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 (www.nothingleftbehind.org),
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. To top
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