ASTM F1744-96
(Guide)Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
SCOPE
1.1 This guide is intended to provide a better understanding of the care of stainless steel surgical instruments intended for reuse. This guide is not intended for use with electrical, pneumatic or other powered surgical instruments.
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Designation: F 1744 – 96
Standard Guide for
Care and Handling of Stainless Steel Surgical Instruments
This standard is issued under the fixed designation F 1744; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.1 Never expose instruments to strong acids such as
hydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-
1.1 This guide is intended to provide a better understanding
taric.
of the care of stainless steel surgical instruments intended for
3.2.2 Avoid contact with salt solutions such as aluminum
reuse. This guide is not intended for use with electrical,
chloride, mercury salts, stannous chloride. Also avoid contact
pneumatic or other powered surgical instruments.
with potassium thiocyanate and potassium permanganate and
2. Referenced Documents limit contact with iodine solutions to periods less than 1 h.
3.2.3 Chloride-bearing solutions such as blood and saline
2.1 ASTM Standards:
can cause localized corrosion. Avoid prolonged exposure to or
F 899 Specification for Stainless Steel Billet, Bar, and Wire
rinsing in saline solutions or corrosion and pitting will occur.
for Surgical Instruments
Use demineralized or distilled water instead. Place instruments
F 921 Definitions of Terms Relating to Hemostatic Forceps
into water, enzymatic solution, or disinfectant bath immedi-
F 1026 Specification for General Workmanship and Perfor-
ately after use so the blood or other material will not dry on
mance Measurements of Hemostatic Forceps
them prior to transport to designated cleaning/reprocessing
F 1078 Terminology for Surgical Scissors—Inserted and
area.
Non-Inserted Blades
F 1079 Specification for Inserted and Non-Inserted Surgical
4. General Care of Instruments
Scissors
4.1 General—Use instruments only for their intended pur-
F 1089 Test Method for Corrosion of Surgical Instruments
pose, such as cutting, holding, clamping, retracting, etc. Avoid
F 1325 Specification for Suture Needle Holders—General
undue stress or strain when handling and cleaning. Standard
Workmanship Requirements and Corresponding Test
terminology relating to Hemostatic Forceps and Surgical Scis-
Methods
sors are found in Definitions F 921 and Specification F 1078.
3. General
4.1.1 Hemostatic Forceps—These forceps are designed to
clamp blood vessels. They should not be used to clamp towels,
3.1 Stainless Steel Types—The stainless steels most used are
suction tubing, or as needle holders or pliers. Misuse generally
martensitic and austenitic types such as those in Specification
results in misalignment and even cracked box locks.
F 899. Martensitic stainless steel contains iron, chromium, and
4.1.2 Needle Holders—Although designed to withstand
sufficient carbon so that when it is hardened by heat treatment,
some force, they are not to be used as pliers, jaw misalignments
a substantial martensitic structure is the result. Austenitic
being the result. Select a needle holder matching the size
stainless steel has better corrosion resistance and contains iron,
needle being used.
chromium, and nickel. It has a substantial austenitic structure
4.1.3 Scissors—Do not use scissors for the wrong job,
and a lower carbon content. Although it cannot be hardened by
otherwise, the tips will become misaligned and the blades will
heat treatment, it can be work-hardened.
dull or chip. Delicate scissors should be particularly guarded
3.2 Passivation—Stainless steel can spot, stain, and cor-
against misuses. Use tissue scissors for tissue dissections only,
rode. This is minimized by passivation which is a process used
not for cutting suture material or wires.
to create a protective chromium oxide surface layer while
4.1.4 Microsurgical Instruments—Microsurgical instru-
removing surface carbon and iron. This is accomplished in the
ments are most susceptible to damage through misuse or rough
atmosphere slowly or through immersion in oxidizing solution
handling. Consequently, extra care must be taken to avoid
or through an electro-polish process. Through repeated pro-
compromising their exacting performance. To minimize dam-
cessing the passivation layer will thicken until a good protec-
age, the following should be done:
tive film is formed.
4.1.4.1 Inspect the instrument when purchased and after
each use and cleaning, preferably under magnification.
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and
4.1.4.2 Only use for its intended purpose.
Surgical Materials and Devicesand is the direct responsibility of Subcommittee
F04.65 on Medical/Surgical Instruments.
4.1.4.3 After each use remove blood and debris from
Current edition approved Oct. 10, 1996. Published January 1997.
instrument. A non-fibrous sponge may be used to eliminate
Annual Book of ASTM Standards, Vol 13.01.
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1744
snagging and breakage. When handling sharp instruments If cleaning must be delayed, place groups of instruments in a
use extreme caution to avoid injury: consult with an covered container with appropriate detergent or enzymatic
infection control practitioner to develop and verify safety solution to delay drying. Wash all instruments whether or not
procedures appropriate for all levels of direct instrument they were used or were inadvertently contacted with blood or
contact. saline solution.
4.1.4.4 Clean and thoroughly dry before packaging or stor-
After surgery, open box locks and disassemble instruments
ing. Avoid using a washer decontaminator or an ultrasonic
with removable parts. Forceps and scissors should be cleaned
cleaner (see Appendix X2).
and sterilized in the open position. This will limit blood drying
4.1.4.5 Avoid metal-to-metal contact by using special racks
on the instruments which may cause them to corrode. Delicate
designed to separate and protect.
and sharp instruments should be cleaned separately. This is
4.1.4.6 Do routine preventive maintenance such as sharpen-
especially true for eye and microsurgery instruments. When
ing and realigning. Sterilization by dry heat or chemical vapor
handling any sharp instruments use extreme caution to
should be considered for these instruments.
avoid injury: consult with an infection control practitioner
4.1.5 Instrument Kits—Select an instrument tray which
to develop and verify safety procedures appropriate for all
suits the size of the kit. Placing a large instrument kit in a small
levels of direct instrument contact. Direct handling and
instrument tray may lead to broken instruments, bent tips, or
cleaning of instruments should be done only when indirect
dull scissors. Put heavier instruments such as retractors on the
methods, for example, tweezers, are not available or not
bottom and light weight instruments on the top. Ring-handled
possible. Sort instruments by similar metal for subsequent
instruments should be kept open with a wire holder or pin.
processing so that electrolytic deposition due to contact be-
Curved clamps should all point in the same direction to protect
tween dissimilar metals will not occur.
the tips. Scissors should be kept separate. Cupped instruments
Prior to regular cleaning, soak in enzyme solution or rinse
should be placed so that water does not collect in them during
instruments in demineralized or distilled water to remove blood
sterilization. Separate instruments of dissimilar metals by
and debris, especially those instruments with hollow tubes such
separate processing, otherwise galvanic corrosion or electro-
as suction tubes and curettes.
lytic deposition may result.
Do not use abrasive pads or cleansers which will scratch the
4.1.6 Other Sharp Instruments—Rongeurs, bone cutting
surface allowing dirt and water deposits to collect. Abrasive
forceps, drill bits, reamers, etc. should be used to cut bone, not
cleaning will remove the passive layer. Do not use chlorine
wire or pins. Sometimes it is necessary to use rongeurs or
bleach at a higher concentration than recommended by the
osteotomes to chip bone away from bone plates and screws,
manufacturer to clean or disinfect stainless steel instruments,
which may nick or dull the blades. An alternate approach is to
as pitting will occur. High concentrations of chlorine-based
keep an older set of rongeurs or osteotomes for such orthopedic
solutions are not recommended as pitting and subsequent
procedures. Instruments that are recommended to be sharpened
damage will occur. (See Appendix X3.)
by the manufacturer should be processed and verified by the
5.2 Detergents—The detergent used should be in keeping
manufacturer’s specific instruction. Instruments should be used
with the cleaning equipment manufacturer’s recommendations.
only for their identified purpose. Careful planning is necessary
Neutral pH detergents, between 7.0 and 8.5, which are low
for selection of the proper amount and type of instruments
sudsing, free rinsing, and have good wetting are best over all
needed for each surgical procedure.
for washer decontaminators and ultrasonic cleaners. High-
4.2 Care During Use:
sudsing detergents must be thoroughly rinsed or instruments
4.2.1 Handle instruments gently.
will spot or stain. (See Appendix X2.)
4.2.2 Avoid dropping instruments or covering them with
5.3 Washer Decontaminator—Equipment of this type will
heavier instruments.
wash and decontaminate instruments. Complete removal of
4.2.3 Handle instruments individually or in small numbers.
soil from serrations and crevices depends on instrument
4.2.4 Protect instrument tips, especially sharp ones. Do not
construction, exposure time, pressure of delivered solution, and
place instruments down on their tips.
pH of the detergent solution, and thus may require prior
4.2.5 Do not drop delicate or sharp instruments into any
brushing.
cleaning receptacle. Such practice may cause damage to the
5.3.1 Be familiar with equipment manufacturers’ use and
instruments.
operation instructions. Be aware that loading detergent water
4.2.6 After a surgical procedure, an instrument count should
temperature and other external factors may change the effec-
be made to avoid sending any instruments to the laundry with
tiveness of the equipment. (See X4.5.)
the soiled linen. Although they eventually may be returned,
5.3.2 Arrange heavier instruments on bottom, disassemble
they create a injury hazard to laundry workers and many are
instruments with removable parts, open box locks, and protect
damaged beyond economical repair.
cutting edges.
4.3 Marking—Do not use a vibrating or impact type mark-
5.3.3 Follow equipment manufacturers’ recommendations
ing devices on the box lock portion. If marking is necessary, do
for detergent, preferably a liquid one. Solid detergents may not
it on the shanks, otherwise the box locks may fail.
disperse as completely. Concentrated detergents placed on the
5. Cleaning
instruments may cause corrosion.
5.1 General—Clean instruments as soon as possible after 5.3.4 Install a water softener if the water is hard and the
use. Do not allow blood and debris to dry on the instruments. water supply is not already treated. This will minimize scum
NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1744
formation. Deionized water is recommended for rinsing to during storage. “Frozen” box locks can be immersed overnight
prevent spotting. and the joint then worked free.
5.6 Inspection—After lubricating, instruments should be
5.3.5 If instruments are dirty after decontamination, the
inspected. Incompletely cleaned instruments should be re-
ejector may be fouled. If fouled, foreign matter remains to
cleaned, and those that need repair set aside. For complex
deposit on the instruments. The ejector must be cleaned and
instruments, the manufacturer’s inspection and testing recom-
extraneous matter removed.
mendations should be followed.
5.3.6 Regularly cleaning decontaminator walls will remove
5.6.1 For hinged instruments such as clamps and forceps,
rust and mineral deposits and avoid transfer of this type of
lock stiffness, jaw alignment, and teeth should be checked.
debris to the instruments being cleaned. Follow the equipment
5.6.2 For sharp instruments such as scissors, rongeurs, and
manufacturer’s instructions or descaling detergent manufactur-
curettes, sharpness should be tested per manufacturer’s instruc-
ers’ instructions to clean decontaminator walls.
tions.
5.4 Ultrasonic Cleaner—Ultrasonic cleaners, when used
5.6.3 Check plated instruments for chipped plating. These
with hot water per manufacturer’s recommended temperature
defects can tear rubber gloves, or cause the instruments to rust.
and specially formulated detergents, are very effective and
Any plated instrument with ruptured plating should be re-
thorough. Debris of all sizes can be removed even from
moved from use and refurbished or discarded.
crevices and corners in five min. After ultrasonic cleaning, the
5.6.4 Pins and screws should be checked to see if they are
instruments cleaned still need to be sterilized.
intact.
5.4.1 Follow manufacturer’s instructions when using an
ultrasonic cleaner. Be aware that loading patterns, instrument
6. Testing
cassettes, water temperature, and other external factors may
6.1 Forceps and hemostats shall conform to performance
change the effectiveness of the equipment. (See X4.5.)
characteristics stated in Specification F 1026.
5.4.2 Arrange instruments with box locks open and cutting
6.2 Scissors shall conform to performance characteristics
edges protected. Do not clean delicate instruments in an
stated in Specification F 1079.
ultrasonic cleaner since the vibrations can cause the tips to
6.3 Suture needle holders shall conform to performance
wear if they come in contact with other metal surfaces.
characteristics stated in Specification F 1325.
5.4.3 It is not recommended to clean plated instruments in
6.4 Scalpel handles should be checked for fit when the blade
an ultrasonic cleaner since the ultrasonic vibration and the
is attached to the scalpel handle. If fit is not snug, discard the
presence of other sharp instrument edges may crack or rupture
handle.
the plating. When the plating is ruptured ultrasonic energy will
NOTE 1—Test Method F 1089 contains test methods for
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