ASTM F1744-96(2008)
(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:F1744–96 (Reapproved 2008)
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 Passivation—Stainless steel can spot, stain, and cor-
rode. This is minimized by passivation which is a process used
1.1 This guide is intended to provide a better understanding
to create a protective chromium oxide surface layer while
of the care of stainless steel surgical instruments intended for
removing surface carbon and iron. This is accomplished in the
reuse. This guide is not intended for use with electrical,
atmosphere slowly or through immersion in oxidizing solution
pneumatic or other powered surgical instruments.
or through an electro-polish process. Through repeated pro-
2. Referenced Documents
cessing the passivation layer will thicken until a good protec-
tive film is formed.
2.1 ASTM Standards:
3.2.1 Never expose instruments to strong acids such as
F 899 Specification for Wrought Stainless Steels for Surgi-
hydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-
cal Instruments
taric.
F 921 Terminology Relating to Hemostatic Forceps
3.2.2 Avoid contact with salt solutions such as aluminum
F 1026 Specification for General Workmanship and Perfor-
chloride, mercury salts, stannous chloride. Also avoid contact
mance Measurements of Hemostatic Forceps
with potassium thiocyanate and potassium permanganate and
F 1078 Terminology for Surgical Scissors—Inserted and
limit contact with iodine solutions to periods less than 1 h.
Non-Inserted Blades
3.2.3 Chloride-bearing solutions such as blood and saline
F 1079 Specification for Inserted and Noninserted Surgical
can cause localized corrosion.Avoid prolonged exposure to or
Scissors
rinsing in saline solutions or corrosion and pitting will occur.
F 1089 Test Method for Corrosion of Surgical Instruments
Use demineralized or distilled water instead. Place instruments
F 1325 Specification for Stainless Steel Suture Needle
into water, enzymatic solution, or disinfectant bath immedi-
Holders-General Workmanship Requirements and Corre-
ately after use so the blood or other material will not dry on
sponding Test Methods
them prior to transport to designated cleaning/reprocessing
3. General
area.
3.1 StainlessSteelTypes—Thestainlesssteelsmostusedare
4. General Care of Instruments
martensitic and austenitic types such as those in Specification
4.1 General—Use instruments only for their intended pur-
F 899. Martensitic stainless steel contains iron, chromium, and
pose, such as cutting, holding, clamping, retracting, and so
sufficient carbon so that when it is hardened by heat treatment,
forth.Avoid undue stress or strain when handling and cleaning.
a substantial martensitic structure is the result. Austenitic
Standard terminology relating to Hemostatic Forceps and
stainless steel has better corrosion resistance and contains iron,
Surgical Scissors are found in Definitions F 921 and Specifi-
chromium, and nickel. It has a substantial austenitic structure
cation F 1078.
and a lower carbon content.Although it cannot be hardened by
4.1.1 Hemostatic Forceps—These forceps are designed to
heat treatment, it can be work-hardened.
clamp blood vessels.They should not be used to clamp towels,
suction tubing, or as needle holders or pliers. Misuse generally
results in misalignment and even cracked box locks.
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
4.1.2 Needle Holders—Although designed to withstand
Surgical Materials and Devices and is the direct responsibility of Subcommittee
someforce,theyarenottobeusedaspliers,jawmisalignments
F04.33 on Medical/Surgical Instruments.
being the result. Select a needle holder matching the size
Current edition approved Feb. 1, 2008. Published March 2008. Originally
e1
approved in 1997. Last previous edition approved in 2002 as F 1744 – 96 (2002) .
needle being used.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.1.3 Scissors—Do not use scissors for the wrong job,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
otherwise, the tips will become misaligned and the blades will
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. dull or chip. Delicate scissors should be particularly guarded
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1744–96 (2008)
against misuses. Use tissue scissors for tissue dissections only, 4.2.5 Do not drop delicate or sharp instruments into any
not for cutting suture material or wires. cleaning receptacle. Such practice may cause damage to the
instruments.
4.1.4 Microsurgical Instruments—Microsurgical instru-
ments are most susceptible to damage through misuse or rough 4.2.6 After a surgical procedure, an instrument count should
handling. Consequently, extra care must be taken to avoid be made to avoid sending any instruments to the laundry with
compromising their exacting performance. To minimize dam- the soiled linen. Although they eventually may be returned,
age, the following should be done: they create a injury hazard to laundry workers and many are
damaged beyond economical repair.
4.1.4.1 Inspect the instrument when purchased and after
each use and cleaning, preferably under magnification. 4.3 Marking—Do not use a vibrating or impact type mark-
ingdevicesontheboxlockportion.Ifmarkingisnecessary,do
4.1.4.2 Only use for its intended purpose.
it on the shanks, otherwise the box locks may fail.
4.1.4.3 After each use, remove blood and debris from
instrument. A non-fibrous sponge may be used to eliminate
5. Cleaning
snagging and breakage. (Warning—When handling sharp
instruments, use extreme caution to avoid injury; Consult with
5.1 General—Clean instruments as soon as possible after
an infection control practitioner to develop and verify safety
use. Do not allow blood and debris to dry on the instruments.
procedures appropriate for all levels of direct instrument
If cleaning must be delayed, place groups of instruments in a
contact.)
covered container with appropriate detergent or enzymatic
solution to delay drying. Wash all instruments whether or not
4.1.4.4 Clean and thoroughly dry before packaging or stor-
ing. Avoid using a washer decontaminator or an ultrasonic they were used or were inadvertently contacted with blood or
cleaner (see Appendix X.2). saline solution.
After surgery, open box locks and disassemble instruments
4.1.4.5 Avoid metal-to-metal contact by using special racks
with removable parts. Forceps and scissors should be cleaned
designed to separate and protect.
and sterilized in the open position. This will limit blood drying
4.1.4.6 Do routine preventive maintenance such as sharpen-
on the instruments which may cause them to corrode. Delicate
ing and realigning. Sterilization by dry heat or chemical vapor
and sharp instruments should be cleaned separately. This is
should be considered for these instruments.
especially true for eye and microsurgery instruments.
4.1.5 Instrument Kits—Select an instrument tray which
(Warning—When handling any sharp instruments, use ex-
suitsthesizeofthekit.Placingalargeinstrumentkitinasmall
tremecautiontoavoidinjury;Consultwithaninfectioncontrol
instrument tray may lead to broken instruments, bent tips, or
practitioner to develop and verify safety procedures appropri-
dull scissors. Put heavier instruments such as retractors on the
ate for all levels of direct instrument contact. Direct handling
bottom and light weight instruments on the top. Ring-handled
and cleaning of instruments should be done only when indirect
instruments should be kept open with a wire holder or pin.
methods, for example, tweezers, are not available or not
Curved clamps should all point in the same direction to protect
possible.) Sort instruments by similar metal for subsequent
the tips. Scissors should be kept separate. Cupped instruments
processing so that electrolytic deposition due to contact be-
should be placed so that water does not collect in them during
tween dissimilar metals will not occur.
sterilization. Separate instruments of dissimilar metals by
Prior to regular cleaning, soak in enzyme solution or rinse
separate processing, otherwise galvanic corrosion or electro-
instrumentsindemineralizedordistilledwatertoremoveblood
lytic deposition may result.
anddebris,especiallythoseinstrumentswithhollowtubessuch
4.1.6 Other Sharp Instruments—Rongeurs, bone cutting
as suction tubes and curettes.
forceps, drill bits, reamers, and so forth should be used to cut
Do not use abrasive pads or cleansers which will scratch the
bone, not wire or pins. Sometimes it is necessary to use
surface allowing dirt and water deposits to collect. Abrasive
rongeurs or osteotomes to chip bone away from bone plates
cleaning will remove the passive layer. Do not use chlorine
and screws, which may nick or dull the blades. An alternate
bleach at a higher concentration than recommended by the
approach is to keep an older set of rongeurs or osteotomes for
manufacturer to clean or disinfect stainless steel instruments,
suchorthopedicprocedures.Instrumentsthatarerecommended
as pitting will occur. High concentrations of chlorine-based
to be sharpened by the manufacturer should be processed and
solutions are not recommended as pitting and subsequent
verified by the manufacturer’s specific instruction. Instruments
damage will occur. (See Appendix X3.)
should be used only for their identified purpose. Careful
5.2 Detergents—The detergent used should be in keeping
planning is necessary for selection of the proper amount and
withthecleaningequipmentmanufacturer’srecommendations.
type of instruments needed for each surgical procedure.
Neutral pH detergents, between 7.0 and 8.5, which are low
4.2 Care During Use:
sudsing, free rinsing, and have good wetting are best over all
4.2.1 Handle instruments gently.
for washer decontaminators and ultrasonic cleaners. High-
4.2.2 Avoid dropping instruments or covering them with
sudsing detergents must be thoroughly rinsed or instruments
heavier instruments.
will spot or stain. (See Appendix X2.)
4.2.3 Handle instruments individually or in small numbers.
5.3 Washer Decontaminator—Equipment of this type will
4.2.4 Protect instrument tips, especially sharp ones. Do not wash and decontaminate instruments. Complete removal of
place instruments down on their tips. soil from serrations and crevices depends on instrument
F1744–96 (2008)
construction,exposuretime,pressureofdeliveredsolution,and 5.4.7 Check screws of instruments after cleaning to ensure
pH of the detergent solution, and thus may require prior that they have not loosened through vibration.
brushing.
5.4.8 Keep cleaning solution particulate-free by changing
5.3.1 Be familiar with equipment manufacturers’ use and often or changing the filter per manufacturer’s recommenda-
tions.
operation instructions. Be aware that loading detergent water
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.Alubricant 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
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