Surgical Sponges Get Smart

By Beth Bacheldor

July 26, 2006—In the next few months, Pittsburgh-based startup ClearCount Medical Solutions says it will introduce its first—and a first-of-its-kind—product: a surgical sponge with an embedded passive RFID tag about the size of a shirt button.

Called the SmartSponge System, the product is designed to prevent surgical teams from inadvertently leaving sponges inside surgical patients. While that's not an everyday occurrence, it does happen. According to ClearCount, recent studies have estimated that cases of retained foreign bodies occur between 1 out of every 100 to 1 out of every 5,000 surgical procedures, and studies have shown that two-thirds of all retained foreign bodies are surgical sponges.

Gautam Gandhi

With SmartSponge, surgical teams will be able to scan the patient with an RFID interrogator in the form of a wand during postoperative safety checks to find any sponges mistakenly left behind. The technology could supplant time-consuming manual counts done by at least two nurses several times during the course of a surgery, or costly and time-consuming X-rays that can detect threads sewn into the sponges.

ClearCount cofounders Gautam Gandhi and Steve Fleck first came up with the idea for SmartSponge while students at Carnegie-Mellon University. The two researched the problem and considered a variety of different RFID tag and reader technologies before realizing they'd have to design their own (the privately held company has declined to divulge technical specifics on its tags and readers). ClearCount now holds patents on the technology.

"The challenge we had was how to get the tag to be read through a body—with bone, muscle and flesh—and how to get an accurate read every time," Gandhi says. The read range between the tag and the interrogator had to be on average 15 inches, to account for the depth of a human body where a sponge might get left. In addition, the tags had to be able to withstand the standard sterilization process all sponges go through before being used during a surgery. After surgery, the sponges are thrown away.

ClearCount had tested its technology in a veterinary clinic, but the bigger question still remained: Would the system make economic sense?

"We knew it would work from a technological point of view," says Gandhi. "But we needed to find out if we would end up building a million-dollar mousetrap."

Consequently, ClearCount turned to Harrison Chow, clinical instructor and perioperative management fellow in Stanford University Medical Center's department of anesthesia, to conduct an independent economic analysis. In his study, which was developed using a spreadsheet economic model, Chow concluded that "RFID-tagged surgical sponges appear to be economically attractive from society's perspective, as long as this new technology approximately cuts in half the time nurses spend counting sponges in the OR."