The FDA recently approved a new device that the manufacturer says could dramatically reduce the incidence of wrong-site surgery by applying a microchip with detailed patient information directly to the planned operative site.
The SurgiChip Tag Surgical Marker System, manufactured by SurgiChip Inc. of Palm Beach Gardens, FL, consists of an adhesive tag with an integrated microchip that acts as a transponder, along with a printer, an encoder and a handheld device for reading the microchip. The maker says this product is the first such surgical marker to use radio frequency identification (RFID) technology to mark an anatomical site for surgery.
While the microchip containing detailed information is at the heart of the system, the chip is not actually embedded in the patient. Instead, it is affixed within an adhesive label that goes on the patient’s operative site. Todd Stewart, vice president for product development at SurgiChip, explains that the steps begin when a small computer chip is programmed with the following critical information: date of surgery, patient’s full name, surgical site, a description of the operation to be performed, and surgeon’s name. The chip may be programmed at the preoperative outpatient visit, in the emergency department, or on the hospital floor if the patient is an inpatient.
A nurse or physician then scans the chip with an RFID reader and the patient reviews the information to be sure it is correct. The chip is locked to prevent inadvertent or intentional altering or deletion of the data.
Chip info verified by patient before surgery
On the day of surgery, the chip again is scanned and the information is reviewed with the patient before he or she is sedated. If correct, the chip is applied to the skin where the incision is to be made. Since the patient assists with the programming and placing of the chip, the chance of error is diminished, Stewart says. The chip is left in place during transport to the operating room, while an anesthetic is administered and while the patient is positioned for surgery.
Stewart says this method diminishes the chance that the information regarding patient identity and surgical procedure will accidentally be switched with that of another patient as may occur when the information is contained in a separate hospital chart. Also, it may prevent mistaking left for right if the patient is positioned prone instead of supine.
In the operating room, the chip is scanned and the information reviewed by the surgical team.
"They don’t have to rely on recognizing the patient with a cap over her hair, a tube in her throat, no makeup, no dentures, and so on," Stewart says. "Reading the operative consent in a chart and confirming the name on a wristband may accomplish the same objective, but occasionally one of these steps is overlooked."
The physical presence of the SurgiChip tag is a major strength of the system, Stewart says. The surgical team is less likely to omit the review of information since the chip would then remain in place as a barrier to the incision, he says.
Of course, if the team fails to locate, read, and remove the SurgiChip — because they’re looking on the wrong leg, for instance — it will offer no protection. But Stewart says that risk will be lowered if the SurgiChip becomes so common that clinicians routinely expect to find it at the operative site.
After the accuracy of the information on the chip is confirmed, the tag with the embedded chip is removed and placed in the chart. Since the word "yes" or the surgeon’s signature also is written on the incision site in accordance with the Universal Protocol, and remains intact during the final surgical prep, an identifying mark still is present after the chip has been removed.
More protection than simply signing site
But Stewart says the SurgiChip procedure provides significantly more protection than a simple "yes" written on the operative site. Stewart says the SurgiChip is designed to complement and work within the other strategies already employed to prevent wrong-site surgery. When a surgical team takes a "time out" to stop and confirm vital information before beginning a procedure, the SurgiChip could be a reliable way to access patient information, he says.
"It’s almost like you’re writing a great deal of information right there on the patient’s leg," Stewart says. "But instead of writing from the knee to the ankle or writing a Cliff’s Notes version, you’re able to put a lot of information in a reliable, legible form."
Higher costs in first year of use
But couldn’t a hospital just use a stick-on tag and write or type the critical information on it? Stewart says the answer is yes, and decals used to identify the proper surgical site, patient, and procedure are commercially available. But to be practical, the tag must be reasonably small. Since the amount of information which can be written or typed on a decal is therefore limited, abbreviations or partial descriptions of the procedure are frequently used and that may lead to error. Any system that relies on handwriting is prone to error, he notes.
So what would this cost you? As with many clinical systems, the cost will be higher up front. Stewart says the average first year cost is $9 to $11 per case. From the second year on out, the cost is half of that because you’ve already paid for the hardware and support that is necessary when setting up the system. The ongoing cost is $2.50 per label, plus ongoing support and maintenance, for a total of about $5 per label.