FDA Approves Surgical RFID Tag

The "smart" label will replace the traditional method of marking a patient's body before surgery. It's intended to prevent surgical errors by providing accurate patient and surgical information near the site of surgery.

Perhaps a bit more practical than the implantable RFID chip with patient information approved by the FDA a few months ago, this tag—dubbed the SurgiChip—aims to provide health care workers with accurate surgical information and possibly prevent errors such as the performance of surgery on the incorrect body part or the execution of the wrong surgical procedure.

So far, its the first RFID product approved for marking an anatomical surgical site. The system embeds and prints information on an RFID "smart" label that travels with the patient into surgery to help prevent errors.

Read the announcement here about approval by the FDA (U.S. Food and Drug Administration).

"JCAHO [the Joint Committee on Accreditation of Healthcare Organizations] is reporting five to six wrong site surgeries per month," said Debbie Murphy, a life sciences expert at Zebra Technologies, the company that provides the RFID printer/encoders and labels for the product. The product could provide a useful means for health care organizations to avoid surgical errors and assuage patient concerns, she said.

The RFID sticker is encoded with information gathered during the preadmissions process. The patients 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 surgeons name.

Placed in a patients file, the information is then verified by the patient immediately prior to sedation. The SurgiChip is then applied near the location where the incision will be made.

In the operating room, a handheld reader is used to confirm the information and to ensure that the label matches the patients chart and ID wristband.

/zimages/3/28571.gifClick here for a column on the perks of medical RFID tagging.

The product has been in beta trials for the past two months, run by the inventor, Dr. Bruce Waxman, who is a Florida-based orthopedic surgeon.

The SurgiChip system has yet to be integrated into larger surgical scheduling or electronic medical record software. But now that approval has been given by the FDA, this could be the next step.

"We can build a standard HL7 database which can send and receive data to numerous software systems," said Peter Stanchfield, director of RFID at AMT Systems. The company helped develop the SurgiChip and is the products authorized reseller.

According to Stanchfield, end-to-end setup of the standalone SurgiChip system will cost health care organizations anywhere from $25,000 to about $75,000, including software, hardware, installation, labels and staff training.

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