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.

Hologic, a manufacturer of diagnostics, surgical products and medical imaging technology for women, has received FDA clearance for its Trident specimen radiography system.

The device uses the company’s proprietary direct digital detector technology to produce high quality images of tissue samples, aiming to reduce procedure steps, streamline workflow and increase accuracy.

Peter Soltani, Senior Vice President and General Manager for Breast Health, said: “Our goal is to provide leading-edge technologies that improve the diagnostic precision of procedures and create a better experience for patients and their healthcare providers.”

The Trident is designed for use in the operating room where breast tissue is surgically excised, and in biopsy suites where minimally-invasive breast biopsies are performed.

Based in Massachusetts, USA, Hologic is a developer, manufacturer and supplier of diagnostics, medical imaging systems and surgical products dedicated to the healthcare needs of women with a focus on breast health, diagnostics, GYN surgical, and skeletal health.