http://www.mdlinx.com/internal-medicine/product-center/medical-device-description.cfm/8922/?featured=no
New device reduces risks, anxiety associated with blood draws
Velano Vascular —
The FDA has granted clearance to a modified version of Velano Vascular’s
novel, needle-free blood draw device, which is designed to reduce blood
draw-related discomfort and anxiety for hospital inpatients, provide a
safer work environment for healthcare providers, and standardize today’s
fragmented approaches to inpatient blood draws. This second FDA
clearance of the device includes two modifications designed to enhance
the product’s usability for inpatient blood draws, one of the most
common medical procedures performed today: The addition of a clamp for
use with syringe draws, a frequent practice in pediatric patients, and a
refinement to the Indication for Use (IFU). The Velano
device is attached to a peripheral IV catheter to draw blood directly
into a vacuum tube or a syringe; the revised IFU removes a limitation in
the earlier clearance that specified when the device could be used with
in-dwelling peripheral IV catheters.
Roughly 760 inpatient blood draws are conducted every minute in the
United States alone. Despite their ubiquity, blood draws create
tremendous disruption for patients and clinicians alike, and are
associated with significant direct and indirect costs. Twenty-eight
percent of adult venipunctures and 44 percent of pediatric venipunctures
require more than one stick to successfully draw blood, and around 10
percent of children aged 3 to 10 years old must be physically restrained
to endure a needle-based blood draw. Published data suggest that U.S.
healthcare professionals endure an average of 200 needle-related
injuries each day. Aside from the significant physical and emotional
toll of these injuries and any related seroconversion, studies suggest
that accidental needle sticks cost hospitals upwards of $50 million per
year.
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