FDA Approves Implantable Chip

Health chip implant OK'd

By Joyce Howard Price
THE WASHINGTON TIMES

The Food and Drug Administration approved an implantable computer chip — about the size of a grain of rice — that can make medical care safer and speedier by providing doctors quick access to vital patient information.
The microchip, known as VeriChip, has a unique serial number that, when electronically scanned, pulls up a patient's blood type and other medical information. Examples include a patient's allergies, prior treatments and current medications.
Late Tuesday, the FDA approved the medical use of VeriChip, a radio-frequency microchip that has been implanted in a million pets nationwide to help reunite them with their owners should they run away.
Applied Digital Solutions Inc. of Delray Beach, Fla., which usually develops security devices, and Digital Angel Corp. of St. Paul, Minn., which manufactures the newly approved medical information tool, applied for FDA approval of medical use of VeriChip last October. They updated their application in July, and the FDA had 60 days to respond.
Applied Digital is the majority owner of Digital Angel. The microchip will be marketed by VeriChip Corp., a wholly owned subsidiary of Applied Digital.
"Because this product is inherently safe, it did not have to go through three years of clinical trials," said a Digital Angel official, who requested anonymity.
The so-called VeriChip Health Information Microtransponder System consists of the implantable computer microchip, an inserter, a proprietary hand-held scanner and a "secure database containing the patient-approved health care information," VeriChip Corp. said.
A group called the Health Privacy Project (HPP) said yesterday that steps should be taken to ensure that only information a patient wants disseminated is available.
"If privacy protections aren't built in at the outset, there could be harmful consequences for patients," HPP policy analyst Emily Stewart told Associated Press.
To protect patient privacy, she said, the devices should reveal only vital medical information needed for health care workers to do their jobs. Blood type and allergic reactions constitute such essential material for doctors in emergency situations, she said.
With the pinch of a syringe, the microchip is inserted beneath the skin in a 20-minute outpatient procedure that requires no stitches. Its recommended placement is in the triceps area between the elbow and the shoulder of the right arm. Once implanted, the chip is invisible to the human eye.
Each VeriChip contains a unique 16-digit code or verification number that is obtained by passing the scanner over the insertion site. A small amount of radio frequency energy passes from the scanner, energizing the dormant microchip, which then emits a radio frequency signal transmitting the verification number.
The "captured" code links to the patient's medical database, which is available on request to registered health care providers via the Internet, VeriChip explains at its Web site.
"The chip is the key to the database. It allows the opening up of a person's medical file," the Digital Angel official said.
To jump-start use of the chips in humans, Applied Digital will donate 650 scanners for free at 200 trauma centers nationwide.
Applied Digital spokeswoman Angela Fulcher said the cost of chip implantation in humans will be $150 to $200.
She said the company hopes that patients with chronic conditions such as diabetes and Alzheimer's disease, which can render them disoriented, and those who undergo complex treatments such as chemotherapy have the chips implanted.
Although this is the first time VeriChip has been approved for medical use in the United States, more than 1,000 patients in Mexico have had scannable chips implanted.
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