ASTM_F_565_-_04_2013.pdf

Designation:F56504(Reapproved 2013)Standard Practice forCare and Handling of Orthopedic Implants and Instruments1This standard is issued under the fixed designation F565;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1This practice covers recommended procedures for thehandling of orthopedic implants and instruments.1.2 Hospital receiving personnel,central supply personnel,operating room personnel,surgeons,and occasionally otherindividuals will handle orthopedic implants and instruments.All personnel should be informed of recommended care andhandling procedures to prevent damage to orthopedic implantsand instruments.1.3This practice does not cover producer level handlingand packaging procedures.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 orthopedic implanta device introduced by surgicallypenetrating the skin or mucosa of the body with the intentionthat it remain within or attached to the skeleton within the bodyfollowing the surgery.This device is referred to in this practiceas an“implant.”2.1.2 orthopedic instrumentany cooperative device usedduring surgical procedures involving the implantation of or-thopedic implants.This device is referred to in this practice asan“instrument.”3.Receiving Implants and Instruments3.1 Receipt:3.1.1Many implants are wrapped in special sterilizable orpre-sterilized packages,envelopes,or other containers.Thesewrappings should not be removed by the receiving personnel.3.1.2Carefully unwrap and handle non-sterilized implantsand instruments upon receipt to avoid scratching,marking,orabrasion by other implants,instruments,unpacking tools,or bydropping or otherwise endangering the surface finish or con-figuration.3.2 TransportPerform transport in a manner to precludeany damage or alteration to the received condition of theimplant or instrument.3.3 Storage:3.3.1Store implants or instruments prior to use in such amanner as to maintain the devices surface finish orconfiguration,or both.3.3.2 Many implants are identified by a serial or lot number,or both,on the package label,package insert,or surface of thedevice.Record these control numbers and retain for transfer topatient records,to facilitate inventory,stock rotation,medicaldevice reporting,and possible traceability to the manufacturer.3.3.3 Stock RotationThe principle of first in,first out,isrecommended.3.3.4 Store implants in the operating room in such a manneras to isolate and protect the implants surface,sterility,andconfiguration.Keep implants made of different metals sepa-rated.3.3.5Store the implants and instruments in the operatingroom in such a manner as to isolate the instruments from theimplants.4.Handling4.1 Mixing MetalsMaintain orthopedic implants and in-struments of different metals separately to avoid the possibilityof mixing during surgery.4.2 Cleaning and Sterilization:4.2.1Prior to initial sterilization and promptly followingeach surgical procedure,thoroughly and carefully clean allinstruments and implants.Ultrasonic cleaners,mechanizedwashers,or hand scrubbing are suitable methods,if carefullydone.The method employed should be utilized to prevent1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Current edition approved Oct.1,2013.Published October 2013.Originallyapproved in 1978.Last previous edition approved in 2009 as F565 04(2009)1.DOI:10.1520/F0565-04R13.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 impact,scratching,bending,or surface contact with anymaterials that might affect the implant or instrument surface orconfiguration.4.2.2Closely follow the manufacturers recommendationson cleaning.When hand scrubbing,use soft brushes and avoidharsh chemicals or harsh cleaning solutions.4.2.3After cleaning,rinse the orthopedic implants andinstruments completely free of all residuals,soap,detergent,orcleaning solutions.Following rinsing,dry them thoroughly.Devote special attention to hinges,pivots,box locks,and otherrecesses since these are points that entrap both chemicals andrinse water.4.2.4Lubricate instruments that require lubrication imme-diately after drying.Follow the recommendations of themanufacturers of such instruments explicitly as to the meth