The Georgia Tech Research Institute (GTRI) is testing how RFID systems affect the function of medical devices–such as pacemakers, implantable cardioverter defibrillators, neurostimulators, implantable infusion pumps and cardiac monitors–with the aim of developing a set of standard testing protocols that companies can use to test their equipment for electromagnetic interference.
The test protocol development is being overseen by AIM Global, the international trade association representing automatic identification and mobility technology solution providers, and also includes MET Laboratories, a company that provides testing and certification services for medical devices.
According to Craig K. Harmon, chairman of AIM Global’s RFID Experts Group, only after testing protocols are developed will researchers truly be able to investigate the cause of electromagnetic interference, the result of any interference, and devise ways manufacturers might eliminate or mitigate interference.
The internal components, firmware and hardware of every company’s medical devices are different, meaning that each device can respond differently to the same electromagnetic environment. This kind of variation necessitates standardization of interference testing, according to GTRI.
In their tests GTRI researchers simulate real-world conditions by placing a medical device in a tank of saline solution that simulates the electrical characteristics of body tissue and fluid. The medical device is then exposed to different active and passive RFID technologies, covering the spectrum from low-frequency to UHF. Several tests are performed with the device placed in different orientations to represent how people typically interact with the emissions.
The test protocols developed by GTRI will be submitted to the U.S. Food and Drug Administration for review, after which a worldwide certification program will be launched and other testing facilities will be invited to participate.