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ClearCount: Keeping Closer Track of Surgical Instruments

Kelly Smith went into the hospital for what she expected to be a routine procedure-a hernia removal. Her doctors said the surgery went fine, but after she got home, Kelly’s pain didn’t seem to be easing at all, even after two weeks. In fact, it was getting worse.

ClearCount

Every 120 minutes, a patient is sewn back together after surgery with an instrument or surgical sponge left inside the body. ClearCount’s radio frequency identification (RFID) tags, which are smaller than a penny, can help doctors better track their instruments—saving the health care industry over a billion dollars in procedural and legal costs every year.

When her surgical team investigated the source of her pain, they found that though they had removed her hernia, they’d left something in exchange-a surgical sponge. Luckily, they were able to surgically remove the sponge before it caused a nasty infection.

Every 120 minutes, a patient like Kelly is sewn back together after surgery with an instrument or surgical sponge left inside the body. Such mistakes cause pain and increased recuperation time for patients-and cost the health care industry over a billion dollars in procedural and legal costs every year.

Tracking Instruments Throughout the Surgery

To prevent surgical sponges from being left in patients, surgical teams count all sponges before and after the procedure to make sure they’re accounted for. But human error sometimes intervenes, and miscounts can and do happen. To combat this problem, ClearCount Medical Solutions, Inc., has developed a radio frequency identification (RFID) solution, allowing surgical sponges to be counted and located easily before the patient’s surgical site is closed.

According to David Palmer, president and CEO, “The RFID tags allow surgical teams to track all the surgical sponges in the operating room to help prevent retained foreign bodies,” which is the term used in the medical community for surgical instruments left in patients.

ClearCount’s system includes both surgical sponges with tags and a counting device used to track them. The RFID tags are tiny microchips sewn directly into the surgical sponges. They act as transponders, listening for a radio signal sent by the scanner, which keeps continuous track of how many sponges are introduced into the body and how many have been removed.

“If the counter reveals that the count is off, a wand can be waved over the patient as a secondary check to determine if the missing sponge is still in the body cavity,” says Palmer.

Support in the Startup Stage

Pittsburgh-based ClearCount was formed in 2004 with support in part from Ben Franklin Technology Partners (BFTP), which recently pledged a third round of funding for a total of $300,000 in financial support. BFTP is also providing expert consultation on the company’s sales and marketing strategy.

Palmer says that the company, which currently employs eight people, plans to grow larger in the future. “We just received a phase II SBIR [Small Business Innovation and Research] grant for over a million dollars to focus on tracking surgical instruments,” he says. “Thanks in large part to Ben Franklin’s guidance, we view our product as a platform technology. There are so many applications for RFID in the operating room. Surgical sponges are just the first in a series.”

Staying Ahead of the Competition

ClearCount’s system, which will be available to hospitals in the second quarter of 2007, has distinct advantages over competing products. There is a bar-coding technology that helps surgical staffs count sponges, but it requires line of site to do the counting, and it doesn’t allow for detection of the sponges. In addition, there’s an RFID product that allows surgical staffs to scan the body cavity, but it doesn’t help them count the sponges. ClearCount can both count and detect.

ClearCount originated from graduate research by Steve Fleck and Gautam Gandhi, two graduate students at Carnegie-Mellon University. “Steve and Gautam had the foresight to apply this technology in the operating room environment,” Palmer says. Both founders are still involved with the company: Fleck is ClearCount’s chief technology officer, and Gandhi is the chief sales and marketing officer. Palmer came on board as CEO in July 2006.

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This article was featured in
Keynotes February, 2007
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