ClearCount Medical Solutions has announced that its patented SmartSponge System, which uses radio frequency identification (RFID) tags attached to surgical sponges, has received US Food and Drug Administration (FDA) 510(k) clearance.
The system uses Texas Instruments’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.
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.”