Analysis of the Adverse Events and Incidents Reported to Departmental Technosurvillance Program of Medical Devices in Antioquia, Colombia During 2016 and 2017

Abstract

The study analyzes the causes of the adverse events reported to technosurveillance program of medical devices in the department of Antioquia in Colombia for the years 2016 and 2017. This paper identifies the main medical equipment involved in the reports and proposes possible improvements that could allow the decrease of the adverse events; having as reference the advances of the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (known in spanish as INVIMA) and international institutes. The three main medical equipment involved in these reports are infusion pumps, dialysis machines and negative pressure wound therapy systems, which represent more than 30% of the reports. The principal causes of events are device usage errors, alarms failure and pressure problems. According to the results of the analysis, it is not only necessary to improve the correct use of these technologies through of proposed training model. In order to achieve a reduction of the adverse events in the department of Antioquia, also is necessary to standardize the equipment and processes whenever possible and to implement usability tests. Through this measure, reliability can be increased, the need for crossed training can be minimized and can be identified potential problems and unintended consequences of the use of technology, like related with alarms failure and pressure problems.