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Objective: To evaluate the evolution of mammographic image quality in the state of Rio de Janeiro on the basis of parameters measured and analyzed during health surveillance inspections in the period from 2006 to 2011. Materials and Methods: Descriptive study analyzing parameters connected with imaging quality of 52 mammography apparatuses inspected at least twice with a one-year interval. Results: Amongst the 16 analyzed parameters, 7 presented more than 70% of conformity, namely: compression paddle pressure intensity (85.1%), films development (72.7%), film response (72.7%), low contrast fine detail (92.2%), tumor mass visualization (76.5%), absence of image artifacts (94.1%), mammography-specific developers availability (88.2%). On the other hand, relevant parameters were below 50% conformity, namely: monthly image quality control testing (28.8%) and high contrast details with respect to microcalcifications visualization (47.1%). Conclusion: The analysis revealed critical situations in terms of compliance with the health surveillance standards. Priority should be given to those mammography apparatuses that remained non-compliant at the second inspection performed within the one-year interval. .

Objetivo: Avaliar a evolução da qualidade da imagem de mamógrafos localizados no Estado do Rio de Janeiro, de 2006 a 2011, com base em parâmetros medidos e observados durante inspeções sanitárias. Materiais e Métodos: Estudo descritivo sobre a evolução de parâmetros que condicionam a qualidade da imagem focalizou 52 mamógrafos, inspecionados no mínimo duas vezes, com intervalo de um ano. Resultados: Dos 16 parâmetros avaliados, 7 apresentaram mais de 70% de conformidade: força do dispositivo de compressão (85,1%), processamento dos filmes (72,7%), resposta do filme do serviço (72,7%), detalhes lineares de baixo contraste (92,2%), visualização de massas tumorais (76,5%), ausência de artefatos de imagem (94,1%), existência de processadoras específicas para mamografia (88,2%). Importantes parâmetros apresentaram-se abaixo de 50% de conformidade: realização de testes mensais da qualidade de imagem pelo estabelecimento (28,8%) e detalhes de alto contraste, que dizem respeito à visualização de microcalcificações (47,1%). Conclusão: A análise revelou situações críticas da atuação da vigilância sanitária, cuja prioridade deveria ser dirigida aos estacionários, ou seja, os mamógrafos que permaneceram na situação de não conformidade nas inspeções realizadas com intervalo de um ano. .

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The occurrence of avoidable adverse events (AEs) represents a problem of quality of care that is responsible for the increase in monetary and social costs, causing suffering to the patient, their family members and the professional involved. This situation is aggravated when it involves newborns (NBs) with very low birth weights and shorter gestational ages, admitted to neonatal intensive care units (NICU). The scope of this study is to understand more about these incidents and adverse events in NICUs. The article aims to identify the occurrence of incidents, with and without injury that have occurred in NICUs in the literature and correlate this with the gestational age group of the NBs most affected. This is a systematic review of the available literature on incidents, particularly AEs as witnessed in NICUs. This study reveals that the types of incidents that occur in NICUs, with or without injury to the patient, are related to errors or failures in medication use, healthcare-associated infections (HAIs), skin injuries, mechanical ventilation and intravascular catheters. The cause of incidents and adverse events in NICUs are associated with human factors and the outcomes that are most damaging are due to HAIs. Furthermore, the study points out ways to mitigate these occurrences.

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OBJECTIVE: To describe the organization of national drug regulatory authorities (DRAs) in Argentina, Brazil, Chile, and Peru through the analysis of categories representing organizational rules. METHODS: The DRAs were selected using the following criteria: being in a South American country, having been identified as DRAs at Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (Conferences of Ibero-American Drug Regulatory Authorities), and having good availability of electronic data regarding organizational structure and the process of drug regulation. The main source of data were websites, which were reviewed between May 2010 and March 2011. The analytical categories were: organizational structure, competencies, directionality (mission and vision statements), and forms of accountability. RESULTS: The DRAs of Argentina and Brazil functioned as autonomous agencies, while those of Chile and Peru were directly subordinated to the ministries of health. Except for the Brazilian DRA, the agencies in the other three countries were dependent on their health ministries to issue sanitary regulations. The scope of action of each DRA differed in terms of the goods and services covered, with the Peruvian DRA being the only one exclusively dedicated to the regulation of drugs. The four DRAs performed all the processes identified by the World Health Organization as essential for effective drug regulation. CONCLUSIONS: The results show an effort by the studied countries to improve their regulatory structure. Nevertheless, all four DRAs need to improve some mechanisms to ensure that, at the end of the regulatory chain, the drugs they regulate have the desired quality and safety, with more transparency in decision-making processes and social accountability.

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OBJETIVO: Descrever a organização das autoridades reguladoras nacionais (ARN) de medicamentos da Argentina, Brasil, Chile e Peru pela análise de categorias representativas de regras organizacionais. MÉTODOS: As ARN estudadas foram selecionadas utilizando-se os seguintes critérios: estar em país da América do Sul, ter sido identificada como ARN nos Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos e apresentar boa disponibilidade de dados eletrônicos sobre estrutura e processo da regulação de medicamentos. Como principal fonte de dados, foram consultadas páginas eletrônicas entre maio de 2010 e março de 2011. As categorias analíticas foram: estrutura da organização, competências, direcionalidade e formas de responsabilidade e prestação de contas. RESULTADOS: As ARN da Argentina e do Brasil funcionavam como agências autônomas, enquanto que as do Chile e do Peru se subordinavam diretamente aos respectivos ministérios da saúde. À exceção da ARN brasileira, evidenciou-se a dependência das demais em relação ao ministério para emitir normas sanitárias. O escopo de ação de cada autoridade se diferenciou pelos bens e serviços a ela sujeitos, sendo a do Peru a única dedicada exclusivamente à regulação de medicamentos. As quatro ARN realizam todos os processos apontadas pela Organização Mundial da Saúde como essenciais para uma regulação efetiva. CONCLUSÕES: Os resultados apontam para um esforço dos países estudados em melhorar sua estrutura regulatória. Não obstante, em diversos aspectos, as quatro ARN ainda precisam aprimorar mecanismos para garantir, ao final da cadeia regulatória, a qualidade e a segurança dos medicamentos por elas regulados, com mais transparência nos processos decisórios e prestação de contas à sociedade.

OBJECTIVE: To describe the organization of national drug regulatory authorities (DRAs) in Argentina, Brazil, Chile, and Peru through the analysis of categories representing organizational rules. METHODS: The DRAs were selected using the following criteria: being in a South American country, having been identified as DRAs at Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (Conferences of Ibero-American Drug Regulatory Authorities), and having good availability of electronic data regarding organizational structure and the process of drug regulation. The main source of data were websites, which were reviewed between May 2010 and March 2011. The analytical categories were: organizational structure, competencies, directionality (mission and vision statements), and forms of accountability. RESULTS: The DRAs of Argentina and Brazil functioned as autonomous agencies, while those of Chile and Peru were directly subordinated to the ministries of health. Except for the Brazilian DRA, the agencies in the other three countries were dependent on their health ministries to issue sanitary regulations. The scope of action of each DRA differed in terms of the goods and services covered, with the Peruvian DRA being the only one exclusively dedicated to the regulation of drugs. The four DRAs performed all the processes identified by the World Health Organization as essential for effective drug regulation. CONCLUSIONS: The results show an effort by the studied countries to improve their regulatory structure. Nevertheless, all four DRAs need to improve some mechanisms to ensure that, at the end of the regulatory chain, the drugs they regulate have the desired quality and safety, with more transparency in decision-making processes and social accountability.

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This paper analyzes the Brazilian Sanitary Surveillance System as an arrangement aimed at regulating and reducing health risks associated with consumption of products, use of health services and the environment. Historical, political and tax aspects were considered and their development compared with the National Health Surveillance System, which has received strong international cooperation. The comparison was based on the trajectory of their national systems and related federal agencies, as well as on criteria adopted for decentralization. The central category of analysis is federative coordination and was based on the framework of federalism and intergovernmental relations. The institutional context of health and sanitary surveillance presents strong political competition, instability in the project and probable reduction of the ability of federal coordination after the Pact for Health. The National Sanitary Surveillance System due to its nature of public good and high externality in its field of action requires federal coordination for increasing the regional and local cooperation, also because of the structural heterogeneity of Brazilian municipalities.

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Considering the importance of nutritional care for the quality of care provided to hospitalized patients, the study aims to assess health care in eight public hospitals that have received support from QualiSUS in four Brazilian states. There were semi-structured interviews with nutritionists, direct observation and review of 219 records of patients admitted to the medical clinics. The findings suggest weaknesses in the hospital nutritional care, poor integration between the production of food and nutritional care in the surveyed hospitals, in addition to structural deficiencies. We highlight problems related to the nutritional care process, including its documentation. In 93% of the records there were no records on the nutritional status on admission, or nutritional assessment of patients in nutritional therapy. It was observed that the assessment made by the health surveillance in routine inspections, focusing on the verification of compliance and structural aspects, does not include the detection of a possible nutritional risk for the patient. We suggest the inclusion of other criteria and strategies for surveillance, among them a review of open medical records.

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Este artigo analisa a construção do Sistema Nacional de Vigilância Sanitária, um arranjo voltado à regulação e redução dos riscos sanitários decorrentes do consumo de produtos, da prestação de serviços de saúde e do ambiente no Brasil. Consideraram-se aspectos históricos, políticos, fiscais e a conjuntura atual para cotejar seu desenvolvimento com o do Sistema Nacional de Vigilância em Saúde, que tem recebido intensa cooperação internacional. O cotejamento se baseou na trajetória de seus sistemas nacionais e respectivos serviços federais, bem como nos critérios para descentralização. A análise teve como categoria central a coordenação federativa e se baseou no referencial do federalismo e das relações intergovernamentais. O contexto institucional da saúde e da vigilância sanitária apresenta forte competição política, instabilidade no projeto e provável redução da capacidade de coordenação federativa após o Pacto pela Saúde. O Sistema Nacional de Vigilância Sanitária, em razão da sua natureza de bem público e da alta externalidade de seu campo de ação, requer coordenação federativa para incremento da cooperação regional e local e também pela heterogeneidade estrutural dos municípios brasileiros.

This paper analyzes the Brazilian Sanitary Surveillance System as an arrangement aimed at regulating and reducing health risks associated with consumption of products, use of health services and the environment. Historical, political and tax aspects were considered and their development compared with the National Health Surveillance System, which has received strong international cooperation. The comparison was based on the trajectory of their national systems and related federal agencies, as well as on criteria adopted for decentralization. The central category of analysis is federative coordination and was based on the framework of federalism and intergovernmental relations. The institutional context of health and sanitary surveillance presents strong political competition, instability in the project and probable reduction of the ability of federal coordination after the Pact for Health. The National Sanitary Surveillance System due to its nature of public good and high externality in its field of action requires federal coordination for increasing the regional and local cooperation, also because of the structural heterogeneity of Brazilian municipalities.

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Considerando a importância do cuidado nutricional para a qualidade da atenção prestada ao paciente internado, a pesquisa objetivou avaliar esse cuidado em oito hospitais públicos que receberam aportes do QualiSUS em quatro estados do país. Realizaram-se entrevistas semiestruturadas com nutricionistas, observação direta e revisão de 219 prontuários de pacientes internados nas clínicas médicas. Os achados sugerem fragilidades no cuidado nutricional hospitalar; deficiente integração entre produção de refeições e assistência nutricional nos hospitais pesquisados, além de deficiências estruturais. Ressaltam-se problemas relacionados ao processo de cuidado nutricional, inclusive na sua documentação. Em 93 por cento dos prontuários não havia registros do estado nutricional na admissão, nem de avaliação nutricional dos pacientes em terapia nutricional. Aponta-se que a avaliação realizada pela vigilância sanitária em inspeções de rotina, centrada na verificação do cumprimento de normas e nos aspectos estruturais, não contempla a detecção de um possível risco nutricional para o paciente. Sugere-se a inclusão de outros critérios e estratégias pela vigilância sanitária, dentre eles a revisão de prontuários abertos.

Considering the importance of nutritional care for the quality of care provided to hospitalized patients, the study aims to assess health care in eight public hospitals that have received support from QualiSUS in four Brazilian states. There were semi-structured interviews with nutritionists, direct observation and review of 219 records of patients admitted to the medical clinics. The findings suggest weaknesses in the hospital nutritional care, poor integration between the production of food and nutritional care in the surveyed hospitals, in addition to structural deficiencies. We highlight problems related to the nutritional care process, including its documentation. In 93 percent of the records there were no records on the nutritional status on admission, or nutritional assessment of patients in nutritional therapy. It was observed that the assessment made by the health surveillance in routine inspections, focusing on the verification of compliance and structural aspects, does not include the detection of a possible nutritional risk for the patient. We suggest the inclusion of other criteria and strategies for surveillance, among them a review of open medical records.

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The aid lent by the emergency services is the object of this paper, which aims to assess the emergency service of the QualiSUS program. The study is descriptive with the application of a questionnaire to the responsible of the emergency services in eight hospitals. The emergency services were always overcrowded, and the causes pointed were the low resolutivity of basic attention and the precariousness of the hospital network. Contributing to this there is the primary care decreased resolutivity and the precariousness of the hospital network. Six hospitals do not manage the emergency service. The entrance system is not organized and only three hospitals work with risk classification. All of them refer difficulties with internal and external services. The hardest pathologies to refer to other services are the chronicles, neurological and social. The professionals do not have specific qualification and the precariousness job contracts do not contribute neither for the professional's fixation nor for his qualification. Clinical protocols are used by one service. It was noticed the influence of the QualiSUS in the hospitals. The failure of the health services network interferes with the emergency patient's profile. The investment of the QualiSUS cannot be restrained to the hospital. Emergency should be more integrated to the system and hospital. The qualification of human resources is indispensable as well as the bed's regulation.

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A obra traz reflexões que iluminam a interseção entre vigilância sanitária e gestão em saúde, ao abordar os conceitos, saberes e práticas relacionadas a esses dois campos. Em linguagem dialógica e acessível, reveste-se de interesse para profissionais da saúde, gestores, professores, pesquisadores e alunos.

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Apresenta uma análise da política pública e da gestão em saúde no Brasil, com o objetivo de propiciar a discussão das implicações desse processo para a vigilância sanitária. Aborda primeiramente algumas questões relativas ao processo político mais geral no Brasil e suas consequências na definição das políticas públicas e para as condições de vida da população brasileira. Delineia a história da saúde no Brasil e o recente movimento reformista e faz uma sistematização sobre a organização da gestão da política pública de saúde no Brasil. Finalmente, discute a descentralização da política de saúde e propõe a reflexão sobre que desafios se apresentam para os gestores da vigilância sanitária.

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