FDA Approves IntelliDOT Bar Code Blood Product Administration

IntelliDOT Corp. received FDA 510(k) clearance for the IntelliDOT Blood Product Administration (IntelliDOT BPA) for commercial sale.

The point-of-care transfusion safety management system is composed of computers, a software application, wireless hand-held bar code scanners and wireless printers. IntelliDOT BPA assists nurses, phlebotomists and laboratory personnel in assuring blood samples are drawn from the correct patients, assists laboratory personnel in accurate matching of blood samples with correct blood or blood products, and assists nursing personnel in administering blood or blood products to the correct patient. It also enables the immediate documentation of any adverse reaction data when needed.

IntelliDOT said the new system will help hospitals meet JCAHO standards for patient identification, and assists in ensuring accurate management, administration and documentation of blood/blood product administration. The system matches patient wristband bar codes to blood sample label bar codes when collected at the bedside. It assists laboratory personnel with matching blood product label bar codes and bar codes on specimen tubes. The system prints an accessory “bag tag” for the blood/blood product, which further identifies the blood/blood product for the correct patient. It prompts blood bank professionals to confirm that the label matches the tag before attaching it to the blood product bag. The system will alert the nurse if there is a blood product tag to patient wristband mismatch.

The latest addition to the IntelliDOT solution portfolio incorporates multiple workflows including blood acquisition, cross match, and transfusion -- including timed reminders to assure nurses complete patient checks. This ensures prompt and accurate patient observations and documentation. The system also provides alerts when blood is ready, reminds the nurse to start transfusion or to return blood to the Blood Bank to avoid wastage, and alerts the nurse to check the patient at configurable intervals during the transfusion.

IntelliDOT BPA is an integrated module of the IntelliDOT CAREt System, a wireless, nurse-centric workflow manager to connect caregivers with the information systems they need at the point-of-care. The other currently available modules in the CAREt System include: IntelliDOT Bedside Medication Administration, IntelliDOT Phlebotomy Specimen Collection, IntelliDOT Mother-Baby Breast Milk Matching, and IntelliDOT Vital Signs Collection.

Built on a design that complements the way nurses work, the CAREt System provides a straightforward user interface that supports a comprehensive approach to medication safety and documentation at the bedside, in a variety of healthcare settings.

June 2008