Quality assurance in electrocardiography: inappropriate performance standards, ECG characteristics and a new test database

In 1993 the Council of the European Community adopted the Directive on Medical Devices which states that "...devices with a measuring function must provide sufficient accuracy and stability within appropriate limits of accuracy...". Following a European project for Establishment of Conformance Testing Services for Computerized Electrocardiography pediatric ECG signal characteristics have been investigated on computer acquired electrocardiograms. It has been found that in a random set of 206 pediatric ECGs the slew rate in leads V2...V5 exceeded by far the IEC/AAMI specified 320 mV/sec. The recommended high frequency response may be unappropriate with a risk of undetected signal distortion. The performance requirements for computer electrocardiography have to be critically reviewed and revised to assure quality for the long term use of digitally stored ECG data.<>