The Safety and Efficacy of Disinfection Cap Use in a Real-World Environment.

PURPOSE: Catheter hub and needle-free connector contamination is a causative element in the development of catheter-related bloodstream infections and demonstrates the necessity for effective hub disinfection. The current study evaluated the safety and efficacy of a disinfection cap used in a real-world environment.

PATIENTS AND

METHODS

This multicenter, single-arm, prospective post-market study was designed to collect clinical data on the safety and performance of a passive disinfection cap. A total of 157 participants were included in this study. The primary performance endpoints were attachment and removal success rates. The primary safety endpoint was the rate of device-related AEs.

RESULTS

A total of 156 participants, aged 3-93 years, had at least one disinfection cap applied during the study. Attachment and removal success was ≥ 99.7%. No device-related adverse events were observed.

CONCLUSION

This study found that disinfection caps can be attached and removed successfully with no device-related adverse events in a real-world environment.