PURACATH MEDICAL INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

ABSTRACT PuraCathandapos 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 to CRBSIs patient days and costs the provider between $ to $ per CRBSI with an attributable mortality rate of to or each CRBSI The annual incidence of CRBSIs in the US is approximately This equates to an annual cost on the health care system in the United States alone of between $ billion and $ 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 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 To engineer an easy to use failsafe and reliable catheter sterilizing device based on UV disinfection using LED technology Aim Design needle less connector Aim Conduct microbiologic bench testing PuraCath intends to obtain FDA for approval for the device as a K Class device using PuraCathandapos s PD device as a predicate Public Health Relevance For hospitals including Intensive Care Units operating rooms emergency rooms dialysis clinics interventional radiology vascular suites and burn centers the current Peripherally Inserted Central Catheter PICC connection disinfection process is a time consuming process that relies upon strict nurse protocol and compliance for efficacy Improper or incomplete disinfection is a significant cause of catheter related blood stream infections CRBSIs which can result in sepsis and even death as well as a costly event for the hospital or care facility since CMS will no longer reimburse hospitals for their treatment This project proposes a medical device to reduce CBSRIs in patients with PICCs this reducing mortality morbidity and cost of care