FDA Investigating Problems With External Biphasic DefibrillatorsNov 11, 2009 | Parker Waichman LLP
The U.S. Food and Drug Administration (FDA) is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. The agency indicated that it has received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion.
The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia, as well. FDA is seeking additional information in order to interpret the significance of these events, and to determine if agency activities are advised.
The FDA addresses this advisory to the clinical community and specific health care professionals including Electrophysiology Labs, code teams, Cardiac Catheterization Labs, Operating Rooms, Intensive Care Units, Emergency Rooms, Risk Managers, Quality Managers, Patient Safety Coordinators, Directors of Nursing, Medical Directors, Biomedical/Clinical engineers, and Emergency Medical Services Professional Organizations, including the American Heart Association, American College of Cardiology, Heart Rhythm Society, American Hospital Association, American Nurses Association, American Medical Association, and Electrophysiology physicians
The cardiac devices include external biphasic defibrillators that deliver energy levels ≤ 200 Joules (J), including monitor/defibrillators and automated external defibrillators (AEDs).
To date, the FDA analysis of the 14 cases does not suggest the need for any change to current clinical practice. As FDA continues its evaluation, it encourages compliance with American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and compliance with manufacturers’ instructions for defibrillator use.
The FDA stated that it has reviewed its adverse event report database and explored the literature on defibrillation effectiveness and said it recognizes that there can exist multiple contributors to defibrillation and cardioversion success. Patient attributes, such as the size and shape of a person’s body, presenting rhythm; defibrillator attributes, such as energy level and waveform, and treatment conditions such as drug therapy and oxygenation, all affect defibrillation and cardioversion outcomes, said the FDA.
The FDA advises that if an event is experienced similar to those reported above, to report the incident to the FDA by filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm. Healthcare personnel employed by facilities subject to FDA’s user facility FDA's user facility reporting requirements at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/default.htm and should follow the reporting procedures established by their facilities.
The FDA asks that the following information be included in adverse event reports regarding external biphasic defibrillators: Energy level/intensity, waveform (biphasic truncated exponential or biphasic rectilinear), acute vs. chronic cardiac rhythms, drug therapy, oxygenation, paddles vs. pads, delay in therapy, device make and model, and time from collapse to shock.