June 13, 2007 — ClearCount Medical Solutions announced its patented SmartSponge System based on radio frequency identification (RFID) received Food and Drug Administration (FDA) 510(k) clearance.
David Palmer, ClearCount's President & CEO said, "We are optimistic the SmartSponge System will address the pervasive problem of retained surgical sponges. 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," he said
ClearCount's 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. Steve Fleck, Co-Founder and Chief Technology Officer added, "Unlike other technologies, ClearCount's RFID-based SmartSponge System allows users to simultaneously count and differentiate between types of sponges. Additionally, since RFID does not require a line-of-sight between the reader and tags, there is no need to physically separate sponges or orient the tags in any way to scan them.”
According to another study in Massachusetts, foreign objects were left in the body in one out of every 10,000 surgeries. Those objects added four days to an average hospital stay and resulted in 57 deaths in 2000. Two-thirds of all objects left in the body cavity were surgical sponges.
For more information: www.clearcount.com