BD Medical, part of Becton, Dickinson and Company (BD), has received US FDA 510(k) clearance for its BD UltraSafe Plus as an anti-needle stick safety device. The company also announced the commercial launch of its new passive needle guard technology.
This product, in addition to offering needle stick 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 which complements our current safety portfolio to offer patients the ability to manually control their injection," said Claude Dartiguelongue, president, BD Medical - Pharmaceutical Systems.
“The BD UltraSafe Plus 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.”
The company 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 provided ease of use with 100 per cent of injections executed successfully.
“Further, the Passive Needle Guard is designed to enable easy integration into existing safety device assembly lines and is compatible with ISO standard prefilled syringes,” informed Peter Nolan, vice president, BD Medical – Pharmaceutical Systems, Safety.
The 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-needle stick device company acquired by BD in December 2012. It 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, stated the company release.