F L U I D
W A S T E
M A N A G E M E N T
We're standing behind our recalled
direct-to-drain system — for now.
Dealing With
Fluid Waste Management's
Uncertain Future
of the recall first broke, we were
informed that the Silvers could
still be used as long as we posted
Sandy Berreth, RN, BS, MS, CASC | Baxter, Minn.
W
warnings on the units and
e've had to recently revamp
jumped through a series of regulatory
our protocols for managing
hoops that are, to be honest, fairly onerous
fluid waste, but the changes
and a major inconvenience. But before
have been far from an improvement. Our
hearing about the recall mess, you must
multi-specialty surgery center uses the
first understand why the prospect of going
Neptune Silver, which is at the center of
without direct-to-drain systems was so
the FDA-mandated recall due to patient
alarming to our staff.
injury and death caused by a surgical team
The best option
that used the unit improperly. When news
FLUID SITUATION
Reasons for the Recall
A
Orthopedics makes up about 38% of our
s reported in Outpatient Surgery Magazine (April 2013,
page 40), Stryker recalled the Neptune 1 Silver and
Neptune 2 Ultra last year, after 2 patients were injured,
one fatally, when a healthcare worker connected the Neptune 2
Ultra to a patient's chest drainage tube after surgery.
To complicate matters further, Stryker then extended the recall to
inform customers that it never obtained 510(k) clearance from the
FDA for the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra
The company plans to discontinue the Neptune 1 Silver and will
withdraw all support for the use of this device by March 1, 2014,
GRIN AND BEAR IT Staff at the Brainerd Lakes Surgery Center
love direct-to-drain fluid management, despite the current turmoil
surrounding the facility's units.
Jennifer Peterson
after which, according to an FDA mandate, customers must stop
using the device. Stryker is currently working with the FDA to get
clearance for the second generation of the Ultra.
— Outpatient Surgery Magazine staff
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SUPPLEMENT
TO
O U T PAT I E N T S U R G E R Y M A G A Z I N E | M AY 2013
M AY 2013 | S U P P L E M E N T
TO
O U T PAT I E N T S U R G E R Y M A G A Z I N E
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