Thursday, January 14, 2010

Medline to Distribute Only FDA-Cleared System to Both Count and Locate Surgical Sponges Left in Patients

Here's an interesting press release that I wanted to share:

Medline to Distribute Only FDA-Cleared System to Both Count and Locate Surgical Sponges Left in Patients

Medline Extends Its "Prevention Above All" Priority Through Exclusive Distribution Agreement With ClearCount Medical Solutions

MUNDELEIN, IL--(Marketwire - January 13, 2010) - Medline Industries, Inc. has been named the exclusive distributor for the SmartWand-DTX™ and SmartSponge® System, the only FDA-cleared systems using radio-frequency identification to both count and locate surgical sponges. The systems, created by ClearCount Medical Solutions, use a technology featuring chip-embedded sponges to count and locate sponges during surgery which, in turn, helps eliminate surgical errors and improve patient safety.

Retained surgical sponges are a big problem. They can hurt and even kill affected patients and cost hospitals an average of $63,000 in follow-up operation expenses (according to Federal Register and Medicare statistics) per incident, not including legal fees and potentially large settlements. Human counting error is the most common cause of unaccounted-for sponges being left behind. Integrating radio frequency identification (RFID) chip technology into surgical sponges -- the sterile, absorbent textiles used inside a patient during an operation -- gives surgeons and operating room teams a new tool to prevent the anxiety of a potentially devastating operating room error.

Conceptually, the process is a little like finding a coin on the beach with a metal detector, but much more high-tech and precise. Each sponge has its own ID number coded in its RFID tag. The SmartSponge System can read and record the unique ID number of each sponge as it comes out of its packaging in the OR, as it is used in the patient, and as it is removed and disposed of. Both the SmartSponge and SmartWand-DTX count multiple sponges and read through blood and tissue, and they can locate a missing tagged sponge using radio waves to signal the RFID tag to identify itself. Both systems also use the same RFID-tagged consumables, providing hospitals for the first time with a choice of devices to best address the unique conditions of each OR.

Despite designation as a "never event," retained items are estimated to occur in one of every 1,000 to 1,500 abdominal surgical procedures. In one study using a retrospective review of medical malpractice claims data from a statewide insurer in Massachusetts, sponge counts had been falsely correct in 76 percent of non-vaginal surgical cases involving retained sponges. Falsely correct sponge counts were attributed to team fatigue, difficult or long operations, sponges "sticking together," shift changes or procedures with a large number of sponges.

About ClearCount Medical Solutions

ClearCount Medical Solutions is a medical device company focused on patient safety solutions. ClearCount has assembled an extendable RFID-based platform that provides a comprehensive solution to improve efficiency while preventing medical errors. ClearCount Medical Solutions has been recognized with a Popular Science 2009 Best of What's New Award, and has received additional recognition from TIME and WIRED magazines, the 2009 Wall Street Journal Technology Innovation Award, the International Design Excellence Award (IDEA) and more. ClearCount's SmartSponge and SmartWand-DTX systems are the only RFID enabled systems for counting and detecting surgical sponges, thereby improving patient and OR safety, enhancing productivity, and reducing cost. To learn more, visit

About Medline Industries, Inc.

Medline, the nation's largest privately held manufacturer and distributor of healthcare products, manufactures and distributes more than 100,000 products to hospitals, extended-care facilities, surgery centers, home care dealers and agencies and other markets. Headquartered in Mundelein, Ill., Medline has more than 800 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 certified 13485:2003. 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,

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