Medline Markets RFID System for Surgical Sponges

The system isn't meant to replace the process of manually recounting equipment following an operation, but rather provide a safeguard, says Port, who notes a study released by the New England Journal of Medicine in 2003 exemplifies his concerns. The study found 61 foreign objects in 54 out of 235 patients, of which 69 percent were sponges and 31 percent instruments.

The problem: Sponges are porous, which means that if they are left in a body, they can calcify over time, leading doctors to mistake them for tumors years after an operation. Port says patients go to doctors as adults with an infection only to discover they retained gauze inside their body from a childhood operation.

The RF-Detect handheld wand contains an RFID antenna.

Although surgical equipment is counted before and after each operating procedure, RF Surgical's Port estimates that "10 percent of counts after a complex operation are incorrect," and often solved by rummaging through mounds of blood-soaked sponges and gauze. "About 1 percent of all cases require an X-ray, which means waiting between 30 and 40 minutes for a technician to put on the correct attire and bring in a portable machine into the operating room to look for lost items," he says.

With approximately 20 million operations done in the United States annually, Port estimates RF Surgical could require its unnamed contract manufacturing facilities in China to produce about a billion tags each year to meet demand. And at a cost of about $50 for the tagged surgical sponges and gauze per operating procedure that could protect patients, the technology could catch on quick.

RF Surgical isn't the only company to develop an RFID system to count or detect objects unintentionally left inside surgical patients. Pittsburgh-based ClearCount Medical Solutions expects its SmartSponge System (see Surgical Sponges Get Smart) will gain FDA approval early in 2007, according to Gautam Gandhi, the company's cofounder and chief marketing officer.