Gerenciamento de risco em tecnovigilância: aplicação dos conceitos seis sigma e técnica delphi para o desenvolvimento e validação de instrumento de avaliação de material médico-hospitalar / Risk management in technovigilance: application of Six Sigma concepts and the Delphi Technique for the development and validation of a medical-hospital material assessment instrument.

AUTOR(ES)
DATA DE PUBLICAÇÃO

2009

RESUMO

Hospital risk management is a complex process, which involves multidisciplinary management actions. Its goal is to set up a system to monitor and identify the probable origin of adverse events and their damage; make appropriate decisions; and perform actions related to Pharmacovigilance, Hemovigilance and Technovigilance. The latter, among other functions, performs activities and procedures for the acquisition, use and quality control of products and equipment used in the health area. This study aims to construct and validate an instrument to assess medicalhospital products. A quantitative, exploratory, longitudinal and methodological development study was carried out. The research structure was based on quality management techniques, using the Six Sigma method to support risk management in Technovigilance and the Delphi technique for data collection. The premise of the Six Sigma method comprises the component steps of the DMAIC Cycle, in which performance improvement through the use of statistical and strategic approaches made it possible to study the processes variabilities. The Delphi technique was used to obtain data from specialized professionals and judges from the Brazilian Sentinel Hospital Network. As venous infusion equipment is widely used in the hospital area, a questionnaire was elaborated, consisting of three questions and 55 items, to indicate the items to be included in that products assessment instrument. In the initial validation, 134 specialized professionals took place, who complied with the criteria for inclusion in the study. The agreement level was set at 80%, obtained after two rounds of the Delphi technique. Next, a two-part instrument was developed: General, addressing administrative and product data; and Specific, with 9 topics and 43 assessment items. The assessment chart contains five different qualifications (Very bad, Regular, Good, Very Good and Excellent) and scores from 1 to 5, respectively. In the Delphi 2 phase, five judges participated in two round to validate the content of the developed model, achieving a 100% consensus. In the Delphi 3 phase, the judges applied the instrument to three brands of Simple equipment and three brands of equipment with Reserve. The study results not only contribute to product assessment, but also propose an instrument development method that can be extended to other medical-hospital products. It is concluded that the developed instrument permitted product assessment, providing distinct results for the tested brands, in line with the studys initial goal of qualifying infusion equipment assessments.

ASSUNTO(S)

medical product assessment dmaic risk management técnica delphi validação dmaic six sigma delphi technique. avaliação produto médico seis sigma gerenciamento de risco

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