Integra LifeSciences Care and Handling of Padgett Instruments - Manual

INDICATIONS FOR USE
Padgett surgical instruments are designed to perform a specific
function, such as cutting, grasping, clamping, dissecting, probing,
retracting, draining, aspirating, suturing, or ligating. For use by,
or as directed by, a surgeon. Instruments should be used only
for the purpose for which they are designed. The proper surgical
technique for the use of instruments is the responsibility of the
surgeon.
CONTRAINDICATION
Instruments should not be used for anything other than their
intended use.
WARNING
Consult individual national infection control/prevention protocols
for specific guidance regarding processing medical devices with
suspected exposure to Creutzfeldt-Jakob Disease (CJD).
CAUTION
After cleaning, especially ultrasonic cleaning, check screws on
instruments because the vibration from the ultrasonic cleaning may
cause them to loosen or fall out.
Padgett surgical instruments are supplied non-sterile, unless
otherwise noted, and must be cleaned, lubricated and sterilized
prior to use according to hospital protocol and the procedures
outlined in this document. Failure to follow these procedures will
invalidate the instrument’s warranty and can cause the instrument
to fail.
Inappropriate use of instruments will lead to damage that is usually
not repairable; for example, a hemostat that is used to clamp
tubing can become misaligned and quickly break.
INSPECTION OF ALL INSTRUMENTS
All instruments are carefully inspected before shipment. Because
damage may occur during transit, the instruments should be
thoroughly inspected upon receipt. All instruments must be inspected
prior to use.
Handling and Operating Instruments: Instruments should be handled
and operated by personnel completely familiar with their use,
assembly and disassembly. Before a new instrument is used
and prior to each surgical procedure, the instrument must be
decontaminated, lubricated and sterilized as described below.
Handle the instrument with care. The instrument must be inspected
to assure proper functioning prior to each use with particular
attention paid to the condition of all moving parts, tips, box locks,
ratchets and cutting edges. Each instrument with a screw must
be inspected before and after use to ensure that the screws do
not move when operating the instrument. Screws can loosen and
back out of an instrument as a result of normal operation and/or
the vibration during ultrasonic cleaning. Failure to make a complete
inspection to assure the proper operation and function of the
instrument may result in unsatisfactory performance, perhaps
because a part is missing. Do not use if the instrument does not
appear to be functioning properly. Use of an instrument for a task
other than that for which it is intended could result in a damaged
or broken instrument, or one which provides an unsatisfactory
performance. In order to insure warranties and guarantees,
instruments in need of repair should be sent to Integra.
DECONTAMINATION AND STERILIZATION PROCEDURES
As with any decontamination procedure, personnel should follow
accepted guidelines for hand washing, the use of protective attire,
etc. as recommended by A.A.M.I. Standards and Recommended
Practice, “Safe Handling and Biological Decontamination of
Medical Devices in Health Care Facilities and in Non-Clinical
Settings”, ANSI/AAMI ST35:2003.
Decontamination is a two step process:
1) Thorough cleaning and rinsing.
2) Sterilization or disinfection.
A. MANUAL DECONTAMINATION
PRECLEANING: Remove gross debris from surgical instruments with
a lap sponge and sterile water routinely during the procedure to
prevent drying on of blood and body fluids, etc. It is important
to rinse instruments that have been exposed to blood and saline
solution before these substances dry. Blood and body fluids as
well as saline solutions are highly corrosive. In addition, blood can
produce a stain that is difficult to remove.
CLEANING: To prevent the formation of biofilm, cleaning should
occur as soon as possible after instrumentation is used. Biofilm
is an accumulation of a biomass of bacteria and extracellular
material that tightly adheres itself to the surface of the instruments.
It cannot be easily removed, and protects microorganisms from
being easily removed by ordinary cleaning/decontamination
methods used in hospitals. It is particularly problematic in lumened
medical devices.
Step 1. Maintain moisture: Immediately after the surgical procedure,
place the instruments in an instrument tray/container and cover
with a towel moistened with sterile distilled water. Foam, spray
or gel products, specifically intended for use with surgical
instruments, are available to keep the soil moist. Transport tray of
soiled instruments in an impervious plastic bag or container with a
tight lid to the decontamination environment (keep the outside of
the containment clean).
Step 2. Enzymatic Soak: Immerse fully opened and/or disassembled
instruments in an enzymatic solution, specific for use with
surgical instruments. Prepare the solution and use per enzyme
manufacturer’s recommendations, paying special attention to
instructions for correct dilution, temperature and soak time.
Flush air from lumens and fill them with enzymatic solution for full
contact with this inner surface during the soak time.
Step 3. Rinse: Remove from enzymatic soak after the time period
recommended by the enzymatic manufacturer and rinse thoroughly
with tap water. Flush lumens until rinse water runs clear.
Step 4. Cleaning Instruments: Choose a cleaning solution
appropriate for surgical instruments and follow the manufacturer’s
instructions for use. The use of neutral pH detergents is vital to
the maintenance of surgical instruments. Contact with acidic or
alkaline solution will remove the instruments’ protective barrier
of chromium oxide, often leading to corrosion, pitting, and
breakage. You may find that depending on the type of soil, a
detergent that is a little more or less acid or alkaline may be more
appropriate. The ideal cleaning agent is nonabrasive, low-foaming
and free-rinsing. Using a small clean hand-held brush, remove
soil from all surfaces of the instrument while fully immersed in
the solution. During manual cleaning, never use steel wool, wire
brushes, scalpel blades or highly abrasive detergent or cleansers
to remove soil from surgical instruments. These will damage
the instruments’ protective surface and lead to corrosion. Use a
clean soft bristled brush to clean instruments with an accessible
channel. Remove the soil from the ratchets, jaws, tips, box locks,
and/or hinge mechanism. The box lock and hinge portion of an
instrument must be thoroughly cleaned after each use. A build-
up of soil, debris, lubricants, etc. in these areas, will make it
difficult to use the instrument and eventually irreparably damage
it. Vigorously flush channels with the cleaning solution. Deionized
water is recommended and preferred because it is free of the many
compounds which exist in ordinary tap water. These substances,
alone, cause stains and when tap water is combined with some
detergents it will form insoluble deposits on the instruments.
Manual cleaning should remove all visible residue. It is essential
to keep the box locks and hinges open during any manual or
automated cleaning process.
Step 5. Rinse: Thoroughly rinse instruments by immersing in tap
water and wiping with a clean, soft cloth. Flush lumens until water
runs clear.
Step 6. Ultrasonic Cleaning and Rinsing: Follow the recommendations
of the ultrasonic manufacturer regarding cycle times, detergents,
proper placement of the instrument tray, and conditioning
(“degassing”) of the cleaning solution, etc. Use an ultrasonic
cleaner to remove soil from hard to reach surfaces such as
grooves, crevices, lumens, instruments with moving parts,
etc., after gross soil has been removed. Open or disassemble
instruments as appropriate. Place instruments in a mesh bottom
stainless steel instrument tray. Place the tray into the ultrasonic
cleaner. Flush air out of lumens and fill them with the ultrasonic
cleaning solution (under the solution level in the chamber) for
effective removal of soil from that inner surface by the ultrasonic
activity.
Step 7. FINAL RINSE should be with “treated water”. Softened
or deionized water should be used for the final rinse to better
remove detergents etc. Softening water removes calcium and
magnesium ions that cause water to be hard. Iron ions may also be
removed by this treatment. Deionization removes ionized salts and
particles from the water. Excessively hard water can spot or stain
instruments and excessive chlorine in water can cause pitting of
the instrument. Deionized water is preferred for the final rinse.
Step 8. Decontaminate Clean Instruments: Once instruments have
been cleaned they must be rendered safe for handling, inspection
and assembly. They may be steam sterilized without a wrapper or
disinfected following the instructions from the instrument, sterilizer
and disinfectant manufacturers.
Step 9. Visual Inspection and Instrument Set Assembly: Visually inspect
the instrument for cleanliness and to ensure all parts are in proper
working order, as the set is assembled. Inspection is a vital part of
proper care and maintenance. Instruments in need of repair will not
perform accurately in surgery and breakage is likely to occur. DO
NOT USE damaged instruments. Worn ratchets, loose box locks