1、Designation: F 1992 99Standard Practice forReprocessing of Reusable, Heat-Stable EndoscopicAccessory Instruments (EAI) Used with FlexibleEndoscopes1This standard is issued under the fixed designation F 1992; the number immediately following the designation indicates the year oforiginal adoption or,
2、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 reusable, heat-stable endoscopicaccessory instruments (EAI)
3、 designed to be inserted intoflexible endoscopes and clearly defined in the user instructionsas devices intended for reuse among patients. The EAIscovered by this practice may or may not have lumens orloosely joined surfaces, may or may not have access ports forflushing, and may or may not be capabl
4、e of being completelydisassembled prior to reprocessing.1.2 This practice is not intended to be applied to thereprocessing of single-use, disposable EAIs specifically de-signed and labeled as such by their manufacturers.1.3 This practice is not intended to address reprocessing ofheat-sensitive EAIs,
5、 for example, those not capable of with-standing heat sterilization. Reprocessing of each heat-sensitiveEAI must be considered on an individual basis according tospecific instructions from the manufacturers of the EAI and thelow-temperature sterilization device.1.4 This practice is intended to compl
6、ement, not replace, theinstructions provided by product manufacturers. EAI manufac-turers should provide properly validated instruction and label-ing necessary for users to understand the basic design, speci-fications, nomenclature, and components of specificaccessories and to properly inspect, prep
7、are, use, reprocess,and store these instruments.1.5 Endoscopic technique and the medical aspects of endo-scopy are not covered in this practice.1.6 This practice details the basic steps necessary to repro-cess a heat-stable EAI and render it patient-ready.1.7 A patient-ready EAI is one that has been
8、 thoroughlycleaned using a validated cleaning procedure, rinsed with waterto remove residual detergent, lubricated (if necessary) anddrained to remove excess lubricant, dried, packaged, heatsterilized and stored to prevent from being compromisedsterility before use.1.8 This practice describes only m
9、anual reprocessing anddoes not address cleaning of an EAI by an automated repro-cessing device.1.9 To ensure the proper adherence to this practice, repro-cessing personnel should meet certain requirements as speci-fied in 5.5 to 5.7.1.10 This practice does not address the steps necessary forthe repr
10、ocessing of flexible endoscopes (see Practice F 1518).1.11 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 to determine theapplicabilit
11、y of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:F 1518 Practice for Cleaning and Disinfection of FlexibleFiberoptic and Video Endoscopes Used in the Examinationof the Hollow Viscera23. Terminology3.1 Definitions of Terms Specific to this Standard:3.1.1 clean, adjvi
12、sibly free from external debris after athorough, manufacturer-validated regimen.3.1.2 critical medical device, nan instrument that may beintroduced directly into the bloodstream or into other normallysterile areas of the body, that is, an invasive device.3.1.3 endoscopic accessory instrument, EAI, n
13、medicalinstrument designed to be inserted into a flexible endoscope.3.1.3.1 DiscussionEAIs may be critical- or semi-criticaldevices. EAIs may or may not have lumens, porous or looselyjoined surfaces, or access ports for flushing and may or maynot be capable of being completely disassembled duringrep
14、rocessing.3.1.4 flexible endoscope, na flexible tubular instrumentthat utilizes fiberoptic or video imaging technology to examinethe interior of a canal or hollow viscus.3.1.5 heat-stable medical device, nan instrument capableof withstanding sterilization using a heat-based process.3.1.6 lubrication
15、, nthe application of a substance used toreduce friction or wear.1This practice is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of Subcommittee F04.35 on GI Endoscopes.Current edition approved October 10, 1999. Published J
16、anuary 2000.2Annual Book of ASTM Standards, Vol 13.01.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3.1.7 manual cleaning, nremoval of debris from an in-strument by hand using detergent solution, cleaning devicessuch as brushes, cl
17、oths, and irrigating devices, and water forrinsing.3.1.8 patient-ready, adjterm used to describe endoscopicaccessory instrument that, following prior patient use, hasundergone an appropriate reprocessing protocol, including heatsterilization, to render it safe, as established by contemporaryprofessi
18、onal standards, for use on a subsequent patient; anoperational check to ensure proper functionality is an essentialcomponent of preparing the EAI for reuse.3.1.9 reprocessing, nthe precise sequence of cleaning,lubricating (if necessary), and sterilizing steps that, whenperformed properly and complet
19、ely, will assure an endoscopicaccessory instrument is patient-ready.3.1.10 reusable, adjinstrument designed and validated bythe manufacturer to be used more than once, provided that aftereach use, an appropriate reprocessing protocol and functional-ity check is performed.3.1.11 semi-critical medical
20、 device, nan instrument in-tended to contact only mucous membranes or non-intact skinduring use.3.1.12 sterilization, nthe complete elimination or destruc-tion of all forms of microbial life, including high numbers ofbacterial spores.3.1.12.1 DiscussionIn this standard, the only methods ofsterilizat
21、ion considered are heat-based, for example, saturatedsteam under pressure (a steam autoclave) or a forced-air dryheat oven certified for medical use.3.1.13 ultrasonic cleaning, na process in which ultra-highfrequency sound waves are converted into mechanical vibra-tions capable of cleaning via a pro
22、cess called cavitation.3.1.13.1 DiscussionDuring cavitation, microscopicbubbles in the cleaning solution implode (burst inward),resulting in a vacuum action that pulls soil and debris awayfrom the surface of items being cleaned.4. Summary of Practice4.1 Each brand, type, and model of EAI has unique
23、speci-fications, nomenclature, interior design, function, and compo-nents.4.2 Most EAIs are critical medical devices because theycome into direct contact with the bloodstream, enter normallysterile areas of the body, or break normally intact mucosalsurfaces.4.3 To prevent patient-to-patient transmis
24、sion of infection,heat-stable EAIs should be thoroughly cleaned, rinsed, lubri-cated if necessary, dried, packaged, and sterilized using aheat-based process, for example, a steam autoclave or aforced-air dry heat oven.4.4 After sterilization, a packaged EAI should be stored in alimited-access, well-
25、ventilated area that provides protectionfrom dust, moisture, and extremes of temperature and humidityso as not to compromise sterility before use.4.5 Before use, the EAI should be tested for functionality.5. Significance and Use5.1 EAIs may have design features such as coiled metalsheaths, pivoting
26、joints, opposed surfaces, and internal lumensor wires which make visual inspection for cleanliness difficultif not impossible.5.2 By nature of their design requirements, EAIs are moredifficult to reprocess than many other types of medical instru-ments.5.3 Because EAIs are used to diagnose and treat
27、disease inboth immunocompetent and immunocompromised individuals,care must be taken to ensure that only patient-ready devices areused for examination.5.4 The use of EAIs in patients having diagnosed orsuspected infections such as hepatitis B, hepatitis C, or humanimmunodeficiency virus (HIV) is not
28、contraindicated. Further,EAIs need not be dedicated for use only in these patients.5.5 Persons responsible for reprocessing must understandthe specifications, nomenclature, function of component parts,and interior design of EAIs in order to render them patient-ready.5.6 Persons responsible for repro
29、cessing EAIs should fol-low this practice and associated labeling and instructions frommanufacturers after each endoscopic procedure to ensure thatthe EAI will be patient-ready.5.7 Reprocessing of EAIs should be the specific responsi-bility of appropriately trained personnel. Temporary employeeswith
30、out the requisite training should not be given theseresponsibilities.5.7.1 The responsibility for reprocessing of EAIs should notbe delegated from person to person unless each has theappropriate training for the position.5.7.2 Reprocessing personnel should have the ability toread, understand, and im
31、plement instructions from manufac-turers and regulatory agencies as they relate to EAI reprocess-ing.5.7.3 Reprocessing personnel should have the opportunityto become completely familiar with the mechanical aspects ofthe devices. They may gain this knowledge through study ofthe manufacturers informa
32、tion and demonstration by repre-sentatives.5.7.4 Reprocessing personnel should be made fully aware ofthe potential chemical and infectious hazards for patients andhealth care personnel associated with the reprocessing of EAIs.Training should include:5.7.4.1 A thorough background in infection control
33、 prin-ciples and concepts based on written in-house infection controlprocedures.5.7.4.2 A thorough background regarding the potential fornegative patient outcomes resulting from lapses in compliancewith written reprocessing guidelines,5.7.4.3 Familiarization with OSHA regulations and in-housepolicie
34、s regarding the appropriate and safe handling of chemi-cal reprocessing agents and equipment used during reprocess-ing of EAIs, and5.7.4.4 Information on the safe handling of EAIs contami-nated with patient tissue and fluids after use, including famil-iarization with principles and practices of stan
35、dard (universal)precautions.NOTE 1Although healthcare workers and patients may benefit fromF 19922adhering to the regulatory guidelines issued by federal and state Occupa-tional Safety and Health Administration (OSHA) agencies, these guide-lines are directed only toward healthcare worker safety and
36、health. Theymay not be sufficiently inclusive for optimum safety and health of patients.Therefore, contemporary infection control guidelines should be consultedin addition to OSHA guidelines.5.8 This practice is not intended to replace the reprocessinginstruction provided by the manufacturers of EAI
37、s or suggestspecific equipment or chemical reagents to be used for repro-cessing. Rather, it is to be used together with manufacturersinstructions that provide specific instructions for specific prod-ucts. See Appendix X1.1.5.9 This practice is not intended to cover endoscopic tech-niques, patient c
38、are, or other medical aspects of flexibleendoscopy.5.10 This practice does not include instruction for repro-cessing flexible endoscopes.6. Reagents6.1 AirAir flow provided by a syringe or compressed airsource. (Refer to the EAI manufacturers instruction to avoidthe use of excessively high air press
39、ure)6.2 DetergentA low foaming, neutral pH detergent, withor without enzymes, used for initial soaking and manualcleaning that is compatible with EAIs and is specificallyformulated for use with medical devices.6.3 Ultrasonic Cleaning DetergentA detergent that iscompatible with EAIs and specifically
40、formulated for use in anultrasonic cleaner.6.4 WaterFresh, potable water.NOTE 2In areas where water hardness may result in scaling orcorrosion of metal instruments, the use of distilled, deionized, or softenedwater should be considered as appropriate for rinsing and preparation ofcleaning reagent di
41、lutions.6.5 LubricantA lubricant that is compatible with EAIsthat require lubrication before sterilization and is specificallyformulated for use with medical devices.7. Equipment and Supplies7.1 BasinsMust be large enough to totally immerse theEAIs without coiling too tightly. See the EAI manufactur
42、ersinstruction for minimum radius of coiling of specific accesso-ries. Basins needed are:7.1.1 Cleaning basin, and7.1.2 Lubrication basin.7.2 Cleaning ToolsSoft, lint-free cloth, brushes, adapters,sponges, syringes, and other manufacturer-recommendedcleaning items.7.3 Personal Protective Equipment:7
43、.3.1 GlovesHigh-quality latex, butyl, or nitrile rubbergloves that fit properly and are of adequate length to preventskin exposure to liquids.7.3.1.1 Gloves must be changed at appropriate times to limitcross contamination and must be removed prior to leaving thedesignated reprocessing area. They mus
44、t be discarded if theyare cracked, peeling, punctured, or when their ability tofunction as a barrier has been otherwise compromised. Handsmust be washed thoroughly with soap and water before eachdonning and after removal of gloves.7.3.2 GownsFluid impervious protective clothing must beworn when hand
45、ling contaminated EAIs and when workingwith reprocessing chemicals.7.3.2.1 Gowns used during EAI reprocessing must be re-moved prior to leaving the designated reprocessing area.7.3.3 Protective Eye WearFace masks and protectiveeyewear or face shields should be worn to protect the face andeyes from c
46、ontact with reprocessing chemicals and potentiallyinfectious material.7.4 Ultrasonic CleanerMust be large enough to totallyimmerse the EAIs without coiling them too tightly, and must beable to operate within a frequency and power range that willnot damage the instruments. See the EAI manufacturersin
47、structions for specifications regarding the minimum radius ofcoiling of specific models, the required frequency range of theultrasonic cleaner, and the maximum power of ultrasonictransducers.7.5 SterilizerMust be a heat-based process (for example,a steam autoclave or forced-air dry heat oven) and ca
48、pable ofmeeting the conditions for the sterilization cycle validated bythe EAI manufacturer.7.5.1 The sterilizer also should be used to dry the packagedEAIs at the conclusion of a moist heat sterilization cycle.7.5.2 Biological and chemical (temperature/color change)monitoring of the sterilizer shou
49、ld be done routinely accordingto the facilitys protocol or national standards, or both.7.5.3 General operation, maintenance, and calibration of thesterilizer should be done according to the sterilizer manufac-turers instructions.7.6 Air VentilationA well-ventilated area with between 8and 10 air exchanges per hour to protect personnel frompotentially hazardous fumes or chemical or biological aerosols.8. Procedure8.1 Cleaning:8.1.1 Manual Cleaning:8.1.1.1 Don all necessary personal protective equipment.8.1.1.2 Prepare fresh aqueous detergent solutions fo
