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

The system's developer says that three U.S. hospitals will soon deploy the technology, testing its ability to track surgical items and ensure they don't remain in a patient, or get lost.
By Claire Swedberg
Aug 27, 2010Having received U.S. Food and Drug Administration (FDA) clearance this month for its surgical sponge and instrument tracking technology, Haldor Advanced Technologies plans to begin trialing its ORLocate system at three U.S. academic hospitals in October. The system, whereby surgical sponges and instruments are fitted with passive high-frequency (HF) RFID tags, has been previously tested in a lab environment and with animals. The company believes ORLocate could help hospitals ensure that equipment and materials are not misplaced during surgery, either in a patient or in waste containers, and track the use, maintenance and status of instruments.

According to Jacob Poremba, the cofounder, president and CEO of Haldor USA (an American subsidiary of the Israeli firm), the solution not only promises to increase safety in the surgical room, it also reduces the chances of shrinkage—by identifying when an instrument is missing from its tray, and by enabling an RFID-based search for that item. The system also saves staff members time otherwise spent in the arduous process of counting instruments and sponges prior to surgery, and again after a patient is closed up.

An ORLocate RFID tag attached to the handle of a surgical instrument
To obtain the FDA's permission to market the product to U.S. health-care providers, Haldor needed to show that the technology was safe to use in a surgical setting. As part of that process, the company submitted the results of biocompatibility testing (which looks for toxicity or other hazards to patients that might result from the technology's use). Those tests were carried out by NAMSA, an independent medical device contract research organization located in Northwood, Ohio, as well as by labs in Germany and Israel.

The complete system consists of multiple components, including an ORLocate console with a 19-inch touch screen, on which information regarding the items present, along with their status, is displayed by the system's Sterile Processing and Distribution (SPD) software. In addition, there is a sponge tray with an RFID antenna and a reader for sterilized sponges, as well as a sponge bucket, also with a reader and an antenna, used to count soiled sponges. For hemostats and other surgical instruments fitted with tags, there is an RFID-enabled "back tray," located on the surgical setup table on which the hospital's trays of instruments are stored in preparation for use, as well as an RFID-enabled Mayo tray, used to detect instruments placed on the Mayo stand as they await surgical use. A handheld reader, known as a locator, is utilized to pinpoint missing items, and a desktop reader dedicated to the sterilization procedure captures each tag's ID number as instruments are sterilized following a surgical procedure. Finally, there are RFID antennas located on the console's upper panel and near the Mayo tray, to identify when new sponges or tools are added during surgery.

The ORLocate system includes RFID tags for instruments. Each tag, explains Donald Mudd, the general manager of Surgical Investments LLC (ORLocate's exclusive U.S. distributor), can sustain at least 1,000 sterilization procedures, as well RFID-enabled sponges or tags to apply to existing sponges. The tags, the company reports, have proven to read well in environments containing large quantities of metal and liquids, and can also sustain the sterilization process thanks to the encapsulation of the tags that Haldor's engineers have developed.

Each tag is encoded with a unique ID number and operates at 13.56 MHz, in accordance with the ISO 15693 RFID standard. The instrument tags can be applied to any flat surface measuring 3 millimeters (0.12 inch) or larger. The SPD software can stand alone on a hospital's server, or be integrated into a facility's existing back-end system.

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