A device to reduce catheter related bloodstream infection rates in patients with peripherally inserted central catheters (PICCs)

摘要

ABSTRACT PuraCath's goal is to develop an FDA-approved catheter hub disinfection system for peripherally inserted central catheter (PICC) that dramatically reduces catheter related blood stream infections (CRBSIs) using LED-Ultra Violet (UV) light. In Phase I of this SBIR project, we propose to optimize the ease of use and robustness to enable home use. The current CRBSI infection rate is estimated to be between 1.8 to 5.3 CRBSIs/1,000 patient days and costs the provider between $34,508 to $56,000 per CRBSI, with an attributable mortality rate of 12% to 25% (or each CRBSI. The annual incidence of CRBSIs in the US is approximately 250,000. This equates to an annual cost on the health care system in the United States alone of between $8.5 billion and $14 billion. Because the cost of treatment of CRBSI is borne by hospitals and not Medicare, hospitals have tremendous incentive to minimize incidence of these infections. Patients receiving chemotherapy frequently have PICC implanted for many months. PICCs require careful cleaning of catheter connections, which requires a number of complex cleaning steps performed by the patient or their care-giver. Observational studies have shown the professional care providers have as low as a 35% compliance rate for proper catheter disinfection protocols, and home care patients often have higher infection rates than inpatient rates. Our proposed device minimizes time and steps required for catheter cleaning, does not rely on user technique, and has failsafe sensing capability. Therefore, it is expected to dramatically reduce the CRBSI rate. PuraCath Medical has already successfully obtained FDA approval for a peritoneal dialysis (PD) catheter sterilization device that uses mercury lamps to generate UV. While the PD catheter is conceptually similar, significant technical challenges to adapt this concept for PICC require a distinct commercial development effort. Technical differences in PICC device that require development include; use of LED to generate UV, engineering of a needleless connector, and integrated usage monitoring. Aim 1: To engineer an easy to use, failsafe, and reliable catheter sterilizing device based on UV disinfection using LED technology. Aim 2. Design needle-less connector Aim 3: Conduct microbiologic bench testing. PuraCath intends to obtain FDA for approval for the device as a 510K, Class 2 device, using PuraCath's PD device as a predicate.