Originally Published MDDI October 2002

NEWS & ANALYSIS

Robert Drummond

The StatLock PICC Plus catheter-securement device offers an alternative to tape or suture securement.

According to the report, catheter use in intensive care units (ICUs) places patients at the highest risk for local and systemic infectious complications, including CRBSI. Studies cited in the report state that approximately 80,000 CVC-associated BSIs occur in ICUs each year in the United States, with an attributable cost per infection estimated at $34,508 to $56,000. The use of catheter-securement devices over sutures or tape was one of several recommendations in the report involving materials or component selection, such as using polyurethane over polyvinyl chloride or polyethylene for catheters, Teflon catheters over steel needles, and antimicrobial- and antiseptic-impregnated catheters.

The guidelines cite a report that appeared in the January 2002 issue of the Journal of Vascular and Interventional Radiology. The study compared the use of a catheter-securement device to suture securement in a group of patients. Although the CDC report called the study "underpowered," it nonetheless found that CRBSIs were significantly reduced in the group of patients that received the sutureless device.

Commenting on the study—and on his own sutureless securement device— Steve Bierman, MD, said catheter securement is a key component in the fight against CRBSI. Bierman is the CEO and medical director of Venetec International (San Diego), a firm that manufactures the StatLock catheter-securement device. He says that currently, catheter-caused BSIs carry a mortality rate "in the neighborhood" of 10%. "Your chances of dying from a catheter-related bloodstream infection if you're in the ICU are quite real," Bierman says. "But these are nosocomial infections. So the question has always been: What can we do to limit and prevent them?"

Bierman believes the answer lies in three of the CDC recommendations: preparing skin with a 2% aqueous chlorhexidine gluconate, selecting catheters that use antimicrobial activity, and using catheter-securement devices. "When you combine these three," he says, " people stop dying in ICUs."

While Bierman has reason to be enthusiastic about the CDC affirmation of his product—he claims Venetec is the only company to manufacture "real securement devices with true clinical data back-up"—the fact that several companies have purchased StatLock for use in their catheter kits reveals that sutureless securement may indeed be a growing trend. Arrow International (Reading, PA), Cook Inc. (Bloomington, IN), and B. Braun (Bethlehem, PA) are among the companies that have purchased his product, Bierman says.

A former emergency room physician, Bierman was motivated to search for alternative catheter-securement methods when he suffered an accidental needle stick and contracted Hepatitis B (he recovered completely). A short time later, Bierman says, he had a catheter disconnect on a patient who was having a heart attack. "I nearly lost the patient," he says. "So as a doctor I was inspired to do something, because I could see that tape and suture were just ineffective."

When asked if he's worried the CDC report will bring new competitors to StatLock, Bierman says not at all. The CDC's endorsement of catheter-securement devices, he says, "is a major advance for anyone else who wants to get clinical data for whatever securement device they might be able to invent."

"I don't think you'll see manufacturers three years from now including sutures in any of their kits," Bierman says, adding that he believes this will go a long way toward decreasing catheter-related infections. "The day is truly fast approaching—I mean faster than anyone realizes—when catheter-related bloodstream infections in ICUs will be all but eliminated," Bierman says.

Copyright ©2002 Medical Device & Diagnostic Industry