Automated endoscope reprocessors - ASC Quality

1 TECHNOLOGY STATUS EVALUATION REPORTA utomated endoscope reprocessorsThe ASGE Technology Committee provides reviews ofexisting, new, or emerging endoscopic technologies thathave an impact on the practice of GI endoscopy. Evidence-based methodology is used, with a MEDLINE literaturesearch to identify pertinent clinical studies on the topicand a MAUDE ( Food and Drug Administration Cen-ter for Devices and Radiological Health) database searchto identify the reported complications of a given technol-ogy. Both are supplemented by accessing the related ar-ticles feature of PubMed and by scrutinizing pertinentreferences cited by the identified studies. Controlled clini-cal trials are emphasized, but in many cases data fromrandomized, controlled trials are lacking. In such cases,large case series, preliminary clinical studies, and expertopinions are used.

2 Technical data are gathered from tra-ditional and Web-based publications, proprietary publi-cations, and informal communications with Status Evaluation Reports are drafted by 1or 2 members of the ASGE Technology Committee, re-viewed and edited by the committee as a whole, andapproved by the Governing Board of the ASGE. Whenfinancial guidance is indicated, the most recent codingdata and list prices at the time of publication are this review, the MEDLINE database was searchedthrough February 2010 for articles related to automatedendoscope reprocessors , using the words endoscope repro-cessing, endoscope cleaning, Automated endoscope repro-cessors, and high-level Status Evaluation Reports are scientific re-views provided solely for educational and informationalpurposes.

3 Technology Status Evaluation Reports are notrules and should not be construed as establishing a legalstandard of care or as encouraging, advocating, requir-ing, or discouraging any particular treatment or paymentfor such disinfection (HLD) is the accepted standardfor the reprocessing of flexible GI have been adopted to ensure that endoscopereprocessing is performed consistently, by using a stan-dardized endoscope reprocessors (AERs) are designed to replace some manual addition, AERs may limit exposure of personnelto liquid chemical germicides (LCGs).TECHNICAL CONSIDERATIONSHLD refers to treatment of medical devices to removeall viable microorganisms except a small residual consensus standards for endoscope re-processing emphasize (1) bedside cleaning and aspirationof enzymatic detergent through the suction channel, (2)manual washing and brushing of accessible channels, (3)subsequent disinfection via immersion for an appropriateduration in an LCG of appropriate concentration, followedby (4) a water rinse, alcohol flush, and air drying of allchannels.

4 A variety of LCGs with differing contact andconcentration requirements are available for the disinfec-tion step (Table 1).7,8A variety of capabilities are incorporated into the avail-able AERs (Table 2). All models have disinfection andrinsing cycles, and some have detergent cleaning, alcoholflush, and/or extended forced-air drying cycles. Additionalfeatures or designs may include (1) variable cycle times,(2) printed documentation of the process, (3) low-intensityultrasound waves, (4) LCG vapor recovery systems, (5)heating to optimize LCG efficacy, (6) variable number ofendoscopes processed per cycle, (7) Automated leak test-ing, (8) Automated detection of channel obstruction, and(9) table-top, floor-standing, and cart-mounted all reprocessors are compatible with all LCGs orwith endoscopes from all manufacturers.

5 Some models aredesigned for use with specific LCG types and/or formula-tions, often on a proprietary basis. Other variations thatmay require attention to the design of the facility includerequirements for (1) water pressure, temperature, and fil-tration; (2) ventilation; (3) plumbing; (4) power supply;and (5) AERs rely on flow of LCG under pressure throughthe endoscope channels and continuous bathing of theexterior of the instrument with LCG. Some AERs consumeand dispose of limited amounts of LCG per HLD cycle,whereas others use a reservoir of LCG that is reused overmany cycles. Thelatter design results in gradual dilution ofthe LCG with repeated use and requires intermittent testing toverify maintenance of the minimum effective LCG concen-Copyright 2010 by the American Society for Gastrointestinal Endoscopy0016-5107/$ 72, No.

6 4 : 2010 GASTROINTESTINAL ENDOSCOPY675 TABLE 1. Liquid chemical germicides available for high-level disinfection in the United StatesAgent/trade nameManufacturerHLDconditions(min/*C) AER specificMaximumduration forreuse (days) 14 Cottrell Ltd (Denver, Col)45/20No14 InexpensiveOmnicide Long-LifeCottrell Ltd45/20No28 Extensive experienceCIDEX activated dialdehydesolutionAdvanced Sterilization Products,(Irvine, Calif)45/20No14 Excellent material Reprocessing SystemsMinntech MedivatorsReprocessing Systems Minntech5/35No28 Fixes tissues and blood to slow mycobacterialactivityCIDEX Formula-7 Advanced Sterilization Products90/25No28 Metricide 28 Metrex Research, Inc (Romulus,Mich)90/25No28 Procide DMetrex Research, Inc90/25No28 Wavicide-01 Medical Chemical Corp (Torrance,Calif)45 Research, Inc45 Medical Inc (Deep River,Conn)

7 25 Industries (Pennsauken,NJ)40 PlusCottrell, Ltd45/20No28 Metricide Plus 30 Metrex Research, Inc90/25No28 Procide D PlusMetrex Research, Inc90/25No28 CIDEXPlusAdvanced Sterilization Products20 AdvancedPascal Co, Inc (Bellevue, Wash)45/25No30 III HLDH ealthpoint Ltd (Fort Worth, Tex)10/20No14 Glutaraldehyde/ International Co(Rockville, Md)20/25No14 Lowest glutaraldehydeconcentration for HLDOPAFast Sterilization Products12/20*5/25 No14 Materials compatibilityExpensive(continued on next page) Automated endoscope reprocessors676 GASTROINTESTINAL ENDOSCOPYV olume 72, No. 4 : between the scheduled replacements of LCG. TheAERs and the LCGs that they use also vary in their potentialfor generation of chemical waste. Some LCGs yield environ-mentally harmless by-products, whereas others require spe-cial disposal procedures (Table 1).

8 INDICATIONSAERs are cleared by the Food and Drug Adminis-tration (FDA) for HLD of flexible endoscopes when usedaccording to manufacturer s recommendations. Most areTABLE 1. (continued)Agent/trade nameManufacturerHLDconditions(min/*C) AER specificMaximumduration forreuse (days) solutionCiden Technologies LLC (WestSpringfield, Mass)12/20*5/25 No14 Stains proteins, mucousmembranes, skin, clothing, andsurfaces OPA ConcentrateAdvanced Sterilization Products5/50 Yes, (EvoTechSystem)Single use, dilutedby system eye irritationSlow sporicidal activityHydrogen peroxideNo activation IIReckitt & Colman, Inc (Wayne, NJ)30/20No21 May enhance removal of organicmaterialsNo disposal, odor, or irritationissuesContact eye toxicityPossible endoscope materialscompatibilityHydrogen peroxide/peraceticacidNo activation PlusCottrell Ltd15/20No14No significant odor, Reprocessing SystemsMinntech Corp5/25No14 Peracetic acid not compatible withsome endoscopesPeracetic acidRapid Automated DG oxidizingchemistrySTERIS Corp (Mentor, Ohio)10/50 Yes (Reliance) Single use onlyRapidly sporicidalSafe by-products35%S40 STERIS Corp6/46-55 Yes (System1-E)Single use only May enhance removal of organicmaterialRapicideperacetic acidMediVators Reprocessing SystemsMinntech Corp5/30 Yes(MediVators)28 ExpenseHypochlorous acid/hypochlorite650-675 PPM active free chlorine Sterilox Technologies, Inc(Radnor, Pa)

9 10/30 Yes, SteriloxSystemsSingle use,generated on siteSuperoxidized water (HOCL) fromelectrolysis of saline solutionNo exposure or disposal risksRapid actionApproved; not yet on market in , Automated endoscope reprocessors ;HLD, high-level disinfection;OPA, ortho-phthaldehyde.*Conditions for manual reprocessing only. Conditions for AER reprocessing endoscope 72, No. 4 : 2010 GASTROINTESTINAL ENDOSCOPY677labeled for HLD after manual cleaning, as outlined by theSociety for Gastrointestinal Nurses and (EvoTech System; Advanced Sterilization Products,Irvine, Calif) has received labeling clearance for use afterbedside precleaning only, without previous manual clean-ing and channel brushing. The company performed asimulated-use evaluation with Evotech cleaning after in-oculation of the endoscopes with artificial test soil, and allchannels and surfaces achieved at least a 6-log10reductionin , at the time of this writing, therewere no published data regarding the performance of thisdevice in the clinical setting.

10 Another endoscope repro-cessing device, the STERIS System 1E (STERIS Corp, Men-tor, Ohio), was recently given clearance by the FDA forliquid chemical sterilization, as opposed to HLD, for heat-sensitive devices that cannot be sterilized by sterilization clearance is based on incorpo-ration of a water filtration device, ultraviolet light expo-sure, and monitoring system designed to achieve steriliza-tion and is similar to the clearance indication on theoriginal STERIS System 1, which has now been discontin-ued after an FDA alert was issued (see Safety section).TABLE 2. Automated endoscope reprocessing machines approved for use in the United StatesManufacturerDeviceLCGcompatibility Basins andendoscopes percyclePlatform designCycle timeFeatures*List price (3/2010)Advanced SterilizationProducts, a Johnson &Johnson Company(Irvine, Calif)EvoTech ECR SystemCIDEX OPAC oncentrate2 basins/1 endoscopeper basin (IC)Floor standing oncasters30-33 minD R, DC, FAD, AF,VCT, VR, H, LT, OD$49,000 Custom Ultrasonics(Ivyland, Pa)System 83 Plus 2 Multiple agents 1 basin/up to 2endoscopesFloor standing8 min HLDcontact timeD R, DC, FAD, AF,VCT, PD, USW, HVR, SD, OD$27,870 System 83 Plus 9 Multiple agents 2 basins/up to 2endoscopes per basinFloor standing8 min HLDcontact R, DC, FAD, AF,VCT, PD, USW, H,VR, SD, OD$47,950 MedivatorsReprocessing SystemsMinntech Corp(Minneapolis, Minn)