The U.S. Food and Drug Administration has approved the country’s first RFID Tags that can be implanted in humans.
The 134.2-KHz RFID chips could save lives and possibly limit injuries from errors in medical treatments, according to VeriChip Corp., a subsidiary of Applied Digital Solutions Inc. The FDA approval was disclosed Tuesday during a conference call with investors.
VeriChip believes so strongly in the chip’s viability that it has tested it on one of its own: The company’s VP of medical applications, Dr. Richard Seelig. When Selig resigned from his New Jersey medical practice in 2001 to work at VeriChip, he had no idea that one day he’d implant under his skin two RFID chips meant to locate dogs. “It didn’t occur to me until the terrorist attack on 9/11,” Seelig says. “That’s what motivated me to take the project to another level.”
The chips could provide easy access to medical information for individuals with life-threatening diseases, and could be particularly useful during a medical crisis, according to the company. “It empowers people to know and manage their health-care issues in an emergency situation at a very critical time,” Seelig says. It also could be used to keep track of other implantable devices, such as a pacemaker, a patient might have. The tag could alert doctors of the implants during surgery and relay necessary information about those implants, such as the size and manufacturer. Also, patients could remain better informed in the event of any device recalls.
VeriChip suggests the chip be inserted in the rear part of the triceps of the right arm under the skin. The company plans to market the chip for $125 (not including implantation). The chip doesn’t contain any medical records, but its 16-digit number could be linked to a database of patient medical information. When the tag is scanned, the number could be quickly cross-referenced to reveal specific medical data about the patient.
The tags are similar to those being embedded in livestock and pets as a form of identification to track mad-cow disease or tuberculosis. Although VeriChip has yet to sign on customers in the United States, Rafael Macedo de la Concha, Mexico’s attorney general, in July said he and 160 of his staffers had received implanted chips from VeriChip that will be used to control access to rooms and documents considered vital in Mexico’s struggle with drug cartels.
From the FDA’s Website:
Radio Frequency Identification (RFID)
Radio Frequency Identification (RFID) refers to a wireless system comprised of two components: tags and readers. The reader is a device that has one or more antennas that emit radio waves and receive signals back from the RFID tag. Tags, which use radio waves to communicate their identity and other information to nearby readers, can be passive or active. Passive RFID tags are powered by the reader and do not have a battery. Active RFID tags are powered by batteries.
RFID tags can store a range of information from one serial number to several pages of data. Readers can be mobile so that they can be carried by hand, or they can be mounted on a post or overhead. Reader systems can also be built into the architecture of a cabinet, room, or building.
RFID systems use radio waves at several different frequencies to transfer data. In health care and hospital settings, RFID technologies include the following applications:
- Inventory control
- Equipment tracking
- Out-of-bed detection and fall detection
- Personnel tracking
- Ensuring that patients receive the correct medications and medical devices
- Preventing the distribution of counterfeit drugs and medical devices
- Monitoring patients
- Providing data for electronic medical records systems
The FDA is not aware of any adverse events associated with RFID. However, there is concern about the potential hazard of electromagnetic interference (EMI) to electronic medical devices from radio frequency transmitters like RFID. EMI is a degradation of the performance of equipment or systems (such as medical devices) caused by an electromagnetic disturbance.
Information for Health Care Professionals
Because this technology continues to evolve and is more widely used, it is important to keep in mind its potential for interference with pacemakers, implantable cardioverter defibrillators (ICDs), and other electronic medical devices.
Physicians should stay informed about the use of RFID systems. If a patient experiences a problem with a device, ask questions that will help determine if RFID might have been a factor, such as when and where the episode occurred, what the patient was doing at the time, and whether or not the problem resolved once the patient moved away from that environment. If you suspect that RFID was a factor, device interrogation might be helpful in correlating the episode to the exposure. Report any suspected medical device malfunctions to MedWatch, FDA’s voluntary adverse event reporting system.
The FDA has taken steps to study RFID and its potential effects on medical devices including:
- Working with manufacturers of potentially susceptible medical devices to test their products for any adverse effects from RFID and encouraging them to consider RFID interference when developing new devices.
- Working with the RFID industry to better understand, where RFID can be found, what power levels and frequencies are being used in different locations, and how to best mitigate potential EMI with pacemakers and ICDs.
- Participating in and reviewing the development of RFID standards to better understand RFID’s potential to affect medical devices and to mitigate potential EMI.
- Working with the Association for Automatic Identification and Mobility (AIM) to develop a way to test medical devices for their vulnerability to EMI from RFID systems,.
- Collaborating with other government agencies, such as the Federal Communications Commission (FCC), the National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) to better identify places where RFID readers are in use.