BD PhaSeal System Receives Clearance from FDA Under Newly Created ONB Product Code

Tue Jan 15, 2013 9:00am EST

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First and Only FDA Cleared Closed System Transfer Device Indicated to Reduce
Exposure to Hazardous Drugs
FRANKLIN LAKES, N.J.,  Jan. 15, 2013  /PRNewswire/ --  BD Medical, a segment of
BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical
technology company, today announced that the U.S. Food and Drug Administration
(FDA) has cleared the BD PhaSeal Closed System Transfer Device (CSTD) under the
newly created ONB code. The BD PhaSeal System is the first and only cleared CSTD
under the new code, which was created for devices that have specific indications
for use with antineoplastic and other hazardous drugs.  

The FDA clearance was based on three criteria: no escape of hazardous drug or
vapor concentration, no transfer of environmental contaminants, and prevention
of microbial ingress. The BD PhaSeal System is the only CSTD currently available
that meets all three of these standards.

"Given BD's commitment to creating a safe working environment for healthcare
workers, we're pleased at the FDA's clearance of the BD PhaSeal System under the
new ONB code. It reinforces our ability to protect healthcare workers from
exposure to hazardous drugs," said  William A. Tozzi, President, BD Medical -
Medical Surgical Systems. "The BD PhaSeal System exemplifies our goal of
enabling healthcare facilities to reduce workplace hazards and exceed compliance
standards while providing quality patient care."

The FDA created the new ONB code because it recognized that a new product code
would be in the best interest of public health and wanted to improve the
information available to users of devices that have specific indications for use
with antineoplastic and other hazardous drugs. The BD PhaSeal System obtained
ONB clearance through validated third-party evidence. Please visit  for more information.

About the BD PhaSeal System  
The BD PhaSeal System is a closed system transfer device (CSTD) that reduces
healthcare workers' exposure to hazardous, parenteral medications from
preparation in the pharmacy to administration with the patient. The BD PhaSeal
System is an airtight and leak-proof CSTD that mechanically prohibits the
transfer of environmental contaminants into the system and the escape of drug or
vapor concentrations outside the system, thereby minimizing individual and
environmental exposure to drug vapor aerosols and spills. The BD PhaSeal System
also prevents microbial ingress. With a limited number of components and only
one connection interface, the BD PhaSeal System dimensions are created to ISO
standards to be compatible with all standard size drug vials and tubing.

About BD
BD is a leading global medical technology company that develops, manufactures
and sells medical devices, instrument systems and reagents. The Company is
dedicated to improving people's health throughout the world. BD is focused on
improving drug delivery, enhancing the quality and speed of diagnosing
infectious diseases and cancers, and advancing research, discovery and
production of new drugs and vaccines. BD's capabilities are instrumental in
combating many of the world's most pressing diseases. Founded in 1897 and
headquartered in  Franklin Lakes, New Jersey, BD employs nearly 30,000
associates in more than 50 countries throughout the world. The Company serves
healthcare institutions, life science researchers, clinical laboratories, the
pharmaceutical industry and the general public. For more information, please

Abigail Cardona
BD Public Relations

SOURCE  BD-Becton Dickinson

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