BD Announces FDA 510(k) Clearance and Commercial Launch of BD UltraSafe PLUS Passive Needle Guard
New Safety Device Designed to Support the Needs of Biologics
BD Medical, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today the commercial launch of a new passive needle guard technology, BD UltraSafe PLUS™. The BD UltraSafe PLUS™ Passive Needle Guard has received 510(k) clearance as an anti-needlestick safety device.
This product, in addition to offering needlestick safety in an easy-to-use one-handed device, is enhanced with ergonomic features designed to facilitate comfort and support for healthcare providers and patients. In addition, this safety device is designed to meet increasingly complex biotechnology drug requirements, including higher viscosity.
"We are pleased to offer the new BD UltraSafe PLUS™ Passive Needle Guard which nicely complements our current safety portfolio," said Claude Dartiguelongue, President, BD Medical - Pharmaceutical Systems. "We now have an ergonomic safety device solution for those customers seeking to offer patients the ability to manually control their injection."
The BD UltraSafe PLUS™ Passive Needle Guard provides many advanced features including a robust plunger rod to help support injection of viscous drugs, a larger drug inspection window to improve drug visibility, extended built-in finger flanges and an enhanced plunger head for improved injection support and stability. These ergonomic improvements provide support for all users, including patients with diminished manual dexterity. BD recently conducted a clinical focus group with patients who had reduced dexterity and also suffered from rheumatoid arthritis and multiple sclerosis. Subjects reported that the BD UltraSafe PLUS™ Passive Needle Guard provided ease of use with 100% of injections executed successfully.
“The new BD UltraSafe PLUS™ Passive Needle Guard is designed to enable easy integration into existing safety device assembly lines and is compatible with ISO standard prefilled syringes,” added Peter Nolan, Vice President, BD Medical – Pharmaceutical Systems, Safety.
The BD UltraSafe PLUS™ Passive Needle Guard is designed to be used in conjunction with 1.0 mL long prefilled syringes with staked needles, such as the BD Hypak™ or BD Neopak™ Glass Prefillable Syringe. The product was developed by Safety Syringes, Inc., an anti-needlestick device company acquired by BD in December 2012. The BD UltraSafe PLUS™ Passive Needle Guard received positive feedback when customers previewed the product at the October 2012 Parenteral Drug Association meeting. Orders have been received, and commercial shipments of BD UltraSafe PLUS™ Passive Needle Guard are expected to commence shortly.
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 .