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Surgical Sponges Get Smart
Next, Gautam and Fleck got in touch with Alex Macario, a physician and professor of anesthesia at Stanford University Medical Center, to plan a study involving humans. In early 2005, Macario oversaw a trial that tested the technology on eight patients undergoing abdominal or pelvic surgery. The trial included eight untagged sponges that served as the control to ascertain if the wand could detect non-tagged sponges (the researchers determined it could not), and 28 RFID sponges, according to a report published in the July issue of American Medical Association's Archives of Surgery by Macario and his two coauthors, both of whom own several patents related to tagged sponges and work for ClearCount.
During the trial, a surgeon placed one RFID sponge in the patient just before closure. The edges of the wound were pulled together "so that the inside of the cavity was not exposed during the detection experiments," according to the report. A second surgeon, who purposely did not watch the first surgeon place the sponge, then used the wand to find the sponge.
The wand detected all sponges correctly in less than three seconds, and there were no false-positive or false-negative results.
Gandhi says the trial yielded some additional information about the system, too.
"The surgeons all liked the concept, but some people felt that maybe the wand was a little bigger than what they had expected," he says. "But once they used it and felt how light it was, they liked it."
Also, there was concern about introducing a new step—the scanning of the patient with the wand—into the surgical process. "As a layman, you might think, 'What is the big deal?'" says Gandhi. "But when you consider a four-hour surgery, five seconds might seem important."
Gandhi and Fleck concluded the technology they were developing was economically and technologically justifiable. "The cost of the chips are declining rapidly," Gandhi says.
More importantly, if a sponge count at the end of a surgery is less than the sponge count at the start, hospitals typically call for an X-ray. Most operating rooms don't have a dedicated X-ray machine, so one has to be located and wheeled in, which can take time. In addition, radiologists have to be brought in to look at any X-rays taken. "That can all take 20 minutes, and an X-ray isn't foolproof. If the sponge is behind bone, the X-ray won't show the sponge," Gandhi says.
Of course, most importantly, if a sponge is left in, he says, "people can die."
ClearCount's SmartSponge System can count multiple sponges at once, but won't count the same sponge twice, and has the ability to distinguish different types of sponges, although Gandhi declined to explain how the system accomplishes this.
The company plans to begin shipping the sponges this fall but has yet to determine how they will be sold and distributed.
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During the trial, a surgeon placed one RFID sponge in the patient just before closure. The edges of the wound were pulled together "so that the inside of the cavity was not exposed during the detection experiments," according to the report. A second surgeon, who purposely did not watch the first surgeon place the sponge, then used the wand to find the sponge.
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| Steve Fleck |
Gandhi says the trial yielded some additional information about the system, too.
"The surgeons all liked the concept, but some people felt that maybe the wand was a little bigger than what they had expected," he says. "But once they used it and felt how light it was, they liked it."
Also, there was concern about introducing a new step—the scanning of the patient with the wand—into the surgical process. "As a layman, you might think, 'What is the big deal?'" says Gandhi. "But when you consider a four-hour surgery, five seconds might seem important."
Gandhi and Fleck concluded the technology they were developing was economically and technologically justifiable. "The cost of the chips are declining rapidly," Gandhi says.
More importantly, if a sponge count at the end of a surgery is less than the sponge count at the start, hospitals typically call for an X-ray. Most operating rooms don't have a dedicated X-ray machine, so one has to be located and wheeled in, which can take time. In addition, radiologists have to be brought in to look at any X-rays taken. "That can all take 20 minutes, and an X-ray isn't foolproof. If the sponge is behind bone, the X-ray won't show the sponge," Gandhi says.
Of course, most importantly, if a sponge is left in, he says, "people can die."
ClearCount's SmartSponge System can count multiple sponges at once, but won't count the same sponge twice, and has the ability to distinguish different types of sponges, although Gandhi declined to explain how the system accomplishes this.
The company plans to begin shipping the sponges this fall but has yet to determine how they will be sold and distributed.
