ASTM_F_1518_-_00.pdf

Designation:F 1518 00Standard Practice forCleaning and Disinfection of Flexible Fiberoptic and VideoEndoscopes Used in the Examination of the Hollow Viscera1This standard is issued under the fixed designation F 1518;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year 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 practice covers the flexible fiberoptic and videoendoscopes that are fully immersible in liquid and are used inthe examination of the hollow viscera(that is,colonoscopes,gastroscopes,duodenoscopes,sigmoidoscopes,and entero-scopes).These endoscopes will be referred to as flexiblegastrointestinal(GI)endoscopes.1.1.1 It is strongly recommended that only immersibleendoscopes be used in order to assure that all parts of theendoscope will be high-level disinfected;however,it is recog-nized that,in some instances,portions of endoscopes thatneither contact patients nor patient fluids may not be immers-ible.In these instances,care must be taken to disinfect thenonimmersible portions to the highest degree with which theyare compatible,according to the manufacturers directions.1.2 This practice is intended to complement,not replace theinstructions and labeling provided by product manufacturers.Endoscope manufacturers must provide instructions and label-ing necessary for users to know the basic design,specifications,nomenclature,and components of specific flexible GI endo-scopes and to properly inspect,prepare,use,clean,disinfect,rinse,dry,and store these instruments.1.3 Endoscopic technique and the medical aspects of gas-trointestinal endoscopy are not covered in this practice.1.4 This practice details the steps necessary to properlyreprocess flexible GI endoscopes and render them patient-ready.1.5 This practice details manual reprocessing as well asautomated reprocessing of flexible GI fiberoptic and videoendoscopes.1.6 The application of all practices relating to endoscopicreprocessing will ultimately fall into the purview of theindividual assigned to that task in an endoscopic area.1.6.1 To ensure the proper adherence to this practice,thosepersonnel should themselves meet certain requirements asspecified in 4.8.1.7 This practice does not detail the steps necessary for thereprocessing of endoscopic accessories.1.8 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.Specific precau-tionary statements are given in Note 1 and Note 2.2.Terminology2.1 Definitions of Terms Specific to This Standard:2.1.1 clean,adjvisibly free from debris.2.1.2 endoscope,nflexible GI endoscope,flexible fiberop-tic or video endoscopes used in the examination of the hollowviscera(that is,colonoscope,gastroscope,duodenoscope,sig-moidoscope,and enteroscopes).2.1.3 High-Level DisinfectantA liquid chemical sterilantused under the same contact conditions as for sterilizationexcept for a shorter contact time.A sterilant is a liquidchemical germicide,which has passed the AOAC sporicidaltest with no failures;therefore,to qualify for a high-leveldisinfection claim,a germicide must be a sterilant as defined bythe AOAC sporicidal test.In addition,the claim should besupported by efficacy data from potency tests,simulated-usetests,and in-use tests.2.1.3.1 DiscussionA high-level disinfectant is a liquidchemical germicide cleared by FDAfor market with a claim forhigh-level disinfection.2.1.4 high-level disinfected,adjdevoid of all vegetativebacteria,viruses,and fungal spores and some but not allbacterial endospores.2.1.5 patient-ready endoscope,nan endoscope renderedclean after being subjected to a validated cleaning procedure,subjected minimally to a high-level disinfection process,andrinsed so that it does not contain residual chemicals in amountsthat can be harmful to humans.2.1.5.1 DiscussionIt is recognized that in limited circum-stances,portions of an endoscope that neither contact patientfluids nor contact the patient directly,may not be immersible(for example,ultrasound endoscopes).In these instances,caremust be taken to disinfect the non-immersible portions of theendoscope to the highest degree with which they are compat-ible according to the manufacturers directions.2.1.6 reprocessing,nthe cleaning and high-level disinfec-tion necessary to render an endoscope patient-ready.1This practice is under the jurisdiction ofASTM Committee F-4 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.35 on GI Endoscopes.Current edition approved April 10,2000.Published July 2000.Originallypublished as F 1518 94.Last previous edition F 1518 94.1Copyright ASTM,100 Barr Harbor Drive,W