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West Receives 510(k) Clearance for NovaGuard SA

Prefillable syringe safety system designed to reduce risk of needlestick injury

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By: Kristin Brooks

Managing Editor, Contract Pharma

West Pharmaceutical Services’ NovaGuard SA (Staked-needle Automatic) safety system has received 510(k) clearance from the FDA. The NovaGuard SA safety system is designed to help reduce the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use.
  
“With increased global emphasis on preventing the spread of bloodborne infectious diseases, there is a need to develop and implement safer systems and practices in healthcare facilities worldwide. This includes adopting devices that can help reduce the risk of infection caused by needlestick,” said Graham Reynolds, vice president, marketing and innovation, West Pharmaceutical Services. “West has deep expertise in needlestick prevention and a portfolio of offerings that enable safe and effective drug administration. It’s our hope that the NovaGuard SA safety system is used as a cost-effective solution to help improve needle safety.”
  
The company has increased its manufacturing capacity at its facility in France, where more than 1.5 billion similar safety systems have already been produced. The NovaGuard SA safety system could be available for all geographic markets and commercial supply. Currently, the NovaGuard SA safety system is commercialized with one marketed drug outside of the U.S., and is being evaluated by multiple West pharmaceutical partners.

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