First and Only RFID-based Surgical Sponge Systems Bearing a CE Mark
PITTSBURGH--(BUSINESS WIRE)-- ClearCount Medical Solutions, a leader in patient safety solutions, announced today that it has received approval to affix the CE mark to its SmartSponge and SmartWand-DTX products. The SmartSponge product line is the first and only RFID-based surgical safety and efficiency technology bearing a CE mark.
The European Union requires companies to comply with the Medical Devices Directive (MDD) in order to sell medical devices in its 27 member countries. The CE mark is evidence that ClearCount and its product offerings meet the quality and other requirements of these directives. The Company is currently pursuing commercial partners to assist in European distribution.
"We have established a perfect safety record over the past two years in the United States. Our hospital customers have never experienced a retained surgical sponge while using our technology," said David Palmer, chief executive officer of ClearCount. "CE mark approval of our SmartSponge® System and SmartWand-DTX™ represents a significant achievement and major milestone for our Company."
ClearCount’s SmartSponge System is a Radio Frequency IDentification (RFID) based platform, providing a comprehensive solution that both verifies sponge counts and detects sponges if they remain in the patient. The system is able to provide a double layer of protection because it uniquely identifies each sponge used during surgery. To date, this counting and detection approach has made retained sponges a true “Never Event” in all operating rooms where ClearCount’s technology has been implemented.
Using manual procedures, retained surgical items are estimated to occur in one of every 1,500 open abdominal / chest procedures, leading to additional surgeries, unnecessary costs, serious infections and even death. In 2010, retained surgical items were the leading Sentinel Event reported to the Joint Commission, which accredits hospitals in the United States. It is also a global problem, though data on these adverse events is not always made public. However, in one example where the data is public, the United Kingdom reported nearly 800 missing or retained surgical swabs or instruments in a single year.1.
ClearCount will be exhibiting its latest technology at Medica 2011, in Dusseldorf, Germany, November 16-19 in Hall 16,Stand G-05. For more information, please visit www.clearcount.com.
About ClearCount Medical Solutions
ClearCount Medical Solutions is a medical device company focused on patient safety solutions. ClearCount has assembled an extendable RFID-based platform that provides a comprehensive solution to improve efficiency while preventing medical errors. ClearCount Medical Solutions has been recognized with a Popular Science 2009 Best of What’s New Award, and has received additional recognition from TIME and WIRED magazines, the 2009 Wall Street Journal Technology Innovation Award, the International Design Excellence Award (IDEA) and more. ClearCount’s SmartSponge and SmartWand-DTX systems are the first RFID enabled systems for counting and detecting surgical sponges, thereby improving patient and OR safety, enhancing productivity, and reducing cost. To learn more, visit www.clearcount.com.
SmartSponge System RFID-tagged OR Lap Sponge
1 NHS National Patient Safety Agency: National Reporting and Learning Service, Alert: NPSA/2009/PSA002/U1; WHO Surgical Safety Checklist, 27 January 2009, pg 10.
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