New Technology For Tracking Surgical Instruments, Sponges During Surgery Earns FDA Clearance

ORLocate uses RFID technology to account for items used during surgery to reduce incidence of retained surgical items left inside patients.

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

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 $2B 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, according to 2007 and 2008 studies in leading surgical journals. In a 2007 study published in the Journal of Surgical Research, 52 percent of RSIs were radiopaque sponges and 43 percent were instruments. Another study of RSIs, published in 2008 in the Annals of Surgery, reported 45 percent were radiopaque sponges, 34 percent were instruments, and 21 percent were needles.

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.

In a July 2010 report, "Recommended Practices for Prevention of Retained Surgical Items," by the Association of periOperative Registered Nurses, the association's Recommended Practices Committee and Board of Directors recommend that operating teams consider the use of adjunct technologies, such as ORLocate, to supplement manual counting procedures. Manual counts can often result in errors. In a 2009 study published in The Joint Commission Journal on Quality and Patient Safety, final counts were documented as correct in 62 percent to 88 percent of retained surgical items cases. Intraoperative radiographs are also not always effective in identifying RSIs. In a 2008 study published in the Journal of the American College of Surgeons, 67 percent of intraoperative radiographs were read as negative when an RSI actually was present.

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 indentifying 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.

"ORLocate was developed with significant input from those who will benefit most from its deployment, and it supports current workflow procedures," said Donald Mudd, general manager of ORLocate. "It won't require changes in typical surgical processes, but it will reduce harmful and costly errors."

About Haldor Advanced Technologies Ltd.
Haldor Advanced Technologies Ltd., a privately held company, specializes in integrating technological solutions that meet the business needs of the healthcare industry. The company was founded in 2006 with a declared purpose to enhance surgical procedures with safe and efficient technological systems to benefit doctors, surgeons, hospitals, and, most importantly, patients. Haldor was founded by Jacob Poremba, Rubi Halberthal and Gadi Lidor in order to bring high-tech solutions to hospital operating rooms.

SOURCE: Haldor Advanced Technologies Ltd.