The U.S. Food and Drug Administration (FDA) has tested the impact of ultrahigh-frequency (UHF) RFID systems on insulin. RFID Journal published a report on this testing in October 2005 (see FDA Tests RFID’s Effect on Insulin). Howard Bassen, leader of the FDA’s Electromagnetics and Wireless Laboratory Division of Physics, Office of Science and Engineering Laboratories, at the Center for Devices and Radiological Health, wrote the FDA’s report on the test.
Using an unidentified commercially available stationary 915 MHz RFID interrogator and antenna, the FDA placed vials of insulin measuring 14.4 centimeters (5.7 inches) in length no further than 40 centimeters (15.7 inches) from the antenna, then exposed them to 1 watt of RF power. Although insulin usually comes in much smaller vials, 14.4-centimeter vials were chosen because they capture the most energy possible and, thus, represent the worst-case scenario. The agency measured the rise in the drug’s temperature, used a computer to model the experiment and compared the temperature change observed in the lab with that predicted by the computer model.
“For a one-hour exposure, our estimates, based on the rate of heating [observed through computer modeling and experiments], indicated a temperature rise of 1.7 degrees Celsius,” the report indicates. “However, preliminary lab measurements [for a one-hour exposure] revealed a 1.1-degree temperature rise.” The full report, entitled “Liquid Pharmaceuticals and 915 MHz Radio Frequency Identification Systems, Worst-Case Heating and Induced Electric Fields,” can be downloaded from the RFID Journal White Paper Library.
Bassen conducted further research, which he presented at IEEE RFID 2007. His paper, entitled “An Exposure System for Evaluating Possible Effects of RFID on Various Formulations of Drug Products,” can be downloaded from the IEEE’s Web site.
I also reached out to Daniel W. Engels, director of the Texas Radio Frequency Innovation and Technology Center, and an associate professor in the University of Texas at Arlington‘s Department of Electrical Engineering. Engels is an expert on RFID in general, and its application in medical and health care specifically, and he has done some research in this area.
Engels writes: “The net result is that for RFID power levels, solid doses are not affected. For the liquid doses, there is a heating impact from UHF. The worry is for the biologics and exotic drugs, not in solid form. Some of these have very weak bonds that may be impacted by RF radiation, though it is likely to come from microwave or higher, and not so much from UHF and lower.”
The bottom line: Additional testing is required, and companies employing radio frequency identification to track pharmaceuticals with weak bonds should test the effects of the technology on those drugs before exposing them to RF energy.
—Mark Roberti, Editor, RFID Journal
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