BETHLEHEM, Pa. -- B. Braun Medical Inc. announced today
it has received U.S. FDA clearance for the use of its Ultrasite Needle-Free
IV System with power injectors up to 300 psi, helping to prevent exposure
to dangerous bloodborne pathogens in the radiology suite. B. Braun is the
first and only company to receive FDA 510(k) clearance for needle-free IV
system use with power injectors.
As a result of sharps injuries, 2,000 workers a year become infected
with hepatitis C, 400 contract hepatitis B, and more than 36 U.S.
healthcare workers a year contract HIV. According to the Society of
Interventional Radiology, self-sheathing or needleless intravenous systems
should be used whenever possible to prevent exposure to bloodborne pathogens
in vascular/interventional radiology.
The Ultrasite Needle-Free IV System is designed to eliminate the risk of
accidental needlestick injuries. Ultrasite features patented technology
that virtually assures compliance by preventing needle access. This highly
effective passive engineering control protects both patients and caregivers.
The Ultrasite is a patented valve with a positive displacement design that
uses an internal plunger to expel fluid when the Luer taper is removed,
preventing blood from being drawn back into the IV system. In addition, its
design offers exceptional flow rates while enabling it to be used across a
variety of IV therapy applications.
"The Needlestick Safety and Prevention Act (NSPA) requires all U.S.
healthcare facilities to implement safer needle devices," said Gregory S.
Jones, director of IV systems at B. Braun Medical Inc. "The Ultraasite Needle-Free
IV System is designed to eliminate the risk of accidental needlestick injury
and support these safety compliance initiatives. We are pleased to
announce that we can now offer this cornerstone product in our "People,
Products and Programs" safety initiative to protect clinicians in the
With more than 28,000 employees worldwide, B. Braun is a full line supplier
of innovative healthcare products and programs designed to improve both
patient and clinician safety.
Source: B. Braun