14th June 2007

The SmartSponge System has been developed by Pittsburgh-based ClearCount Medical Solutions. The system was designed to replace manual counting using sponge counter bags. It consists of a handheld wand-scanning device used to detect commonly used surgical gauze sponges that have been fitted with a radiofrequency identification (RFID) chip approximately the size of a penny.

When a transponder RFID chip sewn onto the sponge receives a certain radio query, the sponge responds with a unique ID code back to the scanner. RFID tags are powered by the radio signal from the scanner. These broadcast signals are designed to be read between a few inches and several feet away, depending on the size and power driving the RFID tags.

Items that have been unintentionally left behind in patients following surgery are referred to as retained foreign bodies. While surgical sponges account for the majority of incidents, needles, knife blades, and other surgical instruments have been reported as well. Recent studies have estimated that cases of retained foreign bodies occur between 1 out of every 100 to 1 out of every 5000 surgical procedures. Gossypiboma is the technical term for a retained surgical sponge.

X-Rays are the last line of defense against retained bodies when manual counts do not match. Over 1.5 million x-rays are taken each year to detect retained bodies. A typical x-ray costs over $200, wastes valuable time, and is subject to a false negative error rate of up to 20%. X-rays used to check for retained objects represent a cost of $375 million each year in the U.S.

ClearCount announced this week that the SmartSponge System has received Food and Drug Administration (FDA) 510(k) clearance.

ClearCount Medical Solutions is a privately held company, founded out of Carnegie Mellon University to address novel ways of preventing retained foreign bodies and to improve surgical safety.

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