Evaluation Background: Disinfection Caps for Needle-Free IV Connectors

Here's background for our Evaluations of disinfection caps for needle-free IV connectors, outlining the key considerations for making wise purchasing decisions. Learn how the technology is used, which specs are important, and what factors we test for. Also review our latest product ratings and ECRI's data describing facilities' interest in each vendor.

Disinfection caps are designed to supplement catheter-related bloodstream infection prevention methods (catheter maintenance bundles, hand hygiene, staff education, etc.). They provide an additional disinfection step for the female ends of needle-free IV connectors (NCs), before users disinfect the female end with an alcohol scrubbing device, allow the connector to dry, and then access the connector with an infusion set or syringe.

Most devices currently on the market are designed to attach to the female ends of NCs. These attaching caps have disinfection times ranging from 30 seconds to five minutes and can remain attached to NCs, serving as a barrier to contamination, for up to four to seven days between IV accesses. The other type of disinfection cap is not designed to attach to NCs. Instead, the non-attaching cap is placed over the female end of the connector and twisted around it for a 10-second disinfection time.

Disinfection caps are sterile, single-use, disposable, colored, nonlatex devices. Most contain a sponge or foam saturated with disinfectant (isopropyl alcohol, chlorhexidine, etc.); one cap contains disinfectant alone (no sponge/foam). The five caps currently available in the United States all use 70% isopropyl alcohol disinfectant.

The history of the marketplace is:

1. The LifeShield EffectIV disinfection cap (Hospira Inc.) was the first disinfection cap to receive FDA 510(k) clearance, in 2008. This product is...