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Friday, February 28, 2020  

Health information may be an arm’s length awayPublished 3/8/2004

byMike Lee

Staff Writer

In the not-too-distant future, reviewing a patient’s medical history may be as easy as swiping a scanner across their arm. Life-saving medical information could be carried around by patients, even if they forget their wallet or purse.

Healthcare professionals may not have to look farther than a person’s arm to know of their allergies if a new product is approved by the U.S. Food and Drug Administration.

At the end of October, Applied Digital Solutions submitted its application to the U.S. Food and Drug Administration seeking the agency’s permission to market VeriChip’s healthcare information applications in the United States.

The VeriChip, which would be implanted just underneath a patient’s skin, is inconspicuous to the naked eye.

The benefits could be dramatic, especially to doctors making decisions.

Dr. Glenn Gade is a pediatrician for Kaiser Permanente Colorado and also the operational chief for medical sub-specialties.

Gade said information is a powerful tool in saving lives.
"The more information about the patient the doctors have, the safer the patient is - anything we can do to improve accessibility is a step up from what we’ve had in the past," Gade said. "You reduce errors when medical information is available. The Internet makes health record easily accessible from a distance."

The VeriChip would allow people to carry their health records with them wherever they went.

The detailed 510(k) submission was necessitated by the FDA’s ruling last October that VeriChip is a regulated medical device "when marketed to provide information to assist in the diagnosis or treatment of injury or illness." In that same ruling, the FDA determined that VeriChip was not a regulated device for its "security, financial, and personal identification/safety applications."

In submitting the 510(k) application, frequently referred to as a premarket notification submission, the company is following the process outlined by an FDA representative at a public seminar about human implantable microchips at the National Academies in Washington, D.C., in November 2002.

During this seminar, the FDA described a submission process for obtaining premarket clearance for safe and effective implantable microchips for human use.

Assuming clearance will be obtained from the FDA, the company plans to market the VeriChip family of potentially life-saving devices in the U.S. as soon as possible.

The company envisions a broad range of medical applications including: implanted medical device identification, emergency access to patient-supplied health information, portable medical records access, in-hospital patient identification, medical facility connecivity via patients, patient/therapy integration, inter-facility patient identification, and disease/treatment management of at-risk populations.

About the size of a grain of rice, each VeriChip product contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. The standard location of the microchip is in the triceps area between the elbow and the shoulder of the right arm.

The brief outpatient "chipping" procedure lasts just a few minutes and involves only local anesthetic followed by quick, painless insertion of the VeriChip.

Once inserted just under the skin, the VeriChip is inconspicuous to the naked eye. A small amount of radio frequency energy passes from the scanner energizing the dormant VeriChip, which then emits a radio frequency signal transmitting the verification number.

In October 2002, the US Food and Drug Administration (FDA) ruled that VeriChip is not a regulated device with regard to its security, financial, personal identification/safety applications but that VeriChip’s healthcare information applications are regulated by the FDA.

The available options for health care providers to gain access to a patient’s medical records are limited. One way is for patients to carry some sort of smart card with them that stores their information. Some potential problems include that the card could be stolen, the information could be affected much like credit cards when they are laid on electronic scanners or the card could be lost.

Gade said there is a currently an information void out there.

"This is true for any person, but as you age, you have more medicines and more complicated illness, a longer history and more frequent memory problems so that combination means older Americans are an ideal source for something like this," Gade said.

The company has already launched the project in Mexico and has provided user testimonial.

Luis Valdez, a biochemical engineer with Type I diabetes said he enjoys the peace of mind the product provides.

"I have been in situations where a lack of information has put my life at risk," Valdez said. "I once suffered a diabetes attack in the street while visiting another city. I practically dropped down dead in a diabetic coma.

"Fortunately, the paramedics didn’t hook me up to a glucose drip, as that would have cost me my life. This technology gives me peace of mind and confidence, because it provides information about who I am, what is wrong with me and who to contact in a similar situation."

Gade applauds the idea, but wonders how diligent both patients and health providers will be at using it.

"Automated medical records may make more sense because they are easily updated," Gade said. "The VChip is helpful for those who can’t give medical history due to an injury or confusion, but not knowing details about the VChip, I’d worry that data could be out of date."v

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