8/4/2010 Article by William Jarvis Highlights Needleless Connector Design Features

FRANKLIN, Tenn.--(EON: Enhanced Online News)--A new article by infection control expert William Jarvis, M.D., President, Jason and Jarvis Associates, LLC, highlights the importance of patient safety features in the design of IV needleless connectors.

“The agency should similarly consider similar action regarding negative-pressure mechanical valve needleless connectors. As my article notes, these connectors also are associated with greater CRBSI risk.”

The article in the journal Infection Control Today (ICT) describes safety features that needleless connectors should possess to minimize the risk of catheter-related bloodstream infections (CRBSI), which kill an estimated 30,000 American patients annually.

A recent action by the Food and Drug Administration (FDA) underscores the article’s timeliness. One day after the article appeared, the FDA posted a notice on its website about the possible dangers of positive-displacement IV connectors, echoing a warning in the ICT article.

The FDA said it is requiring all manufacturers of positive-displacement IV connectors (also called “positive-pressure mechanical valves”) to "assess whether they may be associated with a higher rate of device-associated bloodstream infections (BSI) than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk."

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 CRBSI and positive-displacement connectors.

“I’m gratified that the FDA is taking this step,” Dr. Jarvis said. “The agency should similarly consider similar action regarding negative-pressure mechanical valve needleless connectors. As my article notes, these connectors also are associated with greater CRBSI risk.”

The ICT article describes several features of IV connectors that are preferable for preventing CRBSI, including:

• A needleless connector that does not require a clamping sequence or use of only connectors that require the same clamping sequence;
• A smooth external septum surface with few gaps, so it can be more thoroughly and easily disinfected;
• A straight fluid pathway and simplest internal mechanism design that facilitates adequate flushing and reduces the internal surface for biofilm development;
• Little or no blood reflux;
• A clear connector to facilitate flushing adequately after use.

Dr. Jarvis’s article also discusses the increased risk of deadly CRBSI that is created when hospitals stock several brands of connectors, as many facilities do.

As a recent study shows, confusion about connector types and how to use them is common. The study, by Cynthia Chernecky, Ph.D., RN, AOCN, FAAN, found that 100% of nurses surveyed did not know the type of connector they were using, and/or which specific clamping sequence might be required to use the device correctly.

“Dr. Jarvis’s article is a much-needed addition to the IV therapy and vascular access literature,” said Chernecky. “Few clinicians understand that if they use a connector incorrectly or select a more easily contaminated design, a fatal infection can result.”

The ICT article notes that one hospital, Sutter Roseville Medical Center in Roseville, Calif., has been more successful than any other facility in preventing CRBSI. As of this writing, SRMC has had a zero rate of CRBSI for more than four-and-one-half years.

“The Sutter Roseville approach uses evidence-based practices and technologies, and has produced unprecedented results,” Dr. Jarvis said. “As just one example, Sutter recognized the dangers of positive pressure connectors more than four years ago and stopped using them. I believe that decision has been a major factor in Sutter’s ability to prevent CRBSI.”

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.