AIM Global to Develop Protocols for Testing Effects of RFID Emissions in Health Care

"We can't afford to wait that long," Harmon says. "I'm not aware of anyone who is saying RFID is being banned in hospitals, but I have heard—and this is more rumor than being able to point to one specific example—that some health-care organizations are delaying the use of the technology."

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).

Craig Harmon

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."