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.
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?’
“We provided proprietary testing,” Osinski says, “but felt the need for a standard testing protocol.” When MET Labs began speaking with AIM Global and GTRI, he says, they discovered they had parallel interests. “It was a perfect fit.”
Fourteen years ago, GTRI established its EAS/Medical Device E3 Test Center. According to Gisele Bennett, the director of GTRI’s Electro-Optical Systems Lab (EOSL), which oversees the center, the facility was created to enable manufacturers of implantable cardiac pacemakers and defibrillators to work with providers of electronic article surveillance (EAS) systems, used by retailers, libraries and other establishments to prevent theft and track inventory. The center’s original mission was to help manufacturers improve compatibility between implantable medical devices and EAS systems that radiate electromagnetic energy.
In 2006, GTRI expanded its operations and facilities to test new types of security and logistical systems, including RFID. Today, the center conducts research on a wider variety of medical devices, including implantable hearing devices, drug-infusion pumps, neurostimulators, cardiac monitors and glucose monitors. As part of the AIM Global project, Bennett says, the facility will test and provide testing protocols—consisting of guidelines for use by manufacturers of medical devices and RFID technology—for implants and other medical devices, as to how they are affected by RFID emissions. MET Labs will also develop testing protocols for non-implantable devices.
AIM Global expects the results to comply with recommendations from the American National Standards Institute (ANSI)—a nonprofit organization that oversees the development of voluntary consensus standards for systems in the United States—and the health-care alliance group known as the Association for the Advancement of Medical Instrumentation (AAMI). The project’s participants will ask the FDA to review and officially approve the protocols it has developed with GTRI and MET Labs. According to Mullen, AIM Global expects that the test protocols fall within ANSI and AAMI guidelines—specifically, the ANSI/IEEE C63.18 and ANSI/AAMI TIR-18 recommendations for electromagnetic compatibility (EMC), as well as the AAMI PC69 EMC test protocols for pacemakers and other implantable devices. As such, he hopes the FDA will recognize the AIM Global Healthcare Initiative’s protocols as consensus U.S. standards.
With that acknowledgement from the FDA, Mullen says, RFID and medical device manufacturers could test their technology at GTRI, MET Labs, or other laboratories, then gain FDA approval for their products, based on the fact that the testing had followed those guidelines.
GTRI and MET Labs will test to 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 (LF) to ultrahigh-frequency (UHF), by testing RF emissions from RFID products conforming to the ISO 18000-2, 18000-3, 18000-4, 18000-6 and 18000-7 RFID standards, as well as the ISO 24730-2 and 24730-5 real-time locating system (RTLS) standards. The ISO 14443 and 15693 standards and EPCglobal’s Gen 2 standard will also be included, as will protocols for testing ultra-wideband (UWB) and Wi-Fi RFID devices. Testing will include distances of emission and potential interference as well.
“We think there’s a strong desire for a standardized test protocol that is reflective of the real-world environment these pieces of equipment would be used in,” Mullen states. “We will be working within the perimeters of creating an American national standard.”
The FDA’s Center for Devices and Radiological Health (CDRH) has regulatory authority over several thousand different types of medical devices, with thousands of manufacturers and device variations. The CDRH’s EMC Working Group is charged with assessing the devices to identify EMC concerns, in addition to coordinating the development of a strategy to assure EMC in all appropriate devices. The CDRH has been investigating incidents of device electromagnetic interference, and working on solutions (the 1979 draft EMC standard for medical devices, for instance), since the late 1960s, when there was concern about EMI with cardiac pacemakers. (No CDRH representatives responded to RFID Journal‘s request for comment regarding the EMC Working Group’s progress, or the AIM Global protocols project.)
“Our work will be pretty wide open to those interested in our progress,” Mullen says. “I anticipate that EPCglobal will collaborate with us.” This expectation, he notes, is based on the fact that EPCglobal’s parent organization, GS1, is an REG member, though he’s not certain of the form such collaboration would take. The REG group will also seek feedback from members of the RFID and health-care industries, he says, and plans to release several updates as the work continues.
“Our hope,” Mullen states, “is that folks will utilize these test protocols, and can go to Georgia Tech or MET Labs to have their testing done.” Other labs, he adds, could be used as well.