Surgical chip shows patient info

Thinking there had to be something better than writing on the body part that was to be operated on, a Palm Beach Gardens, Fla., surgeon has invented a computerized label designed to help prevent hospital errors.

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SurgiChip is the product of orthopedic surgeon Bruce Waxman, who devised a one-inch-square chip with embedded information that can be read by computers and hand-held devices so that hospital workers know that they have the right patient and the right procedure.

The Food and Drug Administration was so excited about the concept that it rushed it through the often-cumbersome approval process.

`They were very helpful,` says Waxman. The whole process took less than six weeks to final approval — the agency moving at veritable light speed, since it can take years to approve some devices.

`The device is the first such surgical marker to utilize radio frequency identification RFID technology to mark an anatomical site for surgery,` the FDA said in a press release on Friday when it announced the chip’s approval.

RFID prints scanner-code information on a chip that can be read by computers and other devices.

`The concept is revolutionary. This could be a wonderful device, with

many more exciting applications beyond surgery,` says Paul Barach, director of the University of Miami’s Center for Patient Safety. `But will it accurately deliver?`

Barach can’t test it because it’s not yet for sale. Marketing and manufacturing may take some months, says Peter Stanchfield of AMT Systems, a Connecticut company that helped design SurgiChip.

Waxman said he had been thinking about such a device for more than a decade. `Surgeons were just writing YES on the spot they were going to operate, and I thought there should be something better` — not only the location of the surgery, but the procedure to be performed, the doctor doing it and other information.

Waxman had been hearing about RFID technology and decided to take a class in it. `In May 2003, I took a class in Miami,` a weekend session at a convention center. `Or maybe it was Fort Lauderdale. It was one of those places.`

Waxman’s original idea had been to program RFID into a Palm Pilot a surgeon would carry around, but that created programming and other complications.

Finally, he contracted out the work to Zebra Technologies, a Chicago area company that builds the RFID printers and scanners, and AMT Systems, which helped assemble the software and other parts of the system.

The chip that gets affixed to a patient’s body costs only $2.50, but the total system, with software, scanners and printers, can set back a hospital $20,000 to $70,000, depending on the configuration ordered.

The system works like this: At an initial visit, the information on the operation is placed in the computer. The patient sees it on a monitor and verifies that it’s correct. The data is then printed out on the chip and then re-read by the computer. Again, the patient verifies the data.

On the day of the procedure, the patient once again verifies the chip is correct, and it is then placed on the area to be operated.

At the suggestion of the FDA, the chip will have a notice on it that it should be removed before the procedure.

Barach, the UM expert, doubts that hospitals, particularly those in South Florida where malpractice premiums are so high, will balk at the cost of the system. `If it saves just one $2 million wrongful death suit, it would pay for itself many times over.`

Barach envisions many other uses beyond surgery, such as attaching it to chemotherapy patients, because a wrong dose could destroy kidneys, among other things. The chip could also contain information about a patient’s allergies and other personal data.

But hospitals may wait for some test runs to show `reliability and validity,` says Barach. `We need to know more.`

Many will be concerned about a growing problem in the electronic age: How well SurgiChip communicates with other hospital data systems.

`We need to know more,` Barach said.