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.
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Maisel WH, Sweeney MO, Stevenson WG, Ellison KE, Epstein LM. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001; 286: 793-799.
Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med 1999; 341: 1882-1990 [Erratum, N Engl J Med 2000;342:1300].
Moss AJ, Zareba W, Hall WJ, Klein H, Wilbur DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML, for the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002; 346: 877-883.
ACC/AHA/NASPE 2002 Guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: Summary article. Circulation 2002; 106: 2145-2161.
Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Messenger J. Cardiac resynchronization in chronic heart failure. New Engl J Med 2002; 346: 1845-1853.
Cazeau S, Leclercq C, Lavergne T, Walker S, Varma C, Linde C, Garrigue S, Kappenberger L, Haywood GA, Santini M, Bailleul C, Mabo P, Lazarus A, Ritter P, Levy T, McKenna W, Daubert J-C. Effects of multisite biventricular pacing in patients with heart failure and intraventricular conduction delay. New Engl JMed 2001; 344; 873-880.
Munsey RR. Trends and events in FDA regulation of medical devices over the last fifty years. Food and Drug Law J 1995; 50: 163-177.
Pritchard WF, Carey RF. U.S. Food and Drug Administration regulation of medical devices in radiology. Radiology 1997; 205: 27-36.
Song SL. Bilitch report: Performance of implantable cardiac rhythm management devices. Pacing Clin Electrophysiol 1994; 17: 692-708.
Kawanishi DT, Song S, Furman S, Parsonnet V, Pioger G, Petitot J-C, Godin J-F, for the Bilitch Registry and STIMAREC. Failure rates of leads, pulse generators, and programmers have not diminished over the last 20 years: Formal monitoring of performance is still needed. Pacing Clin Electrophysiol 1996; 19: 1819-1823.
Godin JF, Petitot JC, Pioger G. STIMAREC report: STIMAREC 1996 annual review. Pacing Clin Electrophysiol 1997; 20: 747-750.
Maisel WH, Stevenson WG, Epstein LM. Safety of implantable devices. JAMA 2002; 287: 839-840.
Stanton MS. Safety of implantable devcies. JAMA 2002; 287: 839.
Maisel WH, Stevenson WG, Epstein LM. Changing trends in pacemaker and ICD generator advisories. Pacing Clin Electrophysiol 2002; 25: 1670-1678 (in press).
Maisel WH. Increased failure rate of a polyurethane implantable cardioverter defibrillator lead. Pacing Clin Electrophysiol 2002; 25: 877-878.
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Maisel, W.H. Impact of Expanding Indications on the Safety of Pacemakers and Defibrillators. Card Electrophysiol Rev 7, 30–32 (2003). https://doi.org/10.1023/A:1023678620678
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DOI: https://doi.org/10.1023/A:1023678620678