CASPIAN (Consumers Against Supermarket Privacy Invasion and Numbering) has issued a press release pointing out the areas that the US Food and Drug Administration wants to address before giving the go-ahead for widespread use of the technology, developed by VeriChip.
The FDA notes that the VeriChip is indicated for use as way of providing a patient with a unique identification number that may be used to access a database containing the patient's identity and health information. In this way, it could be used to avoid misprescribing for drugs or medical procedures.
However, while the FDA letter states its classification process provides "reasonable assurance of the safety and effectiveness of the device," CASPIAN takes the opposing view.
The group points out that the FDA has suggested that potential risks to health associated with the device are: adverse tissue reaction; migration of implanted transponder; compromised information security; failure of implanted transponder; failure of inserter; failure of electronic scanner; electromagnetic interference; electrical hazards; magnetic resonance imaging incompatibility; and needle stick.
However, the agency said that it is satisfied that such a device can be marketed safely, without pre-market approval, provided the company sticks to the letter of the approved indication. A copy of the FDA's letter to VeriChip can be downloaded here.
CASPIAN's Katherine Albrecht claims that MRI incompatibility as perhaps the most serious issue. An MRI machine uses powerful magnetic fields coupled with pulsed radio frequency (RF) fields. According to the FDA's Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, "electrical currents may be induced in conductive metal implants" that can cause "potentially severe patient burns," she points out.
"Patients contemplating a VeriChip implant need to know that the FDA has raised incompatibity as a potential risk. "If it's a choicebetween a potentially life-saving diagnostic procedure or a VeriChipimplant, I believe most patients would choose the MRI."
In addition to outlining a number of health risks, the FDA letter also cites the risk of "compromised information security" among its concerns, and this is another issue that CASPIAN is concerned about.
The VeriChip ID implant, about the size of a grain of rice, uses radio waves to transmit medical and financial account information to reader devices. There is a risk that these transmission could be intercepted and duplicated by others or that the devices could be used to track an individual's movements and location, claims the consumer group.
"Once you're chipped, you can be identified by doorway portal readers without your knowledge," says Albrecht.