RF Surgical Pioneers Detection and Prevention of Retained Foreign Objects in Surgery With Its Next Generation RF Assure™ Detection System

Radio frequency surgical detection technology enables powerful, automatic scanning and novel reporting capabilities.

Bellevue, Washington, November 3, 2010—RF Surgical Systems, Inc., the market leader in the prevention and detection of retained surgical sponges, announced the availability of the RF Assure™ Detection System Model 200. This next generation platform, powered by RF Surgical’s market-leading radio-frequency detection technology, features an ingenious automatic detection mat for “hands-free” patient scanning, an easy-to-operate touchscreen color display, a new patient data recording module and a powerful processor to enable fast, accurate and reliable scanning while promoting staff confidence and compliance.

Despite strict counting protocols, surgical sponges are sometimes unintentionally left inside patients after wound closure. These “never events” are a potential source of morbidity for patients and a liability for care providers and institutions. The RF Assure Detection System offers surgical teams reassurance during wound closure that no missing sponges are unintentionally left inside the patient.

With the push of a button, the RF Assure Detection System is able to perform a complete mat scan in 15 seconds without disrupting the surgical field. The RF Surgical Detection Technology has shown to be effective in mitigating the risk of a retained sponge regardless if the surgical counts are correct, and even during high-pressure, emergency “no time to count” procedures, such as trauma cases. The new hands-free scanning functionality minimizes workflow disruption and reduces potential human errors. The system offers a unique dual-detection mode with the Blair-Port Wand® that can still be used to perform a quick scan to rectify sponge counts and is useful for extended coverage in cardiac, trauma and bariatric cases.

The new RF Assure Detection platform includes the following upgrades:

• Detection Mat – Placed on top of the surgical table pad and underneath the drapes/pad covers, the mat features six radiolucent, X-ray compatible antennas that automatically scan for retained surgical items fitted with an RF tag.
• Intuitive User Interface –The system console features a touch-screen with clear, color-coded visuals for less distraction and improved feedback to operating room staff during surgery. Case information can be retrieved directly from the console on-demand.
• Reporting and Compliance– Confirmation of scanning is displayed and recorded after each scan and can later be associated to patient medical records for improved compliance and reduced hospital liability.
• Efficiency – Automatic scanning can reduce time to resolve surgical material miscounts by operating room staff and helps avoid unnecessary X-rays to locate the missing items, potentially reducing the time the patient is under anesthesia and promoting a higher level of patient safety and other cost benefits.
• Bariatric Scanning Capabilities – The system accommodates high Body Mass Index (BMI) patients and offers the only dual detection mode in the market allowing the surgical staff to use the Blair-Port Wand and RF Assure Mat in tandem to gain extended detection range.

Interim results of the first and largest multi-center prospective study on the effectiveness of radio-frequency detection technology to improve surgical counts and staff wound closure confidence were presented last month at the American College of Surgeons Clinical Congress meeting by a team of researchers from the University of North Carolina, Chapel Hill. According to the data, RF Surgical Detection Technology can help avoid the use of radiation to locate missing sponges regardless of whether the surgical counts are correct, help to quickly rectify miscounts and, in almost 90 percent of operations, surgical staff reported RF detection improved overall confidence that no retained surgical sponges were left in the patient.

“Although uncommon, discrepancies in the surgical count can expose a patient to unnecessary risks, including radiation, and increase the likelihood of surgical site infections. RF Detection, as an adjunct inspection technology, increases the safety and confidence of the operating room staff and is an important complement to manual counting,” said Dr. Christopher Clarence Rupp, surgeon and principal investigator at UNC Health Care. “In trauma and emergency procedures, the RF Assure System can help to ensure a patient’s safety without adding additional, cumbersome steps.”

The Association of periOperative Registered Nurses (AORN) recently issued revised Recommended Practices for Prevention of Retained Surgical Items which includes a new recommendation that perioperative staff members evaluate adjunct detection technologies to supplement surgical count procedures. (Limitations of the Surgical Count, Victoria M. Steelman, PhD, RN, CNOR, FAAN, AORN Board of Directors, August 12, 2010)1.

About the RF Assure Detection System
Cleared by the U.S. Food and Drug Administration (FDA) in 2006, the RF Surgical Detection System was the first medical device solution to address the problem of retained surgical sponges in patients. The System safely and accurately reads through deep cavity tissue, fluids and bone to detect if radio frequency tagged surgical sponges, gauze or towels remain in a patient following surgery. The system utilizes low energy, low-frequency passive tags which are understood to perform well in fluids and around metals. The system consists of a self-calibrating console, hand-held wand, radiolucent soft mat, RFmicro-tags and gauze, sponge supplies and is designed for all open-cavity surgeries including emergency, trauma, labor and delivery. To date, it has been used in more than 1,000,000 surgical procedures nationwide.

About RF Surgical Systems, Inc.
RF Surgical Systems, Inc. is the market leader in the prevention and detection of retained surgical sponges. The RF Surgical Detection System is the preferred solution in more than 1,000 operating rooms, trauma and labor & delivery suites nationwide. RF Surgical Systems is based in Bellevue, Washington with R & D facilities in San Diego, California. The advanced technologies used in the RF Surgical Detection System are protected by U.S. patents. Regulatory clearance to market the system was granted by the U.S. Food and Drug Administration in November 2006. The company is online at www.rfsurg.com.

1 Association of periOperative Registered Nurses (AORN). Board of Directors Webinar Series: Limitations of the Surgical Count. August 12, 2010. https://aorn.org/Education/Webinars/PreviouslyRecordedWebinars/