No Souvenirs

Using RFID, one firm makes sure that sponges don't go home with surgical patients

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Patients who undergo surgery aren’t keen on souvenirs. Most draw the line at a scar. But some will go home with an internal takeaway — a surgical sponge left inside them. The majority of U.S. hospitals still use traditional sponges that nurses count manually. (They also count instruments.) But an increasing number have switched to more technologically sophisticated sponge systems that automate the counting to enhance patient safety.

This spring, Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City became the first hospital to switch to the SmartSponge System — a technology that features chip-embedded sponges — created by ClearCount Medical Solutions, a five-year-old company in Pittsburgh, Pa. It relies on radio-frequency identification (RFID) technology. “Ours is the only FDA-cleared system that uses radio-frequency identification to both count and locate surgical sponges,” says David Palmer, ClearCount’s CEO. He expects revenues to reach $8 million this year and $27 million in 2010.

(See pictures of ClearCount and its products.)

Using ClearCount’s system, nurses scan packages of sponges before an operation. The technology verifies and counts each sponge’s internal chip, recording the total in an In column on a display monitor. Used sponges are tossed — either singly or in a compressed wad — into a receptacle with a built-in sensing device that again verifies each chip and tallies the Outs. Ideally, the figures in those two columns match. If not, the number of missing sponges appears in a third column, aptly titled Find. That’s a signal to spring for the wand, which digitally homes in on sponges still inside the patient.

For surgical nurses charged with counting sponges, the device has promise. “Nurses are willing to embrace new technology as long as it doesn’t complicate their work flow or compromise the timing and sequence of their counting,” says Steven Fleck, ClearCount’s co-founder and CTO. At MSKCC, the prospect of improved patient safety and work efficiency won over Michelle Burke, director of perioperative services, and her staff. “One surgeon even tested the detection system for himself by hiding sponges in a corner of the operating room, and the technology located them,” says Burke, who bought 21 of the $15,000 devices.

Large hospitals house 20 to 30 operating rooms and go through hundreds of thousands of sponges a year. Burke acknowledges that adopting the system will significantly escalate sponge costs, but for hospitals there’s a cost-benefit trade-off. Using ClearCount sponges increases the cost of each surgical procedure by an average of $30. Yet the cost of surgical miscues may make the use of systems like ClearCount’s a relative bargain. In 2008 the Centers for Medicare and Medicaid Services stopped reimbursing hospitals for some of the patient care tied to preventable complications, like those caused when objects are left inside patients during surgery. “Many hospitals have begun to more seriously address these ‘never events’ — as in ‘never should happen,’” says ClearCount’s Palmer. “There is a high cost — delays in the surgical schedule, as well as litigation and bad publicity — when hospitals do not take proactive measures.”

At a hospital where 30,000 operations are performed a year, having three or four of these incidents annually is not uncommon, says Dr. Atul Gawande, a surgeon at Brigham and Women’s Hospital in Boston, who has researched medical errors linked to surgical sponges. “Our studies show that automated sponge-counting systems make things markedly safer,” he says. He believes these systems will be standard within five or 10 years.

ClearCount is banking on it. During the past year, the company has sent its SmartSponge System for evaluation to three dozen hospitals, several of which have committed to buy it. The company expects a similar response next year when it expands globally.

Sponges are yet another promising area where RFID has popped up in hospitals. ClearCount plans to expand its tracking to surgical instruments. And more applications await — for instance, ensuring that blood products are delivered with complete accuracy by equipping patients with an RFID device. After all, the first rule of medicine is to do no harm.

TIME’s Coeli Carr profiles the ClearCount System