ASTM F1744-96(2008)e1
(Guide)Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
ABSTRACT
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. The stainless steels most used are martensitic and austenitic types. The instruments shall be used only for their intended purpose, such as cutting, holding, clamping, retracting, and so forth. Undue stress or strain should be avoided when handling and cleaning. The guide includes care in particular for hemostatic forceps, needle holders, scissors, microsurgical instruments, instrument kits, and other sharp instruments. The instrument care specified includes cleaning, lubrication, and inspection. Testing, repair and restoration, and sterilization are specified.
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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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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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 F1744; 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 (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—Editorial changes were made throughout in June 2008.
1. Scope 3.2 Passivation—Stainlesssteelcanspot,stain,andcorrode.
This is minimized by passivation which is a process used to
1.1 This guide is intended to provide a better understanding
create a protective chromium oxide surface layer while remov-
of the care of stainless steel surgical instruments intended for
ing 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-
cessing the passivation layer will thicken until a good protec-
2. Referenced Documents
tive film is formed.
2.1 ASTM Standards:
3.2.1 Never expose instruments to strong acids such as
F899 Specification for Wrought Stainless Steels for Surgical
hydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-
Instruments
taric.
F921 Terminology Relating to Hemostatic Forceps
3.2.2 Avoid contact with salt solutions such as aluminum
F1026 Specification for General Workmanship and Perfor-
chloride, mercury salts, and stannous chloride. Also avoid
mance Measurements of Hemostatic Forceps
contact with potassium thiocyanate and potassium permangan-
F1078 Terminology for Surgical Scissors—Inserted and
ate and limit contact with iodine solutions to periods of less
Non-Inserted Blades
than 1 h.
F1079 Specification for Inserted and Noninserted Surgical
3.2.3 Chloride-bearing solutions such as blood and saline
Scissors
can cause localized corrosion.Avoid prolonged exposure to or
F1089 Test Method for Corrosion of Surgical Instruments
rinsing in saline solutions or corrosion and pitting will occur.
F1325 Specification for Stainless Steel Suture Needle
Use demineralized or distilled water instead. Place instruments
Holders-General Workmanship Requirements and Corre-
into water, enzymatic solution, or disinfectant bath immedi-
sponding Test Methods
ately after use so the blood or other material will not dry on
them prior to transport to the designated cleaning/reprocessing
3. General
area.
3.1 StainlessSteelTypes—The stainless steels most used are
martensitic and austenitic types such as those in Specification
4. General Care of Instruments
F899. Martensitic stainless steel contains iron, chromium, and
4.1 General—Use instruments only for their intended
sufficient carbon so that when it is hardened by heat treatment,
purpose, such as cutting, holding, clamping, retracting, and so
a substantial martensitic structure is the result. Austenitic
forth.Avoid undue stress or strain when handling and cleaning.
stainless steel has better corrosion resistance and contains iron,
Standard terminology relating to Hemostatic Forceps and
chromium, and nickel. It has a substantial austenitic structure
Surgical Scissors are found in Terminology F921 and Termi-
and a lower carbon content.Although it cannot be hardened by
nology F1078.
heat treatment, it can be work-hardened.
4.1.1 Hemostatic Forceps—These forceps are designed to
clamp blood vessels.They should not be used to clamp towels,
This guide is under the jurisdiction of ASTM Committee F04 on Medical and suction tubing, or as needle holders or pliers. Misuse generally
Surgical Materials and Devices and is the direct responsibility of Subcommittee
results in misalignment and even cracked box locks.
F04.33 on Medical/Surgical Instruments.
4.1.2 Needle Holders—Although designed to withstand
Current edition approved Feb. 1, 2008. Published March 2008. Originally
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someforce,theyarenottobeusedaspliers,jawmisalignments
approved in 1997. Last previous edition approved in 2002 as F1744 – 96 (2002)
DOI: 10.1520/F1744-96R08E01.
being the result. Select a needle holder matching the size
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
needle being used.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
4.1.3 Scissors—Do not use scissors for the wrong job,
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. otherwise, the tips will become misaligned and the blades will
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F1744 − 96 (2008)
dull or chip. Delicate scissors should be particularly guarded 4.2.5 Do not drop delicate or sharp instruments into any
against misuses. Use tissue scissors for tissue dissections only, cleaning receptacle. Such practice may cause damage to the
not for cutting suture material or wires. instruments.
4.2.6 After a surgical procedure, an instrument count should
4.1.4 Microsurgical Instruments—Microsurgical instru-
ments are most susceptible to damage through misuse or rough be made to avoid sending any instruments to the laundry with
the soiled linen. Although they eventually may be returned,
handling. Consequently, extra care must be taken to avoid
compromising their exacting performance. To minimize they create a injury hazard to laundry workers and many are
damaged beyond economical repair.
damage, the following should be done:
4.1.4.1 Inspect the instrument when purchased and after
4.3 Marking—Do not use a vibrating or impact-type mark-
each use and cleaning, preferably under magnification.
ing device on the box lock portion. If marking is necessary, 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
5.1 General—Clean instruments as soon as possible after
instruments, use extreme caution to avoid injury. Consult with
use. Do not allow blood and debris to dry on the instruments.
an infection control practitioner to develop and verify safety
If cleaning must be delayed, place groups of instruments in a
procedures appropriate for all levels of direct instrument
covered container with appropriate detergent or enzymatic
contact.)
solution to delay drying. Wash all instruments whether or not
4.1.4.4 Clean and thoroughly dry before packaging or stor-
they were used or were inadvertently contacted with blood or
ing. Avoid using a washer decontaminator or an ultrasonic
saline solution.
cleaner (see Appendix X.2).
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 InstrumentKits—Selectaninstrumenttraywhichsuits
(Warning—When handling any sharp instruments, use ex-
the size of the kit. Placing a large instrument kit in a small
treme caution to avoid injury. Consult with an infection control
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 lightweight 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,freerinsing,andhavegoodwettingarebestoverallfor
washer decontaminators and ultrasonic cleaners. High-sudsing
4.2.1 Handle instruments gently.
detergents must be thoroughly rinsed or instruments will spot
4.2.2 Avoid dropping instruments or covering them with
or stain. (See Appendix X2.)
heavier instruments.
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
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F1744 − 96 (2008)
construction, exposure time, the pressure of the delivered 5.4.7 Check screws of instruments after cleaning to ensure
solution, and the pH of the detergent solution, and thus may that they have not loosened through vibration.
require prior brushing. 5.4.8 Keep cleaning solution particulate-free by changing
often or changing the filter per the manufacturer’s recommen-
5.3.1 Be familiar with equipment manufacturers’ use and
dations.
operating 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-
5.3.2 Arrange heavier instruments on bottom, disassemble
cated with a water-soluble, preserved lubricant after each
instruments with removable parts, open box locks, and protect
cleaning. Since effective ultrasonic cleaning removes all
cutting edges.
lubricant, re-lubrication of the instruments is important. The
5.3.3 Follow equipment manufacturers’ recommendations lubricant should contain a chemical preservative to prevent
for detergent, preferably a liquid one. Solid detergents may not
bacterial growth in the lubricant bath.The bath solution should
disperse as completely. Concentrated detergents placed on the be made with demineralized water. A lubricant containing a
instruments may cause corrosion. rust inhibitor helps prevent electrolytic corrosion of points and
edges. Immediately after cleaning, instruments should be
5.3.4 Install a water softener if the water is hard and the
immersed completely for 30 s and allowed to drain, not wiped
water supply is not already treated. This will minimize scum
off.Alubricant film will remain through sterilization to protect
formation. Deionized water is recommended for rinsing to
them during storage. “Frozen” box locks can be immersed
prevent spotting.
overnight and the joint then worked free.
5.3.5 If instruments are dirty after decontamination, the
ejector may be fouled. If fouled, foreign matter remains to
5.6 Inspection—After lubrication, instruments should be
deposit on the instruments. The ejector must be cleaned and
inspected. Incompletely cleaned instruments should be
extraneous matter removed.
recleaned, and those that need repair set aside. For complex
5.3.6 Regularly cleaning decontaminator walls will remove instruments, the manufacturer’s inspection and testing recom-
rust and mineral deposits and avoid transfer of this type of mendations should be followed.
debris to the instruments being cleaned. Follow the equipment
5.6.1 For hinged instruments such as clamps and forceps,
manufacturer’s instructions or descaling detergent manufactur- lock stiffness, jaw alignment, and teeth should be checked.
ers’ instructions to clean decontaminator walls.
5.6.2 For sharp instruments such as scissors, rongeurs, and
curettes, sharpness should be tested per the manufacturer’s
5.4 Ultrasonic Cleaner—Ultrasonic cleaners, when used
instructions.
with hot water per the manufacturer’s recommended tempera-
5.6.3 Check plated instruments for chipped plating. These
ture 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 the manufacturer’s instructions when using an
intact.
ultrasonic cleaner. Be aware that loading patterns, instrument
cassettes, water t
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