GIF/CF/JF Type E Fiberscope Reprocessing Manual

Contents

Contents Chapter 1

General Policy ...

1

1.1

Instructions...

1

1.2

Signal Words...

2

1.3

Precautions ...

2

Compatible Reprocessing Methods and Chemical Agents

5

2.1

Compatibility Summary ...

5

2.2

Detergent Solution ...

7

2.3

Disinfectant Solution ...

7

2.4

Rinsing Water ...

7

2.5

ETO Gas Sterilization ...

8

2.6

Steam Sterilization (Autoclaving) of Accessories...

9

Chapter 2

Chapter 3

Cleaning, Disinfection and Sterilization Procedures 11

3.1

Required Reprocessing Equipment ...

11

3.2

Cleaning, Disinfection and Sterilization Procedures ...

18

3.3

Precleaning ...

19

3.4

Leakage Testing ...

25

3.5

Manual Cleaning ...

27

3.6

High Level Disinfection ...

39

3.7

Rinsing After High Level Disinfection...

42

3.8

Sterilization ...

44

3.9

Cleaning, Disinfection and Sterilization Procedures for Removable Parts and Cleaning Equipment... 45

Chapter 4

Washing and Disinfection Equipment ...

50

Washing and Disinfection Equipment ...

50

Storage and Disposal...

52

5.1

Storage ...

52

5.2

Disposal ...

52

4.1

Chapter 5

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

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Chapter 1 General Policy

Chapter 1 General Policy 1.1

1

Instructions •

Chapters 1 through 4 describe recommended procedures for cleaning and disinfection or sterilization this instrument.

•

Thoroughly review the manuals of all equipment which will be used with this instrument and use the equipment as instructed.

•

If you have any questions or comments about any information in this manual, or if a problem that cannot be solved occurs while reprocessing, contact Olympus.

•

The medical literature reports incidents of patient cross contamination resulting from improper cleaning, disinfection or sterilization. It is strongly recommended that reprocessing personnel have a thorough understanding of and follow all national and local hospital guidelines and policies. A specific individual or individuals in the endoscopy unit should be responsible for reprocessing endoscopic equipment. It is highly desirable that a trained backup be available should the primary reprocessing individual(s) be absent.

•

All individuals responsible for reprocessing should thoroughly understand: •

your institution’s reprocessing procedures

•

occupational health and safety regulations

•

national and local hospital guidelines and policies

•

the instructions in this manual

•

the mechanical aspects of endoscopic equipment

•

pertinent germicide labeling

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 1 General Policy

1.2

Signal Words The following signal words are used throughout this manual:

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.

Indicates additional helpful information.

1.3

Precautions •

Some endoscope reprocessors are not designed to reprocess an elevator wire channel. When using one of these endoscope reprocessors, the elevator wire channel must be reprocessed manually as described in Chapter 3.

•

Failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety. During use, endoscopes normally comes in contact with intact mucous membranes. To minimize the risk of transmitting diseases from one patient to another, after each examination the endoscope must undergo thorough manual cleaning followed by high-level disinfection or sterilization after each examination.

•

ALL channels of the endoscope, including auxiliary water and elevator wire channels where fitted, MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.

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Chapter 1 General Policy

3

•

If the endoscope is not cleaned meticulously, effective disinfection (or sterilization) may not be possible. Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms or organic material that could hamper the efficacy of disinfection or sterilization.

•

Olympus confirms validation of the endoscope reprocessors recommended by Olympus only. If using endoscope reprocessor that are not recommended by Olympus, the endoscope reprocessor manufacturers are responsible for validation of the endoscope reprocessor with the endoscope models listed in its intended use statement. If using an endoscope reprocessor, confirm that it is capable of reprocessing endoscope including all channels. If there are channels and/or other parts which cannot be cleaned and high-level disinfected by the endoscope reprocessor, have to undergo manual cleaning and high-level disinfection or sterilization as described in Chapter 3, “Cleaning, Disinfection and Sterilization Procedures” after using the endoscope reprocessor. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope. If you are uncertain as to the ability of your endoscope reprocessor to clean and high-level disinfect endoscope including all channels, contact the endoscope reprocessor supplier for specific instructions and/or connectors.

•

Patient debris and reprocessing chemicals are hazardous. Wear personal protective equipment to guard against dangerous chemicals and potentially infectious material. During cleaning and disinfection (or sterilization), wear appropriate personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves that fit properly and are long enough so that your skin is not exposed. Always remove contaminated protective clothing before leaving the cleaning area.

•

Thoroughly rinse off the disinfectant solution. Rinse the outer surface of the endoscope, channels and cleaning equipment thoroughly with clean water to remove the disinfectant solution residue.

•

The disinfection/sterilization room must be adequately ventilated. Adequate ventilation protects against toxic chemical fumes.

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 1 General Policy

•

Store alcohol in an air-tight container. Alcohol stored in an open container may cause fires and will lose its efficacy due to evaporation.

•

With the cleaning, disinfection and sterilization methods stated in this instruction manual, prions, which are considered to be the pathogenic substance of the Creutzfeldt-Jakob disease (CJD) cannot be destroyed or inactivated. When using this instrument on a patient with CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to use this product for such patient only and/or immediately dispose of this product after use in an appropriate manner. For methods to handle CJD, please follow the respective guidelines in your country.

•

This instrument is not durable, or does not have sufficient durability against the respective methods stated in the guidelines of each country for destroying or inactivating prions. For information on the durability against each method, please contact Olympus. If cleaning, disinfection and sterilization methods not stated in this instruction manual are performed, Olympus cannot guarantee the effectiveness, safety and durability of this instrument. Make sure to confirm that there is no abnormality before use, and use under responsibility of a physician. Do not use if any abnormality is found.

•

When aerating or irrigating the endoscope channels, the air or water pressure must not exceed 0.2 MPa.

•

When reprocessing the endoscope models, make sure that the ETO Cap is not installed on the Venting Connector before immersion in reprocessing fluids.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Chapter 2 Compatible Reprocessing Methods and Chemical Agents 2.1

Compatibility Summary Olympus endoscopic equipment is compatible with several methods of reprocessing. Certain components and accessories, however, are not compatible with some methods, which can cause damage. For appropriate reprocessing methods, refer to Table 2.1 below, the recommendations of your infection control committee and national and local hospital guidelines and policies.

5

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

Steam Sterilization (Autoclaving) ETO Gas Sterilization 2 to 3.5% Glutaraldehyde 70% Ethyl or Isopropyl Alcohol Detergent Solution Ultrasonic Cleaning Endoscope Channel Cleaning Brush (BW-20T) Channel-opening Cleaning Brush (MH-507) Air/Water Valve (MB-196) Suction Valve (MB-197) All-Channel Irrigator (CW-3) Channel Cleaning Adapter (MB-19) AW Channel Cleaning Adapter (MB-107) Elevator-wire-channel Cleaning tube (MB-109) Auxiliary Water Tube (MB-1) Mouthpiece (MB-142) Biopsy Valve (MB-358) Distal Hood ETO Cap (MB-156) Biopsy Forceps applicable

not applicable

Table 2.1

Endo-Therapy Accessories and other items which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, a green band or yellow-green marking are compatible with autoclaving.

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

2.2

Detergent Solution Use a magical-grade low-foaming neutral pH detergent or enzymatic detergent and follow the manufacturer’s dilution and temperature recommendations. Contact Olympus for the names of specific brands that have been tested for compatibility with the endoscope. Do not reuse detergent solutions.

Excessive detergent foaming can prevent fluid from adequately contacting internal lumens (e.g. channels).

2.3

Disinfectant Solution In general, 2.0% to 3.5% glutaraldehyde solutions, when used according to the manufacturer’s instructions for achieving high-level disinfection, are compatible with Olympus endoscopes. Contact Olympus for the names of specific brands that have been tested for compatibility with this endoscope. If the disinfectant solution is reused, routinely check its efficacy with a test strip recommended by the manufacturer. Do not use solutions beyond their expiration date.

Alcohol is not a sterilant or high-level disinfectant.

2.4

Rinsing Water Once removed from the disinfectant solution, the instrument must be thoroughly rinsed with sterile water to remove any disinfectant residue. If sterile water is not available, clean potable tap water or water which has been processed (e.g. filtered) to improve its microbiological quality may be used. When non-sterile water is used after manual or automated disinfection, wipe the endoscope and flush the channels with 70% ethyl or isopropyl alcohol, then air-dry all internal channels to inhibit the growth of residual bacteria. Do not use rinsing water.

7

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

2.5

ETO Gas Sterilization This instrument or other accessories compatible with ETO gas sterilization as shown in Table 2.1 can be sterilized by ethylene oxide gas and aerated within the parameters given in Table 2.2. When performing sterilization, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions.

The ETO Cap must be attached to the Venting Connector on the Scope Connector prior to ETO gas sterilization.

Figure 2.1

•

Before sterilization, the instrument must be thoroughly cleaned and dried. Residual moisture inhibits sterilization.

•

The results of sterilization depend on various factors such as how the sterilized instrument was packed or the positioning, method of placing and loading of the instrument in the sterilization device. Please verify the sterilization effects by using biological or chemical indicators. Also follow the guidelines for sterilization issued by medical administrative authorities, public organizations or the infection management sections at each medical facility, as well as the instruction manual of the sterilization device.

•

All instruments must be properly aerated following ETO gas sterilization to remove toxic ethylene oxide residuals.

When reprocessing the endoscope models, install the ETO Cap on the Venting Connector of the Endoscope Connector before ETO gas sterilization as shown in Figure 2.1. If ETO gas sterilization is performed while the Water Resistant Cap is installed or the ETO Cap is removed, air inside the Endoscope will expand and could rupture the covering of the Bending Section.

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

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Chapter 2 Compatible Reprocessing Methods and Chemical Agents

 ETO Gas Exposure Parameters Process

Parameters

ETO Gas Sterilization

Aeration (Minimum)

Temperature

57C

Pressure

0.1 to 0.17 MPa

Humidity

55%

Exposure Time

1.75 hours

ETO Gas Concentration

600 to 700 mg/l

12 hours in an aeration chamber at 50 to 57C or 7 days at room temperature

Table 2.2

 Gas mixture 20% ETO/80% CO2

2.6

Steam Sterilization (Autoclaving) of Accessories These accessories listed as compatible with steam sterilization (autoclaving) in Table 2.1 can be sterilized by steam within the parameters given in Table 2.3. When steam sterilizing, follow the hospital’s protocol and the sterilization equipment manufacturer’s instructions.

•

9

Exceeding the recommended parameters may cause equipment damage.

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 2 Compatible Reprocessing Methods and Chemical Agents

•

The results of sterilization depend on various factors such as how the sterilized instrument was packed or the positioning, method of placing and loading of the instrument in the sterilization device. Please verify the sterilization effects by using biological or chemical indicators. Also follow the guidelines for sterilization issued by medical administrative authorities, public organizations or the infection management sections at each medical facility, as well as the instruction manual of the sterilization device.

•

Do not steam sterilize the endoscope. Steam sterilization (autoclaving) will severely damage the endoscope.

•

Effective sterilization will not be possible if items are packed tightly together in the autoclave; always pack items loosely.

•

Inspect the instrument package for openings, tears and other damage. If the instrument package is open or damaged, seal the components in new packaging and re-sterilize as described below.

•

Allow the packages to dry within the autoclave, using the autoclave’s drying cycle (if available) or by opening the door of the autoclave and allowing the packages to air dry. Handling a wet package can compromise its sterility.

Endo-Therapy Accessories and other items which are marked by the words “AUTOCLAVE” or “AUTOCLAVABLE”, a green band or yellow-green marking are compatible with autoclaving.

Prevacuum

Temperature

Exposure Time

132 to 134C

5 minutes

Table 2.3

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Chapter 3 Cleaning, Disinfection and Sterilization Procedures ALL channels of the endoscope, including auxiliary water and elevator wire channels where fitted, MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.

3.1

Required Reprocessing Equipment Preparation of the Equipment Prior to cleaning, disinfection or sterilization, prepare the equipment shown in Figure 3.1.

Use basins which are at least 40 cm by 40 cm in size and deep enough to allow the endoscope to be completely immersed. Do not wrap the endoscope’s insertion tube and universal cord into a coil with a diameter smaller than 40 cm. The endoscope can be damaged if coiled too tightly.

11

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Channel Cleaning Brush (BW-20T)

AW Channel Cleaning Adapter (MB-107)

ETO Cap (MB-156)

All-Channel Irrigator (CW-3)

Maintenance Unit (MU-1, sold separately)

Biopsy Valve (MB-358)

Channel-opening Cleaning Brush (MH-507)

Suction Pump (KV-4, SSU-2)

Auxiliary Water Tube (MB-1)

Elevator-wire-channel Cleaning Tube (MB-109)

Channel Cleaning Adapter (MB-19)

• Detergent Solution

Leakage Tester (MB-155, sold separately)

• Large non-metallic Basin with a Tight Fitting Lid for Detergent and Disinfectant solution

• Personal Protective Equipment

• Rinsing Water

• Large Basin for Rinsing

• Soft-Bristled Tooth brush

• 70% ethyl or isopropyl Alcohol

• Large Basin for Leakage Testing

• Lint-free Cloth

• Disinfectant Solution

• 30 cm3 (30 ml) Syringe

• 3 cm3 (3 ml) Syringe

Figure 3.1

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

Reprocessing Equipment Parts and Functions For inspection of other equipment than that mentioned below, refer to the instruction manual for the equipment being used.

 All-channel Irrigator (CW-3) Used to plug the openings of the Instrument Channel Port, Gas Valve Port, Air/Water Cylinder, and Suction Cylinder during cleaning. Used to inject detergent solution, disinfectant solution and sterile water into the Air/Water and Suction Channels and to flush air through channels to expel fluids (see Figure 3.2).

Flange Suction Part Air/water Part Lock Cover CO2 Cap

Main Body Intake Tube (with Filter)

Non-slip Finger Rest Channel Cap

Figure 3.2

 Auxiliary Water Tube (MB-1) Used to inject detergent solution, disinfectant solution and sterile water into the Auxiliary Water Inlet and to flush air through the channel to expel fluids (see Figure 3.3).

Figure 3.3

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GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Elevator-wire-channel Cleaning Tube (MB-109) Used to inject detergent solution, disinfectant solution and sterile water into the Elevator Wire Channel and to flush air through the channel to expel fluids (see Figure 3.4).

Figure 3.4

 Channel Cleaning Brush (BW-20T) The Channel Cleaning Brush is used to brush the inside of the suction channel and the holes in the Air/Water and Suction Valves (see Figure 3.5).

Metal Tip

Figure 3.5

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 ETO Cap (MB-156) Installed on the Venting Connector of the Endoscope Connector to allow ETO gas sterilization (see Figure 3.6).

Connector

Notice Card

Figure 3.6

 Channel-opening Cleaning Brush (MH-507) The Channel-opening Cleaning Brush is used to brush the outer surface of the Distal End of the endoscope, the Suction Cylinder and the Instrument Channel Opening (see Figure 3.7).

Figure 3.7

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GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Channel Cleaning Adapter (MB-19) Used to aspirate reprocessing fluids from the Distal End of the endoscope through the instrument channel (see Figure 3.8).

Figure 3.8

 AW Channel Cleaning Adapter (MB-107) For precleaning ONLY. Connects to the Air/Water Valve port. When the adapter valve is depressed, water is fed through the Air/Water channel. Air is continuously fed when the adapter valve is not depressed (see Figure 3.9).

Figure 3.9

Inspection of Equipment For inspection of other equipment than that mentioned below, refer to the instruction manual for the equipment being used.

The cleaning brushes are consumable item. Should the slightest irregularity be suspected, use a spare instead. Using a defective brushes may cause equipment damage. GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

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Chapter 3 Cleaning, Disinfection and Sterilization Procedures

 Inspection of the All-channel Irrigator

1. Check all components of the All-channel Irrigator for cracks, scratches, flaws and debris (see Figure 3.2).

2. Check that the Filler is in the Intake Tube. 3. Attach the 30 cm3 (30 ml) syringe to the Main Body. With the Filter mesh immersed in rinsing water, withdraw the syringe plunger and confirm that rinsing water is drawn into the syringe.

4. Continuing from step 3. depress the plunger and confirm that rinsing water is emitted from the part of Suction Part and Air/Water Part.

 Inspection of the Auxiliary Water Tube Check for cracks, scratches, flaws, debris and other damage (see Figure 3.3).

 Inspection of the Elevator-wire-channel Cleaning Tube Check for cracks, scratches, flaws, debris and other damage (see Figure 3.4).

 Inspection of the Channel Cleaning Brushes

1. Check that the brush section and the Metal Tip of the distal end are securely in place. Check for the loose or missing bristle (see Figure 3.5).

2. Check for bends, scratches and other damage to the shaft. 3. Check for debris on the shaft and/or in the bristles of the brush.  Inspection of the ETO Cap Check for cracks, scratches, flaws, debris and other damage (see Figure 3.6).

 Inspection of the Channel Opening Cleaning Brush

1. Check for loose or missing bristles (see Figure 3.7). 2. Check for debris on the shaft and/or in the bristle of the brush.  Inspection of the Channel Cleaning Adapter Check for cracks, scratches, flaws, debris and other damage (see Figure 3.8).

 Inspection of the AW Channel Cleaning Adapter Check for cracks, scratches, flaws, debris and other damage (see Figure 3.9).

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GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

Chapter 3 Cleaning, Disinfection and Sterilization Procedures

3.2

Cleaning, Disinfection and Sterilization Procedures Reprocessing Summary Chart

Withdrawal of the Endoscope

Precleaning (Section 3.3)

Leakage Testing (Section 3.4)

Manual Cleaning (Section 3.5)

High Level Disinfection (Section 3.6)

ETO Gas Sterilization (page 44)

Rinsing After High Level Disinfection (Section 3.7)

Storage and Disposal (Chapter 5)

ALL channels of the endoscope, including auxiliary water and elevator wire channels where fitted, MUST be cleaned and high-level disinfected or sterilized during EVERY reprocessing cycle, even if the channels were not used during the previous patient procedure. Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.

GIF/CF/JF TYPE E ENDOSCOPE REPROCESSING MANUAL

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