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
"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
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
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.