SOURCE: Medi-Flex, Inc.

October 17, 2005 07:00 ET

Major Advancement in Surgical Skin Preparation Now Available

ChloraPrep® 26 mL -- the Only 2% Chlorhexidine Gluconate and 70% Isopropyl Alcohol Surgical Prep That Is FDA Approved and Meets CDC Guidelines

LEAWOOD, KS -- (MARKET WIRE) -- October 17, 2005 -- Medi-Flex, Inc., announces the availability of a new preoperative skin prep for use in the surgical suite. ChloraPrep® 26 mL with Scrub Teal™ tinting technology is the first FDA-approved preoperative skin prep that contains the Centers for Disease Control and Prevention (CDC)-preferred amount of chlorhexidine gluconate. Compared to iodophors, ChloraPrep® 26 mL demonstrates superior antibacterial activity and is the most rapid-acting, and persistent preoperative skin preparation available in the operating room.

Surgical site infections (SSIs) are a major cause of healthcare-associated infections (HAIs). The root of the problem is simple: skin bacteria. Because most of these debilitating, and sometimes deadly, surgical infections are caused by bacteria on the patient's own skin, a more efficacious skin antiseptic is needed. To meet this need, Medi-Flex developed ChloraPrep® 26 mL -- the first and only 2% chlorhexidine (CHG)/70% isopropyl alcohol (IPA) surgical prep that is FDA approved and meets guidelines published by the CDC.

Reducing targeted surgical adverse events by 50% is one of the CDC's "Seven Healthcare Safety Challenges" for the next five years. According to CDC's Division of Healthcare Quality and Promotion, these goals are designed to promote the CDC's efforts to "protect patients, protect healthcare personnel, and promote safety, quality, and value in the healthcare delivery system."

ChloraPrep®'s unique formulation is the first-of-its kind in the surgical suite. Because it combines the CDC recommended percentage of CHG with IPA, ChloraPrep® has immediate and long-lasting bactericidal properties. Clinical evidence demonstrates that the combination of 2% CHG and 70% IPA possesses superior immediate, residual, and cumulative antibacterial activity than the current standard, iodophors, and other commonly used antiseptics, such as alcohol. While alcohol kills 99.99% of bacteria in 30 seconds, CHG continues to kill bacteria for a minimum of 48 hours. This dual action is the key reducing infection-causing bacteria on the skin.

Healthcare-associated infections kill more people than homicides and auto accidents combined. The CDC estimates two million people contract infections in U.S. hospitals each year, killing nearly 90,000 patients. SSIs contribute significantly to these staggering statistics, making up 16% of all HAIs. Patients with SSIs are twice as likely to die, 60% more likely to be admitted to the intensive care unit, and more than five times more likely to be readmitted to the hospital after discharge than patients who do not contract SSIs. In turn, these added patient days due to SSIs add an average of $1.3 million per hospital in healthcare costs.

The efficacy of ChloraPrep®'s unique formulation has been proven through its use as a skin prep for a variety of procedures. The University of Pittsburgh Medical Center implemented the use of ChloraPrep® as part of a multi-faceted initiative to drive down catheter-related bloodstream infection rates, this effort from the hospital achieved a 71.4% reduction after only one year.

"Reducing the amount of bacteria present on the patient's skin prior to a surgical procedure is one of the essentials in preventing infections," Cynthia Crosby, vice president of clinical affairs at Medi-Flex states. "The combination of 2% chlorhexidine and 70% alcohol is superior to other preoperative skin preps because it kills the bacteria on the skin quickly and continues to kill it for a minimum of 48 hours."

About ChloraPrep® With Tint 26 mL

ChloraPrep® With Tint 26 mL is a one-step patient preoperative skin prep. It delivers precise volumes of tinted ChloraPrep® solution in a unique applicator that keeps the hands away from the prep site and provides a friction scrub. The patented new tinting technology adds the Scrub Teal™ to the ChloraPrep® solution as it passes through the sponge pad so the prep margins are easy to see.

Unlike iodophors, the most commonly used skin preps, the antibacterial properties of ChloraPrep® are not neutralized in the presence of organic matter such as blood and serum. Furthermore, ChloraPrep® is less irritating to the skin than iodophors.

ChloraPrep® is manufactured in Medi-Flex's world-class, FDA-approved facility in El Paso, Texas. The facility is ISO-9001: 2000 and ISO:13488 certified and has the distinction of receiving four consecutive audits without an FDA observation. Rigorous quality control and validation processes are in place to assure reliability and confidence in the ChloraPrep® manufacturing process.

About Medi-Flex, Inc.

Medi-Flex is the leader in providing innovative products and clinical education that improve quality of healthcare. From peripheral IV insertion to major surgery, Medi-Flex is the only company that provides a full line of chlorhexidine gluconate antiseptic skin preps that meet the unique needs of each hospital department. Founded by Chief Executive Officer Joe Brandmeyer in 1985, Medi-Flex has a 20-year history of leading innovative clinical formulation and development of antiseptic skin products. In addition to producing millions of ampoules, unit-dose antiseptics and kits, Medi-Flex also provides private label manufacturing services for a number of nationally recognized first-aid and industrial products and companies. Medi-Flex is based in Leawood, Kan., with manufacturing and distribution facilities in El Paso, Texas, and sales associates located throughout the United States.

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