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Authors
Advisor(s)
Abstract(s)
De acordo com a Organização Mundial de Saúde, nos países desenvolvidos, cerca de 50% dos
Dispositivos Médicos não são adequados ou utilizados de forma correta ou otimizada.
O trabalho teve como objetivo criar um modelo sistemático de análise para a implementação de uma
metodologia estruturada e organizada de Gestão do Ciclo de Vida de Dispositivos Médicos, tendo por
base diretivas, normas nacionais e internacionais e modelos científicos. E demonstrar a importância do
tema às organizações da área da saúde.
A metodologia é baseada numa abordagem de decisão multicritérios, bem definida e hierarquizada, com
a qual se pretende otimizar o processo de seleção/aquisição. Estes requisitos têm que ser assegurados
nesta fase através de Cadernos de Encargos e Contratos de Manutenção bem elaborados (por uma equipa
multidisciplinar), já que as correções posteriores dificilmente são técnico/economicamente viáveis.
Com base no modelo Analytic Hierarchy Process foi desenvolvida uma ferramenta (ASA-DM) para
escolha isenta. O estudo foi aplicado a quatro tomografias computorizadas em quatro Estudos de Caso,
com o intuito de que a sua aplicação seja transversal a outros dispositivos.
A variação das ponderações atribuídas aos critérios e subcritérios em função das necessidades presentes
e futuras de cada instituição resultou em que cada um dos equipamentos se adequasse a um Estudo de
Caso.
Provou-se que não existem dispositivos inúteis ou de má qualidade, quer física, técnica ou operacional,
mas que se pode melhorar o custo-benefício, a qualidade dos serviços e a satisfação dos utilizadores. É
importante conhecer o Custo Total do Ciclo de Vida tendo em atenção o Valor Presente em detrimento
apenas do custo inicial (compreendido entre 2,68% e os 16,91% dos custos totais, nestes estudos).
O Engenheiro Biomédico representa um papel preponderante na formação, liderança da equipa e na
introdução e desenvolvimento das metodologias adequadas, com o intuito de facilitar o processo de
decisão.
According to the World Health Organization, in developed countries, about 50% of the Medical Devices are not adequate, used in a correct or optimized. The objective of this work was to create a systematic analysis model for the implementation of a structured and organized methodology of Medical Device Life Cycle Management, based on guidelines, national and international standards and scientific models. And demonstrate the importance of the topic to health organizations. The methodology is based on a well-defined and hierarchical multicriteria decision-making approach with which to optimize the selection / acquisition process. These requirements have to be ensured at this stage through well-drafted Maintenance Charges and Maintenance Contracts (by a multidisciplinary team), as further corrections are hardly technically / economically feasible. Based on the Analytic Hierarchy Process model, a tool (ASA-DM) was developed for impartial choice. The study was applied to four CT scans in four case studies, with the aim of applying it to other devices. The variation of the weights attributed to the criteria and sub-criteria according to the present and future needs of each institution resulted in each one of the equipments being more suited to each Case Study. It has been proved that there are no useless devices or poor quality ones, whether physical, technical or operational, but that it can improve the cost-benefit and at the same time improve the provision, quality of services and user satisfaction. It is important to know the Total Cost of the Life Cycle considering the Present Value, in detriment of only the initial cost (between 2.68% and 16.91% of the total costs in these studies). The Biomedical Engineer plays a preponderant role in training, team leadership, in the introduction and development of appropriate methodologies, in order to facilitate the decision process.
According to the World Health Organization, in developed countries, about 50% of the Medical Devices are not adequate, used in a correct or optimized. The objective of this work was to create a systematic analysis model for the implementation of a structured and organized methodology of Medical Device Life Cycle Management, based on guidelines, national and international standards and scientific models. And demonstrate the importance of the topic to health organizations. The methodology is based on a well-defined and hierarchical multicriteria decision-making approach with which to optimize the selection / acquisition process. These requirements have to be ensured at this stage through well-drafted Maintenance Charges and Maintenance Contracts (by a multidisciplinary team), as further corrections are hardly technically / economically feasible. Based on the Analytic Hierarchy Process model, a tool (ASA-DM) was developed for impartial choice. The study was applied to four CT scans in four case studies, with the aim of applying it to other devices. The variation of the weights attributed to the criteria and sub-criteria according to the present and future needs of each institution resulted in each one of the equipments being more suited to each Case Study. It has been proved that there are no useless devices or poor quality ones, whether physical, technical or operational, but that it can improve the cost-benefit and at the same time improve the provision, quality of services and user satisfaction. It is important to know the Total Cost of the Life Cycle considering the Present Value, in detriment of only the initial cost (between 2.68% and 16.91% of the total costs in these studies). The Biomedical Engineer plays a preponderant role in training, team leadership, in the introduction and development of appropriate methodologies, in order to facilitate the decision process.
Description
Trabalho final de mestrado para obtenção do grau de mestre em Engenharia Biomédica
Keywords
Engenheiro biomédico Biomedical engineer Gestão do ciclo de vida Life cycle management Equipa multidisciplinar Multidisciplinary team Dispositivos médicos Medical devices Tomografia computorizada Computed tomography
Citation
OLIVEIRA, Vítor Joaquim Jesus de - Gestão do ciclo de vida de dispositivos médicos : papel do engenheiro biomédico. Lisboa: Instituto Superior de Engenharia de Lisboa - Escola Superior de Tecnologia da Saúde de Lisboa, 2018. Dissertação de mestrado.
Publisher
Instituto Superior de Engenharia de Lisboa - Escola Superior de Tecnologia da Saúde de Lisboa