Report From the Meeting of the Circulatory System Devices Panel of the Food and Drug Administration Center for Devices and Radiologic Health

Abstract

The US Food and Drug Administration (FDA) Circulatory System Devices Panel met to discuss the type of data required to effectively evaluate the performance of cardiopulmonary resuscitation (CPR) and hypothermia devices for cardiac arrest patients. Advisory panels make nonbinding recommendations to the FDA. The era of modern CPR began in the 1960s, when mouth-to-mouth ventilation combined with forceful chest compressions were first used together to attempt to resuscitate victims of cardiopulmonary arrest. Unfortunately, despite the promise of a variety of pharmacological, electrical, and mechanical therapies during and after administration of CPR, meaningful improvements in cardiac arrest survival have been difficult to achieve. Earlier generations of CPR devices are designed to assist the rescuer in the performance of CPR. These devices, for example, may compress the chest at a fixed rate and compression depth, or they may provide audible or visual indicators to assist the rescuer with compliance with published CPR guidelines. In general, regulatory guidelines do not require clinical data for these devices as long as they are similar in design and technology to previously marketed “predicate” devices. More than 30 devices for external compression and/or timing assistance during CPR have been cleared for marketing by the FDA. Devices intended to enhance a clinical aspect of CPR, in contrast to devices designed simply to assist the rescuer in the performance of CPR, require clinical data to support approval of the device. These devices, such as those providing interposed abdominal compression, circumferential chest compression, or active compression-decompression, have focused primarily on enhancing hemodynamics during CPR. Despite great interest in improving CPR survival rates, no device intended to enhance hemodynamics during CPR has been approved by the FDA for marketing in the United States. The Circulatory System Devices Panel was asked to discuss and make recommendations about the type of clinical data …