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FDA approves implantable chip to access medical records

New York Janice Hopkins Tanne

The US Food and Drug Administration has approved Verichip, an implantable radiofrequency identification device for patients, which would enable doctors to access their medical records.

Doctors hope that use of the device will result in be better treatment for patients in emergencies or when a patient is unconscious or lacks medical records. Some people have raised fears, however, that it could lead to infringements of patients’ privacy.

The chip is the size of a grain of rice and is implanted under local anaesthesia beneath the patient’s skin in the triceps area of the right arm, where it is invisible to the naked eye. It contains a unique 16 digit identification number. A handheld scanner passed near the injection site activates the chip and displays the number on the scanner. Doctors and other medical staff use the identification number to access the patient’s records on a secure database via encrypted internet access.

A similar chip has been used for about 15 years to trace lost pets and to identify livestock. More than 30 million "Home Again" chips have been implanted in pets, and a million are implanted each year in the United States.

The chip’s manufacturer, Applied Digital Systems, of Delray Beach, Florida, will donate 200 scanners to major trauma centres in the United States. The company sees its main markets as physicians’ practices, emergency rooms at hospitals, and extended care facilities. Each scanner costs about $650 (£354; €508), but the cost will decrease with volume, said Angela Fulcher, the company’s vice president for marketing. She said that implanting a chip in an individual costs $150 to $200.

"We foresee that scanning a patient for a Verichip—as it is a very simple procedure—will be part of the standard patient entry protocol [in an emergency room], such as taking temperature, checking blood pressure, etc," Ms Fulcher told the BMJ.

The Verichip database can include medical records, information about implanted medical devices, personal information, family contact information, and insurance information. The patient and his or her doctors would enter data in the database.

Dr Richard Seelig, the company’s vice president for medical applications, says that the chip would be useful in patients who receive care from several doctors in different locations, who have complex medical histories, and who take many medications.

The chip has potential applications for protecting security, such as limiting access to nuclear power plants, for identifying military personnel and including their medical information, and for protecting financial transactions such as using cash dispensing machines.

About 1000 people worldwide have been implanted with the chip. The attorney general of Mexico and some of his staff use the technology to access secure facilities in Mexico city, the company says. Because the chip can be activated only at close range and because it becomes inactive immediately afterward, it cannot be used for long distance reading of information or tracking of individuals.

Marc Rotenberg, executive director of the Electronic Privacy Information Center in Washington, DC, told the BMJ that use of an implantable chip was "like branding cattle." He thought it was a mistake for the FDA to have approved the chip because of privacy issues.