Eliana Auxiliadora Magalhães Costa

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.

Reprocessamento de produtos médicos: da política regulatória à prática operacional

The number of technological resources used in health care interventions is growing and continually expanding with the introduction of new products and articles. Problems associated with the reutilization of medical products, both reusable and of single use, affect policies and related technical-operational, economic, political, ethical, legal, and environmental matters. This study aims to contextualize the regulatory systems of medical products, and analyze the subsequent operational implications for Brazilian hospital practices. The article consists of a bibliographic review, carried out without time and language restriction, utilizing the Web of Science, Bireme, Scielo and Lilacs databases, with the support of specific descriptors. This study uses the contextualization of regulatory plans for medical products across the world and in Brazil and the existing condition of standardization of the reprocessing of these products as the assessment sources with which to analyze the operational implications for these practices in Brazilian hospitals.

Riesgo y seguridad sanitaria: análisis del reprocesamiento de productos médicos en hospitales de Salvador, Nordeste de Brasil

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.

Risk and sanitary safety: analysis on medical product reprocessing in hospitals in Salvador, Northeastern Brazil

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.

Reprocesamiento de productos médicos: una propuesta de modelo regulatorio para hospitales brasileños

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.