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West Pharmaceutical obtains 510(k) approval for NovaGuard safety system

West Pharmaceutical Services has obtained 510(k) approval from the US Food and Drug Administration for its NovaGuard (Staked-needle Automatic) safety system.

The safety system is said to decrease the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use.

West Pharmaceutical Services marketing and innovation vice-president Graham Reynolds said: "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.

"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."

Suitable for prefilled ISO standard glass syringes, the NovaGuard system offers a tamper-evident needle shield feature and a safety mechanism that helps to prevent pre-activation of the system.

The company noted that the NovaGuard system is currently commercialized with one marketed drug outside the US and is being evaluated by multiple partners of the company.

According to World Health Organization (WHO), every year healthcare workers incur two million accidental needlestick injuries, which may result in infections with hepatitis B and C, HIV and other diseases.