Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Oct 2007
[Safety of in-vitro diagnostics used in transfusion medicine. Experience of the BfArM until end 2005].
The European Directive 98/79/EC on in-vitro diagnostic medical devices (IVD) stipulates the marketing and post marketing surveillance of IVD in the European Economic Area. In cases of incidents and field corrective actions related to IVD, manufacturers have to inform the responsible Competent Authorities. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible Competent Authority for most IVD. ⋯ In consequence, corrective actions were performed in the large majority of cases (n=37; 77.1%). These included customer information, product recalls, changes in production or quality management and software upgrades (the latter predominantly in cases of failures of analysing instruments). Our data suggest that the governmental system for marketing surveillance is an established tool to ensure product safety for IVD used in transfusion medicine.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Sep 2007
[The right to health. Constitutional dimensions].
A fundamental "right to health" is expressly guaranteed by the constitutions of several Bundesländer, but unknown to the German Federal Constitution. Instead the Federal Constitutional Court has - especially on the basis of related human rights - developed the obligation of the State to protect everybody's life and physical integrity, which in some respects comes near to a "right to health". The State's autonomy in financial matters, the scarcity of its financial resources and the individual's natural responsibility for his own health though advise against exaggerated hopes set in a "right to health".
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jul 2007
[International curriculum for medical coders. Recommendations of the Education Committee of the WHO Family of International Classifications Network].
Nationally collected data for mortality and morbidity are coded according to the International Classification of Diseases (ICD). From the coded data international statistics are compiled. ⋯ With the development of core curricula for mortality and morbidity coding, the Education Committee of the WHO Family of International Classifications Network developed an entry level standard for the education of medical coders. Through this enhanced and internationally consistent level of education the quality of the collected data can be increased.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · May 2007
[Pain in children and adolescents in Germany: the prevalence and usage of medical services. Results of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS)].
As part of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), representative data were collected on pain in 14,959 children and adolescents aged 3 to 17 years in Germany. The results are reported separately for 11-17-year olds, who were asked themselves, and 3-10 year olds, whose parents reported on their pain. Among the 3-10 year olds, the prevalence of pain over three months was 64.5% and among the 11-17 year olds it was 77.6% (71.1% altogether for the 3-17 year old children). ⋯ Pain occurring at least once a week in the last three months was reported by 24.3% of the 11-17 year old children and adolescents and by 9.9% of the 3-10 year old children suffering from pain. More than half (54.1%) of the 3-10 year olds and more than one third of the 11-17 year olds (35.9%) who reported recurrent principal pain consulted a doctor for this reason; 36.7% and 46.7% respectively took medicine. These results show that pain is a relevant problem in children and adolescents in Germany.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · May 2007
[Injuries among children and adolescents (1-17 years) and implementation of safety measures. Results of the nationwide German Health Interview and Examination Survey for Children and Adolescents (KiGGS)].
Parent interviews with regard to their children's accidents and to accident protective measures in the Health Interview and Examination Survey for Children and Adolescents (KiGGS) aimed at extending our knowledge of age- and gender-specific injuries and to identify risk groups and risk factors for injury prevention. The parents of 16,706 children (aged 1-17 years) were asked about their children's injuries within the last 12 months which were medically treated, and about accident mechanisms, consequences of injuries, and ambulatory and hospital treatment. In addition, parents and children aged 11 to 17 years (n = 6813) were asked to give information on protective measures. ⋯ The age related data analysis should be the starting point in prevention measures for specific risk groups considering migration and socioeconomic status. Prevention activities in traffic should focus on families with low social status. Adolescents should be specifically and adequately addressed regarding the benefits of certain safety measures when riding a bicycle and when skating.