Ediná Alves Costa

Imagem-objetivo para a descentralização da vigilância sanitária em nível municipal

No consensus has been reached concerning the definition of criteria and standards for evaluating the decentralization of actions by municipal health surveillance systems. With the aim of developing and validating an objective image for municipal health surveillance that would correspond to an appropriate system for the populations health care needs, a logical framework was elaborated, from which a matrix containing dimensions and criteria for management and practices was obtained. The framework was submitted to an expert group for validation at a consensus conference. Of the 54 criteria, there was consensus for 59.3%, while 53 items (98%) were considered important, thus validating the matrix. In view of the provisory nature of the consensuses, the resulting instrument, which can be used either in its entirety or in part, enables modification and adaptation. The authors discuss the potential of the evaluation strategy adopted here, which allows various possibilities for redefining the criteria and renewing the consensus.

Controle de riscos à saúde em radiodiagnóstico: uma perspectiva histórica

This paper presents the history of the discovery of ionizing radiation, as well as its biological effects and the resulting need to control subsequent health risks. It describes the historic evolution of risk control in radiodiagnosis in Brazil, demonstrating that it may be associated not only to the dose received, but also to errors in diagnosis and to costs to the health system. It is stressed that sanitary regulations have a broad remit of social co-responsibility to involve all the players with a view to safeguarding health.

Vigilância sanitária: estratégias para sua descentralização em Mato Grosso, 1996-2005

The decentralization process of sanitary surveillance services to states and municipalities was improved after NOB/96, when funding transferences were defined. In Mato Grosso, this responsibility was incorporated by the Sanitary Surveillance Coordination (Visa/SES) which developed strategies to decentralize at first, the basic actions to all municipalities of the state. The objective of this research is to describe and analyze the strategies adopted by Visa/SES in decentralization of Visa actions to municipalities and the main difficulties found. This research is a qualitative study with documental and interview analysis. The results show as main adopted strategies: several training to professionals from regional, central and local levels; development of technical material to municipals services; assessment with join inspections between three levels of management; creation of law documents. It was observed an active performance in the decentralization, the Visa/SES keeps performing the high and middle complexity actions in almost all municipalities and even those of low complexity, in some, which impede other important tasks as supervision and evaluation of this process, besides continuous support and organization of municipalities services.

Avaliação de desempenho da Agência Nacional de Vigilância Sanitária no modelo de contrato de gestão

The Brazilian National Health Surveillance Agency (Anvisa) is supervised by the Ministry of Health by means of a management contract, a performance evaluation tool. This case study was aimed at describing and analyzing Anvisas performance evaluation model based on the agencys institutional purpose, according to the following analytical categories: the management contract formalization, evaluation tools, evaluators and institutional performance. Semi-structured interviews and document analysis revealed that Anvisa signed only one management contract with the Ministry of Health in 1999, updated by four additive terms. The Collegiate Board of Directors and the Advisory Center for Strategic Management play the role of Anvisas internal evaluators and an Assessing Committee, comprising the Ministry of Health, constitutes its external evaluator. Three phases were identified in the evaluation model: the structuring of the new management model (1999-2000), legitimation regarding the productive segment (2001-2004) and widespread legitimation (2005). The best performance was presented in 2000 (86.05%) and the worst in 2004 (40.00%). The evaluation model was shown to have contributed little towards the agencys institutional purpose and the effectiveness measurement of the implemented actions.

Risco e segurança sanitária: análise do reprocessamento de produtos médicos em hospitais de Salvador, BA

OBJETIVO: Analizar condiciones tecnicas de reprocesamiento de productos medicos en hospitales. METODOS: Estudio descriptivo de casos multiples en centros de material y esterilizacion de cuatro hospitales de la ciudad de Salvador, BA, en 2010. Se realizaron entrevista semi-estructurada y observacion directa, con base en modelo regulatorio de reprocesamiento de productos medicos elaborado con la tecnica de Conferencia de Consenso como patron de referencia. Las categorias analiticas utilizadas en este estudio fueron: gerenciamiento de la practica de reprocesamiento de productos medicos, protocolos de reprocesamiento, monitoreo del proceso de esterilizacion y rastreo de productos. Esas categorias fueron calificadas segun su conformidad con el modelo regulatorio de reprocesamiento utilizado. RESULTADOS: Se observo inadecuacion generalizada de las condiciones tecnicas de reprocesamiento de productos medicos de las condiciones estructurales de los centros de material y esterilizacion estudiados y de las condiciones de los procesos de trabajo, asi como, dificultades organizacionales y gerenciales que interfirieron en las practicas analizadas. CONCLUSIONES: Las practicas de reprocesamiento de los productos medicos en los hospitales analizados configuran riesgo para los pacientes usuarios. Es necesaria la adopcion de un sistema de gerenciamiento de riesgo en tales hospitales y de mayor control sanitario por el Estado, a fin de proteger la salud de los pacientes.

Medical device reprocessing: a regulatory model proposal for Brazilian hospitals

Medical device reprocessing is extremely important and complex, thus requiring both the operational skills for its implementation and the technical qualification of the professionals involved in the activity. The typical issues of medical device reprocessing involve technical, economical and regulatory aspects when involving either the so-called reusable articles or those considered as for a single use. The objective of the present study is to propose a new regulatory model for medical device reprocessing in Brazil that would, on the one hand, satisfy the requirements for quality and safety, as recommended in the literature and, on the other hand, prove to be operational under the conditions prevailing in Brazilian hospitals. The elaboration of the present normative proposal was based on the Consensus Conference technique among specialists in the area. Guided by the contribution of these specialists, a proposal is put forth of a regulatory model for reprocessing medical products, so as to address some previously identified gaps in the normative body currently used in Brazil.Medical device reprocessing is extremely important and complex, thus requiring both the operational skills for its implementation and the technical qualification of the professionals involved in the activity. The typical issues of medical device reprocessing involve technical, economical and regulatory aspects when involving either the so-called reusable articles or those considered as for a single use. The objective of the present study is to propose a new regulatory model for medical device reprocessing in Brazil that would, on the one hand, satisfy the requirements for quality and safety, as recommended in the literature and, on the other hand, prove to be operational under the conditions prevailing in Brazilian hospitals. The elaboration of the present normative proposal was based on the Consensus Conference technique among specialists in the area. Guided by the contribution of these specialists, a proposal is put forth of a regulatory model for reprocessing medical products, so as to address some previously identified gaps in the normative body currently used in Brazil.

Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos: métodos

RESUMO A Pesquisa Nacional sobre Acesso, Utilizacao e Promocao do Uso Racional de Medicamentos (PNAUM) – componente Servicos teve por objetivo caracterizar a organizacao dos servicos de assistencia farmaceutica na Atencao Basica do Sistema Unico Saude. A PNAUM – Servicos foi um estudo transversal, avaliativo, com amostra planejada de 600 municipios, realizado entre 2014 e […]ABSTRACT The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos –Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) aimed to characterize the organization of pharmaceutical services in the Primary Health Care of the Brazilian Unified Health System (SUS). PNAUM – Services is a cross-sectional and evaluative study, with planned sample of 600 cities, held between 2014 and 2015, composed of a remote phase, with telephone interviews with health managers. Of these 600 cities, 300 were selected for a survey on health services. We selected the 27 capitals, the 0.5% largest cities of each region, and the remaining cities were drawn. The estimate of the representative national sample size considered three levels: cities, medicine dispensing services, and patients. The interviews were carried out with a structured questionnaire specific for: municipal secretaries of health, professionals responsible for pharmaceutical services in the city, professionals responsible for the dispensing of medicines, physicians, and patients. The secondary data were obtained in official databases, in the latest update date. PNAUM – Services was the first nationwide research aimed at the assessment and acquisition of national and regional indicators on access to medicines, as well as use and rational use, from the perspective of various social subjects.

Implementação do Regulamento Sanitário Internacional (2005) no ordenamento jurídico-administrativo brasileiro

The scope of this study was to analyze how the International Sanitary Regulation (ISR 2005)has been incorporated into the Brazilian legal-administrative system, in relation to sanitary control measures involving freight, means of transportation and travelers and possible alterations to health surveillance activities, competencies and procedures. This case study has been undertaken using a qualitative approach, of a descriptive and exploratory nature, using institutional data sources and interviews with key-informants involved in implementing ISR (2005). Alterations to the Brazilian legal-administrative system resulting from ISR (2005) were identified, in relation to standards, special competencies and procedures relating to sanitary controls for freight, modes of transportation and travelers. In its present form, the International Sanitary Regulation is an instrument that, in addition to introducing new international and national sanitary control concepts and elements, also helps to clarify questions that are helpful on a national level, relating to the specific competencies and procedures which will, to a certain extent, put pressure on administrative structures in the areas of sanitary control and surveillance.The scope of this study was to analyze how the International Sanitary Regulation (ISR 2005)has been incorporated into the Brazilian legal-administrative system, in relation to sanitary control measures involving freight, means of transportation and travelers and possible alterations to health surveillance activities, competencies and procedures. This case study has been undertaken using a qualitative approach, of a descriptive and exploratory nature, using institutional data sources and interviews with key-informants involved in implementing ISR (2005). Alterations to the Brazilian legal-administrative system resulting from ISR (2005) were identified, in relation to standards, special competencies and procedures relating to sanitary controls for freight, modes of transportation and travelers. In its present form, the International Sanitary Regulation is an instrument that, in addition to introducing new international and national sanitary control concepts and elements, also helps to clarify questions that are helpful on a national level, relating to the specific competencies and procedures which will, to a certain extent, put pressure on administrative structures in the areas of sanitary control and surveillance.

Fatores facilitadores e dificuldades no exercício da vigilância sanitária de farmácias em Salvador-Bahia

Drugstores are the health establishments where medications are dispensed, which is why sanitary surveillance is justified as a means of intervention. The health department uses various technologies to control risk in drugstores. In this study we used the theory of the process of work in health as a benchmark in order to describe and analyze the strengths and difficulties encountered in sanitary surveillance in drugstores in Salvador. Case study methodological strategy was adopted, the analytical categories being facilitating factors and difficulties inherent to technicians, drugstore, sanitary surveillance service and the social environment. Data were collected through direct observation techniques and semi-structured interviews, and the findings were assessed using content analysis. The body of information was processed and categorized using QSR N VIVO software. It was revealed that the nature of the facilitating factors and difficulties found in surveillance activities of drugstores indicate the need for urgent change within the scope of services and the sanitary culture in the country. It also stresses the possibilities of offering a quality service for the protection of health, in a setting conducive to the development of sanitary surveillance and the process of decentralization of these actions.

Os sentidos de segurança sanitária no discurso da Agência Nacional de Vigilância Sanitária

The term sanitary safety (SS) appeared in the international debate mainly due to the emerging sanitary crisis, although its meaning has remained obscure. This paper aims to analyze the concept of SS brought into the Brazilian sanitary surveillance upon the creation of the National Health Surveillance Agency. An exploratory case study was undertaken with technical data analysis and semi-structured interviews with informants who had taken part in the process of formulating the bodys institutional design. The following categories were analyzed: incorporation of the SS term into the institutional mission, the SS concept and SS mechanisms. The SS concept was analyzed in both institutional and technical discursive dimensions. The former elicits the sense of strategy, a reliable relationship and legitimacy whereas the latter shows the sense of an acceptable risk-benefit relationship from the perspective of individual and collective health protection and promotion. The SS concept was found to encompass health-related products, technologies and services, especially those designed for medical diagnosis and treatment, but environmental issues received little mention. The scope of the SS concept was shown to be widening to include the surveillance of hospital infection, drugs and blood.