FDA Undertaking Long-term Evaluation of How Medical Devices Interact with Other Appliances
The US Food and Drug Administration’s years-long effort to evaluate how medical devices are impacted by electromagnetic waves emitted by microwaves, security scanners and other appliances has been spotlighted in a new report by The Wall Street Journal.
The regulator’s current research in this area focuses on radio-frequency identification technology (RFID) commonly deployed by retailers for inventory tracking and theft prevention. RFID transmitters can interfere with pacemaker functionality, prompting the FDA to issue safety recommendations to people using these devices.
The effects of metal detectors on spinal-cord simulators, and of magnetic-resonance imaging machines on pacemakers, are also being examined by FDA researchers.
Electronic medical device manufactures are currently under no regulatory obligation to evaluate how their products interact with other technologies. While FDA studies have resulted in warnings to patients and consumers, and influenced industry guidelines, requiring manufacturers themselves to examine these interactions does not appear to be under consideration.