By Beth Bacheldor
Oct. 14, 2008—
AIM 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.
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Dan Mullen
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"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.