ICU Medical Announces New FDA 510(k) cleared labeling claims for Clave^™ Portfolio of Needlefree IV Connectors with Powerful New Infection Control Data

The first technology of its kind, Clave IV connectors have been used by clinicians for over thirty years to safely access a patient’s IV line for the administration of IV fluids. This technology has been integrated into ICU Medical’s MicroClave^™, NanoClave^™, and Clave Neutron^™ connectors used across the company’s broad portfolio of gravity and Plum^™ infusion sets, allowing for a single connector technology to be used wherever care is given. This clearance unifies these products under a single 510(k) and includes a new product labeling statement noting a statistically significant reduction in the relative risk of bloodstream infection compared to non-Clave connectors.

“This new 510(k) is a testament to our team’s dedication to infusion safety and the patients we serve,” said Jim Paloyan, corporate vice president and general manager of ICU Medical Infusion Consumables. “IV connectors are often treated as a commodity, but this new evidence shows they are anything but. The right connector is a critical part of a hospital’s infection prevention and care strategy—and Clave technology proves how smart standardization can lead to meaningful reductions in infections, mortality, and cost.”

In the study¹ cited in the 510(k), Dr. Marcia Ryder analyzed data from approximately 3,000 hospitals and nearly 17.5 million catheter-days and found that acute care hospitals that utilized Clave connectors in high volumes “experienced a 19% reduction in Relative Risk, avoiding approximately 70 CLABSI cases.” Additional study highlights include:

• “The realized cost savings of the Clave NCT hospitals was estimated to be $27,095,233.”
• “Conclusion: The use of the Clave NCT, in and of itself, is an effective risk reduction strategy for CLABSI prevention, reduced mortality, and substantial cost savings.”

In addition to the CLABSI reduction statement, ICU Medical’s instructions for use included with these products will also reflect enhanced attributes, including use with blood with no required changeout after infusion or aspiration, and the prevention of microbial ingress for seven days.