FDA Approves Surgical Instrument Tracking Tool

The Food and Drug Administration has approved a radio-frequency identification tool that tracks instruments and sponges during surgical procedures.

ORLocate, developed by Maumelle, AR-based Haldor Advanced Technologies Ltd., provides:

• Anytime initial counts and item additions
• The number of items missing
• The number of clean and soiled sponges
• The time of the last count.

The system uses radio-frequency identification to help surgical teams reduce the number of items left in patients during operations, and is designed to improve patient safety and decrease complex and time-consuming counting procedures that are prone to human error. ORLocate is the only RFID-based system that counts sponges and surgical instruments, Haldor says.

“Surgical teams must rely today on manually counting surgical items to ensure that sponges and instruments are not left in patients,” says Jacob Poremba, president/CEO of Haldor USA Inc. “This leaves enough room for errors, causing large hospitals to experience about two to four cases annually of a surgical item left inside a patient after surgery.”

More than a third of all retained surgical items are instruments (52% radiopaque sponges and 43% instruments), according to a 2007 study in the Journal of Surgical Research. Correcting such errors adds about $2 billion each year to the nation's medical bill. 

ORLocate tested 99.8% accurate when counting and monitoring the location of sponges and instruments during lab testing by NAMSA in Northwood, OH, and labs in Germany and Israel. ORLocate tags each item used in surgery with a unique RFID identity. The tag is about the size of a hearing aid battery. The tagged instruments and sponges are detected via antennas located throughout the sterile field and software that continuously and automatically performs the counting.

Before procedures, a count of items is registered, and as they are used, the information is logged electronically. Before the procedure is completed, ORLocate has accounted for each item to ensure the safety and wellbeing of the patient, while increasing efficiency of operating room logistics and workflow processes.

The RFID technology allows ORLocate to:

• Provide a complete and integrated solution to help reduce cases of retained surgical items in patients’ bodies.
• Combine tracking technology and asset management services.
• Potentially increase efficiency of operating room logistics and workflow processes.
• Reduce time-consuming counting and inventory management.
• Enable simple and accurate packing of surgery sets in the sterile processing department.  .