ORLocate RFID-enabled System for Surgical Sponges and Instruments Gets FDA Clearance

Once a surgical procedure is completed, the software closes that surgical record as properly completed, though it will not close if a tagged instrument or sponge is missing, unless the software is forced to close by an authorized individual. Everything is recorded in the database and printed out in a report for the hospital staff following the procedure's completion.

The software can issue an alert if a tagged instrument is found to be missing during sterilization, as well as store data indicating when each tool is sterilized. The software also tracks the number of uses and sterilizations each piece of tagged equipment has undergone, thereby allowing hospital management to know when a piece has been used its maximum number of times, or is due for maintenance, such as sharpening.

An ORLocate sponge tray

If a physician finds that a tagged instrument does not operate satisfactorily during surgery, a module in the software allows hospital employees to read that instrument's tag with the handheld reader, and input any problems it is experiencing. The software will then not allow the tool to be reused until the software has been updated to indicate that the item has been properly repaired by an authorized individual.

The technology list price is slightly less than $100,000 per surgical room, Mudd says, including the console, RFID readers, RFID-enabled back and Mayo trays, SPD software and 200 tags. However, he notes, the price per surgical room could be significantly less for high-volume purchases. The system is designed not only to ensure patient safety and reduce manual counts—which are time-consuming and error-prone—but also to reduce shrinkage by alerting workers whenever an item fails to be returned to a tray during surgery or the sterilization process. (In some cases during the sterilization procedure, hospitals experience a loss of small surgical equipment, which can become missing at some point after a procedure.)

ORLocate is not the first system on the market that uses radio frequency identification to track sponges. In 2007, for example, ClearCount Medical Solutions, a Pittsburgh-based company focused on improving surgical safety, received FDA clearance for its SmartSponge System (see RFID-enabled Surgical Sponges a Step Closer to OR). Although there are currently other RFID solutions in place for tracking sponges, Mudd says, "there is no other company that (is tagging) sponges and instruments."