WASHINGTON — A radio frequency tag that patients can affix like a bandage to ensure doctors perform the right surgery on the right person won government approval Friday.
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The tag, manufactured by SurgiChip Inc. of Palm Beach Gardens, Fla., aims to prevent wrongful surgeries that records show occur more than 60 times per year.
SurgiChip is the first surgical marking device approved by the Food and Drug Administration to use radio frequency identification. The FDA endorsed the same technology this week to track drugs on their journey from manufacturing plants to pharmacists’ shelves.
The chip is part military dog tag and part high-tech smart chip.
The patient’s name and the site of surgery are printed on the SurgiChip tag. Inside is a chip encoded with the type of surgery, date of surgery and the surgeon’s name.
Before surgery, the tag is scanned and the patient is asked to confirm the information is correct.
On the day of surgery, the tag is scanned again and reconfirmed again by the patient before the patient is sedated.
The patient helps stick the tag, which has an adhesive backing, near the site of the surgery. Workers in the hospital’s operating room scan the tag again to compare that information with the patient’s chart. Before surgery, the tag would be removed.
SurgiChip estimated its package, which includes the tag, scanner, printer and proprietary software that would be downloaded by each hospital, would cost a few thousand dollars.
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