ASTM_F_700_-_93_2014.pdf

Designation:F70093(Reapproved 2014)Standard Practice forCare and Handling of Intracranial Aneurysm Clips andInstruments1This standard is issued under the fixed designation F700;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.Scope1.1 This practice covers recommended procedures for han-dling of neurosurgical intracranial aneurysm clips and the clipappliers(instruments).1.2 This practice is intended to inform hospital receivingpersonnel,central supply personnel,operating room personnel,and other individuals who will handle intracranial aneurysmclips and the instruments related thereto of recommended careand handling procedures to prevent damage of intracranialaneurysm clips and instruments.1.3 Handling and packaging procedures for the product arenot a part of this practice and are covered in other practices.2.Terminology2.1 Definitions:2.1.1 clip applierany clip holder designed specifically fora particular type clip used during surgical procedures involvingthe implantation of intracranial aneurysm clips.This device isreferred to in this practice as a clip applier.2.1.2 intracranial aneurysm clipa device introduced sur-gically to occlude the blood inlet into an intracranial aneurysmwith the intention that it remain within the body following thesurgery.This device is referred to in this practice as an“implant,”specifically as an intracranial aneurysm clip.3.Receiving Implants and Instruments3.1 Receipt:3.1.1 Many implants are wrapped in special packages,envelopes,or other containers.These wrappings should not beremoved by the receiving personnel.3.1.2 Carefully handle nonsterilized implants and instru-ments upon receipt to avoid scratching,marking,or abrasionby other implants,instruments,unpacking tools,or by drop-ping or otherwise endangering the surface finish or configura-tion.3.2 TransportTransport in a manner to preclude anydamage or alteration to the received condition of the implant orinstrument(clip applier).3.3 Storage:3.3.1 Store the aneurysm clips and appliers prior to use insuch a manner to maintain the devices surface finish orconfiguration,or both.3.3.2 Implants will be identified by a unique code on thesurface of the device.When implanted,it is necessary that thetype of aneurysm clip and its code be noted in the operativereport.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.4.Cleaning and Sterilization4.1 Prior to resterilization and promptly following eachsurgical procedure,thoroughly and carefully clean all instru-ments and implants with approved cleaning techniques.Ultra-sonic cleaners or hand scrubbing are suitable methods ifcarefully done.The method employed should be utilized toprevent impact,scratching,bending,or surface contact withany materials that might affect the implant or instrumentconfiguration.Aneurysm clips must not be opened except bytheir specific applier.4.2 Any clip that has been implanted or in direct contactwith blood or body fluids and is not used in the procedureshould not be reused in any subsequent procedure.The clipsshould be discarded;in accordance with tracing requirements,the manufacturer must be informed of each clip that isdiscarded.4.3 After cleaning,rinse the neurosurgical intracranial an-eurysm clips and instruments completely free of all residualsincluding soap,detergent,or cleaning solutions;and drythoroughly.Devote special attention to hinges on the instru-ments and recesses on the clips since these are points thatentrap both chemicals and rinse water.In so doing,the clipmust not be opened except by its designated applier.1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.31 on Neurosurgical Standards.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 1981.Last previous edition approved in 2008 as F700 93(2008).DOI:10.1520/F0700-93R14.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.4 Lubricate clip appliers that require lubrication immedi-ately after drying.Follow the recommendations of the manu-facturers of such instruments explicitly as to the method,type,and amount of lubricant.Do not lubricate the clips.4.5 Carry out sterilization by steam autoclaving or othermethods in a manner that protects the integrity of the aneurysmclips and appliers.4.6 Do not sterilize implants in contact with instruments orimplants of other materials.Metallic oxide could transfer to theimplant,initiating an unacceptable condition.5.Use o