ASTM F1744-1996(2008) Standard Guide for Care and Handling of Stainless Steel Surgical Instruments.pdf

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1、Designation: F 1744 96 (Reapproved 2008)Standard Guide forCare and Handling of Stainless Steel Surgical Instruments1This standard is issued under the fixed designation F 1744; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the yea

2、r of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide is intended to provide a better understandingof the care of stainless steel surgical instruments inte

3、nded forreuse. This guide is not intended for use with electrical,pneumatic or other powered surgical instruments.2. Referenced Documents2.1 ASTM Standards:2F 899 Specification for Wrought Stainless Steels for Surgi-cal InstrumentsF 921 Terminology Relating to Hemostatic ForcepsF 1026 Specification

4、for General Workmanship and Perfor-mance Measurements of Hemostatic ForcepsF 1078 Terminology for Surgical ScissorsInserted andNon-Inserted BladesF 1079 Specification for Inserted and Noninserted SurgicalScissorsF 1089 Test Method for Corrosion of Surgical InstrumentsF 1325 Specification for Stainle

5、ss Steel Suture NeedleHolders-General Workmanship Requirements and Corre-sponding Test Methods3. General3.1 Stainless Steel TypesThe stainless steels most used aremartensitic and austenitic types such as those in SpecificationF 899. Martensitic stainless steel contains iron, chromium, andsufficient

6、carbon so that when it is hardened by heat treatment,a substantial martensitic structure is the result. Austeniticstainless steel has better corrosion resistance and contains iron,chromium, and nickel. It has a substantial austenitic structureand a lower carbon content. Although it cannot be hardene

7、d byheat treatment, it can be work-hardened.3.2 PassivationStainless steel can spot, stain, and cor-rode. This is minimized by passivation which is a process usedto create a protective chromium oxide surface layer whileremoving surface carbon and iron. This is accomplished in theatmosphere slowly or

8、 through immersion in oxidizing solutionor through an electro-polish process. Through repeated pro-cessing the passivation layer will thicken until a good protec-tive film is formed.3.2.1 Never expose instruments to strong acids such ashydrochloric, aqua regia, dilute sulphuric, carbonic, and tar-ta

9、ric.3.2.2 Avoid contact with salt solutions such as aluminumchloride, mercury salts, stannous chloride. Also avoid contactwith potassium thiocyanate and potassium permanganate andlimit contact with iodine solutions to periods less than 1 h.3.2.3 Chloride-bearing solutions such as blood and salinecan

10、 cause localized corrosion. Avoid prolonged exposure to orrinsing in saline solutions or corrosion and pitting will occur.Use demineralized or distilled water instead. Place instrumentsinto water, enzymatic solution, or disinfectant bath immedi-ately after use so the blood or other material will not

11、 dry onthem prior to transport to designated cleaning/reprocessingarea.4. General Care of Instruments4.1 GeneralUse instruments only for their intended pur-pose, such as cutting, holding, clamping, retracting, and soforth.Avoid undue stress or strain when handling and cleaning.Standard terminology r

12、elating to Hemostatic Forceps andSurgical Scissors are found in Definitions F 921 and Specifi-cation F 1078.4.1.1 Hemostatic ForcepsThese forceps are designed toclamp blood vessels. They should not be used to clamp towels,suction tubing, or as needle holders or pliers. Misuse generallyresults in mis

13、alignment and even cracked box locks.4.1.2 Needle HoldersAlthough designed to withstandsome force, they are not to be used as pliers, jaw misalignmentsbeing the result. Select a needle holder matching the sizeneedle being used.4.1.3 ScissorsDo not use scissors for the wrong job,otherwise, the tips w

14、ill become misaligned and the blades willdull or chip. Delicate scissors should be particularly guarded1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.33 on Medical/Surgical Instruments.Curre

15、nt edition approved Feb. 1, 2008. Published March 2008. Originallyapproved in 1997. Last previous edition approved in 2002 as F 1744 96 (2002)e1.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards

16、volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.against misuses. Use tissue scissors for tissue dissections only,not for cutting suture material or w

17、ires.4.1.4 Microsurgical InstrumentsMicrosurgical instru-ments are most susceptible to damage through misuse or roughhandling. Consequently, extra care must be taken to avoidcompromising their exacting performance. To minimize dam-age, the following should be done:4.1.4.1 Inspect the instrument when

18、 purchased and aftereach use and cleaning, preferably under magnification.4.1.4.2 Only use for its intended purpose.4.1.4.3 After each use, remove blood and debris frominstrument. A non-fibrous sponge may be used to eliminatesnagging and breakage. (WarningWhen handling sharpinstruments, use extreme

19、caution to avoid injury; Consult withan infection control practitioner to develop and verify safetyprocedures appropriate for all levels of direct instrumentcontact.)4.1.4.4 Clean and thoroughly dry before packaging or stor-ing. Avoid using a washer decontaminator or an ultrasoniccleaner (see Append

20、ix X.2).4.1.4.5 Avoid metal-to-metal contact by using special racksdesigned to separate and protect.4.1.4.6 Do routine preventive maintenance such as sharpen-ing and realigning. Sterilization by dry heat or chemical vaporshould be considered for these instruments.4.1.5 Instrument KitsSelect an instr

21、ument tray whichsuits the size of the kit. Placing a large instrument kit in a smallinstrument tray may lead to broken instruments, bent tips, ordull scissors. Put heavier instruments such as retractors on thebottom and light weight instruments on the top. Ring-handledinstruments should be kept open

22、 with a wire holder or pin.Curved clamps should all point in the same direction to protectthe tips. Scissors should be kept separate. Cupped instrumentsshould be placed so that water does not collect in them duringsterilization. Separate instruments of dissimilar metals byseparate processing, otherw

23、ise galvanic corrosion or electro-lytic deposition may result.4.1.6 Other Sharp InstrumentsRongeurs, bone cuttingforceps, drill bits, reamers, and so forth should be used to cutbone, not wire or pins. Sometimes it is necessary to userongeurs or osteotomes to chip bone away from bone platesand screws

24、, which may nick or dull the blades. An alternateapproach is to keep an older set of rongeurs or osteotomes forsuch orthopedic procedures. Instruments that are recommendedto be sharpened by the manufacturer should be processed andverified by the manufacturers specific instruction. Instrumentsshould

25、be used only for their identified purpose. Carefulplanning is necessary for selection of the proper amount andtype of instruments needed for each surgical procedure.4.2 Care During Use:4.2.1 Handle instruments gently.4.2.2 Avoid dropping instruments or covering them withheavier instruments.4.2.3 Han

26、dle instruments individually or in small numbers.4.2.4 Protect instrument tips, especially sharp ones. Do notplace instruments down on their tips.4.2.5 Do not drop delicate or sharp instruments into anycleaning receptacle. Such practice may cause damage to theinstruments.4.2.6 After a surgical proce

27、dure, an instrument count shouldbe made to avoid sending any instruments to the laundry withthe soiled linen. Although they eventually may be returned,they create a injury hazard to laundry workers and many aredamaged beyond economical repair.4.3 MarkingDo not use a vibrating or impact type mark-ing

28、 devices on the box lock portion. If marking is necessary, doit on the shanks, otherwise the box locks may fail.5. Cleaning5.1 GeneralClean instruments as soon as possible afteruse. Do not allow blood and debris to dry on the instruments.If cleaning must be delayed, place groups of instruments in ac

29、overed container with appropriate detergent or enzymaticsolution to delay drying. Wash all instruments whether or notthey were used or were inadvertently contacted with blood orsaline solution.After surgery, open box locks and disassemble instrumentswith removable parts. Forceps and scissors should

30、be cleanedand sterilized in the open position. This will limit blood dryingon the instruments which may cause them to corrode. Delicateand sharp instruments should be cleaned separately. This isespecially true for eye and microsurgery instruments.(WarningWhen handling any sharp instruments, use ex-t

31、reme caution to avoid injury; Consult with an infection controlpractitioner to develop and verify safety procedures appropri-ate for all levels of direct instrument contact. Direct handlingand cleaning of instruments should be done only when indirectmethods, for example, tweezers, are not available

32、or notpossible.) Sort instruments by similar metal for subsequentprocessing so that electrolytic deposition due to contact be-tween dissimilar metals will not occur.Prior to regular cleaning, soak in enzyme solution or rinseinstruments in demineralized or distilled water to remove bloodand debris, e

33、specially those instruments with hollow tubes suchas suction tubes and curettes.Do not use abrasive pads or cleansers which will scratch thesurface allowing dirt and water deposits to collect. Abrasivecleaning will remove the passive layer. Do not use chlorinebleach at a higher concentration than re

34、commended by themanufacturer to clean or disinfect stainless steel instruments,as pitting will occur. High concentrations of chlorine-basedsolutions are not recommended as pitting and subsequentdamage will occur. (See Appendix X3.)5.2 DetergentsThe detergent used should be in keepingwith the cleanin

35、g equipment manufacturers recommendations.Neutral pH detergents, between 7.0 and 8.5, which are lowsudsing, free rinsing, and have good wetting are best over allfor washer decontaminators and ultrasonic cleaners. High-sudsing detergents must be thoroughly rinsed or instrumentswill spot or stain. (Se

36、e Appendix X2.)5.3 Washer DecontaminatorEquipment of this type willwash and decontaminate instruments. Complete removal ofsoil from serrations and crevices depends on instrumentF 1744 96 (2008)2construction, exposure time, pressure of delivered solution, andpH of the detergent solution, and thus may

37、 require priorbrushing.5.3.1 Be familiar with equipment manufacturers use andoperation instructions. Be aware that loading detergent watertemperature and other external factors may change the effec-tiveness of the equipment. (See X4.5.)5.3.2 Arrange heavier instruments on bottom, disassembleinstrume

38、nts with removable parts, open box locks, and protectcutting edges.5.3.3 Follow equipment manufacturers recommendationsfor detergent, preferably a liquid one. Solid detergents may notdisperse as completely. Concentrated detergents placed on theinstruments may cause corrosion.5.3.4 Install a water so

39、ftener if the water is hard and thewater supply is not already treated. This will minimize scumformation. Deionized water is recommended for rinsing toprevent spotting.5.3.5 If instruments are dirty after decontamination, theejector may be fouled. If fouled, foreign matter remains todeposit on the i

40、nstruments. The ejector must be cleaned andextraneous matter removed.5.3.6 Regularly cleaning decontaminator walls will removerust and mineral deposits and avoid transfer of this type ofdebris to the instruments being cleaned. Follow the equipmentmanufacturers instructions or descaling detergent man

41、ufactur-ers instructions to clean decontaminator walls.5.4 Ultrasonic CleanerUltrasonic cleaners, when usedwith hot water per manufacturers recommended temperatureand specially formulated detergents, are very effective andthorough. Debris of all sizes can be removed even fromcrevices and corners in

42、five minutes. After ultrasonic cleaning,the instruments cleaned still need to be sterilized.5.4.1 Follow manufacturers instructions when using anultrasonic cleaner. Be aware that loading patterns, instrumentcassettes, water temperature, and other external factors maychange the effectiveness of the e

43、quipment. (See X4.5.)5.4.2 Arrange instruments with box locks open and cuttingedges protected. Do not clean delicate instruments in anultrasonic cleaner since the vibrations can cause the tips towear if they come in contact with other metal surfaces.5.4.3 It is not recommended to clean plated instru

44、ments inan ultrasonic cleaner since the ultrasonic vibration and thepresence of other sharp instrument edges may crack or rupturethe plating. When the plating is ruptured ultrasonic energy willaccelerate flaking. Any plated instrument with ruptured platingshould be removed from use and refurbished o

45、r discarded.5.4.4 Use hot water per manufacturers recommended tem-perature (usually 90 to 140F or 30 to 75C).5.4.5 Follow manufacturers recommendations for propercleaning solution, or use cleaning solution formulated specifi-cally for ultrasonic cleaners. Neutral detergents or productswith less than

46、 2 % available alkalinity are suitable for ultra-sonic cleaning. Acidic or alkaline products with more than 2 %available alkalinity are not recommended for ultrasonic sys-tems because they cannot be properly neutralized.5.4.6 Rinse instruments thoroughly after cleaning.5.4.7 Check screws of instrume

47、nts after cleaning to ensurethat they have not loosened through vibration.5.4.8 Keep cleaning solution particulate-free by changingoften or changing the filter per manufacturers recommenda-tions.5.5 LubricationTo protect instruments during sterilizationand storage from staining and rusting, they sho

48、uld be lubri-cated with a water-soluble, preserved lubricant after eachcleaning. Since effective ultrasonic cleaning removes all lubri-cant, re-lubrication of the instruments is important. The lubri-cant should contain a chemical preservative to prevent bacterialgrowth in the lubricant bath. The bat

49、h solution should be madewith demineralized water. A lubricant containing a rust inhibi-tor helps prevent electrolytic corrosion of points and edges.Immediately after cleaning, instruments should be immersedcompletely for 30 s and allowed to drain off, not wiped off. Alubricant film will remain through sterilization to protect themduring storage. “Frozen” box locks can be immersed overnightand the joint then worked free.5.6 InspectionAfter lubricating, instruments should beinspected. Incompletely cleaned instruments should be re-cleaned, and those that