Lifesite Dialysis System
Vasca, Inc.
Vasca, Inc., founded in 1996, is focused on becoming the worldwide
leader in Body Access Management by developing innovative access technologies
that improve the quality of patient care.
With an adage such as that, it may be hard to believe the scrutiny
the LifeSite Hemodialysis Access System has received since its introduction
to the medical community in 1998. At the time of its introduction,
many kidney dialysis patients who require the lifesaving treatment
as often as three times a week, believed it would be a heavenly solution
to a hellish situation.
Hemodialysis is the removal of one's own blood and passing it through
an artificial kidney where the blood is cleansed and then returned
to the body from which it came.
The LifeSite System, manufactured by Vasca, Inc., is a medical device which is surgically placed under the skin (usually under the collarbone)
by a specially trained physician, vastly reducing the painful and
unpleasant impairments associated with dialysis.
The Food & Drug Administration's (FDA) Center for Devices and
Radiological Health (CDRH) regulates medical devices as required by
Congress in the Food, Drug, and Cosmetic Act (Act). The Act defines
a medical device as "an instrument, apparatus, machine, implant,
or other similar article that is intended for use in the treatment
or prevention of disease." The term is very broad and includes
items that the public may not consider to be medical devices.
A uniquely designed valve is implanted under the skin and a catheter
runs from the valve to a large vein. The patient receives two valves.
One designed to remove the blood and one designed to return the cleansed
blood back into their system. The distinct shape of these valves allow
nurses (who also received special training for this procedure) to
locate and insert the dialysis needle through the skin and directly
into the LifeSite System.
Dialysis Unit staff members have filed complaints claiming that the
"specialized training" they received was immensely insufficient
to address significant aspects of this device and the procedures involved.
With this device, you are always connected, and over time and continued
treatments the insertion point resembles the hole of a pierced ear.
The FDA investigations uncovered 129 incident reports involving death
and/or serious injury in Vasca records pertaining to the LifeSite
System.
129 deaths and/or serious injury!
Other indications suggest Vasca was well aware of and attempted to
conceal information that usage of the device could result in injury,
possibly even death. It was determined that the LifeSite device was
"misbranded" failing to specify sufficient instructions
for usage pertaining to the purposes for which it was intended.
When questioned about the alleged deliberateness of turning in required
reports to the FDA past the given deadline or not at all, a spokesman
for Vasca stated that there had been a misunderstanding of the agency
regulations. Vasca felt there were things that didn't have to be reported,
so reports were late.
So much for improving the quality of patient care….
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