Using the PIVO Needle-Free Device for Blood Cultures in Emergency Departments to Reduce Needle Sticks and Contamination

What this Trial Is About

This research aims to evaluate the use of the PIVO device, a needle-free blood draw tool, for collecting blood cultures in emergency department patients. The study focuses on reducing the number of needle sticks while ensuring accurate detection of potential bloodstream infections. The research is observational and will assess the devices usage and blood culture contamination rates in several emergency departments within a large healthcare system. The study will start at three main emergency departments with over 100,000 annual visits combined and may expand to three more sites depending on initial findings. Staff will receive structured training on how to use the PIVO device, including workflow and documentation procedures. Blood cultures will be collected using PIVO in different scenarios aligned with FDA approval, and standard blood draw methods will also be used for comparison. Data collection will last 13 months with periodic interim analyses and a survey of clinical staff comfort and recommendations about the device. Participants will be patients having blood cultures drawn in the emergency department. Researchers will gather data from electronic health records, device logs, and manual culture reviews. They will measure PIVO use rates, contamination rates of blood cultures, and staff satisfaction with the device. Interim analyses will guide ongoing use at study sites, and final results will be prepared after full data review. The study covers a full year of data collection following staff training and includes surveys to assess usability and workflow impact.

PIVO Use for Blood Cultures in the Emergency Department