BD PhaSealâ„¢ System Receives Clearance from FDA Under Newly Created ONB Product Code
Franklin Lakes, NJ (January 15, 2013) — 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 www.bd.com/PhaSeal 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 visit www.bd.com.