RFID-based surgical sponge gains CE Mark

The world’s first RFID-based systems for counting and detecting surgical sponges, avoiding their accidental retention after surgery, have gained CE Mark approval.

The SmartSponge and SmartWand-DTX products from US patient safety specialist ClearCount are also the first RFID-based surgical products to gain approval for marketing in the EU.

ClearCount is currently pursuing commercial partners for European distribution of the two systems.

The SmartSponge is a Radio Frequency Identification (RFID) system that verifies sponge counts and detects sponges retained within the patient, uniquely identifying each sponge used during an operation.

Retained surgical items are estimated to occur in one of every 1,500 open abdominal or chest procedures, leading to serious complications including further surgery, infections and even death.

In the UK, nearly 800 missing or retained surgical swabs or instruments have been recorded by hospitals in a single year.

“CE Mark approval of our SmartSponge System and SmartWand-DTX represents a significant achievement and major milestone for our company,” said David Palmer, CEO of ClearCount.

“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.”

Based in Pittsburgh, ClearCount Medical Solutions is a medical device company specialising in patient safety solutions. The company received the 2009 Wall Street Journal Technology Innovation Award.