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FDA Compliance

FDA Clears World’s First RFID Surgical Sponge-Counting System

Published: Tuesday, June 26, 2007 - 22:00

(ClearCount Medical Solutions: Pittsburgh) -- The patented SmartSponge System, built by ClearCount Medical Solutions of Pittsburgh and based on radio frequency identification (RFID) has received Food and Drug Administration 510(k) clearance.“We are optimistic the SmartSponge System will address the pervasive problem of retained surgical sponges,” says David Palmer, ClearCount’s president and CEO. “This is the world’s first RFID system that detects and counts surgical sponges and towels during surgical procedures. With an estimated 3,000–5,000 incidents a year, retained surgical sponges are a considerable problem. The SmartSponge System can improve patient safety and efficiency by alerting staff when there is a missing sponge.”

The ClearCount SmartSponge System is a novel, RFID-based solution that was designed after extensive work with nurses and surgeons at leading healthcare institutions. The SmartSponge System uses Texas Instruments Inc.’s Tag-it HF-I portfolio of high-frequency products to automate the process of managing surgical sponges during surgery. The sponges are permanently affixed with passive RFID tags smaller than a dime.

“Unlike other technologies, ClearCount’s RFID-based SmartSponge System allows users to simultaneously count and differentiate between types of sponges,” says Steve Fleck, ClearCount’s cofounder and chief technology officer. “Additionally, since RFID doesn’t require a line of sight between the reader and tags, there is no need to physically separate sponges or orient the tags in any way to scan them. This minimizes the handling of soiled sponges by nursing staff.”

Gautam Gandhi, cofounder and chief marketing officer, says, “A retained sponge incident can lead to serious complications, including sepsis, unnecessary X-rays, need for repeat surgeries, and even death. The economic benefit is clear—the SmartSponge System advances operating room safety and reduces hospital and surgeon liability.”

“The problem of surgical sponges being left behind in various body spaces is something that every surgeon and perioperative care nurse in this country has at least thought about, even if they have not directly experienced the problem,” according to Verna Gibbs M.D., director of the “No Thing Left Behind” initiative, which aims to prevent retained surgical items (www.nothingleftbehind.org). “These events are the product of poor communication and faulty processes of care that cause patient injury. The ClearCount SmartSponge System is an ingenious and simple solution to address both problems in communication and problems in counting practices. This is an exciting new modality which could help surgeons and nurses do a better job in the operating room, and deserves to be evaluated.”

ClearCount Medical Solutions previously supported a study titled “Initial clinical evaluation of a hand-held device for detecting retained surgical gauze sponges using radio frequency identification technology.” The study was published in the medical journal, Archives of Surgery in 2006. Alex Macario, M.D., professor of anesthesia at the Stanford University School of Medicine and lead author of the study, says that although procedures are in place to track objects during surgery, errors do still occur. “This risk significantly increases in emergencies, with unplanned changes in procedure and with patients that have a higher body-mass index,” he says.

Current standard procedures for tracking instruments and sponges involve a baseline count before surgery begins, a second count before the surgeon begins sewing the incision, a third count at wound closure, and a final count before closing the skin. This manual process is time-consuming and subject to human error. At most hospitals, when there’s a discrepancy in the counts, an X-ray is required before leaving the operating room. Additionally, many hospitals call for X-rays for high-risk cases such as emergencies, transplants, and surgeries greater than five hours to assure no retained objects.

ClearCount expects to make available a commercial solution that fully integrates into the current workflow of the operating room by the end of this year.

For more information, visit www.clearcount.com/news/clearcount_fda_approval_press_release1.pdf.

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