Of the various studies and reports on the use of RFID in Health Care settings, one key issue has been absent: transparency. While some equipment has been identified and some testing parameters have been specified, there is insufficient detail to allow any of the tests to be replicated by another institution.
The AIM Health Care Initiative (HCI) is designed to change all that.
Perhaps the most widely-publicized test was the one performed by the Academic Medical Centre, VU University of Amsterdam, the
This study was performed with equipment in situ (that is, "in place") in a facility with other potentially RF-emitting equipment. While this is the approved method of testing for potential interference prior to installation of equipment in a health care setting (somewhat similar to performing an RF site survey prior to implementing an RFID or wireless LAN system) and did serve to illustrate worst-case scenario concerns, it did not provide useful empirical data on a wide range of RFID devices or determine whether some were more problematic than others. [See above Viewpoint for additional reference materials.]
Conversely, a study conducted at Indiana University Purdue University Indianapolis (IUPUI) received the 2008 Outstanding Management & Technology Paper award from the Association for the Advancement of Medical Instrumentation(AAMI) for their research on adapting radio frequency identification (RFID) technology to a clinical application. Their paper, Testing Potential Interference with RFID Usage in the Patient Care Environment was published in the November-December 2008 issue of AAMI's peer-reviewed Biomedical Instrumentation and Technology, and concluded that interference was unlikely when antennas were placed in locations appropriate for these use scenarios. The IUPUI study concluded that the JAMA study used unrealistic scenarios to generate incidents of interference [which the Dutch researchers pointed out in their own paper] and that, properly implemented, RFID technology is safe.
The AIM Health Care Initiative (HCI)
It has been demonstrated that, under certain circumstances, RFID technology, indeed any RF-emitting device, has the potential to affect electrical medical equipment such as infusion pumps and wearable/implantable medical devices such as pacemakers. What is lacking is a method to provide scientifically rigorous testing protocols that allow manufacturers of both RF-emitting equipment and manufacturers of health care equipment and devices to determine potential effects of RF-emitting equipment.
In October 2008, AIM's RFID Experts Group (REG) undertook a project to develop scientifically rigorous, transparent, and replicateable test protocols for RF-emitting equipment in the health care setting. The purpose of these protocols is two-fold: first, to develop standard methodologies to identify the nature and type of interference produced by RF-emitters and, second, to determine safe operating parameters within a laboratory environment. Additionally, the testing will help RF-emitter manufacturers understand the specific causes of interference, and could subsequently help identify potential countermeasures that could reduce or eliminate interference.
It is important to note that the HCI is not developing any standards for health care devices or equipment. The HCI's purpose is to develop test protocols for RF-emitting equipment in health care settings. The basis for the test protocols will be relevant, published RF-related standards for health and safety (national and international regulatory standards) as well as those published by other authorities such as AAMI.
Once completed, the test protocols will be submitted to the American National Standards Organization (ANSI) for approval as an American National Standard. Subsequently, they will be submitted for FDA for review and, ultimately, proposed as candidate international standards.
Publishing the protocols as national and international standards will allow any certified testing facility to perform tests of RF-emitters and medical devices and equipment to allow RF-emitting devices to be shown to be benign, under laboratory conditions, within given parameters such as distance from device, power levels, etc.
It is anticipated that such testing will provide a reliable predictor of how this equipment will perform in situ in a health care setting.
Currently, the Georgia Tech Research Institute (GTRI) and MET Laboratories are actively involved in testing RFID equipment and developing protocols. GTRI is working with wearable/implantable medical devices and MET Labs is working with electrical medical equipment.
Both GTRI and MET Labs have extensive experience in RF and health care. An interview with Dr. Gisele Bennett, Director of the Electro-Optical Systems Laboratory, Georgia Tech Research Institute and Ted Osinski, Director of RFID, MET Laboratories on RFID: The Health Care Initiativewas published in the July 2009 issue of "RFID Connections". An interview with Ralph Herkert, Manager of the
To ensure the highest scientific standards, the draft protocols will be cross-reviewed -- with GTRI reviewing MET Lab's work and vice versa.
The REG's HCI working group is in communication with the U.S. Food and Drug Administration (FDA) and AAMI and is actively seeking collaboration with additional organizations in the health care area. The HCI group has established active communication with AAMI's PC69 that sets standards for active implantable medical devices. PC69 is working on a revision to its standard to include RFID and the HCI working group has offered to provide input to PC69s current activity.
A good representation of RFID readers, both active and passive, at common frequencies has been received by the testing facilities. Work is under way to determine specific characteristics of each RFID reader using representative data.
While RFID manufacturers have been forthcoming with donated or loaned equipment, medical device and equipment manufacturers have been somewhat reluctant to participate at this point. It is likely that misunderstanding of the goals of the HCI is one factor. Another factor may well be that health care manufacturers are more familiar with AAMI and other organizations and not so familiar with AIM.
It is anticipated that, as the HCI's outreach activities succeed in developing additional working relationships with relevant organizations, medical device and equipment manufacturers will be more willing to participate in the program.
Additional funding for the development of these test protocols is also being sought.
Manufacturers wishing to become involved with the HCI, or to provide funding, should contact Craig Harmon, REG Chair.