This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Laks, M. M. Articles by Berson, A. Search for Related Content PubMed PubMed Citation Articles by Laks, M. M. Articles by Berson, A. Pubmed/NCBI databases Medline Plus Health Information Medical Device Safety Related Collections Electrophysiology Other heart failure Heart failure - basic studies

(Circulation. 2000;102:823.)
© 2000 American Heart Association, Inc.

Editorial

Revisiting the Question

Will Relaxing Safe Current Limits for Electromedical Equipment Increase Hazards to Patients?

Michael M. Laks, MD; Robert Arzbaecher, PhD; David Geselowitz, PhD; James J. Bailey, MD; Alan Berson, PhD

From Harbor-University of California, Los Angeles Medical Center, Los Angeles (M.M.L.); Pritzker Institute of Technology, Illinois Institute of Technology, Chicago (R.A.); Penn State University, Pittsburgh, Pa (D.G.); National Institutes of Health, Bethesda, Md (J.J.B.); and the National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Md.

Correspondence to Alan Berson, PhD, Division of Heart and Vascular Diseases, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Dr, Suite 9044, MSC 7940, Bethesda, MD 20892-7940. E-mail ab5lu@nih.gov

Key Words: Editorials • electrical stimulation • electrocardiography

This editorial is a follow-up to a 1994 editorial¹ by the same authors with the same title. The 1994 editorial emphasized that revised national standards, which relaxed the maximum allowable current that may be delivered to patients by electromedical equipment, presented unnecessary hazards to patients with indwelling catheters, and it described the need to obtain more scientifically based data to resolve the issues. Recently published data obtained from patients undergoing testing of implanted defibrillators provide the first direct and dramatic evidence that current levels as low as 32 µA can cause hemodynamic collapse simulating ventricular tachycardia before ventricular fibrillation (VF) occurs.² These currents cannot be felt, and their presence cannot be identified on ECG waveforms. Consequently, both the standards of the United States and the recommendations of the American Heart Association (AHA) now need to be reconsidered.^{3 4} We believe that the maximum allowable level of risk current must be changed back to the 1972 AHA recommendations of 10 µA, under single-fault conditions, regardless of the source or pathway of the current. The national standard of the United States, which now allows up to 50 µA in patient-connected leads and 300 µA of leakage current under single-fault conditions must be similarly changed.⁵ Current through the myocardium exceeding 10 µA places subjects at unnecessary risk. Furthermore, ventricular tachycardia with hypotension must be added as a new diagnostic and testing end point for electrical safety.

Background

The following history of the changing standards and various ways in which alternating current can get to the . . . [Full Text of this Article]

This article has been cited by other articles:

				M. S. Lloyd, B. Heeke, P. F. Walter, and J. J. Langberg Hands-On Defibrillation: An Analysis of Electrical Current Flow Through Rescuers in Direct Contact With Patients During Biphasic External Defibrillation Circulation, May 13, 2008; 117(19): 2510 - 2514. [Abstract] [Full Text] [PDF]

				A. H. Kadish, A. E. Buxton, H. L. Kennedy, B. P. Knight, J. W. Mason, C. D. Schuger, C. M. Tracy, W. L. Winters Jr, A. W. Boone, M. Elnicki, et al. ACC/AHA Clinical Competence Statement on Electrocardiography and Ambulatory Electrocardiography: A Report of the ACC/AHA/ACP-ASIM Task Force on Clinical Competence (ACC/AHA Committee to Develop a Clinical Competence Statement on Electrocardiography and Ambulatory Electrocardiography) Endorsed by the International Society for Holter and Noninvasive Electrocardiology Circulation, December 18, 2001; 104(25): 3169 - 3178. [Full Text] [PDF]

				A. H. Kadish, A. E. Buxton, H. L. Kennedy, B. P. Knight, J. W. Mason, C. D. Schuger, C. M. Tracy, W. L. Winters Jr, A. W. Boone, M. Elnicki, et al. ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography: A report of the ACC/AHA/ACP-ASIM Task Force on Clinical Competence (ACC/AHA Committee to Develop a Clinical Competence Statement on Electrocardiography and Ambulatory Electrocardiography) Endorsed by the International Society for Holter and Noninvasive Electrocardiology J. Am. Coll. Cardiol., December 1, 2001; 38(7): 2091 - 2100. [Full Text] [PDF]