Although such mistakes are rare in the thousands of operations that take place in the United States each day, they do happen. Government estimates indicate that five to eight wrong-site surgeries occur each month.
New radio-frequency identification technology approved by the Food and Drug Administration last November is starting to help some patients relax and doctors and surgical staff to be more secure that the correct operation is about to be performed on the right person and on the correct place on the body.
The new RFID verification system, called Surgichip, is being sold by AMTSystems as part of its suite of PatientSafe patient-safety systems, which also include medication-verification products.
Surgichip is an RFID tag that gets encoded by medical staff with the patient's name and other identification such as date of birth and medical-record number, as well as information about the type and site of procedure and other surgical instructions. The tags also are HIPAA-compliant and meet national patient safety standards of the Joint Commission on Accreditation of Healthcare Organizations, says Todd Stewart, AMTSystems' VP of business development.
The 2-inch-by-1-inch nonallergenic label gets stuck to a patient's skin near the surgical site, such as a left knee, before the operation. Before surgery begins, the tags are read by operating-room staff with handheld readers to confirm the patient and procedure.
"This is one more way for us to be super-sure" that the correct patient is about to undergo the right surgery, says Dr. Frank Cook, an orthopedic surgeon at The Palm Beach Orthopedic Institution in Palm Beach, Fla., whose doctors have piloted the system for about a year in about 300 surgical procedures.
While Cook says he can't estimate how many mistakes the system has prevented, there have been no mistakes since its use at the medical practice. Says Cook, "We're batting a thousand."
The RFID skin labels are better for surgical identification procedures than RFID-embedded patient wrist bands because the Surgichip can be placed on the body at the correct site of surgery, says Stewart. So far, pilots of Surgichip have been used only for orthopedic surgeries, since those type of operations are most prone to "wrong-site" mistakes, says Stewart. However, the tags can also be useful for many other types of surgeries, like abdominal and spinal procedures, suggests Cook. AMTSystems is expected to launch new pilots soon at other hospitals in Florida and Rhode Island, says Stewart.
During the first year use of Surgichip, the cost of the system comes to about $6 to $9 per surgery, including the costs of software installation, says Stewart. However, by the second year, the cost drops to about $3 per procedure.