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Ss Neptune Waste Management System Training
1. Surgeons, PA’s,
RN / CST / NP
1st Assistants,
Anesthesiologists
etc.
Proper Use and Safety
Considerations
2. All instructions and
images were taken
from Stryker’s
Neptune Training and
Risk Mitigation
Binder per their
consent.
3. Neptune Recall History
Neptune is a high vacuum/high flow device used in our operating rooms for suction and collection
of fluids and waste from surgical fields
In
June 2012 Stryker was notified that a Neptune was connected to a passive chest drainage tube
postoperatively (clinically known to be a low suction application). Using the Neptune may have
resulted in hemorrhage, which lead to death.
The
FDA decided that the Neptune was not legally marketed and should be removed from use.
Hospitals with limited options could continue to use the Neptune if a Certificate of Medical Necessity
was completed and additional training was provided.
Unfortunately,
additional reports of serious injuries or deaths have occurred requiring mandatory
steps for the continued use of the Neptune. Completing this CBL and its test as well as other
elements (pending job type) will ensure St. Joseph’s/Candler compliance with the FDA mandate.
4. Reference Attached Warning Sign With Each Use
DO
NOT apply High Flow suction or allow extended exposure of suction to tissue
associated with procedures that require either no suction, low vacuum or low flow
suction (for example, passive chest drainage).
DO
NOT use these devices to provide suction to other suction powered accessories,
such as Pleur Evac® devices.
DO
NOT use these devices with closed wound drainage systems.
DO
NOT use this device for post operative use
ALWAYS
consider the type of tissue associated with the surgical procedure BEFORE
using this system.
ENSURE
that in low level suction applications that the appropriate suction device is
used. IT IS RECOMMENDED that an alternate source of low level suction be available
for low level suction applications (for example, suctioning an airway or near vital
anatomical structures).
ENSURE
the user has a clear understanding of the units of measure that are
displayed. It is recommended that you set your unit to mm-Hg.
ENSURE
the level of suction has been checked and is appropriate for the planned
procedure
ENSURE
the device control panel can be clearly seen and is not covered by drapes
or other objects.
ENSURE
that all users of this Neptune device are adequately trained on the
appropriate use of the device and are fully aware of the applications for which it is
intended to be used and the risks of using it improperly.
6. Suction/Vacuum Ranges
The
following risk mitigation
measures should be taken each time
you use the Neptune waste
management system:
Do
not use Neptune 2 in low
suction applications that require
vacuum levels below 50 mm-Hg,
2.0 in-Hg, or 7.0 kPa as this could
result in injury to vital anatomical
structures, and/or hemorrhage,
both of which may result in serious
injury and/or death.
The
Neptune 2 vacuum limit is
adjustable from 50 – 530 mm-Hg, 2.0
– 21.0 in-Hg, or 7.0 – 71.0 kPa.
The
Neptune 2 has a maximum
vacuum level of 530 mm-Hg, 21.0
in-Hg, or 71.0 kPa, and is therefore
considered to be a high vacuum
suction device.
7. Pre-Use Checklist
Stryker
has been working with the FDA on requirements for
ensuring all users are trained on the proper use of the device. We
have developed a 9-point checklist (circulating RN will document
in the OR record) that the Circulating Nurse must complete before
every procedure using the Neptune device.
Please
keep in mind that Stryker and the FDA will be performing
audits on these records to ensure the Pre-Use Checklist is being
used and that all users have been trained on the device. Failure to
use this checklist prior to each procedure is grounds for revoking
the Certificate of Medical Necessity signed by your facility.
