Potential uses of radiofrequency identification tags in surgery
In the last few years, there has been a lot of discussion surrounding the use of “smart chips” or “smart tags”, more precisely known as radiofrequency identification tags or RFID. Actually, RFID has been around for awhile. It was deployed originally by the British military in the1940s to assist in the identification of friendly versus enemy aircraft. In the late 1960s and early 1970s, the need for security surrounding the use of nuclear materials drove further development of RFID tagging of equipment and personnel.
With RFID, data stored in silicon microchips are transmitted with radio waves when interrogated by a properly configured electronic query. The tag is made up of a chip and an antenna. Tags are highly variable in shape and size going from that of a credit card, a keychain dongle, or a patient’s wrist band to something as small as 0.4 by 0.4 millimeters. We can classify RFID tags as “passive” or “active”. Passive tags have no power source and require the energy of the reader device to provoke signal transmission. They have a long life, but a relatively short range of activity. In contrast, active tags contain a battery and can transmit signal autonomously. This increases their effective operating range, but shortens the life span of the tag.
Miniaturization of chips, increases in computer speed and the development of broad-based computer networks have contributed to the increasing momentum of RFID. Technology advocates tout this as an extraordinary opportunity to move information science forward. Others have placed RFID in the same category as the “mark of the devil”. I do not think so, but you will have to decide for yourself. Some privacy groups are concerned about the ability to draw personal inferences from digitally collected information stored in large databases that are accessible to undeterminable future “data miners”. In addition, the ability of undesirable people scanning a chip in your body or your purchases poses additional concerns. These concerns about RFID are real but the technology itself can be balanced against potential benefits. Certainly not all RFID systems have to be networked or contain personal information. In order to move this idea forward I would like to discuss three opportunities that RFID could make your next surgery a bit safer without revealing any personal information.
I can not believe we do not have a…
It is hard to imagine as a patient that a big hospital could run out of some critical device used in operating rooms. Let me assure you it happens. Traditional inventories are done by people who go to shelves and make counts. In an ideal world, when supplies are running low, they inform someone to place an order and the shelves are restocked. What happens when someone is on vacation? I think you are getting the picture. Material management and warehousing applications have been demonstrated to be effective for RFID technology. “Smart shelves” can count the RFID tagged items that remain and place orders automatically to maintain a predetermined stock level.
I did not know that they (should have) recalled that device…
Surgeons use tools but they are not all perfect. From time to time these imperfections are discovered and a process of product recall is engaged. Letters go out, but it can be long from the time it leaves the corporate safety office to the time it arrives to the operating room. This process is further hampered by the fact that it is an even longer road from the operating room to a corporate headquarters. When the device fails in the operating room, it is supposed to be cleaned, bagged and reported to responsible authorities in the government and industry. That is a lot of steps for long chain of humans to take. I think you see my point that it does not always happen. Without this information, the device industry can not make a determination that there is a problem, much less communicate it back. What if all major medical devices had “smart tags” that were registered on the computer that exists in nearly every operating room today? If a device had been recalled in the morning, that information could become known to the operating team the moment the package was registered in the room.
Furthermore, some devices require more training than others. Would patients not want to be certain that their surgeon/team was appropriately trained? That could be determined easily as well. One of the features that make RFID different than bar coding is the fact that each chip is unique. If the device was to fail in the operating room, and if it was actively registered online, the device failure could be reported instantaneously. Maybe all of those particular devices are bad or maybe only the ones made on a certain day. Facts like these could assist manufacturers in recalling the right devices instead of all of them.
I am sorry, but there is still a sponge in your body…
Many instruments, sponges, tools and devices are used during operation. At the end of the procedure a count is performed to make sure everything that was used is accounted for. However, this process is not perfect. Yet the public demands perfection. To be fair how can we pursue perfection with such a flawed tool as the human being? Even improved checklist systems will not bring us to a zero error rate. Attacking the problem by using multiple modalities may bring us closer than where we are today. Imagine that the surgical sponge has an RFID tag inside it. In addition to the human count, an electronic count is performed as well. At least if the count is in error, the same mistake will not be made twice. As retained foreign bodies are one of the greatest fears patients have, we need to do everything we can to reduce their incidence. Prototype systems are currently being tested and the results are promising.
There is much work to be done to make any of these pursuits of perfection possible. While the cost of chips has come down dramatically, information systems to track these types of things still need development. Standards for medical use will need to be set so that patient safety rather than corporate profit will be the priority in the end.
|Author :||Steven D. Schwaitzberg, M.D., FACS
Visiting Associate Professor of Surgery
Harvard Medical School
Chief of Surgery
Cambridge Health Alliance
Foster KR, Jaeger J, (2008) Ethical implications of implantable radiofrequency identification (RFID) tags in humans, Am J Bioeth, 8(8):44-8
Nagy P, George I, Bernstein W, Caban J, Klein R, Mezrich R, Park A, (2006) Radio frequency identification systems technology in the surgical setting, Surg Innov, 13(1):61-7
Schwaitzberg SD, (2006) The emergence of radiofrequency identification tags: applications in surgery, Surg Endosc, 20(8):1315-9.