Surgery, information technology

RFID surgical sponge counting system approved

19 June 2007

Pittsburgh, USA. ClearCount Medical Solutions has announced that its patented SmartSponge System, which uses radio frequency identification (RFID) tags attached to surgical sponges, has received US Food and Drug Administration (FDA) 510(k) clearance.

The system uses Texas Instruments'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.

David Palmer, ClearCount's President & CEO said, "We are optimistic the SmartSponge System will address the pervasive problem of retained surgical sponges. 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."

Steve Fleck, Co-Founder and Chief Technology Officer added, "Unlike other technologies, ClearCount's RFID-based SmartSponge System allows users to simultaneously count and differentiate between types of sponges. Additionally, since RFID does not 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, Co-Founder and Chief Marketing Officer, said, "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."

According to Verna Gibbs MD, director of the No Thing Left Behind initiative (, which aims to prevent retained surgical items, "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. These events are the product of poor communication and faulty processes of care that cause patient injury."

Current 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. When there is a discrepancy in the counts, at most hospitals, 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 in order 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.

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