Oct 14, 2008AIM Global, a worldwide industry association for automated identification and mobility technologies, has announced plans to develop a set of test protocols that it hopes will be employed around the world to study RFID's effects on medical devices, clinical instruments, and pharmaceuticals, blood products and other biologics.
The test protocols, to consist of specific sets of test plans and methodologies, will be crafted by the organization's RFID Experts Group (REG), of which there are currently about 40 member companies, including Q.E.D. Systems, a provider of IT and engineering services. Although only a subset of those 40 will be directly involved in the protocols' development, all members will play some role in the project.
"There have been a number of different studies or tests done [studying the effects of RF in health-care settings]," says Dan Mullen, AIM Global's president, "and to the members of the REG's credit, we have decided to create a set of test protocols that are repeatable and consistent that the industry can look at and use to determine whether there are any concerns or issues."
Mullen cites several studies unveiled in July—particularly one conducted by researchers at Indiana University Purdue University Indianapolis (IUPUI) and by RFID consulting and systems integration firm BlueBean, and another conducted by researchers at the University of Amsterdam's Academic Medical Center in the Netherlands as part of a government research project, and published in the Journal of the American Medical Association (JAMA).
Both studies examined whether electromagnetic radiation from RFID systems would disrupt infusion pumps, EKG monitors and other medical equipment. Their findings, however, differed. The IUPUI/BlueBean study discovered no problems with electromagnetic interference (EMI) (see New RFID Study Finds No Interference With Medical Devices), while the Dutch study did find incidents of EMI by RFID on critical-care equipment in a non-clinical setting (see Researchers Warn RFID May Disrupt Medical Equipment).
"At a certain point, we realized we needed to do something about this," says Craig Harmon, the REG chairperson, and president and CEO of Q.E.D. Systems. Harmon says he and others had received a number of calls regarding the IUPUI/BlueBean and University of Amsterdam studies, and that industry concern greatly spurred action by AIM Global. The organization initially felt the U.S. Food and Drug Administration (FDA) should lead the effort, but later changed its mind upon meeting with FDA representatives who acknowledged such an initiative could take two or three years.
The REG will develop three test protocol suites: one for medical devices (implantables and wearables); a second for clinical instrument susceptibility; and a third for pharmaceuticals, biologics, blood products and human physiology. The protocols will initially focus on radio frequency identification systems based on any of 11 different RFID standards, including ISO 11785 (which employs the 125 kHz frequency band), ISO 14443 and ISO 15693 (13.56 MHz), and ISO 18000-6C and EPC Gen 2 (860-960 MHz), as well as IEEE 802.11, or Wi-Fi (2.45 GHz).
To accomplish its mission, the REG will collaborate with three leading universities in the field of RFID: Georgia Institute of Technology, the University of Pittsburgh and the University of Texas at Arlington. The group hopes to have test protocols ready in the next six months or so, Harmon says, but the effort will take time.
"Some protocols are easier than others," Harmon states. "As an example, you can't just test an ICD [implantable cardioverter defibrillator] in open air. You have to create a fixture of saline solution that approximates the human body. And in order to test on blood or vaccines, you have to get permission from the FDA before you actually start testing."
Once the REG completes its work on the test protocols, it plans to submit them to the FDA for comment and approval. AIM then hopes to make the test protocols available to testing facilities, labs and universities. Details are still being worked out in terms of how the protocols will be licensed, but Harmon says that under collaboration agreements, the protocols will be owned by the companies and university participants directly involved in their development—though who these would be has not yet been determined.
"Our current preference is that they will be licensed," Harmon says, "simply so we have some type of control in their distribution, and that they are being carried out in a reputable manner. But we will do something that is equitable to everyone, and the protocols will be accessible to companies that aren't currently participating in the initiative."
