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RFID-enabled Surgical Sponges a Step Closer to OR
When ClearCount first designed the system, it only included the RFID-enabled wand. More research and feedback from the clinical trials underway, however, led to its redesigning the system and including an RFID interrogator that would automate the counting of sponges before and after operations. "When you just use the wand, you would scan the patient, and unless something is found, there's no feedback," says Gautam Gandhi, who co-founded the company with Steve Fleck. "So the question was, 'Is it working, or is there really nothing found?'"
Hospitals need to count sponges before and after operations. Not only are manual counts time-consuming, however, errors can—and are—made. "That is the biggest problem," Gandhi says. Statistics show that in 85 percent of cases where a surgical sponge was left behind in a patient, the nurses' counts appeared correct.
Thus, the ClearCount team started working on a redesign that could assist in the manual counting, both before an operation and upon its completion. The new design includes an interrogator that automatically counts sponges beforehand and afterward. This, Gandhi says, provides greater assurance that no sponges are left inside patients' bodies. "If the counts don't correlate," he explains, "that tells you something is missing—and if that happens, you'd never let a patient go."
For added assurance, ClearCount recommends surgical teams scan every patient with the wand after surgery. "It only takes five seconds, so you might as well," Gandhi says. By the end of 2007 or early 2008, the firm expects to make a commercial solution available that can be implemented in operating rooms and integrated with surgical processes.
ClearCount has been testing its system in a series of clinical trials run by the No Thing Left Behind project since April 2006. "This is a multi-center study to look at the way the SmartSponge system works" says Verna C. Gibbs, MD, "and the goal is to test the system in 400 to 500 operations, conducted in five different centers throughout the United States." Gibbs, a consultant with the No Thing Left Behind project, is a professor of clinical surgery at the University of California, San Francisco (UCSF) and an attending surgeon at the U.S. Department of Veterans Affairs' San Francisco VA Medical Center.
According to Gibbs, the project team is about half-way through the clinical trial, and will now begin testing the re-designed SmartSponge System for the remainder of the pilot. The RFID-enabled sponges are utilized "exactly the same way they would be used in any other case. They function in the same way, and the surgeons use them in the same way," Gibbs says, noting that manual counts are still conducted for each operation nonetheless. "The standard of care has been that a manual count of all sponges is always done, so in the clinical trial, of course there is always a manual count." Gibbs could not release any findings from the clinical trials, because they are still ongoing.
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Hospitals need to count sponges before and after operations. Not only are manual counts time-consuming, however, errors can—and are—made. "That is the biggest problem," Gandhi says. Statistics show that in 85 percent of cases where a surgical sponge was left behind in a patient, the nurses' counts appeared correct.
Thus, the ClearCount team started working on a redesign that could assist in the manual counting, both before an operation and upon its completion. The new design includes an interrogator that automatically counts sponges beforehand and afterward. This, Gandhi says, provides greater assurance that no sponges are left inside patients' bodies. "If the counts don't correlate," he explains, "that tells you something is missing—and if that happens, you'd never let a patient go."
For added assurance, ClearCount recommends surgical teams scan every patient with the wand after surgery. "It only takes five seconds, so you might as well," Gandhi says. By the end of 2007 or early 2008, the firm expects to make a commercial solution available that can be implemented in operating rooms and integrated with surgical processes.
According to Gibbs, the project team is about half-way through the clinical trial, and will now begin testing the re-designed SmartSponge System for the remainder of the pilot. The RFID-enabled sponges are utilized "exactly the same way they would be used in any other case. They function in the same way, and the surgeons use them in the same way," Gibbs says, noting that manual counts are still conducted for each operation nonetheless. "The standard of care has been that a manual count of all sponges is always done, so in the clinical trial, of course there is always a manual count." Gibbs could not release any findings from the clinical trials, because they are still ongoing.
