Integra LifeSciences Care and Handling of Padgett Instruments - Manual (Page 2)

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 exposure times to
sterilization temperature may need to be longer than the minimum
indicated by the sterilizer manufacturer but must never be shorter.
Below are the recommended sterilization parameters:
Sterilizer Exposure
Temperature
Exposure Time Minimum
Dry Time
Pre-vacuum
(wrapped)
121° C (250° F)
132° C (270° F)
134° C (273° F)
20 min
4 min
3 min
20 min
20 min
15 min
Pre-vacuum
(unwrapped)
132° C (270° F) 4 min
Gravity Steam
(wrapped)
132° C (270° F) 18 min
MAINTENANCE PROCEDURES
Improper, ineffective, and insufficient maintenance can greatly
reduce the life of an instrument and will invalidate the instrument’s
warranty. We cannot make any statement about how long
an instrument will last. Designed and crafted to exacting
specifications, instruments will perform for a reasonable number of
years when the following steps are observed:
Protect Instruments: The most effective method of dealing with
instrument problems is to prevent them from occurring. The use of
“treated water”, careful preliminary cleaning, the use of neutralized
pH solutions, adherence to manufacturer’s instructions, and visual
inspection, will help to keep instruments performing accurately
and cosmetically free of troublesome stains. It is important to act
quickly should a problem arise. Delay will compound the problem
and irreparable harm may result.
• Certain compounds are highly corrosive to stainless steel and will
cause serious damage despite the passivated protective surface.
If instruments are inadvertently exposed to any of the following
substances, they should be rinsed immediately with copious
amounts of water.
Instruments should never be exposed to:
Aqua regia
Iodine
Ferric chloride Sulfuric acid
Hydrochloric acid
The following substances should be avoided whenever possible:
Aluminum chloride
Mercury chloride
Barium chloride Potassium permanganate
Bichloride of mercury Potassium thiocyanate
Calcium chloride Saline
Carbolic acid Sodium hypochlorite
Chlorinated lime Stannous chloride
Dakin’s solution
• Any kind of corrosion will lead to rust on steel. Because rust
particles can be transferred from one instrument to another,
corroding instruments should be removed from service to prevent
the formation of rust on other instruments.
• Instruments must be sterilized in the open position or
disassembled as appropriate. Steam will only sterilize the surface
it can directly touch.
• Every effort should be made to protect sharp cutting edges
and fine working tips during all maintenance procedures. Avoid
loading retractors and other heavy items on top of delicate and
hollow instruments.
Diagnosing Spots and Stains: It is common for instruments to become
stained or spotted despite the best efforts of the manufacturers
and the hospital staff. In nearly all cases these problems are the
result of minerals deposited upon the surfaces of the instruments,
as well as insufficient cleaning. Adhering to proper technique
during cleaning and sterilizing procedures will prevent most
staining occurrences. However, they will sometimes arise very
suddenly and will not disappear on their own. The following
identifies some of the various instrument-related problems
hospitals may encounter.
Brown Stains: Detergents containing polyphosphates may dissolve
copper elements in the sterilizer. This results in copper being
deposited on the instruments by an electrolytic reaction. The
hospital may try a different detergent or check the quantities used.
Usually a dull blue or brown stain is simply a build-up of oxidation
on the surface. This film is harmless and will actually protect the
instrument from serious corrosion.
Blue Stains: Blue stains are usually the result of cold sterilization
techniques. It is important to prepare the solution according to
exact proportions and to change the solution when recommended.
Serious corrosion may occur if the solution is used beyond the
manufacturer’s specified time limit. The use of distilled water and a
rust inhibitor in the solution will help retard discoloration.
Black Stains: Black stains may be the result of contact with
ammonia. Many cleaning compounds contain ammonia and it will
remain on the instruments unless they are well rinsed.
Light or Dark Spots: Spots are often the result of condensation
pooling and then drying on flat and concave instrument surfaces.
The mineral content of the water remains on the instrument.
Using “treated water” as the FINAL rinse will help to remove the
minerals found in water that can cause these residual spots. It is
also important to follow the sterilizer manufacturer’s instructions
for preparing instrument sets for sterilization. Standing instruments