Adverse events and technical complaints related to central venous catheters marketed in Brazil

Aim: The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009. Methods: Notifications were categorized and evaluated to: (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data. Results: Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification. Conclusion: These data support a necessity for cooperation between all entities of the ...

Avaliação da mortalidade de grupos indígenas do norte do Paraná - 1990 a 1999 / Evaluation of the mortality of indian groups of the north of Paraná State, 1990 to 1999

Com o objetivo de conhecer a situação de sáude de índios que vivem no norte do Paraná, realizou-se estudo descritivo, em que são analisados os seguintes indicadores: coeficiente de mortalidade infantil e seus componentes (mortalidade neonatal e pós-natal), indicador de Swaroop-Uemura e indicador de Guedes adaptado por Pereira, no período de 1990 a 1999. A análise foi feita, comparando dois períodos: 1990-94 e 1995-99, para evitar flutuações aleatórias devido ao número pequeno de casos. Os dados foram obtidos em livros de registros de nascimento e óbitos dos índios, existentes em cada reserva indígena, bem como em declarações de nascidos vivos e declarações de óbitos quando esses eventos ocorreram em hospitais. Para evitar perdas e duplicidade nas informações, esses dados foram ainda comparados com os relatórios enviados à Fundação Nacional do Índio (FUNAI). Os resultados revelaram queda do nível de saúde da população indígens dessa região, com piora de todos os indicadores e aumento de mortalidade prematura, o que sugere a piora ds condições de vida e a necessidade de rever as stratégias nas ações ligadas à assistência à saúde desses povos

A descriptive study was conducted with the objective of evaluating the health status of indians who live in the north of the State of Paraná, Brazil. For the period of 1990 to 1999, the following health indicators were calculated and analyzed: infant mortality rate and its components (neonatal and post-neonatal mortality), Swaroop-Uemura indicator, and Guedes indicator (adapted by Pereira). Analysis was performed comparing two periods: 1990 to 1994 and 1995 to 1999 in order to avoid random variation due to the small number of cases. Data were obtained from books of births and deaths registration in each indigenous reserve, as well as from death and birth certificates when these events had happened in hospitals. Data was compared with the reports sent to the Indian National Foundation (FUNAI) to avoid duplicated and to recover omitted information. Results revealed a decline in the health status of the indigenous population of this region with an increase in premature mortality and a decline in all mortality indicators. These suggest deterioration of the living conditions and the need to revise strategies of health care actions related to this population.