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.
Highlights
According to the World Health Organization (WHO), a medical device is an “apparatus, instrument, machine, software, material or another similar article, intended for a medical purpose” as monitor treatments, help people with disabilities, diagnose and treat illnesses[1]
The results show a total of 3,100 cases registered in the FDA for the six types of medical devices addressed in this work and 75 cases registered in the ANVISA/Brazil for two of them
Throughout our research, we found that the risks addressed in this work are common to several medical devices; there preventative measures to avoid them must be established, for example, training users to use and maintain the equipment, improving their quality, and reporting adverse events to manufacturers
Summary
According to the World Health Organization (WHO), a medical device is an “apparatus, instrument, machine, software, material or another similar article, intended for a medical purpose” as monitor treatments, help people with disabilities, diagnose and treat illnesses[1]. In the current COVID-19 pandemic, measures of prevention and control of health services have been defined by the Brazilian Association of Clinical Engineering, whose guidelines include checking the configuration and availability of Intensive Care Unit (ICU) beds and their primary devices: mechanical ventilator, multi-parameter monitor, defibrillator, and infusion pumps, noting the need for staff training to use them. It is necessary to identify defective or unused equipment due to a lack of parts or inadequate maintenance.[2] In this sense, clinical engineers play an essential role in managing fundamental medical devices for treating patients affected by the disease.[3]. Despite the importance and benefits of medical equipment in health care, adverse events are associated with them. These events can occur because the medical device environment is a complex system of human-machine interaction that requires understanding the environment and identify risk factors.[5]
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