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November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers
November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers
November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers
November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers
November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers
November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers
November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers
November 2001 Flexible Endoscope Reprocessors, Automatic Scope of this Product Comparison This Product Comparison covers

November 2001

Flexible Endoscope Reprocessors, Automatic

Scope of this Product Comparison

This Product Comparison covers automated dis- infecting and sterilizing units for immersible flexible endoscopes (e.g., gastroscopes, colonoscopes, bronchoscopes). Some units also in- clude a wash cycle, although this does not replace the need to manually clean the scopes before automatic reprocessing. Some of the units cov- ered in this report can also reprocess other de- vices (e.g., rigid endoscopes, surgical instruments). Devices intended to aid in manual cleaning of endoscopes are excluded, as are the disinfecting and sterilizing agents used in these devices. For information on other disinfecting and sterilizing units, see the following Product Comparisons:

Sterilizing Units, Ethylene Oxide

Sterilizing Units, Plasma

Sterilizing Units, Steam, Bulk

Sterilizing Units, Steam, Tabletop

Washers/Decontaminators

Washers/Sterilizing Units

UMDNS information

This Product Comparison covers the following device terms and product codes as listed in ECRI’s Universal Medical Device Nomenclature System™ (UMDNS™):

Disinfecting Units, Liquid, Flexible Endoscope

[11-279]

Sterilizing Units, Liquid [18-006]

Purpose

Endoscope reprocessors are designed to standardize and automate the preparation of a manually pre- cleaned endoscope so it is safe for immediate reuse. Because of the number of complicated steps involved and the need to reprocess endoscopes quickly between patient procedures, manual reprocessing is not always performed effectively or consistently. Automatic re- processors can reduce the likelihood that a crucial reprocessing step will be skipped, help ensure that reprocessing is performed consistently using a recom- mended protocol, and reduce personnel exposure to the irritating effects of liquid disinfectants/sterilants. En- doscopy staff exposure to 2% activated glutaraldehyde has caused respiratory complications such as asthma and sinusitis, serious skin sensitivity reactions, and conjunctivitis, thus precluding the use of glutaral- dehyde in many hospitals.

Medical devices can be divided into three groups according to the risk of infection associated with their use: critical, semicritical, and noncritical. Endoscopy

use: critical, semicritical, and noncritical. Endoscopy 226193 5200 Butler Pike, Plymouth Meeting, PA 19462-1298,

226193 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

424-008

Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail hpcs@ecri.org Fax +1 (610) 834-1275 E-mail hpcs@ecri.org

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is a minimally invasive diagnostic and therapeutic procedure that is gaining wider acceptance; the Cen- ters for Disease Control and Prevention (CDC) and the Association for Professionals in Infection Control and Epidemiology (APIC) consider flexible endoscopes semicritical devices because they come in contact with mucous membranes but do not normally enter sterile tissue. Consequently, CDC and APIC recommend that flexible endoscopes receive at least high-level disinfec- tion (HLD). The U.S. Food and Drug Administration (FDA) has required all liquid chemical germicide manufacturers to submit premarket 510(k) applica- tions for their products. As a result, labeling of certain 2% glutaraldehyde solutions now specifies exposure conditions of 45 minutes at 25°C (77°F) to achieve HLD. However, this does not include any manual or automatic precleaning (Walter 1996). Some hospitals may prefer to sterilize their scopes.

Because endoscopes are used repeatedly during the course of a day, they must be reprocessed quickly between procedures. Therefore, neither ethylene oxide (EtO) sterilization, which can take up to 36 hours, nor glutaraldehyde cold sterilization, which can take up to 10 hours and possibly damage endoscopes, is practical. In addition, no current flexible endoscopes can with- stand steam sterilization without deterioration. Therefore, most hospitals usually choose either HLD or liquid sterilization (at present, there is no conclusive evidence indicating that one method is safer than the other). Most hospitals use either an activated 2% glu- taraldehyde solution for HLD or 6% hydrogen peroxide or peracetic acid for sterilization. For more information on endoscope manufacturers’ reprocessing recommen- dations, see the following Product Comparisons:

Bronchoscopes

Colonoscopes; Sigmoidoscopes

Duodenoscopes; Gastroscopes; Choledochoscopes

Laparoscopes

Principles of operation

Endoscope reprocessors are designed to either dis- infect or sterilize using an automatic system to soak the endoscope and purge its channels. All reprocessors have a disinfect/sterilize and rinse cycle; some units allow the cycling times to be set by the operator. Some models also offer wash or predisinfection, multiple rinse (including alcohol), and air-purging cycles.

An automatic reprocessor connects to the facility’s water supply and typically consists of the following components:

A basin (with a lid) in which the endoscope is reproc- essed

Channel tubing with adapters that irrigate most, but not necessarily all, of the endoscope’s channels

A timing mechanism to control the time of the reprocessing phases

Liquid and air pumps

A reservoir for the disinfectant/sterilant

Using the connecting sections of the endoscope and the connectors of the endoscopic reprocessor, the op- erator attaches the reprocessor to the endoscope’s channels, places the endoscope in the unit, and starts the reprocessing procedure. (Some units can reprocess several scopes at a time.) The disinfectant/sterilant is transferred from a reservoir into the basin containing the endoscope; one processor uses a prepackaged, sin- gle-use sterilant container that is automatically opened, aspirated into the basin, and mixed with ster- ile, filtered water. Some models contain a heater to raise the temperature of the disinfectant/sterilant, allowing a wider variety of solutions to be used. How- ever, if the temperature of the disinfectant/sterilant exceeds 25.6°C, the concentration of irritating fumes could increase.

Most reprocessors provide documentation of the disinfection/sterilization cycle, either in the system’s memory or as a hard-copy printout. The documenta- tion should indicate either that all the necessary pa- rameters have been met or that the cycle has been automatically canceled or aborted by the user and the reason why.

Once the final rinse cycle is complete, the endoscope is ready for reuse. If the endoscope is going into stor- age, it may be necessary to purge its channels with forced air to ensure thorough drying, preventing the proliferation of bacteria. Sometimes an alcohol rinse is performed to facilitate the drying process.

To reduce the possibility of contaminating an en- doscope during reprocessing, the reprocessor itself should be regularly disinfected or sterilized according to the manufacturer’s recommendations; some units have programmed cycles that perform this function.

The Society of Gastroenterology Nurses and Associ- ates recommends wearing protective equipment (e.g., gloves, gown, eyewear) while operating en- doscopic reprocessors, having leakage test equipment and channel cleaning adapters, and using separate rooms for endoscopic procedures and endoscopic re- processing.

Flexible Endoscope Reprocessors, Automatic

Reported problems

There are two major ways in which a flexible en- doscope can cause nosocomial infection: the endoscope can autoinoculate a patient with his or her own mi- crobes (i.e., endogenous infection), or a contaminated endoscope can act as a carrier, transmitting a wide variety of microorganisms to the patient (or physician) from either a previous patient or the environment. There have been reports of reprocessors becoming con- taminated and subsequently passing contamination to scopes that were processed in them. (See the citations in the Bibliography for specific reports.) The microor- ganisms often found in tap water can proliferate to significant levels in endoscopes, their accessories, and ancillary equipment during improper storage.

Glutaraldehyde residues are toxic and can have deleterious effects on a patient’s mucous membranes when not adequately removed from the endoscope during rinsing. Endoscopy staff must be aware of possible glutaraldehyde exposure, even with an auto- mated system.

Purchase considerations

Before purchasing an endoscope reprocessor, hospi- tals need to assess their current endoscope reprocess- ing protocol. Hospital staff may want to consider an automatic reprocessor if they are experiencing the following problems: (1) glutaraldehyde exposure com- plaints, (2) reprocessing inconsistency, and/or (3) in- ability to handle the volume of endoscopes that need reprocessing.

Several issues need to be considered before purchas- ing a reprocessor:

Whether to choose HLD or sterilization

The level of disinfectant/sterilant exposure reduc- tion and whether extra ventilation may be required by the manufacturer

Whether the reprocessor requires the endoscopes to be modified by the manufacturer to fit into the unit

The ability to abort/skip a cycle without warning the operator

The number of scopes a unit can process simultane- ously

The time per cycle

The ease and adequacy of reprocessor disinfection/ sterilization

Reports of reprocessor contamination

Whether the reprocessor is equipped with a water filtration system and the life expectancy and re- placement costs of its filters

The type of disinfectant/sterilant the unit can ac- commodate and its cost per cycle

The space required for the unit (i.e., whether it is a tabletop or floor model)

Special temperature and pressure requirements for the water supply

The processor’s ability to circulate liquids through channels without producing air pockets

The length of the rinse and forced-air cycles

The processor’s capacity to self-disinfect

Cost containment

A life-cycle cost (LCC) analysis can be used to com- pare high-cost alternatives and/or to determine the positive or negative economic value of a single alterna- tive. For example, hospitals can use LCC analysis techniques to examine the cost-effectiveness of leasing or renting equipment versus purchasing the equip- ment outright. Because it examines the cash-flow im- pact of initial acquisition costs and operating costs over a period of time, LCC analysis is most useful for comparing alternatives with different cash flows and for revealing the total costs of equipment ownership. One LCC technique — present value (PV) analysis — is especially useful because it accounts for inflation and for the time value of money (i.e., money received today is worth more than money received at a later date). Conducting a PV/LCC analysis often demon- strates that the cost of ownership includes more than just the initial acquisition cost and that a small in- crease in initial acquisition cost may produce signifi- cant savings in operating costs. The PV is calculated using the annual cash flow, the dollar discount factor, and the lifetime of the equipment (in years) in a mathe- matical equation.

The following represent sample five-year PV/LCC analyses for a disinfecting unit and a sterilizing unit.

Present Value/Life-Cycle Cost Analysis

Assumptions

Operating costs are considered for years 2 through

5

Dollar discount factor is 6.25%

Inflation rate is 4% for disposables

Operating and ownership costs are for 1 unit being used 10 times/day for 365 days/year

Alternative 1 — Disinfecting Unit

Capital Costs

Disinfecting unit = $32,781

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Total Capital Costs = $32,781

Operating Costs

Disinfectant (2% glutaraldehyde) = $6,388/year

Service contract = $2,046/year

Total Operating Costs = $8,434/year

PV = ($41,079)

Alternative 2 — Sterilizing Unit

Capital Costs

Sterilizing unit = $22,471

Total Capital Costs = $22,471

Operating Costs

Sterilant = $17,870 for year 1; $18,250/year for years 2 through 5

Service contract = $1,525/year

Total Operating Costs = $19,395 for year 1; $19,775/year for years 2 through 5

PV = ($109,238)

Other costs not included in the above analysis that should be considered for budgetary planning include those associated with the following:

Replacement filters

Disinfectants other than glutaraldehyde (per cycle)

Contributions to overhead

Installation of additional ventilation

Potential staffing changes

Personal protective equipment (e.g., gloves, gowns, eyewear)

Accessory equipment (e.g., leakage test equipment, channel cleaning adapters)

Use of separate rooms for endoscopic procedures and reprocessing

As illustrated by the above sample PV/LCC analysis, the initial acquisition cost is only a fraction of the total cost of operation over five years. Therefore, before mak- ing a purchase decision based solely on the acquisition cost of an endoscope reprocessor, buyers should con- sider operating costs over the lifetime of the equipment.

For further information on PV/LCC analysis, cus- tomized analyses, and purchase decision support, readers should contact ECRI’s SELECT™Group.

Stage of development

Automatic flexible endoscope reprocessors were in- troduced in the 1970s. Since then, manufacturers and healthcare professionals have become more aware of the potential hazards associated with contaminated endoscopes and reprocessors and are moving toward producing better systems for disinfecting/sterilizing them.

One manufacturer offers a sterile disposable outer sheath that fits over its colonoscopes and sigmoi- doscopes. The sheath has air, water, and biopsy/suction channels, eliminating the need to clean and disinfect the endoscope between procedures (only removable control knobs require cleaning and disinfection).

Future trends will most likely be toward a more automated endoscope cleaning process to eliminate the need for manual precleaning. More units may incorporate an alcohol rinse, along with higher air pressures to facilitate drying. Manufacturers will also investigate new ways of reprocessing endoscopes, in- cluding chlorine dioxide, ozone, vapor-phase hydrogen peroxide, and plasma sterilization, and disposable en- doscopes and sheaths.

Bibliography

American Society for Gastrointestinal Endoscopy. Re- processing of flexible gastrointestinal endoscopes [position statement]. Gastrointest Endosc 1996

May;43(5):540-6.

Babb JR, Bradley CR. Endoscope decontamination:

where do we go from here? J Hosp Infect 1995 Jun;

30(Suppl):543-51.

Bottrill PM, Axon AT. Cleaning and disinfection of flexible endoscopes and ancillary equipment: use of automatic disinfectors. J Gastroenterol Hepatol 1991 Jan-Feb;6(1):45-7.

Bradley CR, Babb JR, Ayliffe GA. Evaluation of the Steris System 1 peracetic acid endoscope processor. J Hosp Infect 1995 Feb;29(2):143-51.

Brown NM, Hellyar EA, Harvey JE, et al. Mycobacte- rial contamination of fibreoptic bronchoscopes. Thorax 1993 Dec;48(12):1283-5.

CS: know thy scopes. Hosp Purch News 1993 Jun 15; 17(6):23, 25.

Daschner F, Kralovic RC. STERIS System 1 in Ger- many [letter and reply]. Infect Control Hosp Epidemiol 1994 May;15(5):294-5.

Flexible Endoscope Reprocessors, Automatic

DesCôteaux JG, Tye L, Poulin EC. Reuse of disposable laparoscopic instruments: cost analysis. Can J Surg

1996 Apr;39(2):133-9.

DiMarino AJ, Bond WW. Flexible gastrointestinal en- doscopic reprocessing [editorial]. Gastrointest En- dosc 1996 May;43(5):522-4.

Fraser VJ, Jones M, Murray PR, et al. Contamination of flexible fiberoptic bronchoscopes with Mycobac- terium chelonae linked to an automated broncho- scope disinfection machine. Am Rev Respir Dis 1992 Apr;145(4 Pt 1):853-5.

Fraser VJ, Zuckerman G, Clouse RE, et al. A prospec- tive randomized trial comparing manual and auto- mated endoscope disinfection methods. Infect Control Hosp Epidemiol 1993 Jul;14(7):383-9.

Glutaraldehyde: FDA holds firm on need for 45-minute soak. OR Manager 1996 Jun;12(6):12-3.

Gurevich I, Qadri SM, Cunha BA. False-positive re- sults of spore tests from improper clip use with the STERIS chemical sterilant system [letter]. Am J Infect Control 1993 Feb;21(1):42-3.

Ido K, Ishino Y, Ota Y, et al. Deficiencies of automatic endoscopic reprocessors: a method to achieve high- grade disinfection of endoscopes. Gastrointest En- dosc 1996 Nov;44(5):583-6.

Jackson J, Leggett JE, Wilson DA, et al. Mycobac- terium gordonae in fiberoptic bronchoscopes. Am J Infect Control 1996 Feb;24:19-23.

Kaczmarek RG, Moore RM, McCrohan J, et al. Multi- state investigation of the actual disinfection/sterili- zation of endoscopes in health care facilities. Am J Med 1992 Mar;92:257-61.

Lynch DA, Parnell P, Porter C, et al. Patient and staff exposure to glutaraldehyde from Keymed auto-dis- infector endoscope washing machine. Endoscopy

1994 May;26(4):359-61.

Lynch DA, Porter C, Murphy L, et al. Evaluation of four commercial automatic endoscope washing ma- chines. Endoscopy 1992 Nov;24(9):766-70.

Martin MA, Reichelderfer M. APIC guideline for infec- tion prevention and control in flexible endoscopy. Am J Infect Control 1994 Feb;22(1):19-38.

Muscarella LF. Advantages and limitations of auto- matic flexible endoscope reprocessors. Am J Infect Control 1996 Aug;24(4):304-9.

Nosocomial outbreaks linked to endoscope cleaning. Hosp Infect Control 1993 Jun;20(6):83-5.

Pineau L, Roques C, Luc J, et al. Automatic washer disinfector for flexible endoscopes: a new evaluation process. Endoscopy 1997 Jun;29(5):372-9.

Reichert M. Automatic washers/disinfectors for flex- ible endoscopes. Infect Control Hosp Epidemiol 1991

Aug;12(8):497-9.

Reynolds CD, Rhinehart E, Dreyer P, et al. Variability in reprocessing policies and procedures for flexible fiberoptic endoscopes in Massachusetts hospitals. Am J Infect Control 1992 Dec;20(6):283-90.

Rutala WA, Weber DJ. Disinfection of endoscopes:

review of new chemical sterilants used for high-level disinfection. Infect Control Hosp Epidemiol 1999

Jan;20(1):69-76.

Society of Gastroenterology Nurses and Associates, Inc. Standards for infection control and reprocessing of flexible gastrointestinal endoscopes. Gastroenterol Nurs 1997 Mar-Apr;20(2 Suppl):1-13.

Urayama S, Kozarek RA, Sumida S, et al. Mycobacte- ria and glutaraldehyde: is high-level disinfection of endoscopes possible? Gastrointest Endosc 1996

May;43(5):451-6.

Vesley D, Norlien KG, Nelson B, et al. Significant factors in the disinfection and sterilization of flex- ible endoscopes. Am J Infect Control 1992 Dec;20(6):

291-300.

Walter V. Reprocessing of flexible gastrointestinal en- doscopes — an American Society for Gastrointesti- nal Endoscopy white paper. Gastroenterol Nurs 1996 May-Jun;19(3):109-12.

What does it cost to clean an endoscope? Mater Manag Health Care 1992 Jun;1(4):52.

Standards and guidelines

Note: Although every effort is made to ensure that the following list is comprehensive, please note that other applicable standards may exist.

American National Standards Institute/Association for the Advancement of Medical Instrumentation. Safe current limits for electromedical apparatus [standard]. 3rd ed. ANSI/AAMI ES1-1993. 1985 (re- vised 1993).

Safe handling and biological decontamination of medical devices in health care facilities and in non- clinical settings [standard]. 2nd ed. ANSI/AAMI ST35-1996. 1996.

Healthcare Product Comparison System

American Public Health Association. Cleaning, sterili- zation and disinfection of rigid and flexible en- doscopes and their accessories [position paper].

1982.

American Society for Gastrointestinal Endoscopy. Is- sues of flexible gastrointestinal endoscope reproc- essing [position statement]. Ad Hoc Committee on Disinfection. Gastrointest Endosc 1996 May;43(5):

541-6.

Technology assessment position paper: transmis- sion of infection by gastrointestinal endoscopy. Technology Assessment Committee. Gastrointest Endosc 1993 Oct;39(6):885-8.

American Society for Testing and Materials. Practice for cleaning and disinfection of flexible fiberoptic and video endoscopes used in the examination of the hollow viscera [standard]. ASTM Committee F04 on Medical and Surgical Materials and Devices. F1518- 94. 1994.

Association for Practitioners in Infection Control. APIC guideline for infection prevention and control in flexible endoscopy. Am J Infect Control 2000 Apr;

28(2):138-55.

APIC guideline for selection and use of disinfec- tants. Am J Infect Control 1996 Aug;24(4):313-42.

Association for the Advancement of Medical Instru- mentation. Chemical sterilants and sterilization methods: a guide to selection and use [technology information report]. TIR7-152-EC. 1990.

Safe handling of biologically contaminated medical devices in nonclinical and clinical settings [stan- dard]. TIR10-152-EL. 1994.

Association of Operating Room Nurses. Care of instru- ments, scopes, and powered surgical instruments [recommended practice]. 1997.

Recommended practices for the use and care of endoscopes [recommended practice]. AORN J 1998 Jan;67(1):256-8, 261-2.

International Electrotechnical Commission. Medical electrical equipment — part 1: general require-

ments for safety [standard]. IEC 60601-1 (1988-12).

1988.

Medical electrical equipment — part 1: general re- quirements for safety. Amendment 1 [standard]. IEC 60601-1-am1 (1991-11). 1991.

Medical electrical equipment — part 1: general re- quirements for safety. Amendment 2 [standard]. IEC 60601-1-am2 (1995-03). 1995.

Medical electrical equipment — part 1: general re- quirements for safety. Section 2. Collateral stan- dard: electromagnetic compatibility — requirements and tests. IEC 60601-1-2 (1993-04). 1993.

Society of Gastroenterology Nurses and Associates, Inc. Standards for infection control and reprocess- ing of flexible gastrointestinal endoscopes [guide- line]. 1997 (revised 2000).

Standards Association of Australia. Code of practice for cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities [standard]. AS 4187-1994.

1994.

Citations from other ECRI publications

Health Devices

Contamination of the modified Olympus EW-10 and EW-20 automatic flexible endoscope reprocessors [hazard]. 1994 Apr;23(4):143-5.

Liquid disinfecting and sterilizing reprocessors used for flexible endoscopes [evaluation]. 1994 Jun;23(6):

214-53.

Reducing endoscopic contamination levels: are liquid disinfecting and sterilizing reprocessors the solu- tion? 1994 Jun;23(6):212-3, 252-3.

Liquid disinfecting and sterilizing reprocessors used for flexible endoscopes [evaluation update]. 1994

Dec;23(12):477-81.

ECRI’s recommended protocol for reprocessing immer- sible flexible endoscopes [clarification/update]. 1995 Dec;24(12):506-7.

MediVators endoscope disinfector does not alarm for disinfection failures caused by blown fuse [hazard report]. 1998 Apr-May;27(4-5):171-2.

ECRI responds to Newsweek article on dirty en- doscopes [editorial]. 1999 May-Jun;28(5-6):177-9.

Automated LCG reprocessors. An alternative for flex- ible endoscopes [guidance article]. 1999 Nov;28(11):

434.

Health Devices Alerts

This Product Comparison lists Health Devices Alerts (HDA) citations published since the last update of this report. Each HDA abstract is identified by an Accession Number. Recalls and hazard reports include descriptions of the problem involved; abstracts of other published articles are referenced by bibliographic in- formation. HPCS subscribers can call the Hotline for additional information on any of these citations or to request more extensive searches of the HDA database.

Flexible Endoscope Reprocessors, Automatic

A3899 FDA and CDC have issued a Public Health Advisory alerting healthcare facilities to several inci- dents in which patients developed serious infections after being examined with bronchoscopes that appar- ently were inadequately reprocessed in an automated endoscope reprocessor (AER). CDC reported apparent patient-to-patient transmission of infections following bronchoscopic procedures that used bronchoscopes that were inadequately reprocessed by AERs. Investi- gation of the reported incidents revealed that there were inconsistencies between the reprocessing in- structions provided by the manufacturer of the bron- choscope and the manufacturer of the AER and that bronchoscopes were inadequately reprocessed when inappropriate channel connectors were used with the AER. Additionally, some users are using AERs to reprocess endoscopes that are not suitable for AERs; this practice may have resulted in damaged en- doscopes and also raises questions about whether such processing results in an endoscope that is properly prepared for patient contact. Source: United States. Food and Drug Administration. Center for Devices and Radiological Health. Centers for Disease Control and Prevention. National Center for Infectious Diseases. FDA and CDC public health advisory: infections from endoscopes inadequately reprocessed by an automated endoscope reprocessing system. 1999 Sep 10.

A4376 FDA has designated Class II Recall Nos. Z- 0364/0366-1 STERIS liquid sterilizing units. Accord- ing to STERIS, the instruction booklets for the C1402, C1403, and C1622 Quick Connect Kits may not be clear to all users regarding the appropriate processing of Pentax 30/40/30K Series gastroscopes with forward water jets. All affected U.S. customers have received the revised instruction booklets. The manufacturer initiated a recall by letter dated December 12, 2000. Verify that you have received the December 12, 2000, letter from STERIS. Identify and isolate any affected product in your inventory. Source: FDA Enforcement Rep 2001 Mar 14; Manufacturer.

D4389 The Australian Therapeutic Goods Admini- stration (TGA) issued a Safety Alert informing health- care facilities that there have been reports of patients developing serious infections after being examined with bronchoscopes that were inadequately cleaned in an automated endoscope cleaner (AEC). TGA states that investigation of the reported incidents revealed that there were inconsistencies between the cleaning in- structions provided by the bronchoscope manufacturer and the AEC manufacturer; that bronchoscopes were inadequately cleaned because inappropriate channel connectors were used; and that some users were using the AEC to clean endoscopes that should not be proc- essed in an AEC. Source: Australia. Therapeutic

Goods Administration. Safety alert — endoscope cleaning. Aust Ther Device Bull 1999 Dec; No. 40-

3/99:8-9.

35593 Tsuji S, Kawano S, Oshita M, et al. Endoscope

disinfection using acidic electrolytic water. Endoscopy 1999 Sep;31(7):528-35.

Health Technology Trends

Endoscope infection control needs more hospital atten- tion. 1994 Feb;6(2):3, 5.

Supplier information

ASP

Advanced Sterilization Products A Johnson & Johnson Co [186653] 33 Technology Dr Irvine CA 92618 Phone: (949) 581-5799, (800) 595-0200 Fax: (949) 450-6800 E-mail: aspcomment@aspus.jnj.com Internet: http://www.sterrad.com

Advanced Sterilization Products (Belgium) c/o Johnson & Johnson Medical NV [307241] Eikelenbergstraat 20 B-1700 Dilbeek Belgium Phone: 32 (2) 4817400 Fax: 32 (2) 4817350 Internet: http://www.sterrad.com

Advanced Sterilization Products (Singapore) c/o Johnson & Johnson Medical Inc [306945] 3 International Rd Jurong Singapore 2261 Republic of Singapore Phone: 65 2658922 Fax: 65 2686974 Internet: http://www.sterrad.com

Belimed

Belimed AG [140149] Dorfstrasse 4 Postfach 188 CH-6275 Ballwil Switzerland Phone: 41 (41) 4497888 Fax: 41 (41) 4497889 E-mail: info@belimed.com Internet: http://www.belimed.com

Healthcare Product Comparison System

BHT

BHT HygieneTechnik GmbH [230341] Winterbruckenweg 30 D-86316 Friedberg/Derching Germany Phone: 49 (821) 2789313 Fax: 49 (821) 784099 E-mail: bht.verkauf@t-online.de Internet: http://www.bht-hygienetechnik.de

Custom Ultrasonics

Custom Ultrasonics Inc [107046]

PO Box 850

Buckingham PA 18912 Phone: (215) 364-1477 Fax: (215) 364-7674 E-mail: q-net@msn.com Internet: http://www.customultrasonics.com

Krause

Krause Medizin Technik Service GmbH [279550] Hoher Holzweg 44 D-30966 Arnum Germany Phone: 49 (510) 13006 Fax: 49 (510) 15093 E-mail: info@kmts.de Internet: http://www.kmts.de

LABcaire

LABcaire Systems Ltd [184258]

15 Hither Green

Clevedon, Avon BS21 6XU England Phone: 44 (1275) 340033 Fax: 44 (1275) 341313

Lancer

Lancer Holland bv [391355] Postbus 33 NL-6659 ZG Wamel

The Netherlands

Phone: 31 (487) 518088 Fax: 31 (487) 517978 Internet: http://www.lancer.com

Lancer Industrie

Div Getinge Industrier AB [138079]

30 boulevard de l’Industrie

Zone Industrielle de Pahin F-31170 Tournefeuille France Phone: 33 (5) 61151111 Fax: 33 (5) 61151616 Internet: http://www.getinge.com

Lancer UK Ltd [391354] 1 Pembroke Ave Waterbeach Cambridge, Cambridgeshire CB5 9QR England Phone: 44 (1223) 861665 Fax: 44 (1223) 861990 Internet: http://www.lancer.com

Lancer USA Inc [107921] 140 State Rd 419 Winter Springs FL 32708 Phone: (407) 327-8488, (800) 332-1855 Fax: (407) 327-1229 E-mail: sales@lancer.com Internet: http://www.lancer.com

Medlore

Medlore [232375] 43 boulevard de la Barniere F-13010 Marseille France Phone: 33 (491) 832122 Fax: 33 (491) 832110 E-mail: medlore@aix.pacwan.net Internet: http://www.medlore.com

Newamatic

Netzsch Belimed GmbH [328040] Liebigstrasse 28 Postfach 1240 D-84465 Waldkraiburg Germany Phone: 49 (8638) 946300 Fax: 49 (8638) 881830 E-mail: netzsch-belimed@iiv.de Internet: http://www.belimed.de

Olympus

Olympus America Inc Endoscopy Group [364575] Two Corporate Center Dr Melville NY 11747-3157 Phone: (631) 844-5000, (800) 645-8130 Fax: (631) 844-5442 Internet: http://www.olympus.com

Flexible Endoscope Reprocessors, Automatic

Pauldrach

Pauldrach Medical GmbH [366855] Porschestrasse 22 D-30827 Garbsen Germany Phone: 49 (5131) 49650 Fax: 49 (5131) 92014 E-mail: endoman@t-online.de Internet: http://www.pauldrach.de

Plade

Plade Ltd [397119] Plade Works Gladstone Avenue Barrhead, Glasgow G78 1QT Scotland Phone: 44 (141) 8818241 Fax: 44 (141) 8818143 E-mail: plade@plade.com Internet: http://www.plade.com

STERIS

STERIS Corp [107114] 5960 Heisley Rd Mentor OH 44060-1834 Phone: (440) 354-2600, (800) 548-4873 Fax: (440) 350-7086 E-mail: john_kurowski@steris.com Internet: http://www.steris.com

STERIS Corp (Hong Kong) [227264] Room 301-2 3/Floor Kodak House II 39 Healthy St E North Point Hong Kong SAR People’s Republic of China Phone: 852 25633623 Fax: 852 25637387 Internet: http://www.steris.com

STERIS Ltd (Europe) Jays Close Viables, Basingstoke Hampshire RG22 4AX England Phone: 44 (1256) 840400 Fax: 44 (1256) 866502 E-mail: duncan_wilson@steris.com Internet: http://www.steris.com

STERIS Singapore [320749] 61 Lam Leong Bldg #03-01 Geylang Lorong 17 Singapore 388574 Republic of Singapore Phone: 65 8417677 Fax: 65 8417655 Internet: http://www.steris.com

About the chart specifications

The following terms are used in the chart:

Manual air capability: The ability of the user to force air through the endoscope’s channels.

Autodisinfection: A cycle that disinfects the reproces- sor. In some units, this cycle is part of the overall reprocessing procedure; other units have a separate autodisinfection cycle.

Abbreviations:

ARO — After receipt of order

CE mark — Conformite Europeene mark

CSA — Canadian Standards Association

DGHM — Deutsche Geseuschaft Hygiene and Mik- robiology

ETL — ETL Testing Laboratories

FDA — U.S. Food and Drug Administration

GERMANDE — French association of gastroen- terologists working on washer-disinfectors in Europe to establish a standard procedure to test these devices

ISO —

International Organization for Stand-

ardization

LCD — Liquid crystal display

LED — Light-emitting diode

MDD — Medical Devices Directive

PC — Personal computer

TUV — Technischer Ueberwachungs Verein

UL — Underwriters Laboratories

UV — Ultraviolet

Note: The data in the charts derive from suppliers’ specifications and have not been verified through inde- pendent testing by ECRI or any other agency. Because test methods vary, different products’ specifications are not always comparable. Moreover, products and speci- fications are subject to frequent changes. ECRI is not responsible for the quality or validity of the information

Healthcare Product Comparison System

presented or for any adverse consequences of acting on such information.

When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect supplier discounts. And although we try to indicate which features and characteristics are standard and which are not, some may be optional, at additional cost.

For those models whose prices were supplied to us in currencies other than U.S. dollars, we have also

listed the conversion to U.S. dollars to facilitate com- parison among models. However, keep in mind that exchange rates change often.

Need to know more?

For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or hpcs@ecri.org (e-mail).

About ECRI

ECRI is a nonprofit health services research agency and a Collaborating Center of the World Health Organization, providing information and technical assistance to the healthcare community to support safe and cost-effective patient care for more than 25 years. The results of ECRI’s research and experience are available through its publications, information systems, databases, technical assistance program, laboratory services, seminars, and fellowships.

Our full-time staff includes a wide range of specialists in healthcare technology, hospital admini- stration, financial analysis, risk management, and information and computer science, as well as hospital planners, attorneys, physicists; biomedical, electrical, electronic, chemical, mechanical, and registered engineers; physicians; basic medical scientists; epidemiologists and biostatisticians; and writers, editors, and communications specialists.

Underlying ECRI’s knowledge base in healthcare technology are its integrity and objectivity. ECRI accepts no financial support from medical product manufacturers, and no employee may own stock in or consult for a medical equipment or pharmaceutical company.

The scope of ECRI’s resources extends far beyond technology. ECRI keeps healthcare professionals, manufacturers, legal professionals, information specialists, and others aware of the changing trends in healthcare, healthcare standards and regulations, and the best ways to handle environmental and occupational health and safety issues. ECRI also advises on management issues related to healthcare cost containment, accreditation, risk management, human resources, quality of care, and other complex topics.

ECRI has more than 35 publications, databases, software, and services to fulfill the growing need for healthcare information and decision support. They focus on three primary areas: healthcare technology, healthcare risk and quality management, and healthcare environmental management.

Flexible Endoscope Reprocessors, Automatic

Product Comparison Chart

MODEL

ASP

BELIMED

BHT

BHT

Automatic Endoscope

WD 420

INNOVA E 2

INNOVA E 3

Reprocessor

WHERE MARKETED

Worldwide

Asia, Australia, Europe, Middle East

Worldwide

Worldwide

FDA CLEARANCE

Yes

Submitted

No

Submitted

CE MARK (MDD)

Yes

Yes

Yes

Yes

CONFIGURATION

Floor

Floor, stand-alone

Freestanding under

Freestanding under

 

counter

counter

DISINFECT/STERILIZE

High-level disinfect

Disinfect

Disinfect

Disinfect

CHAMBER SIZE, H x L x W, cm (in)

12.7 x 58.4 x 50.8 (5 x 23 x 20)

51 x 51 x 55 (20.1 x 20.1 x 21.7)

55 x 48 x 38 (21.7 x 18.9 x 15)

53.5 x 51 x 52 (21.1 x 20.1 x 20.5)

SCOPES PER CYCLE

1 or 2

1 or 2

1

1 or 2

CYCLE TIME, min Wash Disinfect/sterilize Rinse Dry

1-166, user select 1-166, user select 3 fresh water

See footnote * See footnote * See footnote * See footnote *

Varies

Varies

Varies

Varies

Varies

Varies

5

Varies

Varies

GERMICIDAL AGENTS

Types used

Orthophthaldehyde, peracetic acid, 2% glutaraldehyde, hydrogen peroxide

0.15%

All

All

glutaraldehyde,

peracetic acid

Heater Temp range, C

Yes 25-50, set at factory

Yes

Yes

Yes

To 95

<60

<60

WATER SUPPLY

Tap, filtered, 1 and 0.2 micron

Tap

Cold and warm mixed potable filtered tap water

Cold and warm mixed potable filtered tap water

Temperature

requirements, C

Not to exceed 50

55 warm water, ~18 cold water

30

30-60

DETERGENT LOADING

Automatic

Automatic

Automatic

Automatic

RESERVOIR VOLUME,

L (gal)

18.9 (5)

5 (1.3)

Not specified

Not specified

MANUAL AIR

CAPABILITY

Yes

Yes

No

No

DOCUMENTATION

Identification codes, LED display, printer

Optional printer,

Optional printer

Printer and optional bar-code reader

bar code

AUTODISINFECTION

Yes

Yes

Yes

Yes

AVAILABLE CHEMICAL PROCESS INDICATORS

From chemical

Metering device

Digitally controlled

Digitally controlled

germicide

dosing pumps

dosing pumps

manufacturer

Colons separate data on similar models of a device.

* Total processing time is 20 min without dry cycle and 40 min with dry cycle.

This is the first of two pages covering the above model(s). These specifications continue onto the next page.

Healthcare Product Comparison System

Product Comparison Chart

MODEL

ASP

BELIMED

BHT

BHT

Automatic Endoscope

WD 420

INNOVA E 2

INNOVA E 3

Reprocessor

SCOPE COMPATIBILITY

All flexible

All

All flexible

All flexible

fiberoptic and

video

OVERALL SIZE, H x W x D, cm (in)

99.1 x 69.2 x 76.2 (39 x 27.25 x 30)

90 x 90 x 70 (35.4 x 35.4 x 27.6)

85 x 60 x 60 (31 x 23.6 x 23.6)

90 x 80 x 70 (35.4 x 31.5 x 27.6)

WEIGHT, kg (lb)

90.7 (200)

148 (326.3)

80 (176.4)

160 (352.8), depend- ing on configuration

POWER REQUIREMENTS, VAC

100, 60 Hz or 230, 50 Hz (10, 20, 50 A)

208, 60 Hz, 9.5 kW (10.3 kW total)

208-230, 400,

3 x 208, 60 Hz; 3 x 400, 50 Hz

50/60 Hz

PLANNING & PURCHASE List price

$17,900

Not specified

Not specified

Not specified

Warranty

1 year, parts/labor

1 year

1 year

1 year

Delivery time, ARO

2-4 weeks

3 weeks

4-6 weeks

4-6 weeks

Service contract

Not specified

Available

Available

Available

Training w/purchase

On-site

Full service with installation; included in price

Included

Included

Year first sold Number installed USA Worldwide Fiscal year

1989

1990

1999

1997

Not specified Not specified January to December

NA

Not specified Not specified January to December

Not specified Not specified January to December

800

January to December

OTHER SPECIFICATIONS

Large basin capacity; hydro- dynamic spray tower; thermostatic disinfectant reservoir; 6 separately controlled pressure perfusion ports; custom-fit lid; portable or permanent installa- tion; optional water-filtration system.

Microprocessor controlled; auto- matic, continous density test. Meets requirements of German Workshop of Endoscopy.

Stainless steel; microprocessor con- trolled; LCD; leakage testing; thermal disinfection of final rinsing; sterile drying. Meets requirements of CSA, German Association of Endoscopy, and ISO 9001.

Stainless steel; microprocessor con- trolled; LCD; foam-control feature; leakage testing; thermal disinfection of final rinsing; sterile drying. Meets requirements of CSA, German Association of Endoscopy, and ISO 9001.

Colons separate data on similar models of a device.

Flexible Endoscope Reprocessors, Automatic

Product Comparison Chart

MODEL

CUSTOM ULTRASONICS

CUSTOM ULTRASONICS

KRAUSE FAILED TO RESPOND * Profi 2000

LABCAIRE

83 Plus (Models 83+ 2 : 83+9 : 83+10)

83 Plus DT (Models 83+2 : 83+9 : 83+10)

Autoscope F2

WHERE MARKETED

Australia, Canada, Ireland, Italy, Japan, Korea **

Australia, Canada, Ireland, Italy, Japan, Korea **

Europe, other countries on demand

Asia, Australasia, Europe, Middle East, UK

FDA CLEARANCE

Yes

Yes

Not specified

No

CE MARK (MDD)

Yes

Yes

Not specified

Yes

CONFIGURATION

Floor with mobile casters

Floor with mobile casters

Floor

Cart

DISINFECT/STERILIZE

Wash cycle, high- level disinfection

Wash cycle, high- level disinfection

Disinfect

Both

CHAMBER SIZE, H x L x W, cm (in)

41.9 (16.5) or 49 (19) diam x 19 (7.5) depth

41.9 (16.5) or 49 (19) diam x 19 (7.5) depth

23 x 2.5 x 2.5 (9 x 1 x 1)

Molded tray, 8 (3.1) W x 65 (26) D

SCOPES PER CYCLE

2 : 4 : 6

2 : 4 : 6

1 or 2 ( 18 cm in length)

1 or 2

CYCLE TIME, min Wash Disinfect/sterilize Rinse Dry

3

3

1-60

2 washes @ 2 each 4-599, variable 2 rinses @ 2 each

Chemical dependent 3-4 rinses @ 1.5 ea 40 sec

Chemical dependent 3-4 rinses @ 1.5 ea 40 sec

1-60

1-60

1-60

1

GERMICIDAL AGENTS

Types used

Not limited

Not limited

Liquids after DGHM

Glutaraldehyde,

 

peracetic acid,

super-ionized water,

chlorine dioxide,

orthophthaldehyde

Heater Temp range, C

Optional ***

Unlimited

See footnote *** Unlimited

Yes

Optional

20-40

20-25

WATER SUPPLY

Tap, filtered at 5 microns, 0.1 micron for sediment and bacteria

Tap, filtered at 5 microns, 0.1 micron for sediment and bacteria

UV-sterilized water

Multistage filtration to 0.22 micron

Temperature

requirements, C

43 ±5

43 ±5

0-40

Ambient

DETERGENT LOADING

Manual

Automatic

Automatic

Semiautomatic w/full

 

fume containment

RESERVOIR VOLUME,

L (gal)

22.7 (6), 16.5 in; 30 (8), 19 in

22.7 (6), 16.5 in; 30 (8), 19 in

12 (3.2)

15 (4)

MANUAL AIR

CAPABILITY

Also automatic

Also automatic

Yes

Yes

DOCUMENTATION

Printer; database

Printer; database

Possible printer

Printer

available

available

connection

AUTODISINFECTION

Yes

Yes

Yes

Fully automatic

AVAILABLE CHEMICAL PROCESS INDICATORS

From chemical

From chemical

Endozyme

Low-flow alarms, user locked out when chemical exceeds maximum use life

germicide

germicide

manufacturer

manufacturer

Colons separate data on similar models of a device.

Specifications current as of February 2000. Also marketed in Scotland, UAE, UK, and USA.

***

**

*

Thermocouple/computer controlled.

Preset based on chemical and scope compatibility.

This is the first of two pages covering the above model(s). These specifications continue onto the next page.

Healthcare Product Comparison System

Product Comparison Chart

MODEL

CUSTOM ULTRASONICS

CUSTOM ULTRASONICS

KRAUSE FAILED TO RESPOND * Profi 2000

LABCAIRE

83 Plus (Models 83+ 2 : 83+9 : 83+10)

83 Plus DT (Models 83+2 : 83+9 : 83+10)

Autoscope F2

SCOPE COMPATIBILITY

All channels of all scopes

All channels of all scopes

All flexible fiber- optic and video

All flexible

OVERALL SIZE, H x W x D, cm (in)

Model dependent

Model dependent

240 x 58.5 x 62 (94.5 x 23 x 24.4)

154 x 82 x 72 (62.6 x 32.3 x 28.3)

WEIGHT, kg (lb)

Model dependent

Model dependent

~86 (189.6)

130 (286.7)

POWER REQUIREMENTS, VAC

120, 60 Hz, 10 A

120, 60 Hz, 10 A

230, 60 Hz, 6 A

110/230, 50/60 Hz

PLANNING & PURCHASE List price

$20,000 : $38,000 :

$22,000 : $40,000 :

~$43,200 for 1, ~$64,800 for 2 1 year, parts/labor

£16,500

$56,000

$59,000

(US$23,352)

Warranty

1 year

1 year

1 year

Delivery time, ARO

8-10 weeks

8-10 weeks

8 weeks

4-6 weeks

Service contract

Available

Available

~$2,664/year

Depends upon location 2 days on-site

Training w/purchase

2 days on-site

2 days on-site

Not specified

Year first sold Number installed USA Worldwide Fiscal year

1980

1980

Not specified

1999

Not specified

Not specified

Not specified

NA Not specified July to June

>2,000

>2,000

Not specified

July to June

July to June

Not specified

OTHER SPECIFICATIONS

PC controlled with proprietary, patent- ed software; hard- copy documentation; low-intensity ultrasound. Meets requirements of CE, CSA and ETL.

PC controlled with proprietary, patent- ed software; hard- copy documentation; low-intensity ultrasound. Meets requirements of CE CSA and ETL.

Ring nozzle washes the tube of the endoscope “lift up” system; magnetic tapes for doors; 1-channel steer- ing; reuse of disin- fection solvent.

Automatic detergent loading (enzyme cleaner). Tested and passed by Hospital Infection Research Laboratory, Birmingham; full COSHH compliance assured (independent test report available).

Colons separate data on similar models of a device.

* Specifications current as of February 2000.

Flexible Endoscope Reprocessors, Automatic

Product Comparison Chart

MODEL

LABCAIRE

LABCAIRE

LABCAIRE

LABCAIRE

Autoscope F4

Autoscope Guardian

Autoscope Guardian

Autoscope RF2

 

G2

G4

WHERE MARKETED

Asia, Australasia, Europe, Middle East, UK

Asia, Australasia, Europe, Middle East, UK

Asia, Australasia, Europe, Middle East, UK

Asia, Australasia, Europe, Middle East, UK

FDA CLEARANCE

No

No

No

No

CE MARK (MDD)

Yes

Yes

Yes

Yes

CONFIGURATION

Cart

Cart

Cart

Cart

DISINFECT/STERILIZE

Both

Both

Both

Both

CHAMBER SIZE, H x L x W, cm (in)

2 molded trays, 7.4 (2.9) W x 65 (26) D

Molded tray, 8 (3.1) W x 65 (26) D

2 molded trays, 7.4 (2.9) W x 65 (26) D

Stainless steel, 8 (3.1) W x 65 (26) D

SCOPES PER CYCLE

1 or 2 per tray

1 or 2

1 or 2

1 or 2 and/or selec- tion of rigid scopes

CYCLE TIME, min Wash Disinfect/sterilize Rinse Dry

2 washes @ 2 each 4-599, variable 2 rinses @ 2 each

2 washes @ 2 each 4-599, variable

2 washes @ 2 each 4-599, variable 2 rinses @ 2 each

2 washes @ 2 each 4-599, variable

2 rinses @ 2 each

2 rinses @ 2 each

1111

GERMICIDAL AGENTS

Types used

Glutaraldehyde,

Glutaraldehyde,

Glutaraldehyde,

Glutaraldehyde,

peracetic acid,

peracetic acid,

peracetic acid,

peracetic acid,

super-ionized water,

super-ionized water,

super-ionized water,

super-ionized water,

chlorine dioxide,

chlorine dioxide,

chlorine dioxide,

chlorine dioxide,

orthophthaldehyde

orthophthaldehyde

orthophthaldehyde

orthophthaldehyde

Heater Temp range, C

Optional

Optional

Optional

Optional

20-25

20-25

20-25

20-25

WATER SUPPLY

Multistage filtration to 0.22 micron

Multistage filtration to 0.22 micron

Multistage filtration to 0.22 micron

Multistage filtration to 0.22 micron

Temperature

requirements, C

Ambient

Ambient

Ambient

Ambient

DETERGENT LOADING

Semiautomatic w/full

Semiautomatic w/full

Semiautomatic w/full

Semiautomatic w/full

fume containment

fume containment

fume containment

fume containment

RESERVOIR VOLUME,

L (gal)

15 (4) per tray

15 (4)

15 (4) per tray

15 (4)

MANUAL AIR

CAPABILITY

Yes

Yes

Yes

Yes

DOCUMENTATION

Printer

Printer, smart card data recorder

Printer, smart card data recorder

Printer

AUTODISINFECTION

Fully automatic

Fully automatic

Fully automatic

Fully automatic

AVAILABLE CHEMICAL PROCESS INDICATORS

Low-flow alarms, user locked out when chemical exceeds maximum use life

All channels indi- vidually monitored for flow and connec- tion

All channels indi- vidually monitored for flow and connec- tion

Low-flow alarms, user locked out when chemical exceeds maximum use life

Colons separate data on similar models of a device.

This is the first of two pages covering the above model(s). These specifications continue onto the next page.

Healthcare Product Comparison System

Product Comparison Chart

MODEL

LABCAIRE

LABCAIRE

LABCAIRE

LABCAIRE

Autoscope F4

Autoscope Guardian

Autoscope Guardian

Autoscope RF2

 

G2

G4

SCOPE COMPATIBILITY

All flexible

All flexible

All flexible

All flexible and rigid

OVERALL SIZE, H x W x D, cm (in)

154 x 150 x 72 (60.6 x 59 x 28.3)

154 x 82 x 72 (60.6 x 32.3 x 28.3)

154 x 150 x 72 (60.6 x 59 x 28.3)

154 x 82 x 72 (60.6 x 32.3 x 28.3)

WEIGHT, kg (lb)

200 (441)

130 (286.7)

200 (441)

130 (286.7)

POWER REQUIREMENTS, VAC

110/230, 50/60 Hz

110/230, 50/60 Hz

110/230, 50/60 Hz

110/230, 50/60 Hz

PLANNING & PURCHASE List price

£25,000

£25,000

£39,000

£17,000

(US$35,383)

(US$35,383)

(US$55,197)

(US$24,062)

Warranty

1 year

1 year

1 year

1 year

Delivery time, ARO

4-6 weeks

4-6 weeks

4-6 weeks

4-6 weeks

Service contract

Depends upon location 2 days on-site

Depends upon location 2 days on-site

Depends upon location 2 days on-site

Depends upon location 2 days on-site

Training w/purchase

Year first sold Number installed USA Worldwide Fiscal year

1999

2001

2001

1999

NA Not specified July to June

NA Not specified July to June

NA Not specified July to June

NA Not specified July to June

OTHER SPECIFICATIONS

Automatic detergent loading (enzyme cleaner). Tested and passed by Hospital Infection Research Laboratory, Birmingham; full COSHH compliance assured (independent test report available).

All variable cycle parameters assessed and reported; automatic detergent loading (enzyme cleaner). Designed to ensure compliance with HTM2030 and prEN ISO 15883. Tested and passed by Hospital Infection Research Laboratory, Birmingham; full COSHH compliance assured (independent test report available).

All variable cycle parameters assessed and reported; automatic detergent loading (enzyme cleaner). Designed to ensure compliance with HTM2030 and prEN ISO 15883. Tested and passed by Hospital Infection Research Laboratory, Birmingham; full COSHH compliance assured (independent test report available).

Automatic detergent loading (enzyme cleaner). Tested and passed by Hospital Infection Research Laboratory, Birmingham; full COSHH compliance assured (independent test report available).

Colons separate data on similar models of a device.

Flexible Endoscope Reprocessors, Automatic

Product Comparison Chart

MODEL

LABCAIRE

LANCER

MEDLORE

NEWAMATIC FAILED TO RESPOND * WD 440

Autoscope RF4

Fibro-Cleaner

Soluscope

WHERE MARKETED

Asia, Australasia, Europe, Middle East, UK

Europe

Asia, Australia,

Asia, Australia, Europe, New Zealand

Europe

FDA CLEARANCE

No

No

No

No

CE MARK (MDD)

Yes

Yes

Yes

Yes

CONFIGURATION

Cart

Stand-alone

Tabletop, optional

Floor with casters

 

cart

DISINFECT/STERILIZE

Both

Disinfect

Disinfect

Disinfect

CHAMBER SIZE, H x L x W, cm (in)

2 stainless steel trays, 7.4 (2.9) W x 65 (26) D

46 x 51 x 50 (18.1 x 20.1 x 19.7)

59 x 40 x 15 (23.2 x 15.7 x 5.9), oval

Not specified

SCOPES PER CYCLE

1 or 2 and/or selec- tion of rigid scopes

1 or 2

See footnote **

1 or 2, simultaneous or asynchronous

CYCLE TIME, min Wash Disinfect/sterilize Rinse Dry

2 washes @ 2 each 4-599, variable 2 rinses @ 2 each

5

3

5

12

5

5

5, 6

3

1

1

3

1

5, 10, or 15

GERMICIDAL AGENTS

 
 

Types used

Glutaraldehyde,

Aperlan (peracetic

Soluscope D glutaraldehyde, Soluscope E enzyme cleaner

Neutral agent with 6% glyoxal and 3.5% glutaraldehyde (diluted to 1%)

 

peracetic acid,

acid)

super-ionized water,

chlorine dioxide,

orthophthaldehyde

 

Heater Temp range, C

Optional

No

Yes

Yes Up to 58

20-25

NA

45

WATER SUPPLY

Multistage filtration to 0.22 micron

Filtered; 1, 0.3, 0.1 micron

Prefiltered tap,

Tap, sterile filtered, 0.2 micron

0.2-micron filter

 

Temperature

 

requirements, C

Ambient

Ambient

45

Ambient

DETERGENT LOADING

Semiautomatic w/full

Automatic dosing

Automatic

Automatic

fume containment

RESERVOIR VOLUME,

 
 

L (gal)

15 (4) per tray

115 (30.4)

11 (2.9)

NA

MANUAL AIR

 
 

CAPABILITY

Yes

Airtightness

Yes

Automatic after each wash & rinse cycle

 

control

DOCUMENTATION

Printer

Printer

Yes

Optional printer or RS232 interface

AUTODISINFECTION

Fully automatic

Yes

Chlorine and

Yes

 

glutaraldehyde ***

AVAILABLE CHEMICAL PROCESS INDICATORS

Low-flow alarms, user locked out when chemical exceeds maximum use life

Not specified

No

No

Colons separate data on similar models of a device.

 

This is the first of two pages covering the above model(s). These specifications continue onto the next page.

*

**

Specifications current as of February 2000. Capacity includes 1 gastroscope, 2 bronchoscopes, and 1 colonoscope. Through hydraulic circuit including filter.

 

***

Healthcare Product Comparison System

Product Comparison Chart

MODEL

LABCAIRE

LANCER

MEDLORE

NEWAMATIC FAILED TO RESPOND * WD 440

Autoscope RF4

Fibro-Cleaner

Soluscope

SCOPE COMPATIBILITY

All flexible and rigid

All flexible

All

All flexible scopes from leading manufacturers

OVERALL SIZE, H x W x D, cm (in)

154 x 150 x 72 (60.6 x 59 x 28.3)

174 x 90 x 68 (68.5 x 35.4 x 26.7)

63 x 63 x 31 (24.8 x 24.8 x 12.2) **

112 x 144 x 75 (44.1 x 56.7 x 29.5)

WEIGHT, kg (lb)

200 (441)

230 (507)

40 (88.2)

180 (397) + 80 (176) for boiler

POWER REQUIREMENTS, VAC

110/230, 50/60 Hz

230, 50 Hz

220-240, 50 Hz

230, 50/60 Hz + 400, 50/60 Hz (boiler)

PLANNING & PURCHASE List price

£27,000

$23,000-30,000

15,900

Not specified

(US$38,220)

(US$13,843)

Warranty

1 year

1 year, parts/labor

1 year

1 year, parts/labor

Delivery time, ARO

4-6 weeks

8 weeks

4 weeks

8-12 weeks

Service contract

Depends upon location 2 days on-site

Not specified

Not specified

Not specified

Training w/purchase

Not specified

Not specified

Not specified

Year first sold Number installed USA Worldwide Fiscal year

1999

1994

1994

1994

NA Not specified July to June

NA

NA

Not specified Not specified January to December

Not specified

800

Not specified

July to June

OTHER SPECIFICATIONS

Automatic detergent loading (enzyme cleaner). Tested and passed by Hospital Infection Research Laboratory, Birmingham; full COSHH compliance assured (independent test report available).

Independent washing and cleaning of each channel; tightness control; total cycle time of 29.3 min.

8 cycle programs; standard cycle of 15 min; optional printer. Validated in Australia by AMAL Laboratories, in England by Hospital Infection Research Laboratory, and in France by GERMANDE.

Automatic leakage test; channel- separation system provides cleaning action by a separate pump for each channel; automatic obstruction test on each channel; tightness control. Hygienically tested and approved by leading European institutions.

Colons separate data on similar models of a device.

*

Specifications current as of February 2000.

**

Overall size is measured while device is closed.

Flexible Endoscope Reprocessors, Automatic

Product Comparison Chart

MODEL

OLYMPUS

OLYMPUS

OLYMPUS

OLYMPUS

DSD by MediVators

MV-1 by MediVators

MV-2 by MediVators

SSD by MediVators

WHERE MARKETED

Puerto Rico, USA

Puerto Rico, USA

Puerto Rico, USA

Puerto Rico, USA

FDA CLEARANCE

Yes

Yes

Yes

Yes

CE MARK (MDD)

Yes

Yes

Yes

Yes

CONFIGURATION

Floor

Tabletop, optional

Tabletop, optional

Floor

 

cart

cart

DISINFECT/STERILIZE

High-level

High-level

High-level

High-level

disinfection

disinfection

disinfection

disinfection

CHAMBER SIZE, H x L x W, cm (in)

14 x 47 x 30.5 (5.5 x 18.5 x 12), oval

15.2 x 47.6 x 38.1 (6 x 18.7 x 15)

15.2 x 50.2 x 38.1 (6 x 19.8 x 15)

14 x 47 x 30.5 (5.5 x 18.5 x 12), oval

SCOPES PER CYCLE

1 or 2

1

1 or 2

1

CYCLE TIME, min Wash Disinfect/sterilize Rinse Dry

0-90, variable

3-5

3-5

0-90, variable

5-90, variable

5, 12, 22, 32, 47 2 or 3 rinses @ 3-4 2.5, 10

5, 12, 22, 32, 47 2 or 3 rinses @ 3-5 2.5, 10

5-90, variable

4-180, variable

4-180, variable

0-180, variable

0-180, variable

GERMICIDAL AGENTS

Types used

2.4-2.6% glutaralde-

2.4-2.6% glutaralde-

2.4-2.6% glutaralde-

2.4-2.6% glutaralde-

hyde, hydrogen

hyde, hydrogen

hyde, hydrogen

hyde, hydrogen

peroxide, ortho-

peroxide, ortho-

peroxide, ortho-

peroxide, ortho-

phthaldehyde

phthaldehyde

phthaldehyde

phthaldehyde

Heater Temp range, C

Yes

Yes

Yes

Yes

20-50

20-50

20-50

20-50

WATER SUPPLY

2-stage prefiltra- tion (0.45 micron)/ 0.2-micron bacterial final filter

3-/1-micron pre-fil- ter and 0.2-micron bacterial retention final filter

3-/1-micron pre-fil- ter and 0.2-micron bacterial retention final filter

2-stage prefiltra- tion (0.45 micron)/ 0.2-micron bacterial final filter

Temperature

requirements, C

Cold tap

Cold tap

Cold tap

Cold tap

DETERGENT LOADING

Automatic

Manual

Manual

Automatic

RESERVOIR VOLUME,

L (gal)

15 (4)

18.9 (5)

18.9 (5)

15 (4)

MANUAL AIR

CAPABILITY

Yes, also automatic

Yes

Yes

Yes, also automatic

DOCUMENTATION

Printer, log

No

No

Printer, log

AUTODISINFECTION

Yes

Yes

Yes

Yes

AVAILABLE CHEMICAL PROCESS INDICATORS

NA

NA

NA

NA

Colons separate data on similar models of a device.

This is the first of two pages covering the above model(s). These specifications continue onto the next page.

Healthcare Product Comparison System

Product Comparison Chart

MODEL

OLYMPUS

OLYMPUS

OLYMPUS

OLYMPUS

DSD by MediVators

MV-1 by MediVators

MV-2 by MediVators

SSD by MediVators

SCOPE COMPATIBILITY

All flexible

All flexible

All flexible

All flexible

OVERALL SIZE, H x W x D, cm (in)

116.8 x 91.4 x 53.3 (46 x 36 x 21) *

43 x 61 x 46 (17 x 24 x 18)

43 x 61 x 46 (17 x 24 x 18)

122 x 56 x 53 (48 x 22 x 21) *

WEIGHT, kg (lb)

159 (350)

32 (70)

32 (70)

91 (200)

POWER REQUIREMENTS, VAC

110, 60 Hz, 15 A

110, 60 Hz, 15 A

110, 60 Hz, 15 A

110, 60 Hz, 8 A

PLANNING & PURCHASE List price

$26,500

$8,750

$17,000

$17,000

Warranty

1 year, parts/labor

1 year, parts/labor

1 year, parts/labor

1 year, parts/labor

Delivery time, ARO

3 weeks

3 weeks

3 weeks

3 weeks

Service contract

Available

Available

Available

Available

Training w/purchase

1 day on-site

1 day on-site

1 day on-site

1 day on-site

Year first sold Number installed USA Worldwide Fiscal year

1996

1999

1999

2001

Not specified Not specified April to March

Not specified Not specified April to March

Not specified Not specified April to March

Not specified Not specified April to March

OTHER SPECIFICATIONS

Automated alcohol purge; 9 program- mable cycles; disinfectant- filtration system; double-barrier dis- infectant vapor containment; standard 2-stage water prefiltration system; full sensor package; 4 endoscope connector sets; optional active-charcoal filter vapor manage- ment system, passive vapor management system. Canadian distribution, Cook County, City of Los Angeles; ETL and TUV listed. Warnock Hersey mark.

Liquid chemical

Liquid chemical

Automated alcohol purge; 9 programma- ble cycles; disin-

germicide fume

germicide fume

control;

control;

semiautomated semiautomated fectant-filtration

alcohol purge of endoscope channels; disinfectant reser- voir housed outside unit; optional mobile cart and germicide transfer pump; optional water filtration system.

alcohol purge

system; double-bar-

of endoscope rier disinfectant

channels; disinfectant reser- voir housed outside unit; optional mobile cart and germicide transfer pump; optional water filtration system.

vapor containment; onboard liquid chemical germicide transfer pump; stan- dard 2-stage water prefiltration sys- tem; full sensor package; 2 endoscope

 

Meets require- connector sets; op-

Meets require- ments of ETL and TUV.

ments of ETL and TUV.

tional automatic en- doscope leakage tester; optional ac- tive-charcoal filter vapor management system, passive vapor management system. Canadian distribu- tion, Cook County, City of Los Angeles. ETL and TUV listed. **

Colons separate data on similar models of a device.

*

Height with lid open is 162.5 cm (64 in).

**

Warnock Hersey mark.

Flexible Endoscope Reprocessors, Automatic

Product Comparison Chart

MODEL

PAULDRACH

PAULDRACH

PAULDRACH

PLADE

ECOCLEANER

HANDY CLEANER

UNICLEANER

PLADE 2000

WHERE MARKETED

Brazil, England, Greece, Morocco, Poland, South Africa *

Brazil, England, Greece, Morocco, Poland, South Africa *

Austria, Egypt, France, Germany, Italy, New Zealand **

UK

FDA CLEARANCE

No

No

No

No

CE MARK (MDD)

Yes

Yes

Yes

Yes

CONFIGURATION

Floorstanding with

Floorstanding with

Floorstanding with

Floorstanding

casters

casters

casters

cabinet

DISINFECT/STERILIZE

Disinfect

Disinfect

Disinfect

Disinfect

CHAMBER SIZE, H x L x W, cm (in)

16 x 55 x 45 (6.3 x 21.7 x 17.7)

16 x 55 x 45 (6.3 x 21.7 x 17.7)

16 x 55 x 45 (6.3 x 21.7 x 17.7)

60 x 84 x 64 (23.6 x 33.1 x 25.2)

SCOPES PER CYCLE

3

3

3

1 x 2 cycles

CYCLE TIME, min Wash Disinfect/sterilize Rinse Dry

1-99

1-99

1-99

See footnote *** See footnote *** See footnote *** See footnote ***

1-99

1-99

1-99

1-99

1-99

1-99

1-99

1-99

1-99

GERMICIDAL AGENTS

Types used

Minimum 3%

Minimum 3%

2% glutaraldehyde

2% peracetic acid, 2% glutaraldehyde, 5% formaldehyde

glutaraldehyde

glutaraldehyde

Heater Temp range, C

No

No

Water temp regulator

Optional

15-40

15-40

15-40

Not specified

WATER SUPPLY

Tap or filtered

Tap or filtered

Tap or filtered

As delivered to ma- chine; bacteria filters available

Temperature

requirements, C

Not specified

Not specified

40

Ambient

DETERGENT LOADING

Semimanual

Manual

Automatic

Automatic

RESERVOIR VOLUME,

L (gal)

15 (4)

15 (4)

NA

2, each 15 (4)

MANUAL AIR

CAPABILITY

Yes

Yes

Yes

Yes

DOCUMENTATION

Yes

No

Optional printer

Standard printer and resident database in PC

AUTODISINFECTION

Yes

Yes

Yes

Overnight automatic

 

program

AVAILABLE CHEMICAL PROCESS INDICATORS

Not specified

Not specified

Glutaraldehyde

None (proprietary

 

indicators from

chemical supplier

recommended)

Colons separate data on similar models of a device.

Also marketed in Tunisia. Also marketed in Poland and Saudi Arabia.

***

**

*

All times programmable using IBM or PC controller.

Cold and warm.

This is the first of two pages covering the above model(s). These specifications continue onto the next page.

Healthcare Product Comparison System

Product Comparison Chart

MODEL

PAULDRACH

PAULDRACH

PAULDRACH

PLADE

ECOCLEANER

HANDY CLEANER

UNICLEANER

PLADE 2000

SCOPE COMPATIBILITY

Yes

Yes

Yes

All flexible scopes

OVERALL SIZE, H x W x D, cm (in)

110 x 70 x 60 (43.3 x 27.6 x 23.6)

110 x 70 x 60 (43.3 x 27.6 x 23.6)

110 x 70 x 60 (43.3 x 27.6 x 23.6)

235 x 112 x 98 (92.5 x 44.1 x 38.6)

WEIGHT, kg (lb)

85 (187.4)

85 (187.4)

85 (187.4)

~200 (441) *

POWER REQUIREMENTS, VAC

230, 60 Hz

230, 60 Hz

230, 60 Hz

220-240, 50 Hz

PLANNING & PURCHASE List price

DM12,000

DM8,000

DM18,000-24,600

~$50,000 **

(US$5,295)

(US$3,530)

(US$7,943-10,856)

Warranty

1 year

1 year

1 year

1 year

Delivery time, ARO

4-5 weeks

4-5 weeks

4-5 weeks

6 weeks

Service contract

Yes

Yes

Yes

10% of new machine value per year 2 days on-site

Training w/purchase

1-2 days on-site

1-2 days on-site

1-2 days on-site

Year first sold Number installed USA Worldwide Fiscal year

1999

1999

1995

1990

NA

NA

NA

NA

20

80

180

~50

Not specified

Not specified

Not specified

April to March

OTHER SPECIFICATIONS

None specified.

None specified.

None specified.

Integral fume containment and filtration system for operator pro- tection. Approved by the Hospital Infection Research Laboratory.

Colons separate data on similar models of a device.

*

Weights vary depending on fitted components and the working conditions of the machine.

**

Prices of the machines vary depending on the chemical used for disinfection.

Flexible Endoscope Reprocessors, Automatic

Product Comparison Chart

MODEL

PLADE

PLADE

STERIS

PLADE 2004R

SELECTA 2000 Mobile

STERIS SYSTEM 1 PROCESSOR

WHERE MARKETED

UK

UK

Worldwide

FDA CLEARANCE

No

No

Yes

CE MARK (MDD)

Yes

Yes

Yes

CONFIGURATION

Floorstanding

Cart

Tabletop

cabinet

DISINFECT/STERILIZE

Disinfect

Disinfect

Sterilize

CHAMBER SIZE, H x L x W, cm (in)

60 x 84 x 64 (23.6 x 33.1 x 25.2)

18 x 45 x 38 (7.1 x 17.7 x 15)

See footnote *

SCOPES PER CYCLE

2 flexible x 2 independent cycles

2 flexible or rigid scopes/instruments

1

CYCLE TIME, min Wash Disinfect/sterilize Rinse Dry

See footnote ** See footnote ** See footnote ** See footnote **

Variable

NA 12, standardized 4 (sterile water) 1 (sterile air purge)

Variable

Variable

Variable

GERMICIDAL AGENTS

Types used

2% peracetic acid, 2% glutaraldehyde, 5% formaldehyde

2% peracetic acid, 2% glutaraldehyde, 5% formaldehyde

Peracetic acid

(active ingredient)

Heater Temp range, C

Optional

No

Yes

Not specified

NA

50-56 (standardized)

WATER SUPPLY

As delivered to ma- chine; bacteria filters available

As delivered to ma- chine; bacteria filters available ***

Potable tap water, filtered

Temperature

requirements, C

Ambient

Ambient

43-48

DETERGENT LOADING

Automatic

Manual

See footnote

RESERVOIR VOLUME,

L (gal)

2, each 25 (6.6)

15 (4)

NA

MANUAL AIR

CAPABILITY

Yes

Yes

No

DOCUMENTATION