Ross company's product designed to keep better track of surgical sponges

By Steve Twedt, Pittsburgh Post-Gazette
John Colombo

David Palmer is CEO of ClearCount. A 2006 Archives of Surgery article looked at the results when ClearCount products were used in surgeries on eight patients at Stanford University. Every sponge was detected, on average within three seconds.

They are called "never events" because they are never supposed to happen.

But they do -- in an estimated one in 1,000 to 1,500 open abdominal surgeries, patients get wheeled out of an operating room with an undetected sponge or towel still inside of them.

A Ross business wants to reduce that number.

ClearCount Medical Solutions has developed a method to embed a computer chip into the 30 or so sponges and towels typically used during a surgery. The chip will respond to a low-level radio frequency wave so, using a wand, the surgical staff can locate misplaced sponges.

It also keeps a precise count of sponges before, during and after surgery, including their type and size.

If one is missing, "it's important to know that type of information because the surgeon has an idea of where they packed certain kinds of sponges," said Chief Executive Officer David Palmer.

The ability to wand over a patient is critical, he added, because most often the sponge gets left behind because of a miscount -- the surgical team incorrectly believes it has accounted for all sponges and instruments.

ClearCount "is the only product that can both count and detect surgical sponges," he said.

Those in the industry have known about ClearCount for more than two years, but the product only went on the market in April. Curtis Groppe, vice president for sales and marketing, said the company was nearing final negotiations with four health systems, including one with 14 hospitals, although none in Western Pennsylvania.

Early studies have been encouraging. A 2006 Archives of Surgery article looked at the results when ClearCount products were used in surgeries on eight patients at Stanford University. Every sponge was detected, on average within three seconds.

Beginning next month, hospitals will have added financial incentive to consider such products. As of Oct. 1, the federal Center for Medicare and Medicaid Services will no longer reimburse hospitals for the added cost of 27 different "never events," including surgeries to recover objects left behind. Payments to physicians are not affected, nor will the hospital be allowed to bill the patient.

"Clearly, everyone is aware of the new regulations, and we have noticed an increased interest in our product" because of it, Mr. Palmer said.

The company is marketing nearly a dozen different-sized sponges, with plans to increase the offerings. Mr. Palmer also said ClearCount has a $1 million grant from the National Institutes of Health to develop a means of tracking surgical instruments using radio frequency identification.

"It's not a matter of if we can do it. It's a matter of when we can do it."

Mr. Palmer estimates that the products will add about $20 to $40 to the cost of a procedure.

It's not that leaving sponges and towels inside a patient is common, but the implications are serious.

Last year, a Cleveland television station reported the case of Audrey Cimino, whose wound from an open heart surgery never seemed to heal. After three years, she went to a different surgeon who found a small strip of gauze that had been left behind from the earlier operation. Her body had reacted to the foreign object, causing an infection that wouldn't go away.

A 2003 New England Journal of Medicine study looked at 54 patients who had surgical sponges or instruments left in them following an operation, including a few where more than one sponge was left inside. Of those, 37 required another operation and one patient died. The study found the risk of having an object left inside a patient increases during emergency surgery, unplanned changes in the surgery or if the patient is overweight.

A separate study in the Journal of the American Medical Association published in June found that wireless systems can interfere with some surgical equipment, including ventilators, pacemakers and dialysis machines. But Mr. Palmer said the study, based in the Netherlands, did not test the frequency used in ClearCount products and did not account for other possible reasons for the interference.

ClearCount, he noted, has been cleared by the U.S. Food and Drug Administration.
Steve Twedt can be reached at stwedt@post-gazette.com or 412-263-1963.
First published on September 11, 2008 at 12:00 am

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