4. November 2011 10:14
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.
14. October 2011 15:00
Mobisante has launched its MobiUS SP1 in the US, the world’s first smartphone-based ultrasound imaging system.
The device joins other portable point-of-care diagnostics that have recently entered the mobile health sector, including GE’s handheld visualisation tool Vscan and Siemens' Acuson P10.
The £4,700 MobiUS SP1 is designed for use in foetal, cardiac, pelvic, paediatric, musculoskeletal, peripheral vessel and abdominal imaging, providing the potential for enhanced patient care in any location, even remote areas.
The mobile health technology uses both cellular and WiFi networks, and consists of a Windows Mobile 6.5-based Toshiba TG01 smartphone, an ultrasound probe and computer software.
The manufacturer claims that the system could also be more suitable for use in low-income regions than traditional ultrasound equipment due to its lower operating costs and the increased convenience it would provide for patients.
Mobisante actually received FDA clearance for the device in February 2011, but it took eight months to implement necessary FDA-mandated controls.
The company is exploring the option of making a version of the product for healthcare-specific tablet computers as well.