West receives 510(k) clearance for NovaGuard SA safety system

Prefillable syringe safety system helps reduce risk of needlestick injury to healthcare workers and patients

Novaguard SA helps reduce the risk of needlestick injuries

West Pharmaceutical Services says its NovaGuard SA (Staked-needle Automatic) safety system has received 510(k) clearance from the US FDA. The system helps reduce the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use.

The World Health Organization (WHO) estimates that there are two million accidental needlestick injuries each year to healthcare workers that may result in infections with hepatitis B and C, HIV and other diseases.

Acknowledging this public health threat, the WHO, the European Union, the Occupational Safety and Health Administration and other leading health organisations have developed guidelines focused on needle safety and recommending the use of safety-engineered devices to reduce sharps injuries.

'With increased global emphasis on preventing the spread of blood-borne 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. Itís our hope that the NovaGuard SA safety system is used as a cost-effective solution to help improve needle safety.'

The NovaGuard SA safety system helps protect patients and healthcare workers by shielding a syringeís exposed needle once activated. It is suitable for prefilled ISO standard glass syringes and provides a tamper-evident needle shield feature and a safety mechanism that helps to prevent pre-activation of the system. It is part of Westís NovaGuard family of syringe safety technology offerings.

West 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 commercialised with one marketed drug outside the US, and is being evaluated by multiple West pharmaceutical partners.

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