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FDA Clears World’s First RFID Surgical Sponge-Counting System

Quality Digest
Tue, 06/26/2007 - 22:00
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(ClearCount Medical Solutions: Pittsburgh) -- The patented SmartSponge System, built by ClearCount Medical Solutions of Pittsburgh and based on radio frequency identification (RFID) has received Food and Drug Administration 510(k) clearance.“We are optimistic the SmartSponge System will address the pervasive problem of retained surgical sponges,” says David Palmer, ClearCount’s president and CEO. “This is the world’s first RFID system that detects and counts surgical sponges and towels during surgical procedures. With an estimated 3,000–5,000 incidents a year, retained surgical sponges are a considerable problem. The SmartSponge System can improve patient safety and efficiency by alerting staff when there is a missing sponge.”

The ClearCount SmartSponge System is a novel, RFID-based solution that was designed after extensive work with nurses and surgeons at leading healthcare institutions. The SmartSponge System uses Texas Instruments Inc.’s Tag-it HF-I portfolio of high-frequency products to automate the process of managing surgical sponges during surgery. The sponges are permanently affixed with passive RFID tags smaller than a dime.

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