GSK gets FDA approval for OSHA-compliant, all-in-one vaccine delivery system
GlaxoSmithKline has received U.S. Food and Drug Administration (FDA) approval for Safety Tip-Lok: prefilled Tip-Lok syringes packaged with BD SafetyGlide Needles for pediatric doses of Havrix (Hepatitis A Vaccine, Inactivated) and Engerix-B [Hepatitis B Vaccine (Recombinant)]. Havrix and Engerix-B are the first and only pediatric vaccines available with Safety Tip-Lok and the only vaccines to be available with an all-in-one delivery system, which meets the Occupational Safety and Health Administration's (OSHA) newly revised bloodborne pathogens standard. The OSHA standard, designed to help protect healthcare workers from needlestick injuries, went into effect April 18, 2001.
Getting stuck with a contaminated needle is a major concern for many healthcare workers, with up to 800,000 needlestick injuries and potential exposures to bloodborne pathogens occurring each year. The impact of needlestick injuries can be not only physical, but emotional and financial as well. The prevention of needlestick injuries will save costs associated with testing, diagnosing and treating needlestick injuries.
"As a nurse, I am aware of the risks and fears involved with administering injections," said Barbara Ochester, RN, Nurse Educator and Consultant for the Vaccines Business Unit at GlaxoSmithKline. "Healthcare worker safety is crucial but unfortunately often overlooked. GlaxoSmithKline is proud to provide Safety Tip-Lok on the Havrix and Engerix-B pediatric vaccines. The safety needle feature on the prefilled syringe will help protect healthcare workers from contracting dangerous diseases from needlestick injuries."