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AIM to Clarify RFID Interference with Medical Devices

AIM Global announced it is creating independent test protocols to determine the safety of using RFID systems in healthcare environments. The protocols will measure how RFID impacts medical devices, pharmaceuticals and human physiology. AIM hopes to have the protocols created and the first certifications issued within 12 months.
Oct 14, 2008This article was originally published by RFID Update.

October 14, 2008—Whether RFID creates interference and dangers in healthcare environments remains an unresolved argument, with published reports available to support both sides. Technology industry association AIM Global wants to resolve the issue and announced a new initiative to develop test protocols that will produce repeatable results. The Pittsburgh-based industry organization, which represents RFID and other technology developers, wants to help healthcare providers determine what effect various RFID technologies will have in their environments and to certify equipment for use there.

"In the presence of conflicting information, it is incumbent on the RFID industry to come up with a study that provides definitive information," Craig Harmon, chairman of AIM's RFID Experts Group (REG), told RFID Update. Harmon is also president and CEO of QED Systems, a consulting firm with extensive experience in RFID standards development.

AIM plans to develop testing protocols for 11 different ISO standards for RFID technology. The ISO air interface standards span multiple frequencies commonly used in healthcare and clinical RFID systems, including 125 KHz, 13.56 MHz (high frequency or "HF"), 860-960 MHz (ultra high frequency or "UHF") and 2.45 GHz, which includes many WiFi systems. AIM plans to develop the first 11 protocols within six months, and hopes the first certifications can be issued six months after that.

The protocols will be designed to determine how and if RFID impacts implantable medical devices (e.g. pacemakers), monitors and other clinical equipment, and to determine effects on human physiology, blood bags, vaccines and other pharmaceuticals.

The protocols will be submitted to the U.S. Food and Drug Administration (FDA) for comment and approval. AIM announced three universities are collaborating in the protocol development: Georgia Tech, the University of Pittsburgh and the University of Texas at Arlington.

After the initial protocols are developed AIM may expand the scope of the project to include ultra-wideband (UWB) technology, which operates at different bandwidths and is taking a growing share of the healthcare market for real-time location system (RTLS) deployments (see Startup to Deliver Standards-Compliant UWB RTLS for a recent update on UWB technology and standards).

RFID's suitability for use in healthcare was called into question this June when the prestigious Journal of the American Medical Association (JAMA) published a study by Dutch researchers that documented medical devices experiencing electromagnetic interference when in the presence of UHF and 125 KHz RFID systems (see Study Finds RFID Interferes With Medical Equipment). The study recommended healthcare providers perform on-site tests prior to RFID deployment (a practice that most RFID technology providers commonly recommend) and did not call for any restrictions on RFID use in hospitals.

However, the study received widespread media attention, which often highlighted the risks. Several RFID vendors and consultants responded by releasing contradictory information or statements that their particular type of technology was safe, which caused some confusion and was a contributing factor to AIM's initiative.

"We're trying to take a proactive stance," said AIM Global CEO Dan Mullen. "The industry needs to focus on the long term and on developing protocols that are repeatable."
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