Management Approach

The BD Quality Policy states: “We will consistently provide superior products and services worldwide to help all people live healthy lives. We will achieve this through compliance with customer and regulatory requirements and the maintenance of an effective quality system.”

We take product responsibility very seriously. Healthcare workers are key users of BD products, and their health and safety is critically important. BD is the world's leading supplier of devices that help to reduce the incidence of sharps injuries and exposure to bloodborne pathogens. We pioneered the development of safety-engineered medical devices and have been at the forefront of this field for nearly two decades. Since the invention of the BD Safety-Lok™, first safety syringe, in 1989, BD has offered the most complete line of advanced protection products in the industry. No company has committed more money, human resources, or technological know-how to reducing sharps injuries. We have engineered our products to be safe for patients and healthcare professionals working. Our range of safety products offered by two BD business segments includes hundreds of catalog items for injection, infusion therapy, sample collection, surgery and sharps disposal:

• BD Medical provides innovative IV flush syringes and closed IV catheter systems designed to enhance patient safety by reducing the potential for medical errors and device contamination while improving healthcare worker safety. We also offer low-cost, auto-disabling injection devices for immunization and parenteral therapies, intended to prevent disease spread associated with syringe reuse in developing countries.
  
  
• BD Diagnostics – Preanalytical Systems focuses on specimen collection and accelerating growth through continued emphasis on safety, where innovation has led to second- and third-generation safety-engineered products offering greater protection and improved functionality.

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Providing Educational Resources

BD is committed to providing educational materials and training for healthcare professions through the BD Education Center, a comprehensive resource for up-to-date educational materials on a wide variety of healthcare issues. The Center offers over 200 carefully selected titles from over 30 sources made available through strategic alliances with leading professional associations and publishers, as well as titles created and offered by BD.

Through its online catalog, the BD Education Center provides a valuable, centralized resource for many current educational materials addressing human health topics in varying formats.

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Serving the Needs of Researchers

Throughout the world, researchers rely on BD Biosciences’  state-of-the-art technologies, products and leading expertise to study cells to better understand disease, speed the discovery and development of novel therapeutics and improve diagnosis and disease management. Recent launches of several flow cytometry platforms and associated sample preparation and automation systems have helped us lead the way in all major customer segments.

BD Biosciences also focuses on serving researchers from pharmaceutical and biotechnology companies. Our growing line of drug metabolism assays from the Discovery Labware unit help screen out nonviable drug candidates early, increasing the ultimate likelihood of clinical trial success. In addition, our broad array of laboratory products for tissue culture and fluid handling are utilized in research laboratories globally.

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Medical Device Reports

BD has a formal process in place to submit Medical Device Reports (MDRs) to the U.S. Food and Drug Administration (FDA) concerning BD products involved in a reported death, serious injury or malfunction. In fiscal year 2007, BD filed 465 MDRs out of the more than three billion BD products manufactured and sold.

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Product Liability Litigation

BD, along with a number of other manufacturers, was named as a defendant in approximately 524 product liability lawsuits in various state and Federal courts related to natural rubber latex gloves that BD ceased manufacturing in 1995. Cases pending in Federal court are being coordinated under the matter In re Latex Gloves Products Liability Litigation (MDL Docket No. 1148) in Philadelphia, and analogous procedures have been implemented in the state courts of California, Pennsylvania, New Jersey and New York. Generally, these actions allege that medical personnel have suffered allergic reactions ranging from skin irritation to anaphylaxis as a result of exposure to medical gloves containing natural rubber latex. Since the inception of this litigation, 467 of these cases have been closed with no liability to BD, and 46 cases have been settled for an aggregate de minimis amount. BD, along with another manufacturer and several medical product distributors, was named as a defendant in three product liability lawsuits relating to healthcare workers who allegedly sustained accidental needlesticks, but have not become infected with any disease. Generally, these actions allege that healthcare workers have sustained needlesticks using hollow-bore needle devices manufactured by BD and, as a result, require medical testing, counseling and/or treatment. In some cases, these actions additionally allege that the healthcare workers have sustained mental anguish. Plaintiffs seek money damages in all of these actions. BD had previously been named as a defendant in eight similar suits relating to healthcare workers who allegedly sustained accidental needlesticks, each of which has either been dismissed with prejudice or voluntarily withdrawn.

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