Impact of expanding indications on the safety of pacemakers and defibrillators

William H Maisel; American Cardiology College; American Heart Association; North American Society of Pacing and Electrophysiology (NASPE)

doi:10.1023/a:1023678620678

Impact of expanding indications on the safety of pacemakers and defibrillators

Card Electrophysiol Rev. 2003 Jan;7(1):30-2. doi: 10.1023/a:1023678620678.

Authors

William H Maisel¹; American Cardiology College; American Heart Association; North American Society of Pacing and Electrophysiology (NASPE)

Affiliation

¹ Cardiac Arrhythmia Service, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. wmaisel@partners.org

PMID: 12766513
DOI: 10.1023/a:1023678620678

Abstract

The number of patients living with a pacemaker or implantable cardioverter defibrillator (ICD) increased markedly during the 1990's. Expanding device indications and increasing device sophistication has important implications for patient and device safety. While the FDA is responsible for assessing the safety and efficacy of medical devices, manufacturers, physicians, patients, medical professional societies, and legislators will all play a role in ensuring that medical device patients continue to receive safe, quality medical care.

Publication types

Guideline
Practice Guideline
Review

MeSH terms

Arrhythmias, Cardiac / physiopathology
Arrhythmias, Cardiac / therapy
Cardiac Pacing, Artificial / standards
Cardiac Pacing, Artificial / trends
Clinical Trials as Topic
Coronary Artery Disease / physiopathology
Coronary Artery Disease / therapy
Defibrillators, Implantable* / standards
Defibrillators, Implantable* / trends
Equipment Safety / standards
Equipment Safety / trends
Heart Failure / physiopathology
Heart Failure / therapy
Humans
Pacemaker, Artificial* / standards
Pacemaker, Artificial* / trends
Stroke Volume / physiology
United States