Clinical Risk Evaluation Research: A Clinical Study to Assess the Potential for Hand-Held Wireless Phones to Interfere with Implanted Pacemakers. G. K. Findlay and G. L. Carlo, Health & Environmental Sciences Group, Ltd., 1711 N Street, NW, Washington, DC 20036
With rapidly expanding use of wireless technologies, concern has been raised about potential electromagnetic interference (EMI) with implantable devices. To address the issue of interference between cellular phones in the 800-900 MHZ frequency range and implanted pacemakers, we have developed a three phase approach. The first phase includes clinical studies to assess if and how pacemakers and phones interact in vivo. The second phase includes the evaluation of the clinical and public health significance of EMI in implanted pacemakers by an independent panel of cardiologists and other experts in the field. The third phase includes recommendations for corrective intervention if needed. The common protocol for the clinical study, which is to be conducted in triplicate, was developed in a collaborative effort among representatives from government, academia, wireless and health instruments industries and professionals in health care. The clinical studies will test 1200 patients with pacemakers with a series of cellular phone technologies. The phones will be held to the ear and directly over the pulse generator of the pacemaker while the patient is constantly monitored for electrocardiographic abnormalities. Results from all three phases are expected in the fall.
Work supported by Wireless Technology Research, L.L.C. (WTR)).