ROANOKE TIMES

                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: SATURDAY, September 9, 1995                   TAG: 9509110090
SECTION: BUSINESS                    PAGE: A6   EDITION: METRO 
SOURCE: BLOOMBERG BUSINESS NEWS
DATELINE: WASHINGTON                                 LENGTH: Short


FDA INQUIRY TARGETS PACEMAKER HAZARDS

The Food and Drug Administration said Friday it is launching an investigation into the effect of airport metal detectors, store security systems and some cellular phones on implantable heart devices.

The agency has received at least six reports of possibly serious injury from electromagnetic emissions to people wearing pacemakers or implantable defibrillators, said Donald Witters, head of an FDA task force on the issue.

A Florida cardiologist told the FDA last month that a 61-year-old patient's defibrillator fired while he was leaning against a store theft-prevention system. An unnecessary defibrillator firing can trigger an erratic heartbeat that could be life-threatening, cardiologists say.

``This is a concern for public health and safety that we're not taking lightly,'' Witters said. Still, he said, ``our preliminary reviews suggest that consequences are generally not that serious, that it's a temporary, transient thing for most people.''

The FDA's formal study has no criminal implications, Witters said. No deaths have resulted from electromagnetic interference with heart devices, the FDA said.

Major companies that make theft-prevention devices, metal detectors and digital cellular phones say their products have no significant effect on people with pacemakers or defibrillators.



 by CNB