The
FDA
authorized
the
first
robotic
device
that
can
independently
draw
patients’
blood
without
a
hands-on
operator,
the
agency
announced
on
Wednesday.
The
Aletta
device
uses
near-infrared
light
and
Doppler
ultrasound
to
locate
an
appropriate
vein.
It
is
authorized
for
use
in
adults
in
outpatient
settings,
under
the
supervision
of
a
trained
phlebotomist.
“Blood
draws
are
one
of
the
most
commonly
performed
medical
procedures
in
the
United
States,
yet
patients
may
face
delays
due
to
a
growing
shortage
of
trained
phlebotomists,”
said
Michelle
Tarver,
MD,
PhD,
director
of
the
FDA’s
Center
for
Devices
and
Radiological
Health,
in
the
press
release.
One
phlebotomist
can
oversee
up
to
three
devices
at
once,
which
may
help
mitigate
the
current
phlebotomist
shortage.
While
a
trained
phlebotomist
initiates
each
session,
“once
a
vein
is
identified,
the
Aletta
proceeds
through
the
remaining
steps
on
its
own:
applying
a
tourniquet,
preparing
the
skin,
inserting
and
disposing
of
the
needle,
changing
collection
tubes,
and
placing
a
bandage,”
the
FDA
explained.
If
a
patient
moves
too
much
during
the
draw,
the
needle
automatically
detaches,
and
if
unsafe
conditions
are
identified,
onboard
sensors
can
halt
the
procedure,
the
agency
added.
The
supervising
phlebotomist
verifies
that
the
collection
tubes
are
filled
in
the
right
order
and
adequately
full.
The
authorization
was
based
on
data
that
showed
that
the
Aletta
achieves
successful
blood
draw
rates
similar
to
or
better
than
trained
human
phlebotomists
when
it
proceeds
with
a
stick.
In
a
multicenter
study
across
three
outpatient
phlebotomy
departments,
the
first-stick
success
rate
with
the
device
was
94.5%
when
an
appropriate
vein
was
identified.
This
rate
remained
high
in
patients
with
obesity
(97.4%),
those
with
self-reported
hard-to-access
veins
(92.7%),
and
adults
ages
65
and
older
(93.4%).
Adverse
events
occurred
in
0.6%
of
participants
—
all
were
mild
and
included
vasovagal
reactions,
vasovagal
syncope,
hematoma,
and
self-limiting
paresthesia.
In
addition,
90%
of
patients
said
they
experienced
far
less
(19%),
less
(32%),
or
similar
pain
(39%)
when
compared
with
manual
phlebotomy,
and
82%
said
they
either
had
no
preference
(35%),
would
strongly
prefer
(16%),
or
prefer
(31%)
the
Aletta
over
manual
phlebotomy.
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