RESUMO
The convergence between wearable and medical device technologies is a natural progression. Miniaturization has allowed the design of small, compact monitoring systems that can record physiological signals over longer periods of time. Thus, the potential for these devices to expand the understanding of disease progression and patients' clinical status is very high. The accuracy of these devices, however, is dependent upon the computer algorithms utilized in the analysis of the large volume of physiological data monitored and/or recorded by the devices. Automated interpretation of the data by these new technologies, therefore, necessitates closer examination by regulatory organizations. The current requirements for the validation of novel Ambulatory ECG (A-ECG) annotation algorithms are based on the AAMI/ANSI-EC57 and IEC60601-2-47 Standard. These standards are being updated, but they rely on a very limited set of digitized ECG recordings from a couple of ECG databases built in the first half of the 70's. These reference signals are obsolete. We are developing a validation tool for computerized methods designed to detect and monitor cardiac activities based on body-surface ECGs. We will rely on a set of existing digital high-resolution 12lead A-ECG recordings acquired in cardiac patients and healthy individuals. These ECG signals include a large and unique set of electrocardiographic events. This tool is being qualified by the Center for Devices and Radiological Health of the United States Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). This document provides insights into the design of the M.A.D.A.E. database, its functionalities, and its ultimate role in enabling the next generations of automatic interpretation of ECG signals.
