Technical Data MonographAMSCO® 3052 Single-Chamber Washer/Disinfector
AMSCO® 5052 Single-Chamber Washer/Disinfector

Table of Contents
1. The AMSCO® 3052 Single-Chamber Washer/Disinfector andthe AMSCO® 5052 Single-Chamber Washer/Disinfector  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3
2. Prolystica® Ultra Concentrate System  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  3
3. Cycle Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  4
4. Validation Test Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5
5. Cleaning Efficacy Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  5
6. Rinsing Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  7
7. Thermal Profile Evaluation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  8
8. Thermometry  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  9
9. Disinfection Efficacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10
10. Self-Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11
11. References  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  11

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The AMSCO® 3052 Single-Chamber Washer/Disinfector andthe AMSCO® 5052 Single-Chamber Washer/Disinfector

The ultimate goal of infection control practices is to prevent infection from occurring in the first place. In the operating room, special
attention is needed to prevent patient cross-contamination when instruments are processed for reuse. Furthermore, all surgical instrument patient care utensils and reusable non-invasive instruments must be thoroughly cleaned and decontaminated before they can be
successfully sterilized. Since this cleaning and disinfection step is so crucial, the capabilities and quality of a facility’s washer-disinfector become critical factors for effective reprocessing and infection prevention.
This latest generation of STERIS washer/disinfectors incorporates a design that fits your requirements. The AMSCO 3052
Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector’s total coverage cleaning system isdesigned to provide maximum surface area spray coverage inside the chamber and includes features such as innovative spray nozzles,
cool touch handles, and ease of loading from any side.
The independent monitoring system of the AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber
Washer/Disinfector is designed to monitor the critical parameters needed for reliable, effective cleaning and disinfection. The controlof the AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector verifies vital
phases of the cycle, the volume of detergent injected and the attainment of intermediate disinfection levels. The data captured by thecontrol are processed and an alarm is emitted if parameters do not meet cycle specifications.
To optimize the cycle times with The AMSCO 5052 Single-Chamber Washer/Disinfector use with Prolystica® Ultra Concentratechemicals.

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Prolystica® Ultra Concentrate System

Prolystica Ultra Concentrate Chemicals are formulated with biodegradable ingredients to help protect the environment. Prolystica
Ultra Concentrate Chemicals provide superior cleaning and protection of surgical instruments, while providing optimal safety andease-of-use for staff. The system consists of several formulations; an enzymatic cleaner, a neutral or alkaline detergent, and an optional
lubricant.
The ability to enhance productivity with shorter cycle times without sacrificing cleaning performance is the result of a dual–productcleaning cycle using Prolystica Ultra Concentrate Enzymatic Cleaner and Neutral or Alkaline Detergent.
The Prolystica Ultra Concentrate Chemicals are precisely injected at specified intervals and temperatures, allowing them to act under
their individual optimal conditions together within the wash cycle for the appropriate and most beneficial cycle times.

Prolystica® Ultra Concentrate Enzymatic Cleaner
Prolystica Ultra Concentrate Enzymatic Cleaner achieves exceptional cleaning performance against blood, mucous and the mostchallenging fatty soils. This dual enzyme system works exceptionally well within a wide range of water qualities and types.

Prolystica® Ultra Concentrate Neutral Detergent
Prolystica Ultra Concentrate Neutral Detergent cleans blood, mucous and a wide range of challenging fatty soils. Built-in corrosion
inhibitors protect instruments and prolong washer life, while chelating and sequestering agents enhance cleaning performance regardless of water quality.

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Prolystica® Ultra Concentrate Alkaline Detergent
Prolystica Ultra Concentrate Alkaline Detergent provides exceptional and safe cleaning without a second neutral rinse. Built-in
corrosion inhibitors protect instruments and prolong washer life, while chelating and sequestering agents enhance cleaning performance regardless of water quality.

Prolystica® Ultra Concentrate Lubricant
Prolystica Ultra Concentrate Lubricant is a non-silicone product; it protects the condition and functionality of surgical instruments anddevices but does not compromise steam or ethylene oxide sterilization processes. Since it’s a concentrated formulation, a low volumeof chemistry is needed in each cycle to maintain the integrity and performance of the devices.

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Cycle Options

The AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector are pre-programmed with 8 dedicated cycles designed for specific types of loads and also 8 customizable cycles.

Orthopedic Cycle
Surgical instruments for orthopedic procedures can be very complex. The design of many orthopedic devices, such as drills, reamersand other items, presents a significant cleaning challenge because of crevices, joints and other structural design elements.
Orthopedic soils, such as trapped bone chips, marrow and other debris, are more challenging to remove than other soils.
The AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector provide a specialized cycle for orthopedic instruments; that cycle is programmed to inject precise doses of Prolystica Ultra Concentrate Enzymatic
Cleaner and either Neutral or Alkaline detergent.
54 different orthopedic instruments and 250 hemostats were tested and validated in the AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector. Devices for hip, knee, shoulder and general orthopedic surgeries
were selected to assure a representative sampling of this instrument category.

Anesthesia Cycle
The AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector offer a programmed Anesthesia Cycle and a specialized anesthesia rack accessory to clean and disinfect reusable semi-critical components ofanesthesia and respiratory equipments. The Anesthesia Rack is designed to hold different types of tubing, bags, masks and respiratory
goods.
The Anesthesia Cycle includes a thorough cleaning stage followed by a thermal disinfection phase that is comparable to pasteurizationand compliant to the CSA Standard Z314.8-08 Decontamination of Reusable Medical Devices. The cycle begins with a pre-wash
performed below 45oC (113oF) to avoid coagulation of proteins. Next, two separate washing phases are performed using the Prolystica Ultra Concentrate system for optimum cleaning performance. Enzymatic, neutral or alkaline chemicals can be used during thesecleaning phases.
After the wash and rinse phases, the heat-sensitive anesthesia devices are exposed to a thermal disinfection phase. The temperature
is lower and longer than other cycles to protect these items. Disinfection is achieved with a thermal rinse; 15 minutes at 172.9°F(78.3°C) for heat-sensitive devices and 1 minute at 194°F (90°C) for non heat-sensitive devices. Both configurations result in an A0 of
600 and offer the same level of disinfection. The thermal phase can also reach an A0 of 3000, if needed. (A0 will be discussed later inthis monograph.)

Rigid MIS Cycle
Rigid endoscopic and minimally invasive surgical (MIS) instrumentation must be carefully cleaned and dried before sterilization. The
Rigid MIS Cycle provides the proper automated sequence of phases to remove both microorganisms and organic soils.

4Immediately after the pre-wash phase, a washing phase with a neutral pH enzymatic cleaner begins breaking down blood, fat andprotein from instrument surfaces. Next, a neutral detergent that is safe for a range of metals and plastic compounds is used for thesecond wash to thoroughly clean all scopes inside and out.
The MIS Rack is equipped with 12 quick-connect ports for locks and more than 40 adapter fittings for scopes with working channels.
Delicate and disassembled parts are held securely in a tray with a cover. In addition to the MIS Rack, four small instrument trays canbe loaded to process surgical instruments or to keep sets intact during processing.

• Instrument Cycle: The Instrument Cycle is designed to clean, thermally disinfect and dry surgical instruments.
• Utensil Cycle: The Utensil Cycle is designed to clean, thermally disinfect and dry utensils such as trays, basins and bowls.
• Gentle Cycle: The Gentle Cycle is designed to clean, thermally disinfect and dry delicate surgical instruments.
• Decontamination Cycle: The Decontamination Cycle is used on a weekly basis to descale the chamber and rack.

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Validation Test Program

STERIS designed a test program to separately assess the cleaning, disinfecting and rinsing efficacy of the AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector in accordance with U.S. Food and Drug
Administration ("FDA") Guidance Document1, standards EN ISO 15883, AAMI 15883 and CSA Z15883. 2,3,4,5,6,7
STERIS conducted this validation program in a specialized validation laboratory using documented protocols and standard operatingprocedures. To ensure statistical significance, all tests were conducted in triplicate.

5Cleaning Efficacy Testing

Cleaning efficacy was evaluated using visual and non-visual inspection to assess soil removal. Items were processed through only thewashing phase of the appropriate cycle and were evaluated immediately after the washing process without exposure to the Thermal
Rinse and Drying phases for each respective cycle. For each validated cycle, a load was selected to represent worst-case conditions.

Cleaning Standards
To challenge the washing process and to demonstrate compliance with the FDA guideline, CSA Z15883, EN ISO 15883 and AAMI
15883 standards, all cleaning tests were conducted with a coagulated blood and serum based soil. This soil represents a challenge
simulating actual in-use conditions and was also used to demonstrate the ability to remove representative organic contamination fromreusable medical devices.
To assess the efficacy of the AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector to reduce protein soil on surgical instruments to an acceptable level as recommended, a Ninhydrin Protein Detection Test Kit(produced by Albert Browne, Ltd., a subsidiary of STERIS Corporation) (less than 9µg/cm2) or a fluorescence detection method (lessthan 5µg/cm2) were performed to quantify the level of residual proteins after the washing phases.
Testing with Blood and Serum-Based Soil was performed using the following accessories and load configuration (see Table 1 and 2).

Instrument Cycle
Instrument Cycle is designed to process surgical instruments. This cycle was tested with the 5-Level Vision Manifold Rack loadedwith 500 hemostats and equipped with eight flexible hoses for canulated instruments. Hemostats forceps were selected because such
instruments are used in surgery procedures and present a cleaning challenge due to their configurations and joints mated surfaces.

5Orthopedic Cycle
Orthopedic Cycle is designed to process orthopedic instruments. Hips, knees, shoulders and general orthopedic instruments are
considered critical as they are introduced directly into the human body. Orthopedic instruments present difficulties when cleaning. 54
orthopedic instruments and 250 hemostats were tested in the 5-Level Vision Manifold Rack equipped with eight flexible hoses forcanulated instruments.

Gentle Cycle
Gentle Cycle is performed at low speed to protect delicate instruments and use the General Purpose rack to offer cleaning and disinfection with a lower impact. Ophthalmic Micro-instruments were selected to test the Gentle cycle.

Utensil Cycle
Utensil Cycle is designed to process bedpans, trays, basins and bowls. This cycle was validated with bedpans in a General Purpose
rack and Multi-functions rack for large items. Bedpans present a cleaning challenge due to their configurations compared to plastic,
stainless-steel bowls and kidney dishes.

Table 1. Cleaning Results with Blood and Serum-Based Soil
Prolystica® 2xConcentrate
Chemistries

Rack

Load

VisualDetermination

Instrument

Enzymatic/Neutral

5-Level Vision
Manifold Rack + 8
flexible hoses

500 hemostats(10 trays of 50
hemostats) and 8
suction tips

Clean

Orthopedic

Enzymatic/Neutral

5-Level Vision
Manifold Rack + 8
flexible hoses

250 Hemostats +orthopedic items + 8
suction tips

Clean

Utensil

NeutralGeneral Purpose
Vision Rack with
Multi-functions rack
for large items

Bedpans

Clean

GentleNeutralGeneral Purpose
Vision Rack

Micro-instruments

Clean

Anesthesia

NeutralAnesthesia/
Respiratory Rack

Anesthesia tubing andrespiratory goods

Clean

MIS

Enzymatic/Neutral

Rigid MIS Instrument
Rack

Various MIS
instruments

Clean

Cycle

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Table 2. Quantitative Cleaning Evaluation with Blood and Serum-Based Soil
Test Conditions

Test Results

Cycle

Rack

Prolystica® 2xConcentrate
Chemistries

Instrument

5-Level Vision
Manifold Rack

Enzymatic/Neutral

500 hemostats (10trays of 50 hemostats)and 8 suction tips

Pass(< 0.87 µg/cm2)*

Orthopedic

5-Level Vision
Manifold Rack + 8
flexible hoses

Enzymatic/Neutral

250 Hemostats +orthopedic items + 8
suction tips

Pass(< 9µg/cm2)**

Utensil

General Purpose
Vision SC Rack with
Multi-functions rack
for large items

NeutralBedpans

Pass(< 9µg/cm2)**

GentleGeneral Purpose
Vision SC Rack

NeutralMicro-instruments

Pass(< 9µg/cm2)**

Anesthesia

Anesthesia/
Respiratory Rack

NeutralAnesthesia tubing andrespiratory goods

Pass(< 9µg/cm2)**

MIS

Rigid MIS Instrument
Rack

Enzymatic/Neutral

Various MIS
instruments

Pass(< 9µg/cm2)**

Load

Non-Visual Quantitative
Cleaning Evaluation

6* fluorescence detection method** No visible purple discoloration of the swab using Ninhydrin Protein Detection Test Kit.

Rinsing Efficacy

Rinsing efficacy was evaluated with the Instrument and Gentle Cycles by comparing the amount of residue per load item comparedto calculated toxicological limits.8,9 The evaluation of rinsing efficacy should show that the rinse phase of the Instrument and Gentle
cycles removes the residues coming from cleaning chemicals to levels that are not hazardous to patients or end-users, and that do notinterfere with a terminal process such as sterilization.

Instruments cycle
The rinsing efficacy of the Instruments Cycle, using a 5-Level Vision Manifold Rack loaded with hemostats, was assessed using a
combination of Prolystica Ultra Concentrate Enzymatic Cleaner and Prolystica Ultra Concentrate Alkaline Cleaner.
For this evaluation, the Total Organic Carbon (TOC) method was used to determine the level of organic residues. By this method, thelevel of organic carbon is measured from all sources, including protein carbons such as enzymes found in enzymatic detergents. The
Colorimetric method was also used to determine the level of Enzymes retained in the detergents, since the presence of an enzymatic
residual is critical for the patient.
Furthermore, the Conductivity method was used to evaluate the ionic residue since some substances in the Alkaline Cleaner are notdetectable either by the TOC method or by the Colorimetric method.
For each method, calibration curves depicting residue concentration as a function of Carbon, Enzyme or Conductivity were createdusing known concentrations of each chemical.

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The measurements were made after processing the test items in the washer/disinfector using the appropriate combination of detergents, and calibration curves were used to determine the concentration of active substances and the average residue level per item
(see Table 3).

Gentle Cycle
The rinsing efficacy of the Gentle cycle, using a General Purpose Rack loaded with micro-instruments, was assessed using
Prolystica Ultra Concentrate Neutral Detergent.
For this evaluation, the Total Organic Carbon (TOC) method was used to determine the level of organic residues. By this method, thelevel of organic carbon present in the Neutral Detergent is measured.
Table 3 presents the test configurations and results for the rinsing efficacy.

Table 3. Rinsing Efficacy Results
Test Conditions

Test Results

Prolystica
Ultra
Concentrate
Chemistries

Total
Detergent
Criteria(mg/item)

Total
Detergent
Results(mg/item)

EnzymeFraction
Criteria(mg/item)

EnzymeFraction
Results(mg/item)

Ionic
Fraction
Criteria(mg/item)

Ionic
Fraction
Results(mg/item)

Enzymatic and
Alkaline

3.77

Pass
(0.009)5.80

Pass(<0.006)

1.06

Pass
(0.0086)

Neutral2.67

Pass(0.009)®

Cycle

Instrument

Gentle7

Rack
5-LevelVisionManifold
Rack
GeneralPurposeRack-

Thermal Profile Evaluation

STERIS performed thermal profile testing to verify that the accessory and the load reached and maintained the desired preset disinfection temperature for the pre-programmed period of time. This thermal profile also helped identify the coolest spots for the disinfection
study.

Table 4. Thermal Profile Results
Cycle

Speed

Configuration

Rack

Load

Results

Orthopedic(Instruments)

High

1 minute at
180°F/82.2°C

250 Hemostats + orthopedic
items + 8 suction tips

Pass

UtensilLow

1 minute at
180°F/82.2°C

Bedpans

Pass

GentleLow

1 minute at
180°F/82.2°C

5-Level Vision Manifold Rack
+ 8 flexible hoses
General Purpose Vision
SC Rack with Multi-functions
rack for large items
General Purpose Vision
SC rack

Micro-instruments

Pass

AnesthesiaHigh

1 minute at
180°F/82.2°C

Anesthesia/Respiratory Rack

Anesthesia tubing andrespiratory goods

Pass

MIS

High

1 minute at
180°F/82.2°C

Rigid MIS Instrument Rack

MIS and Rigidscopes

Pass

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Thermometry

STERIS performed thermometric tests to verify that the specified conditions are achieved throughout the chamber, the load and theload carrier during the operating cycle. Thermocouples were placed on the load, on the load carrier and on the chamber walls tomonitor the appropriate phase as per specifications in EN ISO 15883, AAMI 15883 and CSA Z15883 standards. Temperature wasrecorded at one-second intervals throughout the appropriate validated cycle phase.
The thermometric profile was assessed for the washing and thermal phases of the Instrument and Utensil Cycles. The results demonstrated that there was temperature uniformity throughout the load, the load carrier and the chamber; that the temperature setpoint wasmaintained during the holding period for the phases analyzed; and that the temperature profiles were repeatable in subsequent cycles.
The thermometric conditions of the load, the load carrier and the chamber for these cycles were verified. For all the tests, the disinfection temperature was 90°C (194°F).

Table 5. Thermometric Test Results
Cycle

Speed

Rack

Load

Results

Orthopedic(Instruments)

High

5-Level Vision Manifold Rack + 8 flexible hoses

250 Hemostats + orthopedic
items + 8 suction tips

Pass

Utensil

Low

General Purpose Vision SC Rack with
Multi-functions rack for large items

Bedpans

Pass

GentleLow

General Purpose Vision SC rack

Micro-instruments

Pass

Anesthesia

High

Anesthesia/Respiratory Rack

Anesthesia tubing andrespiratory goods

Pass

MIS

High

Rigid MIS Instrument Rack

MIS and Rigidscopes

Pass

Thermal disinfection with the A0 option

According to EN ISO 15883 series standards, the use of A0 is recommended to achieve the desired level of disinfection for certain
categories of processed items. Energy in a washer/disinfector during thermal disinfection with moist heat can be measured by theA0, a parameter closely related to temperature and time. It is linked to the inactivation of microorganisms; when microorganisms are
exposed to a specific temperature over a specified time, the microorganisms are killed.
In the AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector, four different
A0 settings are available: A0 60, 600, 3000 and 12,000. Different guidelines are suggested for each A0 cycle, depending on howpatient-critical the load items are. For example, A0 60 setting is recommended for items that can only be in contact with intact skin,while A0 600 is recommended for surgical instruments. The guidelines follow ISO 15883 recommendations, but healthcare providers
can select the setting that works best under their own established procedures and protocols.
After selecting the A0 setting on the PC control, the control will calculate the thermal phase time depending of the maximum temperature that can be reached inside the washer/disinfector. This temperature is related to the altitude where the washer/disinfector isinstalled; 185.9°F [85.5°C] if washer/disinfector is configured at an altitude higher than 1640 ft [500 m] and 194°F [90°C] if washer/disinfector is configured at a lower altitude (unit Hardware Option).

99Disinfection Efficacy

To evaluate the disinfection effectiveness of a washer/disinfector, FDA recommends a specific reduction of microorganisms measured
by a log reduction.
The FDA criterion to achieve an intermediate-level thermal disinfection is to achieve at least a 6-log reduction of a mixed suspensionof vegetative organisms and a 3-log reduction of a thermophilic mycobacterium species.1
The test method consisted of positioning ampoules containing a mixed suspension culture of vegetative organisms and ampoules
containing mycobacteria suspension in predefined “coldest” spots of the rack accessories and test items (defined in the thermal profile
study) and processing them in the appropriate disinfection cycle. The ampoules were then evaluated by the method of microbial charge
reduction and expressed as log-reduction values.
To evaluate the log reduction value after the thermal phase, microbial charge reduction of each process ampoule containing microorganisms was performed and compared with a positive control not exposed to thermal disinfection. Positive controls were seriallydiluted and enumerated by spread plate methods, as were the ampoules processed in the disinfection cycle. Test results are shown in
Table 6.

Table 6. Disinfection Efficacy Testing
Test Conditions
Cycle

Rack

Orthopedic(Instrument)

5-Level Vision
Manifold Rack

Utensil

General Purpose
Vision SC Rack with
Multi-functions rack
for large items

GentleAnesthesia respiratory
goods cycle 1 minuteat 82.2°C

General Purpose
Vision SC Rack

Anesthesia/Respiratory
Rack

Anesthesia respiratory
Anesthesia/Respiratory
goods cycle 15 minutes
Rack
at 78.3°C (172.9°F)

Rigid MIS

1.

Rigid MIS
Instrument Rack

Test Results
Test Organisms

Positive Controls(cfu/ml)

Recovered
Counts(cfu/mL)

1.46 x109<1

9.0 x106<1

1.3 x109<1

9.16 x106<1

9.4x108<1

1.16x107<1

1.1x109<1

1.13x107<1

1.03x109<1

1.23x107<1

1.03x109<1

1.3x107<1

Mixed suspension
vegetative organisms1
Mycobacterium
hassiacum broth
Mixed suspension
vegetative organisms1
Mycobacterium
hassiacum broth
Mixed suspension
vegetative organisms1
Mycobacterium
hassiacum broth
Mixed suspension
vegetative organisms1
Mycobacterium
hassiacum broth
Mixed suspension
vegetative organisms1
Mycobacterium
hassiacum broth
Mixed suspension
vegetative organisms1
Mycobacterium
hassiacum brothA mixed suspension of Staphylococcus aureus, Pseudomonas aeruginosa and Enterobacter aerogenes

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Log
Reduction
Pass> 9.16Pass> 6.96Pass> 9.13Pass> 6.96Pass> 8.97Pass> 7.06Pass> 9.04Pass> 7.05Pass> 9.01
Pass> 7.09Pass> 9.01
Pass> 7.11

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Self-Decontamination

Washing systems carry the inherent risk of microbial adhesion and retention. The AMSCO 3052 Single-Chamber Washer/Disinfector
and the AMSCO 5052 Single-Chamber Washer/Disinfector were designed with features to reduce this risk to a minimum. Specificdesign elements include the tilting of piping, using materials unfavorable to microbial adhesion, increasing and stabilizing chamber
heat, and ensuring maximum self-draining.
The AMSCO 3052 Single-Chamber Washer/Disinfector and the AMSCO 5052 Single-Chamber Washer/Disinfector also offer adecontamination cycle for the chamber. STERIS studies have demonstrated that a decontamination cycle is a good procedure to use todecontaminate and prevent biofilm formation when performed every seven days using Liquid Descaler as the chemical agent.

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References

1. Food and Drug Administration/Office of Device Evaluation. Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors;
Guidance for the Medical Device Industry and FDA Review Staff, FDA, Rockville, MD, USA
2. EN ISO 15883-1: 2006, ANSI/AAMI ST 15883-1 and CSA Z15883-1:2009-Washer/Disinfectors-General requirements, definitions and tests
3. EN ISO 15883-2:2006, ANSI/AAMI ST-15883-2 (draft) Requirements and tests for washer/disinfectors employing thermal disinfection for surgical instruments,
aesthesia equipment, hollowware, utensils, glasswares, etc.
4. CSA Z15883-1:2009: Washer-disinfectors-Part 1: General Requirements, Terms and definitions and Tests.
5. CSA Z15883-2:2009: Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthesia equipment, bowls, dishes, receivers, utensils, glassware, etc.
6. ANSI/AAMI ST15883-1:2009: Washer-disinfectors - Part 1: General requirements, terms and definitions and tests.
7. ANSI/AAMI ST15883-02 :2013 -Washer-disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthesic equipment, bowls, dishes, receivers, utensils, glassware, etc.
8. Conine, D.L., Naumann, B.D. and Hecker, L.H. (1992) Setting Health-Based Residue Limits for Contaminants in Pharmaceuticals and Medical Devices, Quality
Assurance: Good Practice, Regulation, and Law, 1: 3, pp. 171-180.
9. Margaret A. McDowell, Ph.D., M.P.H., R.D.; Cheryl D. Fryar, M.S.P.H., Anthropometric Reference Data for Children and Adults: United States, 2003–2006,
National health statistics reports, Number 10, October 22, 200811

Document #10077066 Rev. C©2017 STERIS Corporation
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