Flexible Endoscope Reprocessors, Automatic PDF
Flexible Endoscope Reprocessors, Automatic PDF
Flexible Endoscope Reprocessors, Automatic PDF
Product Comparison
Flexible Endoscope Reprocessors, Automatic
UMDNS information
This Product Comparison covers the following device terms and product codes as listed in ECRI’s Universal Medical Device
Nomenclature System™ (UMDNS™):
9 Disinfecting Units, Liquid, Flexible Endoscope [11-279]
9 Sterilizing Units, Liquid [18-006]
Table of Contents
Scope of this Product Comparison ...............................................................................................................................3
Purpose..........................................................................................................................................................................3
Principles of operation..................................................................................................................................................4
Reported problems........................................................................................................................................................5
Purchase considerations...............................................................................................................................................5
ECRI recommendations...........................................................................................................................................5
Cost containment .....................................................................................................................................................6
Present Value/Life-Cycle Cost Analyses ............................................................................................................6
Stage of development....................................................................................................................................................7
Bibliography..................................................................................................................................................................7
Standards and guidelines.............................................................................................................................................9
Citations from other ECRI publications ....................................................................................................................10
Supplier information ..................................................................................................................................................10
About the chart specifications....................................................................................................................................14
Product Comparison Chart ........................................................................................................................................16
226193 Flexible Endoscope Reprocessors, Automatic
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October 2005
Flexible Endoscope Reprocessors, Automatic
Purpose
Endoscope reprocessors are designed to
standardize and automate the preparation of a
manually precleaned endoscope so that 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
reprocessors can reduce the likelihood that a crucial
reprocessing step will be skipped, help ensure that
reprocessing is performed consistently using a
recommended protocol, and reduce personnel
exposure to the irritating effects of liquid
disinfectants/sterilants. Endoscopy 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 glutaraldehyde in many
hospitals.
Medical devices can be divided into three
groups—critical, semicritical, and noncritical—
according to the risk of infection associated with their use. Endoscopy is a minimally invasive
diagnostic and therapeutic procedure; the Centers 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 disinfection (HLD). 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 withstand 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% glutaraldehyde solution for HLD or 6% hydrogen
peroxide or peracetic acid for sterilization. For more information on endoscope manufacturers’
reprocessing recommendations, see the following Product Comparisons:
• Bronchoscopes
• Colonoscopes; Sigmoidoscopes
• Duodenoscopes; Gastroscopes; Choledochoscopes
• Laparoscopes
Principles of operation
Endoscope reprocessors are designed to
either disinfect 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 reprocessed
• 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 connectors of the endoscopic reprocessor, the operator 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, single-use
sterilant container that is automatically opened, aspirated into the basin, and mixed with sterile,
filtered water. Some models contain a heater to raise the temperature of the disinfectant/sterilant,
allowing a wider variety of solutions to be used.
Most reprocessors provide documentation of the disinfection/sterilization cycle, either in the
system’s memory or as a hard-copy printout. The documentation should indicate either that all the
necessary parameters 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 storage, 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 endoscope 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 Associates recommends the use of protective
equipment (e.g., gloves, gown, eyewear) while operating endoscopic reprocessors, having leakage test
equipment and channel cleaning adapters, and separate rooms for endoscopic procedures and
endoscopic reprocessing.
Reported problems
There are two major ways in which a flexible endoscope can cause nosocomial infection—the
endoscope can autoinoculate a patient with his or her own microbes (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 contaminated and subsequently passing contamination to scopes that were
processed in them. (See Bibliography for specific reports.) The microorganisms often found in tap
water can proliferate to significant levels in endoscopes, their accessories, and ancillary equipment
during improper storage or as a result of improper maintenance of a reprocessor.
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 automated system. Exposure to any
reprocessing agent can result in user injury. Use of any subpotent agents in automatic reprocessors
or failure to follow proper procedures can lead to both failed reprocessing and contamination.
Not all endoscopes are compatible with every endoscope reprocessor. Discrepancies have been
noted between the claims made by automatic endoscope reprocessor manufacturers and by endoscope
manufacturers. Reprocessor manufacturers may claim that endoscopes are compatible with their
products, but endoscope manufacturers may disagree. Compatibility must be guaranteed by both
parties for safe reprocessing.
Purchase considerations
ECRI recommendations
Cost containment
A life-cycle cost (LCC) analysis can be used to compare high-cost alternatives and/or to determine
the positive or negative economic value of a single alternative. For example, hospitals can use LCC
analysis techniques to examine the cost-effectiveness of leasing or renting equipment versus
purchasing the equipment outright. Because it examines the cash-flow impact 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 demonstrates that the cost of ownership includes
more than just the initial acquisition cost and that a small increase in initial acquisition cost may
produce significant 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 mathematical equation.
The following represent sample five-year PV/LCC analyses for a disinfecting unit and a sterilizing
unit.
Present Value/Life-Cycle Cost Analyses
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 one unit being used 10 times/day for 365
days/year
Alternative 1 — Disinfecting Unit
Capital Costs
• Disinfecting unit = $32,781
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)
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 analyses 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 analyses, the initial acquisition cost is only a fraction
of the total cost of operation over five years. Therefore, before making a purchase decision based
solely on the acquisition cost of an endoscope reprocessor, buyers should consider operating costs
over the lifetime of the equipment.
For further information on PV/LCC analysis, customized analyses, and purchase decision support,
readers should contact ECRI’s SELECT™ Group.
Stage of development
Automatic flexible endoscope reprocessors were introduced 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,
sigmoidoscopes, and cystoscopes. 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, including chlorine dioxide, ozone, vapor-phase hydrogen peroxide, and
plasma sterilization, as well as disposable endoscopes and sheaths.
Bibliography
American Society for Gastrointestinal Endoscopy. Reprocessing 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.
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. Mycobacterial 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 Germany [letter and reply]. Infect Control Hosp
Epidemiol 1994 May;5(5):294-5.
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 endoscopic reprocessing [editorial]. Gastrointest
Endosc 1996 May;43(5):522-4.
Fraser VJ, Jones M, Murray PR, et al. Contamination of flexible fiberoptic bronchoscopes with
Mycobacterium chelonae linked to an automated bronchoscope disinfection machine. Am Rev
Respir Dis 1992 Apr;145(4 Pt 1):853-5.
Fraser VJ, Zuckerman G, Clouse RE, et al. A prospective randomized trial comparing manual and
automated 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 results of spore tests from improper clip use with
the STERIS chemical sterilant system [letter]. Am J Infect Control 1993 Feb;21(1):42-3.
Heller J. Revising instrument processing practices. AORN J 2001 Nov;74(5):716-21.
Hospital writes FDA on scope infection outbreak. OR Manager 2003 Mar;19(3):7.
Ido K, Ishino Y, Ota Y, et al. Deficiencies of automatic endoscopic reprocessors: a method to achieve
high-grade disinfection of endoscopes. Gastrointest Endosc 1996 Nov;44(5):583-6.
Ishino Y, Ido K, Koiwaii H, et al. Pitfalls in endoscope reprocessing: brushing of air and water
channels is mandatory for high-level disinfection. Gastrointest Endosc 2001 Feb;53(2):165-8.
Jackson J, Leggett JE, Wilson DA, et al. Mycobacterium gordonae in fiberoptic bronchoscopes. Am J
Infect Control 1996 Feb;24(1):19-23.
Lillis K. Scope sterilization tough due to time constraints and complex devices. Health Purch News
2003 Apr;27(4):58-9.
Lynch DA, Parnell P, Porter C, et al. Patient and staff exposure to glutaraldehyde from Keymed
auto-disinfector endoscope washing machine. Endoscopy 1994 May;26(4):359-61.
Martin MA, Reichelderfer M. APIC guideline for infection prevention and control in flexible
endoscopy. Am J Infect Control 1994 Feb;22(1):19-38.
Muscarella LF. Advantages and limitations of automatic 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 flexible endoscopes. Infect Control Hosp Epidemiol
1991 Aug;12(8):497-9.
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. Standards for infection control and reprocessing
of flexible gastrointestinal endoscopes. Gastroenterol Nurs 1997 Mar-Apr;20(2 Suppl):1-13.
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safety requirements for medical electrical systems. 2nd ed. IEC 60601-1-1 (2000-12). 1992
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of flexible gastrointestinal endoscopes [guideline]. 1997 (revised 2000).
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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
Internet: http://www.sterrad.com
E-mail: [email protected]
E-mail: [email protected]
Endo-Technik
Endo-Technik Wolfgang Griesat GmbH [158099]
Heilingenstock 32
D-42697 Solingen
Germany
Phone: 49 (212) 267430 Fax: 49 (212) 2674350
Internet: http://www.endo-technik.de
E-mail: [email protected]
Krause
Krause Medizin Technik Service GmbH [279550]
Hoher Holzweg 44
D-30966 Arnum
Germany
Phone: 49 (510) 13006 Fax: 49 (510) 15093
Internet: http://www.kmts.de
E-mail: [email protected]
Labcaire
Labcaire Systems Ltd [184258]
175 Kenn Road
Clevedon North Somerset BS21 6LH
England
Phone: 44 (1275) 793000 Fax: 44 (1275) 341313
Internet: http://www.labcaire.co.uk
E-mail: [email protected]
Medivators
Minntech Corp [107711]
14605 28th Ave N
Minneapolis, MN 55447-4822
Phone: (763) 553-3300 (800) 328-3345 Fax: (763) 553-3387
Internet: http://www.minntech.com
E-mail: [email protected]
Olympus/Medivators
Minntech Corp [107711]
14605 28th Ave N
Minneapolis, MN 55447-4822
Phone: (763) 553-3300 (800) 328-3345 Fax: (763) 553-3387
Internet: http://www.minntech.com
E-mail: [email protected]