FDA Approves IntelliDOT(R) Blood Product Administration(TM) - Solution Extends Patient Safety From The Blood Bank To The Bedside

Main Category: Medical Devices
Also Included In: Blood / Hematology
Article Date: 24 Jun 2008 - 2:00 PDT

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IntelliDOT Corporation, a leading provider of wireless, handheld, barcode point-of-care (BPOC) solutions to hospitals, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for IntelliDOT Blood Product Administration (IntelliDOT BPA™) for commercial sale.

This new solution is a point-of-care Transfusion Safety Management System composed of computers, a software application, wireless handheld barcode 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.

"The FDA approval for IntelliDOT Blood Product Administration advances our corporate mission to provide innovative and easy-to-adopt, point-of-care solutions to enhance patient safety, improve nurse efficiency, and help hospitals reduce risk and liability," said Thomas G. Klopack, President and CEO of IntelliDOT. "With this latest addition, IntelliDOT extends its ability to support improved quality of care across the full spectrum of patient needs."

IntelliDOT BPA helps hospitals meet JCAHO standards for patient identification, and assists in ensuring accurate management, administration and documentation of blood/blood product administration in the following ways:

-- Matches patient wristband barcodes to blood sample label barcodes when collected at the bedside

-- Assists laboratory personnel with matching blood product label barcodes and barcodes on specimen tubes

-- Prints an accessory "bag tag" for the blood/blood product which further identifies the blood/blood product for the correct patient

-- Prompts blood bank professionals to confirm that the label matches the tag before attaching it to the blood product bag

-- Alerts nurse if there is a blood product tag to patient wristband mismatch prior to blood/blood product transfusion so the transfusion does not continue

"IntelliDOT BPA assists nurses and phlebotomists in providing step-by-step accuracy and crystal-clear communication among all clinicians involved in the complex blood product administration process," said David Swenson R. Ph, Co-Founder and Chief Clinical Officer of IntelliDOT. "We are excited to expand the benefits of the IntelliDOT CAREt® System by adding this end- to-end blood administration safety and workflow system that will assist hospitals in preventing life-threatening blood transfusion errors -- from the blood bank to the bedside."

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, the first 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. The lightweight, wireless CAREt handheld enables nurses to perform safety checks and safely administer medications at the bedside with just one hand.

About IntelliDOT Corporation

IntelliDOT is a leading provider of wireless, handheld, barcode point-of- care (BPOC) solutions that connect to any healthcare information system to improve patient safety and nurse workflow. When using the IntelliDOT system, nurses can easily manage all tasks associated with five-rights medication administration safety checks and related documentation. Additional modules include specimen collection, blood product administration, mother- baby breast milk matching and vital signs collection. IntelliDOT was founded in 2002 and is headquartered in San Diego. More information can be found at http://www.intellidotcorp.com.

Except for the historical information contained herein, this news release contains forward-looking statements that involve risks and uncertainties, including, but not limited to, risks and uncertainties associated with market acceptance of the CAREt System, whether the company will be successful in raising additional funds, the risk that sales of the CAREt System will not increase to target levels, and the effectiveness and marketability of healthcare information technologies, as well as other risks.

IntelliDOT Corporation