Posted by Colleen Terry on Wed, Jan 27, 2010 @ 11:11 AM
WaveMark CTO, Jean-Claude Saghbini, responds to recent FDA testing of RFID in a clinical setting.
Dear WaveMark Friend,
You may have recently read about tests conducted by the FDA to assess the reaction of ICDs and pacemakers to RFID. At the frequency used by WaveMark, 13.56MHz HF, the study concluded that a small fraction of pacemakers and ICDs (6% and 1% respectively) exhibit some form of a reaction at short distances. The conclusion of the FDA study stated: "We do not believe the current situation reveals an urgent public health risk."
WaveMark uses low power passive HF RFID and the system is designed such that the active electromagnetic field is retained within the smart cabinet. We are awaiting the details of the study to be published, in order to better understand the power levels used during the testing and the design of the tests. Meanwhile, we are confident in the basic design principles of the WaveMark system of low power and confined electromagnetic field, fully supported by the fact that we are approaching six years of clinical deployments with no known adverse interactions. We are also encouraged by the FDA's general conclusion that the current situation does not reveal urgent public health risks.
Our commitment to patient safety is one of the founding principles of our inception and mission. We take great pride in our ability to deliver real-time product visibility, providing nurses and techs with the confidence that expired and recalled products never reach a patient. The automated tracking of product use ensures the right mix of products is always available and hands-free tracking allows clinicians to spend more time caring for patients and less time with administrative tasks.
We are fully confident that we have a safe and clinically-friendly system. We will continue our due diligence in this research, while continuing our focus on providing our customers the best solution and service in the industry.
We will keep you apprised of any new developments. We welcome your discussion.
Sincerely,
Jean-Claude Saghbini
CTO, WaveMark, Inc.
Read about RFID standards that were recently approved and have always been supported by WaveMark solutions.
ANSI Approves HIBCC Standard That Addresses RFID/Medical Device Safety Concerns Health Industry Business Communication Council, July 31, 2009
Attend RFID in Healthcare Conference, January 28, 2010