President & CEO

Au contraire mon ami!

It is arguable that the Hokkaido study may have used dated pacemakers, ICDs, and readers, but the FDA study used the most current of what could be procured.

If the FDA had published the list of the equipment they used, everyone who was not tested would probably issue a press release noting that the FDA did not say there was a problem with their equipment, only their competitors.

The FDA, the Association for Advancement of Medical Instrumentation (AAMI), and the RFID Experts Group (REG) have been working on the development of test protocols that can be used by RF emitter and medical device companies to insure that there is minimal EMI.

At a recent meeting between the REG, the FDA, and AAMI, the Chief of Surgical Electrophysiology at the University of Miami Medical Center stood up and asked quite bluntly, "So what is the RFID industry doing about this? You know there is a problem, so what are you doing?"

The REG test protocols are being developed by Georgia Tech Research Institute, MET Labs, the REG, AAMI, and the FDA. We could certainly use funding, as GTRI and MET Labs are presently donating their time, causing the development to be slowed.

We need to develop solutions, this is an issue that can be solved but it needs attention and not posturing.

Craig K. Harmon
craig.harmon@qed.org