BD Receives FDA 510(k) Clearance for New Blood Collection Device to Help Enhance Patient and Clinician Experience
Novel PentaPoint™ Comfort and RightGauge™ Needle Technologies Help Improve Comfort, Access to Difficult Veins
FRANKLIN LAKES, N.J., Feb. 17, 2016 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and European CE marking for a new safety blood collection set – the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set – that uses proprietary needle technology to help enhance the patient experience during this important procedure.
"Phlebotomy is often one of the first procedures hospital patients undergo, and it can set the tone for their entire stay," said Dr. Ana K. Stankovic, worldwide vice president of Medical Affairs for BD Life Sciences – Preanalytical Systems and Global Health. "With U.S. reimbursement levels tied to patient satisfaction and the rise of online patient reviews, clinicians are seeking ways to improve these vital, high-touch procedures by reducing patient pain and improving their ability to access difficult veins."
The BD Vacutainer UltraTouch Push Button Blood Collection Set employs patented PentaPoint™ Comfort 5-bevel needle technology. Studies have shown that this design helps reduce the chance of a painful injection by creating a flatter, thinner surface to help penetrate the skin with significantly greater ease.[i]
When combined with BD RightGauge™ technology, which increases the needle's inner diameter and enables clinicians to select a smaller gauge needle without sacrificing sample quality and blood flow, this new device has been shown to reduce penetration forces by up to 32 percent when compared to another leading blood collection set.[ii]
"The ability to use smaller gauge needles should also help clinicians access veins more successfully," said Dr. Stankovic. "This could prove especially valuable in patient populations, such as oncology, geriatric and pediatric, that often have difficult or fragile veins."
According to Dr. Stankovic, clinicians are traditionally reluctant to use smaller gauge needles (i.e. a 25-gauge needle versus a 23-gauge) even though it would likely increase their ability to access a patient's vein for fear of increasing hemolysis – the rupture or destruction of red blood cells – as the blood passes slowly through the narrow cannula.
"With BD Vacutainer UltraTouch blood collection sets, clinicians can select the gauge that is most appropriate for their patients, without compromising sample quality, testing accuracy and their own efficiency," said Dr. Stankovic.
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 45,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit bd.com.
[i] Hirsch L.J., et al. Journal of Diabetes Science and Technology. 2012, 6(2):328-35.
[ii] 2015 BD bench testing versus BD Vacutainer® Push Button Blood Collection Sets.
BD Public Relations
Monique N. Dolecki
BD Investor Relations