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
and misaligned jaws can be repaired at a fraction of the cost of new
instruments. Contact your local representative for information regarding
a cost-effective instrument repair program.
Step 10. Lubricate: The use of an instrument lubricant, that is
compatible with the method of sterilization to be used, is recommended
before instruments are sterilized. Be certain that the instrument
lubricant is diluted and maintained properly, according to the
manufacturer's instructions. This type of lubricant is referred to as
"instrument milk" and is usually applied by spraying into the box
locks and moving parts or by dipping the opened instruments into a
solution. Lubricants that are too concentrated or too heavily applied will
result in slippery instruments that will also be mistaken as wet after
sterilization. After thoroughly cleaning instruments, proper application
of lubricants to joints will keep them moving freely and aid in protecting
the surface from mineral deposits. Note that ultrasonic cleaners remove
all lubrication; therefore this maintenance procedure should be done
routinely after ultrasonic cleaning and before sterilization. Proper
lubrication is an integral step in maintaining the long-life of the surgical
instrument. Lubrication will prevent the friction of metal on metal and
preserve the smooth function of the instrument thus avoiding corrosion
by friction. Furthermore, routine use of lubricating agents, on thoroughly
clean instruments, will prevent hinged and other movable parts from
sticking. Lubrication will aid in protecting the entire instrument surface
from mineral deposits.
Step 11. Drying: Before instruments are wrapped for sterilization or
storage, they must be thoroughly dry. If a set of instruments is wet
when wrapped for sterilization it is likely to come out of the sterilizer
wet. "Wet Packs" are not suitable for use after sterilization because
they may be easily contaminated when handled. In addition, remaining
moisture, particularly in box locks and hinges may result in corrosion
that will weaken the instrument and lead to breakage during use.
Prepare instrument sets for sterilization using a wrapper, pouch or
rigid sterilization container that is appropriate for the method of
sterilization to be used. The Association for the Advancement of Medical
Instrumentation (AAMI) and individual sterilizer manufacturers provide
guidance for the proper preparation of surgical instrument trays for
sterilization. Some sterilizer manufacturers can also provide information
regarding wet pack problem solving. See also, Sterilization for the
Healthcare Facility, 2nd Edition, Reichert, M.; Young, J., "Wet Pack
Problem Solving," Lee, S. (Frederick, MD: Aspen, 1997).
B. MECHANICAL DECONTAMINATION
General surgical instrumentation may be processed in a washer
sterilizer or washer decontaminator/disinfector. Some of these
processes include an enzyme application phase and a lubrication phase
that is designed into the cycle.
Follow the manufacturer's specifications when using automatic
washer-sterilizers or washer decontaminators/disinfectors. They usually
require the use of a low foaming, free rinsing detergent with a neutral
pH (7.0). A high-foaming detergent may clean effectively but will often
leave residual deposits on the instruments and do harm to mechanical
washers. Automated washer sterilizers and washer decontaminator/
disinfectors usually have adjustable wash and rinse times. Some
washers enable the user to customize extra cycles to process heavily
soiled surgical instruments more effectively. Check with a Technical
Service representative at 1-800-431-1123 for questions regarding
processing delicate, complex and/or multipart instruments by this
method.
C. TERMINAL STERILIZATION
After following the decontamination recommendations, reusable
instruments are ready for sterilization. Independent laboratory
testing, conducted according to the F.D.A. (21 CFR PART 58) and
Good Laboratory Practice Regulations (G.L.P.), has validated steam
sterilization as an effective process for reusable instruments. See also,
AAMI Standards and Recommended Practices, "Steam Sterilization and
Sterility Assurance in Health Care Facilities," ANSI/AAMI ST46:2002;
"Flash Sterilization Steam Sterilization of Patient Care Items for
Immediate Use, ANSI/AAMI ST37:3ed. AAMI standards recommend that
the sterilizer manufacturer's written instructions for cycle parameters
should also be followed. Steam sterilization of lumened instruments
requires that they be flushed with sterile water just prior to wrapping
and sterilization. The water generates steam within the lumen to move
air out. Air is the greatest enemy to steam sterilization, preventing
steam contact if not eliminated. Medical device manufacturer's