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RFID-enabled Surgical Sponges a Step Closer to OR

Approved by the FDA, ClearCount's redesigned SmartSponge System is currently being tested in several U.S. hospital operating rooms.
By Beth Bacheldor
Jun 27, 2007ClearCount Medical Solutions, a Pittsburgh, Penn.-based company focused on improving surgical safety, is getting closer to launching a commercial version of its SmartSponge System, designed to help prevent medical teams from inadvertently leaving sponges inside surgical patients. The company has redesigned the sponge-tracking system, clinical trials are underway and the system has received clearance from the U.S. Food and Drug Administration (FDA).

Earlier this month, the FDA approved ClearCount to market surgical sponges embedded with passive RFID tags. The SmartSponge System uses Texas Instruments' Tag-it HF-I tags, which operate at 13.56 MHz and support the ISO 15693 and 18000-3 standards. The FDA granted clearance under Section 510(k) of the Food, Drug and Cosmetic Act. With such clearance, the SmartSponge System can be marketed and commercially distributed in the United States.

An independent organization, No Thing Left Behind, is half-way through clinical trials testing ClearCount's RFID-enabled sponges, interrogators and companion software, in surgical cases in five different medical centers across the country. The No Thing Left Behind project's overall objective is to help hospitals, surgeons, perioperative care nurses and patients work together to ensure that surgical tools used in an operation are never left inside a patient.

Recent studies have estimated that cases of surgical objects left in patients occur between 1 out of every 100 to 1 out of every 5,000 surgical procedures, ClearCount says, and other studies have shown that two thirds of all retained foreign bodies are surgical sponges. ClearCount first unveiled its RFID system about a year ago (see Surgical Sponges Get Smart).

The SmartSponge System has been redesigned so surgical teams can more easily—and accurately—verify the number of sponges at the start of an operation with the number of sponges actually used during the procedure. The system can be wheeled from OR to OR, and now has a built-in RFID interrogator that records the number of tagged sponges in pre-packs as workers set them on a tray affixed to the interrogator at the start of an operation.

After an operation, used sponges are discarded into a bucket, also affixed to the interrogator, which records the tags in discarded sponges. A small LCD screen displays the counts, confirming whether there's a match. Because each tag embedded into the sponge contains a unique ID number associated in the ClearCount software with a specific sponge type—either a laparotomy sponge or a 4 in. by 4 in. sponge—the system can also account for different sponge types. The SmartSponge System comes with an RFID interrogator in the form of a wand, enabling surgical teams to scan a patient during postoperative safety checks and locate any sponges mistakenly left behind.

Presently, surgical nurses must manually count the sponges (which have X-ray-detectable threads sewn into them) before and after every operation. If a discrepancy exists, hospitals must X-ray the patient as well. Since few operating rooms have a dedicated X-ray machine, one must be located and wheeled in, which can take time. In addition, radiologists have to be called to examine any X-rays taken, and even that isn't fail-proof, because if the sponge is hidden behind a bone, X-rays might not detect it.

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