Resumo

ALFONSO MARIN, Lilian Patricia; SALAZAR LOPEZ, Carolina  e  FRANCO HERRERA, Astolfo León. INCIDENCE OF ADVERSE EVENTS ASSOCIATED WITH MEDICAL DEVICES WITHIN A HEALTH INSTITUTION IN COLOMBIA. Rev. ing. biomed. [online]. 2010, vol.4, n.8, pp.71-84. ISSN 1909-9762.

This paper presents the results of a retrospective study of adverse events associated with medical devices (AEAMDS), presented during the period of January through June of 2010 in the Surgery Department of a healthcare institution in Colombia. A total of 29 AEAMDS, which according to the severity of its outcome were classified as: 2 mild, 17 moderate, 4 serious, and 6 potential events (also called adverse incidents). The information sources were the institutional software for the report of adverse events, and surveys administered to the institution staff. After selecting the adverse events according the inclusion parameters from this project and from the survey results, the investigation of the causes considered 21 AEAMDS. The potential AEAMDS events were determined entirely preventable and the others in a large part. The incorrect use of the medical device is the most important contribution factor in the incidence of these events. The study proposes to the institution some strategies and improvement plans that tend to delete the causes of these events and, also to create a tool to standardize, in an institutional level, the analysis of AEAMDS.

Palavras-chave : Medical device; Medical devices-associated adverse events; Medical equipment; Contribution factor.

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