Framework for a comprehensive method of evaluating heart rate and arrhythmia monitors

Several methods exist for evaluating the performance of cardiac and arrhythmia monitors. The authors discuss the limitations of these methods with respect to predicting clinical performance. An alternative method of evaluating ECG algorithm performance using simulated ECG data is proposed. This method involves systematically testing the response of a system to a wide variety of simulated conditions, each of which is based on actual clinical data. The tests to be performed include basic QRS complex tests (single morphology, fixed rate), pacemaker tests, rhythm tests, noise tests, and long-term stability tests