RESUMO
Annex II of the Medical Device Directive (MDD) is used frequently by manufacturers to obtain CE-marking. This procedure relies on a full quality assurance system and does not require an assessment of the individual medical device by a Notified Body. An investigation into the availability and the quality of technical documentation for Annex II devices revealed severe shortcomings, which are reported here.
Assuntos
Documentação , Equipamentos e Provisões , Gestão da Informação/normas , Gestão da Informação/legislação & jurisprudência , Controle de QualidadeRESUMO
The European radiotherapy society has for many years had a great interest in quality assurance. The EORTC radiotherapy group has put enormous effort into its quality assurance programmes. However, besides programmes for dosimetry and guide-lines for infrastructure, the organisation of a department should also be subject to a quality assurance system. In 1992, in the radiotherapy department in Leiden, a project was started to develop a quality assurance system based on the so-called ISO 9001 quality standards. This paper describes how these standards can be applied to create a quality assurance system in a hospital department.
Assuntos
Cooperação Internacional , Garantia da Qualidade dos Cuidados de Saúde , Serviço Hospitalar de Radiologia/normas , Radioterapia/normas , Competência Clínica , Equipamentos e Provisões Hospitalares , Europa (Continente) , Guias como Assunto , Administração Hospitalar , Humanos , Formulação de Políticas , Avaliação de Processos em Cuidados de Saúde , Doses de Radiação , Radioterapia (Especialidade)/educação , Radioterapia (Especialidade)/organização & administração , Radioterapia (Especialidade)/normas , Serviço Hospitalar de Radiologia/organização & administração , Radioterapia/instrumentação , Sociedades MédicasRESUMO
Fifty-nine drug addicts and alcoholics were treated with clothiapine for a period up to 2 months for alleviation of their withdrawal symptoms. Most of the patients cooperated with the treatment, and this was due to the very few side effects that were experienced by them. The patients were completely withdrawn from physical dependence on drugs and we were able to discharge them without an irresistible impulse for the drug.
Assuntos
Alcoolismo/reabilitação , Dibenzotiazepinas/uso terapêutico , Síndrome de Abstinência a Substâncias/tratamento farmacológico , Adolescente , Adulto , Feminino , Humanos , Dietilamida do Ácido Lisérgico , Masculino , Metadona/uso terapêutico , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/reabilitação , ÓpioRESUMO
Transient bliandness following minor head injury is a rare, although well known, and totally reversible entity. As the condition may have legal implications, a 5-year follow-up study was carried out on 4 young patients. Repeated ophthalmological, neurological and psychiatric examination both early nd late after injury did not reveal any organic or psychiatric diseases which might predispose to this disorder. The case reports, including one recurrent case, a follow-up study and a discussion of the aetiology are presented.
