FDA Clearance of SmartWand-DTX

ClearCount Medical Solutions has announced 510(k) clearance from the United States Food and Drug Administration (FDA) to begin commercialization of its lower cost SmartWand-DTX system. The SmartWand-DTX provides hospitals and surgery centers with a new patient safety tool that simply and easily augments their manual sponge counts while also providing positive identification and detection of retained surgical sponges. This complementary offering to ClearCount's award-winning SmartSponge System provides an economical and flexible approach to implementing the latest RFID technology.

By virtue of its ability to both count and detect, the system can be used to validate manual counting of all tagged sponges before, during, and after surgery. Further, the surgeon is able to scan the patient before closing to identify and locate unintentionally retained surgical sponges. The SmartWand-DTX is easy-to-use and provides more information than other detection systems. The system is not only compact and portable, it also allows for less waste than other options because it is reusable.

"This clearance to market is a significant milestone for our customers, employees and investors," says David Palmer, Chief Executive Officer of ClearCount. "We are commercializing a detection system that offers broad advantages over current offerings. SmartWand-DTX, in addition to our award-winning SmartSponge System, for the first time provides hospitals a choice of devices to best address the unique conditions of each O.R."

The Centers for Medicare and Medicaid Services (CMS) mandated as of October 2008 they would no longer reimburse for procedures associated with "never" events such as left-behind surgical sponges. Many private insurers are following suit. Published studies today indicate that one in every 1,000 to 1,500 intra-abdominal surgeries results in a sponge left behind in a patient. A retained sponge incident can lead to serious complications, including sepsis, unnecessary X-rays, need for repeat surgeries and even death.

ClearCount Medical Solutions is the only provider of RFID-based systems for the prevention of retained surgical sponges. The ClearCount SmartSponge System, for count reconciliation and detection of surgical sponges, has received multiple awards including Popular Science's Best of What's New in 2009. Both products are now available through Medline Industries, Inc., the nation's largest privately held manufacturer and distributor of healthcare supplies.