Healthcare Industry News:  Medline 

Devices Surgery FDA

 News Release - November 7, 2006

RF Surgical Systems, Inc. and Medline Announce Regulatory Clearance to Market RF-Detect, a Breakthrough Surgical Detection System

RF-Detect will enhance patient safety by helping to prevent the retention of surgical sponges.

BELLEVUE, Wash.--(HSMN NewsFeed)--RF Surgical Systems Inc. and Medline Industries Inc announced regulatory clearance today by the U.S. Food and Drug Administration of RF-Detect, a patented surgical disposable detection system for surgical gauze, towels and sponges on the United States market. RF-Detect will help protect patients by accurately alerting the user when the RF-tagged surgical disposables remain in the patient before surgical closing procedures. Developed by RF Surgical, the system will be exclusively distributed by Medline, the nation's largest privately held manufacturer and distributor of medical supplies.

Retained surgical sponges are one of the leading safety concerns in operating rooms across the country. According to a study in the New England Journal of Medicine, retained surgical sponges occur at an estimated rate of 1 of every 1000 to 1,500 intra-abdominal operations. This type of incident can lead to serious complications including infection, the need for re-operation and even death.

Until RF-Detect, counting was the only mechanism for preventing sponges from being left in patients. Operating room staff are required to count sponges three times: once before surgery, once during, and again when the incision is closed to determine that the number of sponges going into the patient matches the number that are taken out. If these numbers do not match, an x-ray is taken to determine if the object can be seen within the patient. The counting system is time consuming, subject to human error and exposes staff to potentially hazardous material.

RF Surgical Systems Inc. has developed RF-Detect, a patented detection system that accurately alerts the user when RF-tagged surgical disposables remain in the patient before surgical closing procedures. The System consists of three components: a micro RF tag imbedded in gauze, sponges and towels; a sterile handheld wand that is connected to the third component; an easy-to-use, self-calibrating consul. By passing the wand over the patient, hospital personnel will be able to accurately detect, within seconds, retained tagged surgical disposables before surgical closure. The system was developed over a number of years by co-founders of RF Surgical, Chairman Jeffery Port, MD, a thoracic surgeon and Chief Technology Officer William Blair, an electrical engineer. RF-Detect does not detect non-tagged surgical items.

"The RF system provides an additional layer of safety for patients undergoing surgical procedures. While other groups have attempted to adapt bulky, expensive RFID tags to this medical application, this system is the first small, low cost, accurate, custom product for this troubling health care problem," said RF Surgical Chairman Jeffery Port, M.D.

"The RF Surgical detection system provides a better way to manage RF-tagged retained surgical disposables and provides an additional layer of safety for surgical patients. This is another important step for Medline in its commitment to patient safety," said Medline Primary Care Division President Jack Bowser "Bringing products such as RF-Detect to market is a critical part of our partnership in national patient safety campaigns including the Surgical Care Improvement Project (SCIP). We're excited to introduce this breakthrough product to our customers."

About RF Surgical Systems, Inc.

RF Surgical Systems is a privately held medical device company headquartered in Bellevue, Washington and maintains engineering R & D facilities in San Diego, California. Founded by Dr. Jeffrey Port, a Thoracic Surgeon, and Mr. William Blair, an Electrical Engineer, the company's goal is to provide a better way to prevent retained surgical objects. For more information, please visit www.rfsurg.com

About Medline

Medline, headquartered in Mundelein, IL, manufactures and distributes more than 100,000 products to hospitals, extended care facilities, surgery centers, home care dealers and agencies and other markets. Medline has more than 700 dedicated sales representatives nationwide to support its broad product line and cost management services.

Meeting the highest level of national and international quality standards, Medline is FDA QSR compliant and ISO 13485 registered. Medline serves on major industry quality committees to develop guidelines and standards for medical product use including the FDA Midwest Steering Committee, AAMI Sterilization and Packaging Committee and various ASTM committees. For more information on Medline visit our Web site. www.Medline.com


Source: Medline

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