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.
ClearCount will be exhibiting its latest technology at Medica 2011, in Dusseldorf, Germany, November 16-19 in Hall 16,Stand G-05.