Engineers at the Georgia Tech Research Institute (GTRI) recently began developing testing protocols for radio frequency identification (RFID) technology used in healthcare environments.
RFID systems are widely used for inventory management, package tracking, toll collection and airport luggage security applications. Such systems have also found their way into medical environments to track patients, equipment assets and staff members.
However, there is currently no published standard, repeatable method by which manufacturers of RFID equipment or medical devices can assess potential issues with electromagnetic interference and evaluate means to mitigate them.
The test protocol development is being overseen by AIM Global, the international trade association, and also includes MET Laboratories, a company that provides testing and certification services for medical devices.
‘A comprehensive set of test protocols, which are sufficiently precise to permit repeatable results, is required to understand if there is an interaction between various types of RFID systems and medical equipment,’ said Craig Harmon, president and chief executive of QED Systems and chairman of AIM Global’s RFID Experts Group, which has representatives from 40 organisations in the US, Europe and Asia.
‘Only after the protocols are developed will we be able to investigate the cause of any interactions and ways manufacturers might eliminate or mitigate them,’ he added.
GTRI researchers will test how RFID systems affect the function of implantable and wearable medical devices, such as pacemakers, implantable cardioverter defibrillators, neurostimulators, implantable infusion pumps and cardiac monitors.
‘The internal components, firmware and hardware of every company’s devices are different, so each device can respond differently to the same electromagnetic environment. Since there have been various preliminary tests and publications from different organisations indicating that there may or may not be issues with RFID system environments and these devices, it is important to standardise the way to test them,’ said Ralph Herkert, director of GTRI’s Medical Device Test Center.
Herkert and Gisele Bennett, director of GTRI’s Electro-Optical Systems Laboratory, will determine the best method for measuring whether interference takes place as a result of RFID emission in both active and passive RFID technologies covering the spectrum from low frequency to ultra-high frequency.
The researchers will then test whether radio-frequency-emitting devices cause any negative effects on the medical devices, and under what conditions these effects might occur. Testing will also determine whether specific medical devices are particularly susceptible to certain radio frequency identification characteristics and if any corrective actions can be taken to mitigate such susceptibility.
Test protocols developed by the GTRI will be submitted to the US Food and Drug Administration, after which, a worldwide certification programme will be launched and other testing facilities will be invited to participate.
Funding to develop these test guidelines is currently being provided by GTRI, but the researchers are actively looking for external funding.