ASTM F1744-96(2002)e1

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
e1
Designation:F1744–96 (Reapproved 2002)
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.
e NOTE—Warning statements were corrected throughout in November 2002.
1. Scope removing surface carbon and iron. This is accomplished in the
atmosphere slowly or through immersion in oxidizing solution
1.1 This guide is intended to provide a better understanding
or through an electro-polish process. Through repeated pro-
of the care of stainless steel surgical instruments intended for
cessing the passivation layer will thicken until a good protec-
reuse. This guide is not intended for use with electrical,
tive film is formed.
pneumatic or other powered surgical instruments.
3.2.1 Never expose instruments to strong acids such as
2. Referenced Documents
hydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-
taric.
2.1 ASTM Standards:
3.2.2 Avoid contact with salt solutions such as aluminum
F 899 Specification for Stainless Steels for Surgical Instru-
chloride, mercury salts, stannous chloride. Also avoid contact
ments
with potassium thiocyanate and potassium permanganate and
F 921 DefinitionsofTermsRelatingtoHemostaticForceps
limit contact with iodine solutions to periods less than 1 h.
F 1026 Specification for General Workmanship and Perfor-
3.2.3 Chloride-bearing solutions such as blood and saline
mance Measurements of Hemostatic Forceps
can cause localized corrosion.Avoid prolonged exposure to or
F 1078 Terminology for Surgical Scissors—Inserted and
rinsing in saline solutions or corrosion and pitting will occur.
Non-Inserted Blades
Use demineralized or distilled water instead. Place instruments
F 1079 Specification for Inserted and Non-Inserted Surgical
into water, enzymatic solution, or disinfectant bath immedi-
Scissors
ately after use so the blood or other material will not dry on
F 1089 Test Method for Corrosion of Surgical Instruments
them prior to transport to designated cleaning/reprocessing
F 1325 Specification for Stainless Steel Suture Needle
area.
Holders—General Workmanship Requirements and Corre-
sponding Test Methods
4. General Care of Instruments
3. General
4.1 General—Use instruments only for their intended pur-
pose, such as cutting, holding, clamping, retracting, and so
3.1 StainlessSteelTypes—Thestainlesssteelsmostusedare
forth.Avoid undue stress or strain when handling and cleaning.
martensitic and austenitic types such as those in Specification
Standard terminology relating to Hemostatic Forceps and
F 899. Martensitic stainless steel contains iron, chromium, and
Surgical Scissors are found in Definitions F 921 and Specifi-
sufficient carbon so that when it is hardened by heat treatment,
cation F 1078.
a substantial martensitic structure is the result. Austenitic
4.1.1 Hemostatic Forceps—These forceps are designed to
stainless steel has better corrosion resistance and contains iron,
clamp blood vessels. They should not be used to clamp towels,
chromium, and nickel. It has a substantial austenitic structure
suction tubing, or as needle holders or pliers. Misuse generally
and a lower carbon content.Although it cannot be hardened by
results in misalignment and even cracked box locks.
heat treatment, it can be work-hardened.
4.1.2 Needle Holders—Although designed to withstand
3.2 Passivation—Stainless steel can spot, stain, and cor-
someforce,theyarenottobeusedaspliers,jawmisalignments
rode. This is minimized by passivation which is a process used
being the result. Select a needle holder matching the size
to create a protective chromium oxide surface layer while
needle being used.
4.1.3 Scissors—Do not use scissors for the wrong job,
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
otherwise, the tips will become misaligned and the blades will
Surgical Materials and Devices and is the direct responsibility of Subcommittee
dull or chip. Delicate scissors should be particularly guarded
F04.33 on Medical/Surgical Instruments.
against misuses. Use tissue scissors for tissue dissections only,
Current edition approved Oct. 10, 1996. Published January 1997.
not for cutting suture material or wires.
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
e1
F1744–96 (2002)
4.1.4 Microsurgical Instruments—Microsurgical instru- 4.2.6 After a surgical procedure, an instrument count should
ments are most susceptible to damage through misuse or rough be made to avoid sending any instruments to the laundry with
handling. Consequently, extra care must be taken to avoid the soiled linen. Although they eventually may be returned,
compromising their exacting performance. To minimize dam- they create a injury hazard to laundry workers and many are
age, the following should be done: damaged beyond economical repair.
4.3 Marking—Do not use a vibrating or impact type mark-
4.1.4.1 Inspect the instrument when purchased and after
ing devices on the box lock portion. If marking is necessary, do
each use and cleaning, preferably under magnification.
it on the shanks, otherwise the box locks may fail.
4.1.4.2 Only use for its intended purpose.
4.1.4.3 After each use, remove blood and debris from
5. Cleaning
instrument. A non-fibrous sponge may be used to eliminate
5.1 General—Clean instruments as soon as possible after
snagging and breakage. (Warning—When handling sharp
use. Do not allow blood and debris to dry on the instruments.
instruments, use extreme caution to avoid injury; Consult with
If cleaning must be delayed, place groups of instruments in a
an infection control practitioner to develop and verify safety
covered container with appropriate detergent or enzymatic
procedures appropriate for all levels of direct instrument
solution to delay drying. Wash all instruments whether or not
contact.)
they were used or were inadvertently contacted with blood or
4.1.4.4 Clean and thoroughly dry before packaging or stor-
saline solution.
ing. Avoid using a washer decontaminator or an ultrasonic
After surgery, open box locks and disassemble instruments
cleaner (see Appendix X.2).
with removable parts. Forceps and scissors should be cleaned
4.1.4.5 Avoid metal-to-metal contact by using special racks
and sterilized in the open position. This will limit blood drying
designed to separate and protect.
on the instruments which may cause them to corrode. Delicate
4.1.4.6 Do routine preventive maintenance such as sharpen-
and sharp instruments should be cleaned separately. This is
ing and realigning. Sterilization by dry heat or chemical vapor
especially true for eye and microsurgery instruments.
should be considered for these instruments.
(Warning—When handling any sharp instruments, use ex-
tremecautiontoavoidinjury;Consultwithaninfectioncontrol
4.1.5 Instrument Kits—Select an instrument tray which
suits the size of the kit. Placing a large instrument kit in a small practitioner to develop and verify safety procedures appropri-
ate for all levels of direct instrument contact. Direct handling
instrument tray may lead to broken instruments, bent tips, or
and 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
should be placed so that water does not collect in them during Prior to regular cleaning, soak in enzyme solution or rinse
instrumentsindemineralizedordistilledwatertoremoveblood
sterilization. Separate instruments of dissimilar metals by
separate processing, otherwise galvanic corrosion or electro- anddebris,especiallythoseinstrumentswithhollowtubessuch
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, and so forth should be used to cut
cleaning will remove the passive layer. Do not use chlorine
bone, not wire or pins. Sometimes it is necessary to use
bleach at a higher concentration than recommended by the
rongeurs or osteotomes to chip bone away from bone plates
manufacturer to clean or disinfect stainless steel instruments,
and screws, which may nick or dull the blades. An alternate
as pitting will occur. High concentrations of chlorine-based
approach is to keep an older set of rongeurs or osteotomes for
solutions are not recommended as pitting and subsequent
suchorthopedicprocedures.Instrumentsthatarerecommended
damage will occur. (See Appendix X3.)
to be sharpened by the manufacturer should be processed and
5.2 Detergents—The detergent used should be in keeping
verified by the manufacturer’s specific instruction. Instruments
withthecleaningequipmentmanufacturer’srecommendations.
should be used only for their identified purpose. Careful
Neutral pH detergents, between 7.0 and 8.5, which are low
planning is necessary for selection of the proper amount and
sudsing, free rinsing, and have good wetting are best over all
type of instruments 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,exposuretime,pressureofdeliveredsolution,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
e1
F1744–96 (2002)
temperature and other external factors may change the effec- 5.5 Lubrication—To protect instruments during sterilization
tiveness of the equipment. (See X4.5.) and storage from staining and rusting, they should be lubri-
cated with a water-soluble, preserved lubricant after each
5.3.2 Arrange heavier instruments on bottom, disassemble
cleaning. Since effective ultrasonic cleaning removes all lubri-
instruments with removable parts, open box locks, and protect
cant, re-lubrication of the instruments is important. The lubri-
cutting edges.
cantshouldcontainachemicalpreservativetopreventbacterial
5.3.3 Follow equipment manufacturers’ recommendations
growth in the lubricant bath. The bath solution should be made
for detergent, preferably a liquid one. Solid detergents may not
with demineralized water. A lubricant containing a rust inhibi-
disperse as completely. Concentrated detergents placed on the
tor helps prevent electrolytic corrosion of points and edges.
instruments may cause corrosion.
Immediately after cleaning, instruments should be immersed
5.3.4 Install a water softener if the water is hard and the
completely for 30 s and allowed to drain off, not wiped off. A
water supply is not already treated. This will minimize scum
lubricant film will remain through sterilization to protect them
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.
5.3.5 If instruments are dirty after decontamination, the
5.6 Inspection—After lubricating, instruments should be
ejector may be fouled. If fouled, foreign matter remains to
inspected. Incompletely cleaned instruments should be re-
deposit on the instruments. The ejector must be cleaned and
cleaned, and those that need repair set aside. For complex
extraneous matter removed.
instruments, the manufacturer’s inspection and testing recom-
5.3.6 Regularly cleaning decontaminator walls will remove
mendations should be followed.
rust and mineral deposits and avoid transfer of this type of
5.6.1 For hinged instruments such as clamps and forceps,
debris to the instruments being cleaned. Follow the equipment
lock stiffness, jaw alignment, and teeth should be checked.
manufacturer’s instructions or descaling detergent manufactur-
5.6.2 For sharp instruments such as scissors, rongeurs, and
ers’ instructions to clean decontaminator walls.
curettes,sharpnessshouldbetestedpermanufacturer’sinstruc-
5.4 Ultrasonic Cleaner—Ultrasonic cleaners, when used
tions.
with hot water per manufacturer’s recommended temperature
5.6.3 Check plated instruments for chipped plating. These
and specially formulated detergents, are very effective and
defects can tear rubber gloves, or cause the instruments to rust.
thorough. Debris of all sizes can be removed even from
Any plated instrument with ruptured plating should be re-
crevices and corners in five minutes.After ultrasonic cleaning,
moved from use and refurbished or discarded.
the instruments cleaned still need to be sterilized.
5.6.4 Pins and screws should be checked to see if they are
5.4.1 Follow manufacturer’s instructions when using an
intact.
ultrasonic cleaner. Be aware that loading patterns, instrument
cassettes, water temperature, and other external factors may
6. Testing
change the effectiveness of the equipment. (See X4.5.)
6.1 Forceps and hemostats shall conform to performance
5.4.2 Arrange instruments with box locks open and cutting
characteristics stated in Specification F 1026.
edges protected. Do not clean delicate instruments in an
6.2 Scissors shall conform to performance characteristics
ultrasonic cleaner since the vibrations can cause the tips to
stated in Specification F 1079.
wear if they come in contact with other metal surfaces.
6.3 Suture needle holders shall c
...