anvisa participaron en el taller. El principal problema definido fue "Diseminación del coronavirus SARS-COV-2, poco conocido, no tratado y con una alta tasa de contagio". Se identificaron 10 consecuencias relacionadas con el problema, y el empeoramiento de los problemas de salud mental fue uno de ellos. Como ilustración, el estudio destacó cinco de las 20 causas enumeradas por los participantes. La baja adherencia de la población a las medidas de prevención y control se consideró una de las causas del problema. La población de grupos de riesgo, como los ancianos y las personas con comorbilidades, fue uno de los 30 agentes afectados por el problema identificado en el taller. Este estudio es una contribución para hacer frente a COVID-19, así como a otras futuras emergencias de salud públicaRevista do Serviço Público - RSP, v. 71, ed. especial, p. 165-188Gestão PúblicaSpecial Edition - "Governments and Covid-19"ISSN Eletrônico: 2357-8017ISSN Impresso: 0034-924

    Development of the 2-Component-Injection Moulding for Metal Powders

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    2-Component-Metal Injection Moulding (2-C-MIM) is a technique derived from plastics industry which has been adapted to metal powders. By using this technology, the production of titanium parts combining dense and porous parts becomes possible. Such a structure with a gradient in porosity is attractive for biomedical implants, as the pores promote a mechanical interlock between bone tissue and implant material. The dense part of the structure is responsible for the mechanical stability of the implant. For the fabrication of metal parts with a gradient in porosity, feedstocks with and without space holder particles are employed. A 2-C-MIM machine and a specifically designed tool are used for the combination of these feedstocks in the same green part. After removal of the binder and space holder material, the parts are sintered and a structure with a gradient in porosity is obtained. First 2-C-MIM experiments were conducted with a standard binder system previously developed at the institute IEK-1 at Forschungszentrum Ju¨lich\textit{Forschungszentrum Jülich}. Results achieved with this binder system indicated binder-powder phase separation during injection, which occurred due to the low viscosity of the binder system used (0.15 Pa·s). The need for the development of a new binder system with a more suitable flowing behaviour became clear. Moreover, the partial debinding method employed so far (wicking) needed to be substituted by another method with a more industrial approach. New binder systems comprising a wide range of viscosity were developed, where the partial debinding method employed was solvent extraction in n-hexane. A binder system with a viscosity of 12.4 Pa·s was chosen for further investigations, due to the suitability of flowing behaviour of its feedstock. The viscosity of feedstocks was measured, where the use of space holder particles was found to decrease viscosity. After addition of stearic acid and optimisation of the solids content, feedstocks with 72 and 64 Vol.% solids loading (with and without space holder, respectively) were used in injection moulding trials. After optimisation of the injection temperature of feedstock, prototypes of titanium spinal implants with a gradient in porosity were successfully produced and characterised. The availability of the net-shape production of such implants by 2-C-MIM means a reduction of costs in case of large scale production, as compared to the fabrication method current employed (pressing and green machining)
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