Advances in ambulatory monitoring: regulatory considerations.
Conventional ambulatory electrocardiogram (ECG) (Holter) monitoring involves 2 or 3 surface leads recorded with electrode positions and signal characteristics that are different from diagnostic quality 12-lead ECGs due to the limitations imposed by technology on the ambulatory recorders. The rapid pace of technological development for medical devices, particularly electrocardiography, has now enabled the recording of diagnostic quality 12-lead ECG waveforms for extended time periods. This capability allows Holter recording to become another source for diagnostic 12-lead ECG records on a par with other modalities such as resting ECG and exercise stress testing. Additionally, other diagnostic techniques such as S-T segment analysis and Q-T interval analysis that rely on diagnostic quality waveforms can now be applied. All of these enhancements to the traditional Holter modality have altered the regulatory perspective of these devices, since the enhancements may represent a new intended use for the device.
Buckles
David
D
Center for Devices and Radiological Health, US Food and Drug Administration, Department of Health and Human Services, Rockville, MD, USA.
Aguel
Felipe
F
Brockman
Randall
R
Cheng
James
J
Demian
Cindy
C
Ho
Charles
C
Jensen
Donald
D
Mallis
Elias
E
D001698:Biomedical Engineering / Q000295:instrumentation; D004562:Electrocardiography / Q000295:instrumentation / Q000379:methods; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation / Q000379:methods*; D004566:Electrodes; D004867:Equipment Design; D004869:Equipment Safety; D033161:Government Regulation; D006801:Humans; D013677:Medical Laboratory Science / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence