Evaluation of Adverse Events Recorded in FDA/USA and ANVISA/Brazil Databases for the Medical Equipment: Pulmonary Ventilators, Defibrillators, Infusion Pumps, Physiological Monitors and Ultrasonic Scalpels

Abstract

Medical equipment is used in the diagnostic, monitoring and therapy, offering numerous benefits to the patients. However, these devices’ technical factors and the human aspects can produce adverse events, which may cause severe consequences for the patients. Therefore, it is crucial to provide means to mitigate these situations by improving safety in equipment use. Thereby, our objectives are to present to the scientific community the main alerts, dangers and failures related to medical equipment use and ways to attenuate them. For that purpose, we performed an analysis of adverse events reported for some 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 3100 cases registered in the FDA for the equipment at the study and 75 cases in ANVISA for two of this equipment. Based on the list of the top ten health hazards (2016–2020) provided by the Emergency Care Research Institute (ECRI) we were able to understand which equipment most offer hazards and the main ways to mitigate them. Overall, we found that the risks are common to medical devices, so the best way to deal with adverse events is prevention, through good maintenance and medical staff training for dealing with them.