ASTM F1744-96(2016)
(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)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F1744 − 96 (Reapproved 2016)
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.
1. Scope create a protective chromium oxide surface layer while remov-
ing surface carbon and iron. This is accomplished in the
1.1 This guide is intended to provide a better understanding
atmosphere slowly or through immersion in oxidizing solution
of the care of stainless steel surgical instruments intended for
or through an electro-polish process. Through repeated pro-
reuse. This guide is not intended for use with electrical,
cessing the passivation layer will thicken until a good protec-
pneumatic or other powered surgical instruments.
tive film is formed.
2. Referenced Documents 3.2.1 Never expose instruments to strong acids such as
hydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-
2.1 ASTM Standards:
taric.
F899 Specification for Wrought Stainless Steels for Surgical
3.2.2 Avoid contact with salt solutions such as aluminum
Instruments
chloride, mercury salts, and stannous chloride. Also avoid
F921 Terminology Relating to Hemostatic Forceps
contact with potassium thiocyanate and potassium permangan-
F1026 Specification for General Workmanship and Perfor-
ate and limit contact with iodine solutions to periods of less
mance Measurements of Hemostatic Forceps
than 1 h.
F1078 Terminology for Surgical Scissors—Inserted and
Non-Inserted Blades 3.2.3 Chloride-bearing solutions such as blood and saline
F1079 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.
F1089 Test Method for Corrosion of Surgical Instruments Use demineralized or distilled water instead. Place instruments
F1325 Specification for Stainless Steel Suture Needle into water, an enzymatic solution, or a disinfectant bath
Holders-General Workmanship Requirements and Corre- immediately after use so the blood or other material will not
sponding Test Methods dry on them prior to transport to the designated cleaning/
reprocessing area.
3. General
4. General Care of Instruments
3.1 StainlessSteelTypes—The stainless steels most used are
martensitic and austenitic types such as those in Specification
4.1 General—Use instruments only for their intended
F899. Martensitic stainless steel contains iron, chromium, and
purpose, 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 Terminology F921 and Termi-
chromium, and nickel. It has a substantial austenitic structure
nology F1078.
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,
3.2 Passivation—Stainlesssteelcanspot,stain,andcorrode.
suction tubing, or as needle holders or pliers. Misuse generally
This is minimized by passivation which is a process used to
results in misalignment and even cracked box locks.
4.1.2 Needle Holders—Although designed to withstand
someforce,theyarenottobeusedaspliers,jawmisalignments
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
being the result. Select a needle holder matching the size
F04.33 on Medical/Surgical Instruments.
needle being used.
Current edition approved Oct. 1, 2016. Published October 2016. Originally
ε1
4.1.3 Scissors—Do not use scissors for the wrong job,
approved in 1997. Last previous edition approved in 2008 as F1744 – 96 (2008)
DOI: 10.1520/F1744-96R16.
otherwise, the tips will become misaligned and the blades will
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
dull or chip. Delicate scissors should be particularly guarded
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
against misuses. Use tissue scissors for tissue dissections only,
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. not for cutting suture material or wires.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1744 − 96 (2016)
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 they create a injury hazard to laundry workers and many are
damage, the following should be done: damaged beyond economical repair.
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 X2).
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
with the cleaning equipment manufacturer’s recommendations.
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
4.2.1 Handle instruments gently.
washer decontaminators and ultrasonic cleaners. High-sudsing
detergents must be thoroughly rinsed or instruments will spot
4.2.2 Avoid dropping instruments or covering them with
heavier instruments. 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
4.2.5 Do not drop delicate or sharp instruments into any construction, exposure time, the pressure of the delivered
cleaning receptacle. Such practice may cause damage to the solution, and the pH of the detergent solution, and thus may
instruments. require prior brushing.
F1744 − 96 (2016)
5.3.1 Be familiar with equipment manufacturers’ use and 5.4.8 Keep the cleaning solution particulate-free by chang-
operating instructions. Be aware that loading detergent water ing often or changing the filter per the manufacturer’s recom-
temperature and other external factors may change the effec- mendations.
tiveness of the equipment. (See X4.5.)
5.5 Lubrication—To protect instruments during sterilization
5.3.2 Arrange heavier instruments on bottom, disassemble
and storage from staining and rusting, they should be lubri-
instruments with removable parts, open box locks, and protect
cated with a water-soluble, preserved lubricant after each
cutting edges.
cleaning. Since effective ultrasonic cleaning removes all
5.3.3 Follow equipment manufacturers’ recommendations
lubricant, re-lubrication of the instruments is important. The
for detergent, preferably a liquid one. Solid detergents may not lubricant should contain a chemical preservative to prevent
disperse as completely. Concentrated detergents placed on the
bacterial growth in the lubricant bath.The bath solution should
instruments may cause corrosion. be made with demineralized water. A lubricant containing a
rust inhibitor helps prevent electrolytic corrosion of points and
5.3.4 Install a water softener if the water is hard and the
edges. Immediately after cleaning, instruments should be
water supply is not already treated. This will minimize scum
immersed completely for 30 s and allowed to drain, not wiped
formation. Deionized water is recommended for rinsing to
off.Alubricant film will remain through sterilization to protect
prevent spotting.
them during storage. “Frozen” box locks can be immersed
5.3.5 If instruments are dirty after decontamination, the
overnight and the joint then worked free.
ejector may be fouled. If fouled, foreign matter remains to
deposit on the instruments. The ejector must be cleaned and 5.6 Inspection—After lubrication, instruments should be
extraneous matter removed. inspected. Incompletely cleaned instruments should be
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
5.4 Ultrasonic Cleaner—Ultrasonic cleaners, when used
curettes, sharpness should be tested per the manufacturer’s
with hot water per the manufacturer’s recommended tempera-
instructions.
ture and specially formulated detergents, are very effective and
5.6.3 Check plated instruments for chipped plating. These
thorough. Debris of all sizes can be removed even from
defects can tear rubber gloves, or cause the instruments to rust.
crevices and corners in five minutes.After ultrasonic cleaning,
Any plated instrument with ruptured plating should be re-
the instruments cleaned still need to be sterilized.
moved from use and refurbished or discarded.
5.4.1 Follow the manufacturer’s instructions when using an
5.6.4 Pins and screws should be checked to see if they are
ultrasonic cleaner. Be aware that loading patterns, instrument
intact.
cassettes, water tempera
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