ORLocate system designed to prevent medical errors in surgical procedures receives FDA clearance

Aug 25 2010

A new technology that tracks instruments and sponges during surgical procedures has earned clearance from the Food and Drug Administration.

“The comprehensive logistical and sterile inventory management capabilities enable the hospital to improve efficiency, while enhancing patient safety.”

Haldor Advanced Technologies Ltd. has developed ORLocate, a system specifically designed to improve patient safety and decrease complex and time-consuming counting procedures that are prone to human error. The system uses radio-frequency identification to help surgical teams reduce the number of items left in patients during operations. This automated system focuses on preventing medical errors in surgical procedures that currently cost the U.S. healthcare industry more than $2 billion annually. The system is the only RFID-based system on the market that goes beyond counting sponges to include surgical instruments.

"Surgical teams must rely today on manually counting surgical items to ensure that sponges and instruments are not left in patients," said Jacob Poremba, chief executive officer and president 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 percent radiopaque sponges and 43 percent instruments), according to a 2007 study published in the Journal of Surgical Research.

ORLocate™ has tested 99.8 percent accurate when counting and monitoring the location of sponges and instruments during lab testing by NAMSA in Northwood, Ohio, the world's leading medical device contract research organization, and labs in Germany and Israel. It works by tagging each item used in surgery with a unique RFID identity. The tag is about the size of a small hearing aid battery. The tagged instruments and sponges are detected via antennas located throughout the sterile field and a robust software application 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, the surgical team can be confident that ORLocate has reconciled that each item is accounted for to ensure the safety and wellbeing of the patient, while increasing efficiency of operating room logistics and workflow processes.

Along with the OR system, ORLocate offers an additional platform for use in the Sterile Processing and Distribution Departments (SPD) that provides advanced tracking solutions for the lifecycle of surgical instruments. This is done by enabling simple and accurate packing of surgery sets in the sterile processing department. Instruments are tagged and carefully tracked in the system, allowing hospitals to maximize the overall productivity while automatically identifying defective instruments that could pose a risk to patient care and identifying instruments that need maintenance.

"ORLocate provides - at any time - the initial counts and item additions, the number of items not located, the number of clean and soiled sponges, and the time of the last count," Poremba said. "The comprehensive logistical and sterile inventory management capabilities enable the hospital to improve efficiency, while enhancing patient safety."

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 to meet the highest healthcare standards.
• Potentially increase efficiency of operating room logistics and workflow processes.
• Reduce time-consuming counting and inventory efforts.
• Enable simple and accurate packing of surgery sets in the sterile processing department.
• Enable hospitals to provide higher and safer quality of care for patients.

SOURCE Haldor Advanced Technologies Ltd.