Article Stresses Value of Safe Design for IV Connectors

Experts Warn Some Needleless Connector Designs Can Increase Infection Risk

FRANKLIN, Tenn.--(BUSINESS WIRE)-- A new article about IV catheter care warns that several IV needleless connector designs are prone to repeated blood reflux that can cause the build-up of fibrin, which is a precursor to bacterial colonization and catheter-related bloodstream infections (CR-BSI).

Only one design – a “zero fluid displacement connector” -- does not cause blood reflux, the authors say.

The article, titled “Improving IV Catheter Care to Safeguard against Deadly Infections,” is the cover story in the July/August 2010 issue of the journal Patient Safety & Quality Healthcare.

Authors and nursing experts Denise Macklin, BSN, RNC and Cynthia Chernecky, Ph.D., RN, AOCN, FAAN note the pivotal role that connectors play in preventing CR-BSI. They describe the types of connectors available today and their various design features.

“A connector can seriously increase CR-BSI risk unless it is configured so that no blood reflux occurs when a syringe or administration set is connected or disconnected,” said Macklin. “Blood reflux can leave residue that leads to biofilm formation, which is the precursor to CR-BSI.”

It is also crucial that a connector have other design features that prevent biofilm formation, she said: “Unfortunately, some of the most widely used designs are prone to blood reflux. They are vulnerable to biofilm formation in other ways, too. It is no surprise that they are associated with higher CR-BSI rates.”

The Food and Drug Administration (FDA) recently posted a notice on its website about the possible dangers of positive reflux (“positive displacement”) connectors.

The FDA noted that clinical studies have associated positive-displacement IV connectors with higher rates of infection. The agency said it had received three reports of patient deaths associated with CR-BSI and positive-displacement connectors.

Studies also associate negative reflux connectors with higher CR-BSI rates, Macklin and Chernecky write.

In addition to zero reflux, the article lists other connector design features that are important for preventing CR-BSI. These include:

  • A smooth septum surface that is easily disinfected
  • A straight fluid pathway with no dead spaces or moving parts
  • No clamping sequence for connection or disconnection

The article notes that several healthcare institutions have eliminated or dramatically reduced CR-BSI after opting for a safer connector design. One is Sutter Roseville Medical Center (Roseville, Calif.), which has not had a CR-BSI since implementing a zero fluid displacement connector and several other practices and devices for two of its units in January 2006. The time span, unprecedented in U.S. healthcare, covers more than four-and-one-half years.

Another of the institutions mentioned is the nationally prominent University of Texas MD Anderson Cancer Center (Houston, Tex.). According to a scientific poster presented at the 2008 annual conference of the Association for Vascular Access, the institution saw its CR-BSI rate plunge 10-fold in the intensive care unit during 15-week usage of a zero fluid displacement connector.

The article describes the importance of implementing an effective central line bundle and also covers measures that can improve clinicians' compliance with such a bundle of practices and technologies.

A sidebar to the article titled “Technology Review” names four products as preferable choices for inclusion in a central line bundle. The four products and their generic descriptions are:

  • Zero fluid displacement connector: InVision-Plus® with Neutral Advantage™ technology by RyMed Technologies (Franklin, Tenn.)
  • Foam disc that secretes antiseptic at catheter site: BioPatch® Protective Disc with CHG by Ethicon (Somerville, N.J.)
  • Skin preparation: ChloraPrep® by Care-Fusion (Leawood, Kan.)
  • Catheter stabilization device: StatLock® PICC Stabilization Devices by CR Bard (Murray Hill, N.J.)

Each of these technologies has been used at Sutter Roseville Medical Center to prevent CR-BSI.

Macklin and Chernecky note that CR-BSI kill an estimated 30,000 patients per year, cost tens of thousands of dollars on average to treat, and contribute substantially to healthcare costs.

“I hope this article will raise awareness about the importance of implementing more effective measures to prevent CR-BSI,’ said Chernecky. “If we are serious about minimizing these infections, we must realize that is only possible if institutions adopt both practices and technologies that support those efforts.”

About RyMed Technologies, Inc.

It is believed that RyMed Technologies, Inc. is the only U.S. maker of needleless IV connectors that is not required by the FDA to conduct post-market studies of its connectors. RyMed makes only zero-fluid-displacement (neutral-pressure) connectors, such as the InVision-Plus® with Neutral Advantage™.

Founded in 1994, RyMed Technologies specializes in the development and marketing of innovative safety products in the field of intravenous catheter care management. The company’s products are designed to help reduce catheter-related infections associated with vascular access. More than 10 years of research and development have gone into InVision-Plus.

The company is headquartered in Franklin, Tenn. For more information, call (615) 790-8093 or access www.rymedtech.com.



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KEYWORDS:   United States  North America  Tennessee

INDUSTRY KEYWORDS:   Health  Hospitals  Infectious Diseases  Medical Devices  FDA  Medical Supplies  Nursing

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