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Care Fusion Announces FDA 510k Clearance for wBloodCare.


MCLEAN, Va. -- Care Fusion, a leading provider of barcode enabled positive patient identification systems that support the clinical workflow of nursing, laboratory and blood bank related patient care activities, announced today that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted 510(k) clearance to market its wBloodCare(TM) product. Care Fusion and wBloodCare(TM) have taken the industry lead in obtaining this type of clearance.

wBloodCare(TM) is a comprehensive wireless software application that tracks patient identification information; displays orders for patient blood product administrations; tracks blood product release, delivery, and administration; performs an electronic cross check of information to assist in confirmation of the ordered and assigned blood products for the patient; documents transfusion Transfusion Definition

Transfusion is the process of transferring whole blood or blood components from one person (donor) to another (recipient).
 activities and maintains a transfusion record.

"Obtaining FDA 510(k) clearance for wBloodCare(TM) further illustrates Care Fusion's commitment to providing medical professionals a complete suite of interoperable The ability for one system to communicate or work with another. See interoperability.  point-of-care solutions," said Ken Tighe, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Care Fusion. "Our company is proud to have the opportunity to play an important role in addressing the problem of patient misidentification errors."

Care Fusion utilizes the Symbol Technologies PPT 8846 handheld PDA (Personal Digital Assistant) A handheld computer for managing contacts, appointments and tasks. It typically includes a name and address database, calendar, to-do list and note taker, which are the functions in a personal information manager (see PIM).  for wireless, barcode enabled positive patient identification. The Symbol PDA has an integrated scanner and utilizes Care Fusion's wBloodCare application software to scan the barcode on the patient wristband wristband An identifying bracelet attached to a Pt's wrist at the time of admission to a health care facility, which may be the only identifier used during a person's stay in a hospital  and then scan the blood product unit label barcodes. These identifiers are then cross checked with the related identifier codes in the electronic medical record. Through this electronic matching process wBloodCare confirms that the right patient receives the right blood product as assigned by the blood bank prior to administration.

"The breadth and maturity of Care Fusion's positive patient I.D. products are unique in the industry," states John Cuddeback, M.D., Ph.D., the Vice President of Clinical Informatics Clinical Informatics is a sub-field of medical informatics. It focuses on computer applications that address medical data (collection, analysis, representation). Clinical informatics is a combination of information science, computer science, and clinical science designed to assist  at MedStar Health MedStar Health is a $2.9 billion non-profit healthcare organization. It operates 25 businesses, including seven hospitals in the Baltimore-Washington region of the United States. , the largest health care provider in the Baltimore-Washington region. "Care Fusion's focus on the entire workflow at the point of care contrasts with single-function solutions that others offer. This is consistent with our thinking and direction at MedStar. We look forward to a continued close relationship with Care Fusion."

The Care Fusion "Power of One" enterprise suite of barcode enabled positive patient identification products includes: wCareMed(TM) to support medication administration, allergy allergy, hypersensitive reaction of the body tissues of certain individuals to certain substances that, in similar amounts and circumstances, are innocuous to other persons. Allergens, or allergy-causing substances, can be airborne substances (e.g.  warnings, safety alerts and complex IVs; wCareCollect(TM) to verify and label lab specimens; wBloodCare(TM) to verify blood products prior to transfusion; wCareAssist(TM) to record vital signs and patient care information; wCareView(TM) for a consolidated view of patient data; and wCareCapture(TM) for point of care billing of supplies. One Vendor. One Device. Many Powerful Solutions.

For more information on Care Fusion's wireless barcode solutions, visit www.carefusion.com
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Dec 14, 2004
Words:441
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