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Researchers Warn RFID May Disrupt Medical Equipment
Experts not involved with the study note that there have been no reports of injuries caused by electromagnetic interference with medical devices, though they do recommend further study.
By Beth Bacheldor
June 25, 2008—A new study published today in the Journal of the American Medical Association warns that radio frequency identification may disrupt the operation of defibrillators and other medical equipment, and occasionally induce "potentially hazardous incidents in medical devices." Experts not involved in the study note that no injuries related to electromagnetic interference (EMI) have been reported in an actual clinical setting, but recommend that before deploying a specific RFID system, a hospital should test it first to see if it has any effect on the medical devices the facility uses.
The study, conducted by Remko van der Togt, Erik Jan van Lieshout, and four of their colleagues at the University of Amsterdam's Academic Medical Center (AMC), in the Netherlands, was part of a research project entitled RFID in Health Care, initiated by the Dutch Ministry of Health in May 2006. That project has been focused on the use of RFID to track and trace blood products and expensive medical supplies in the operating rooms, intensive care unit (ICU) and blood transfusion lab at the 1,002-bed hospital.
Few formal studies have been conducted investigating whether RFID systems interfere with the operation of medical devices, but the technology's use has been growing in the health-care sector, particularly to track such devices. Many of those implementations involve Wi-Fi-enabled real-time location systems (RTLS), which the University of Amsterdam did not test during its study.
Additionally, the U.S. Food and Drug Administration (FDA) has been considering using RFID as a unique device identification (UDI) mechanism for tracking and tracing medical devices in the supply chain (see FDA Works on Draft ID System for Medical Devices, Supplies). In January 2007, the agency published a draft guidance document addressing issues and concerns relating to the use of RF wireless technology in medical devices, including whether RFID's electromagnetic waves could interfere with such devices. The FDA is currently evaluating the commentary and input it received on this issue last year.
According to Peper Long, a spokeswoman for the FDA, the agency has not yet received any reports of injuries directly caused by electromagnetic interference with medical devices. "We certainly understand there is a potential for problems," she says, "and, of course, we are looking into this." In fact, Long notes, the FDA is working with standards organizations and device manufacturers to evaluate RFID's impact on device performance, and to discern whether any vulnerabilities would create a public health concern.
The University of Amsterdam study was carried out in a controlled, nonclinical setting specifically to assess and classify incidents of EMI by RFID on critical care equipment. The researchers set up two RFID systems—one consisting of a 124 kHz battery-powered tag and a reader, the other a passive 868 MHz tag and interrogator. Both systems employed in the test (the active system is from Avonwood, while the passive is made by Feig Electronic) comply with RFID standards set forth by the European Telecommunications Standards Institute (ETSI). Forty-one separate devices—such as defibrillators, infusion pumps, ventilators, fluid warmers and pacemaker programmers—from a variety of medical equipment manufacturers were included in the tests, which were conducted in a one-bed patient room at the hospital, though no patients were involved in the testing.
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June 25, 2008—A new study published today in the Journal of the American Medical Association warns that radio frequency identification may disrupt the operation of defibrillators and other medical equipment, and occasionally induce "potentially hazardous incidents in medical devices." Experts not involved in the study note that no injuries related to electromagnetic interference (EMI) have been reported in an actual clinical setting, but recommend that before deploying a specific RFID system, a hospital should test it first to see if it has any effect on the medical devices the facility uses.
The study, conducted by Remko van der Togt, Erik Jan van Lieshout, and four of their colleagues at the University of Amsterdam's Academic Medical Center (AMC), in the Netherlands, was part of a research project entitled RFID in Health Care, initiated by the Dutch Ministry of Health in May 2006. That project has been focused on the use of RFID to track and trace blood products and expensive medical supplies in the operating rooms, intensive care unit (ICU) and blood transfusion lab at the 1,002-bed hospital.
Few formal studies have been conducted investigating whether RFID systems interfere with the operation of medical devices, but the technology's use has been growing in the health-care sector, particularly to track such devices. Many of those implementations involve Wi-Fi-enabled real-time location systems (RTLS), which the University of Amsterdam did not test during its study.
Additionally, the U.S. Food and Drug Administration (FDA) has been considering using RFID as a unique device identification (UDI) mechanism for tracking and tracing medical devices in the supply chain (see FDA Works on Draft ID System for Medical Devices, Supplies). In January 2007, the agency published a draft guidance document addressing issues and concerns relating to the use of RF wireless technology in medical devices, including whether RFID's electromagnetic waves could interfere with such devices. The FDA is currently evaluating the commentary and input it received on this issue last year.
According to Peper Long, a spokeswoman for the FDA, the agency has not yet received any reports of injuries directly caused by electromagnetic interference with medical devices. "We certainly understand there is a potential for problems," she says, "and, of course, we are looking into this." In fact, Long notes, the FDA is working with standards organizations and device manufacturers to evaluate RFID's impact on device performance, and to discern whether any vulnerabilities would create a public health concern.
The University of Amsterdam study was carried out in a controlled, nonclinical setting specifically to assess and classify incidents of EMI by RFID on critical care equipment. The researchers set up two RFID systems—one consisting of a 124 kHz battery-powered tag and a reader, the other a passive 868 MHz tag and interrogator. Both systems employed in the test (the active system is from Avonwood, while the passive is made by Feig Electronic) comply with RFID standards set forth by the European Telecommunications Standards Institute (ETSI). Forty-one separate devices—such as defibrillators, infusion pumps, ventilators, fluid warmers and pacemaker programmers—from a variety of medical equipment manufacturers were included in the tests, which were conducted in a one-bed patient room at the hospital, though no patients were involved in the testing.
READERS' COMMENTS
Why even install this technology?
Isn't a barcode enough for hospitals? Why use this technology for this purpose? it seems unnecessarily cumbersome and expensive to employ and unlikely to increase efficiency.
Posted By: R. 6/25/2008 at 6:57:07 PM
http://to.swang.googlepages.com/rfid
There is a good overview of RFID. possibly a little bit aged. http://to.swang.googlepages.com/rfid something useful
Posted By: W. S 6/25/2008 at 11:13:44 PM
Equipment Shielding Inadeqaute
If medical equipment is subject to malfunctions due to the presence of RFID technologies, the real issue seems to be the need to create better shielding on the medical equipment. As a security company, one of the basic points we emphasize over and over again is that it is the responsibility of vulnerable entities to secure against the vulnerability, and not pass the buck to the avenue of attack. If you drive your convertible with the top down in Florida in the Summer, don't blame Mother Nature for raining on your leather seats. RFID is here to stay just like cell phones, radios, microwaves, etc. I agree that studies should be done. In the meantime, those that manufacture and use affected equipment should act to fix the problem with the assumption that RFID technologies are not going away, because that is reality.
Posted By: M. Ahmadi 6/26/2008 at 8:29:30 AM
Equipment Shielding Inadeqaute
If medical equipment is subject to malfunctions due to the presence of RFID technologies, the real issue seems to be the need to create better shielding on the medical equipment. As a security company, one of the basic points we emphasize over and over again is that it is the responsibility of vulnerable entities to secure against the vulnerability, and not pass the buck to the avenue of attack. If you drive your convertible with the top down in Florida in the Summer, don't blame Mother Nature for raining on your leather seats. RFID is here to stay just like cell phones, radios, microwaves, etc. I agree that studies should be done. In the meantime, those that manufacture and use affected equipment should act to fix the problem with the assumption that RFID technologies are not going away, because that is reality.
Posted By: M. Ahmadi 6/26/2008 at 8:30:57 AM
RFID EMI
I read that Dutch study and they did not test today’s 2 GHz units. Most medical equipment today communicate wirelessly in 802.11g (2 GHz) so if there were a problem, they would do it to them selves. Our entire hospital complex is wired with 802.11g nodes and they are not interfering. we have contacted Alaris, our pump manufacturer, and the only stipulation they gave us is not to drill any holes in the chassis. In any case, we are testing our equipment with 802.11g RFID sample units just to document that we did. So far, no problems found (yet). Mark Volkomener CBET Clinical Engineering Network Security/Video Admin. Benefis Healthcare 1101 26th St S Great Falls, Montana 59405 Phone: 406.455.4252 Fax: 406.455.4144 volkmare@benefis.org -------------
Posted By: M. Volkomener 6/26/2008 at 2:57:13 PM
rfid
When was the last time you tried to find a piece of equipment that was past due for pm? Have you lost any wheel chairs? Have you ever had a wondering patient? I could go on... Once you have a WAP network in your hospital it opens the door for RFID, VIOP tags, eliminates the need for pagers, and so on. It is very cost effective to implement. Mark Volkomener CBET Clinical Engineering Network Security/Video Admin. Benefis Healthcare 1101 26th St S Great Falls, Montana 59405 Phone: 406.455.4252 Fax: 406.455.4144 volkmare@benefis.org -------------
Posted By: M. Volkomener 6/26/2008 at 3:07:14 PM