By Claire Swedberg
June 2, 2009—
AIM Global, in collaboration with the
Georgia Tech Research Institute (GTRI) and
MET Laboratories, will begin developing testing protocols for
RFID technology in the health-care setting, as well as the effects RFID may have on implantable medical devices. If all goes as planned, says AIM Global's president, Dan Mullen, the testing guidelines to be developed by the group will be presented to the
U.S. Food and Drug Administration (FDA) for approval by December of this year. The group signed an agreement last week, and intends to commence the project immediately.
The project, known as the AIM Global Healthcare Initiative, is being overseen by AIM Global's RFID Experts Group (REG), which includes representatives from 40 organizations with experts in RFID technology, in the United States, Europe and Asia. These include MET Labs, GTRI,
GS1,
Avery Dennison and
Feig Electronic. MET Labs, GTRI and AIM Global will determine specific guidelines to test for
electromagnetic interference (
EMI) that could result from RFID transmissions, as well as how they may affect the function of medical devices. The resulting protocols, Mullen says, would provide RFID vendors and medical device manufacturers with a comprehensive guide for testing the RFID technology they may be introducing into a hospital or other health-care environment.
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Ted Osinski, MET Labs' director of RFID systems
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To date, there have been multiple tests conducted by universities, manufacturers and other groups regarding specific RF frequencies, to ensure that RFID emissions do not interfere with medical equipment (see
New RFID Study Finds No Interference With Medical Devices and
UCLA Group Offers Interference-Testing Service for Medical Devices). In 2008, the
Journal of the American Medical Association published a Dutch study suggesting the possibility that RFID might pose an interference risk in health-care facilities (see
Researchers Warn RFID May Disrupt Medical Equipment and
Dutch RFID Interference Study Is a Worst-Case Test).
There are no formal guidelines, however, regarding testing for RFID interference with medical devices. That, Mullen says, is due to the fact that
radio frequency identification is still a fairly recent inclusion in the health-care environment. But increasingly, hospitals are employing RFID devices to track patients, assets and staff members. In addition, there is little research to provide details as to how RFID in public places—libraries and retail locations, for instance—could affect the operation of medical implants, such as cardiac pacemakers.
To address the growing need for RFID emission testing standards, the REG first established a committee in 2008, seeking partners to work with AIM Global to develop the protocols. As a result, both GTRI and MET Labs have agreed to participate in the research, as well as provide their labs as sites at which to conduct testing, and to serve as simulated clinical health-care environments.
MET Labs, an independent third-party testing laboratory, had already been undertaking safety testing for electronic medical devices, says Ted Osinski, the organization's director of RFID systems. Approximately five years ago, MET Labs began providing RFID testing for nonprofit standards organization
EPCglobal. Since that time, he notes, medical device manufacturers have been asking, 'Can you tell us the impact of RFID?'