Evaluation of Adverse Events Recorded in FDA/USA and ANVISA/Brazil Databases for Medical Devices: Defibrillator, Infusion Pump, Physiological Monitor, Pulmonary Ventilator and Ultrasonic Scalpel

Main Article Content

Josiany Carlos de Souza
Sheida Mehrpour
Matheus Modolo Ferreira
Yves Luduvico Coelho
Gustavo De Castro Vivas
Denis Delisle Rodriguez
Francisco De Assis Santos
Teodiano Freire Bastos-Filho

Keywords

Adverse events, ANVISA, ECRI’s top ten health hazards, FDA, Medical devices

Abstract

The use of medical technologies has grown steadily in all health fields, offering numerous benefits to patients. However, related adverse events, which may cause severe consequences for patients, also have increased. Technical factors and human aspects that cause dangers to patients may be related to the complexity of the devices, quality control in manufacturing, software used, maintenance procedures, materials, and mode of use. Thereby, our objective is to present the main alerts, dangers, and failures related to medical equipment and ways to attenuate them. For that purpose, we performed an analysis of adverse events reported for medical equipment in the Food Drugs Administration (FDA/USA) and the Brazilian Health Surveillance Agency (ANVISA) databases, since 2016. Finally, we classified the events into different categories, according to similarity. The results show a total of 3,100 cases registered in the FDA for six types of equipment at the study and 75 cases in ANVISA for two of these equipment. Based on the top ten health hazards (2016-2020) provided by the Emergency Care Research Institute (ECRI) we were able to understand which equipment most offers hazards and the main ways to mitigate them. We found that the risks are common to medical devices, therefore, it is crucial that there are preventative measures to avoid them, for example, training users to use the products, maintenance, improving quality, and reporting adverse events to manufacturers.

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