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

Laura Serrano Díaz,1 Barbara Defilippo,2 Marita Windpassinger,3 Sabine Maes,4 María Elena Gesto Lagüela,5 Trevor J Steele,6 Jenny Serrano,6 Kyle De Boer6 1Hospital Arnau de Vilanova, València, Spain; 2Careggi University Hospital, Florence, Italy; 3Department of Anesthesiology & Intensive Care Medicine, Medical University of Vienna, Vienna, Austria; 4Antwerp University Hospital, Edegem, Belgium; 5Hospital Teresa Herrera, A Coruña, Spain; 6Becton Dickinson & Company, 1 Becton Drive, Franklin Lakes, NJ, USACorrespondence: Kyle De Boer, Medical Affairs, Becton, Dickinson and Company (BD), 1 Becton Drive, Franklin Lakes, NJ, 07417-1880, USA, Email [email protected]: 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.Keywords: disinfecting cap, antiseptic barrier cap, disinfection device, passive disinfection, 70% IPA, needleless connector