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 p...

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Published inJournal of electrocardiology Vol. 37; pp. 65 - 67
Main Authors Buckles, David, Aguel, Felipe, Brockman, Randall, Cheng, James, Demian, Cindy, Ho, Charles, Jensen, Donald, Mallis, Elias
Format Journal Article
LanguageEnglish
Published United States Elsevier Inc 01.01.2004
Elsevier Science Ltd
Subjects
12-lead ECG
ambulatory monitoring
Biomedical Engineering - instrumentation
Electrocardiography - instrumentation
Electrocardiography - methods
Electrocardiography, Ambulatory - instrumentation
Electrocardiography, Ambulatory - methods
Electrodes
Equipment Design
Equipment Safety
Government Regulation
Holter
Humans
Medical Laboratory Science - instrumentation
regulatory
S-T segment analysis
United States
United States Food and Drug Administration - legislation & jurisprudence
United States
ambulatory monitoring
12-lead ECG
S-T segment analysis
Holter
regulatory
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Summary: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.
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ISSN:0022-0736
1532-8430
DOI:10.1016/j.jelectrocard.2004.08.048