ENF-GP2 RHINO-LARYNGO FIBERSCOPE Reprocessing Manual

Contents

Contents Chapter 1 General Policy ... 1 1.1

Instructions ... 1

1.2

Importance of reprocessing ... 2

1.3

Signal words ... 2

1.4

Precautions ... 3

1.5

Reprocessing before the first use ... 6

1.6

Reprocessing and storage after use ... 7

1.7

Reprocessing before patient procedure ... 8

Chapter 2 Function and Inspection of the Accessories for Reprocessing ... 9 2.1

ETO cap (MB-156) ... 9

Chapter 3 Compatible Reprocessing Methods ... 11 3.1

Compatibility summary ... 11

3.2

List of the compatible methods ... 12

3.3

Detergent solution for manual cleaning ... 14

3.4

Disinfectant solution for manual disinfection ... 15

3.5

Water ... 16

3.6

Rinse water ... 16

3.7

Alcohol ... 16

3.8

ETD (Endo Thermo Disinfectors) ... 17

3.9

OER-AW (Olympus Endoscope Reprocessor) ... 18

3.10 Hydrogen peroxide sterilization ... 19 3.11 Steam sterilization (autoclaving) ... 22 3.12 Signs of degradation from reprocessing and its number of times ... 24

Chapter 4 Reprocessing Workflow for Endoscopes and Accessories ... 27 4.1

Summary of reprocessing workflow ... 27

4.2

Workflow for manually cleaning and disinfecting endoscopes and accessories ... 28

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Contents

Chapter 5 Reprocessing the Endoscope ... 31 5.1

Summary of reprocessing the endoscope ... 31

5.2

Preparing the equipment for reprocessing ... 32 Equipment needed ... 32

5.3

Precleaning the endoscope ... 34 Equipment needed ... 34 Preparation ... 35 Wipe the insertion section ... 36 Detach the endoscope and accessories from the light source ... 37

5.4

Leakage testing of the endoscope ... 42 Equipment needed ... 42 Perform the leakage test ... 43

5.5

Manually cleaning the endoscope ... 52 Equipment needed ... 52 Clean the external surfaces ... 52 Immerse the endoscope in detergent solution ... 55 Remove detergent solution from the endoscope ... 55 Dry the endoscope ... 55

5.6

Manually disinfecting the endoscope ... 56 Equipment needed ... 56 Preparation ... 56 Immerse the endoscope in disinfectant solution ... 57 Remove the endoscope from disinfectant solution ... 57

5.7

Rinsing the endoscope following disinfection ... 58 Equipment needed ... 58 Rinse the endoscope ... 59

5.8

Sterilizing the endoscope and accessories ... 59 Equipment needed ... 59 STERRAD® 100S/NX®/100NX® sterilization of the endoscope and accessories ... 60 V-PRO® maX sterilization of the endoscope and accessories ... 61

5.9

Presoaking the endoscope ... 63 Equipment needed ... 63 Presoak the endoscope ... 64

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Contents

Chapter 6 Reprocessing the Accessories ... 65 6.1

Summary of reprocessing the accessories ... 65 Equipment needed ... 66

6.2

Manually cleaning the accessories ... 67 Equipment needed ... 67 Disassembling the light guide adapter (MAJ-900) ... 68 Preparation ... 68 Clean the external surfaces ... 69 Flush the accessories with detergent solution ... 69 Immerse the accessories in detergent solution ... 70 Remove detergent solution from all accessories ... 70 (Optional) Alcohol flush ... 71 Dry the accessories ... 71

6.3

Manually disinfecting the accessories ... 72 Equipment needed ... 72 Preparation ... 72 Flush the accessories with disinfectant solution ... 73 Immerse the accessories in disinfectant solution ... 74 Remove the accessories from disinfectant solution ... 74

6.4

Rinsing the accessories following disinfection ... 75 Equipment needed ... 75 Rinse the accessories ... 76 Remove the accessories from rinse water ... 77 (Optional) Alcohol flush ... 77 Dry the accessories ... 77

6.5

Sterilizing the accessories ... 78 Steam sterilization (autoclaving) of the accessories ... 78 STERRAD® 100S/NX®/100NX® sterilization of the accessories ... 79 V-PRO® maX sterilization of the accessories ... 79

Chapter 7 Reprocessing Endoscopes Using an AER/WD ... 81 7.1

Reprocessing endoscopes using an AER ... 81

7.2

Reprocessing endoscope and accessories using an ETD ... 82 (Optional) Alcohol flush ... 82 Dry the endoscope and accessories ... 82 ETD ... 82

7.3

Reprocessing endoscopes and accessories using an OER-AW ... 83 OER-AW ... 83 Dry the endoscope ... 83

7.4

Reprocessing accessories using a WD ... 84 Washer-Disinfector ... 84 Dry the accessories ... 84

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Contents

Chapter 8 Storage and Disposal ... 85

iv

8.1

Precautions of storage and disposal ... 85

8.2

Storing the disinfected endoscope and accessories ... 86

8.3

Storing the sterilized endoscope and accessories ... 87

8.4

Disposal ... 87

ENF-GP2 REPROCESSING MANUAL

1.1 Instructions

Chapter 1 1.1

General Policy

Ch.1

Instructions • This manual contains the reprocessing methods recommended by Olympus for the endoscopes and accessories listed on the front cover. • This instruction manual contains essential information on reprocessing endoscopes and accessories safely and effectively. • Before reprocessing, thoroughly review this manual and the manuals for the reprocessing equipment and chemicals that will be used for reprocessing. Reprocess all the devices as instructed. • Note that the complete instruction manual set for the endoscope and accessories consists of this manual and the “OPERATION MANUAL” with your endoscope model listed on the cover. Both manuals accompanied the endoscope at shipment. • Keep this manual and all related manuals in a safe and accessible location (e.g., in the reprocessing area). • 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. • This manual is based on the requirement of ISO 17664: 2017.

 Terms used in this manual AER/EWD/WD: AER is the abbreviation for Automated Endoscope Reprocessor, which is used for reprocessing the endoscopes and accessories. EWD is the abbreviation for Endoscope Washer-Disinfector, which is used for reprocessing the endoscopes and accessories. EWD refers to AER and AER is used in this manual. WD is the abbreviation for WasherDisinfector, which is used for reprocessing the heat-stable endoscopes, accessories and medical instruments employing alkaline cleaning and thermal disinfection.

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1.2 Importance of reprocessing

Ch.1

1.2

Importance of reprocessing

The medical literature reports incidents of cross-contamination resulting from improper reprocessing. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals for all ancillary equipment, and have a thorough understanding of the following items: • Professional health and safety policies of your healthcare facility. • Instruction manuals for the endoscope, accessories, and all the other reprocessing equipment • Structure and handling of the endoscope and accessories • Handling of pertinent chemicals When selecting appropriate methods and conditions for reprocessing, follow the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices, in addition to the instructions given in this manual.

1.3

Signal words

The following signal words are used throughout this manual:

WARNING

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

CAUTION

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.

NOTE

2

Indicates additional helpful information.

ENF-GP2 REPROCESSING MANUAL

1.4 Precautions

1.4

Ch.1

Precautions WARNING • An insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them. • The endoscope reprocessor, light source, and/or front panels of equipment may cause an infection control risk. Perform proper cleaning and/or disinfection as described in their respective instruction manuals. A tap, basin, and/or nozzle of pharyngeal anesthetic spray that medical personnel come in contact with may cause an infection control risk as well. Perform proper replacement, cleaning, and/or disinfection. • All disinfection methods (whether performed manually or by an AER) and all sterilization methods (whether performed by ethylene oxide gas or steam) require thorough prior cleaning of the instruments being reprocessed. If the instruments are not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope. • All accessories used with the endoscope during the patient procedure must be reprocessed after each patient procedure, even if the accessories were not used during the patient procedure. Insufficient reprocessing of these components may pose an infection control risk to patients and/or operators. • Residual disinfectant solution and detergent solution may cause adverse reactions in patients. Therefore, rinse all external surfaces of the endoscope and accessories thoroughly with water to remove residual disinfectant solution following disinfection and detergent solution following cleaning. • The results of sterilization depend on various factors. These factors include how the equipment was packaged and the placing and loading of the package in the sterilization device. Verify the sterilization process using biological and/or chemical indicators. Follow the guidelines for sterilization issued by national authorities, professional organizations, and infection control professionals, including the frequency of the above verification, as well as the instruction manual for the sterilization device. • Establish an internal system of identifying contaminated versus reprocessed endoscopes and accessories to prevent both mix-ups and cross-contamination. Some national or professional guidelines recommend separating dirty (contaminated) area, clean area, and storage area. Touching a reprocessed endoscope and/or accessories with contaminated gloves or placing them on a contaminated hanger or surface, including letting them touch the floor, will recontaminate them. ENF-GP2 REPROCESSING MANUAL

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1.4 Precautions

Ch.1

WARNING • Prior to each patient procedure, confirm that the endoscope and accessories have been properly reprocessed and stored. If there are any doubts or questions, reprocess them again before the patient procedure, following the instructions given in this manual. • Perform a leakage test on the endoscope after each precleaning procedure. Do not use the endoscope if a leak is detected. Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions. Use of a leaking endoscope may also pose an infection control risk. Leakage tester

Figure 1.1 • Store alcohol in an airtight container. Alcohol stored in an open container may cause a fire hazard and may result in a loss of efficacy due to evaporation. • The accessories listed on the front cover of this manual cannot be refurbished or repaired and are intended to be replaced once they show any signs of wear and tear. Should any irregularity be observed, use a replacement accessory instead. Using defective accessories may cause equipment malfunction, reduce the efficacy of reprocessing, present a risk to patients and/or operators, or damage the endoscope and/or accessories. • Patient debris and used reprocessing chemicals pose infection control risks. To guard against contact with dangerous chemicals and potentially infectious material, wear appropriate personal protective equipment during reprocessing. Such protective equipment should include appropriate eyewear, face mask, cap, moisture-resistant clothing, shoe covers, and chemical-resistant gloves that fit properly and are long enough to prevent skin exposure. • The reprocessing room must be adequately ventilated to minimize the risks from chemical vapors. • Always remove contaminated personal protective equipment before leaving the reprocessing area to prevent contamination from spreading.

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1.4 Precautions

Ch.1

WARNING • Only Olympus-recommended or Olympus-endorsed AERs have been validated by Olympus. When using an AER that is not recommended by Olympus, the manufacturer of the AER is responsible for validating compatibility of the AER with each Olympus endoscope, accessories and medical instruments. • Only use the AER/WD that meets the requirements of the relevant parts of EN ISO 15883 series in the member states of the EU. • Before using an AER, confirm that it is capable of reprocessing the endoscope. Be sure to attach all required connectors. Otherwise, insufficient reprocessing may pose an infection control risk. If you are uncertain as to the ability of your AER to reprocess the endoscope including all accessories, contact the manufacturer of the AER for specific instructions and information on compatibility and required connectors. • The instructions provided in this manual are not valid for Olympus devices repaired by a non-Olympus facility. The Olympus recommended reprocessing procedures have not been validated for reprocessing devices repaired by a non-Olympus facility. In the event that your device has been repaired by a non-Olympus facility, contact the repair facility for instructions regarding reprocessing. • Prions, which are the pathogenic agents of the Creutzfeldt-Jakob disease (CJD), cannot be destroyed or inactivated by the reprocessing methods stated in this instruction manual. When using the endoscope and accessories on patients with CJD or variant Creutzfeldt-Jakob disease (vCJD), be sure to use them for such patients only, or immediately dispose of them after use in an appropriate manner to prevent the usage of exposed devices on other patients. For methods to handle CJD/vCJD, follow the respective guidelines in your country. • The endoscope and accessories may be damaged by published methods for destroying or inactivating prions. For information on the durability of Olympus equipment against a particular reprocessing method, contact Olympus. In general, Olympus cannot guarantee the effectiveness, safety, and durability of reprocessing methods not described in this reprocessing manual. If you choose to use a reprocessing method not recommended in this manual, the local institution and/or physicians must assume responsibility for its safety and efficacy. Make sure to carefully inspect each piece of endoscopic equipment for irregularities (damage) prior to each patient procedure. Do not use the equipment if any irregularity is observed. • Good quality control practices typically require appropriate documentation. Items such as local SOPs (Standard Operating Procedures), confirmation of operator training, routine testing of the disinfectant’s MEC (Minimal Effective Concentration), confirmation of the disinfectant’s use-life, etc. should be documented as performed. • In case of performing any microbial test or other test using extraction fluid on the reprocessed endoscope, the reprocessing process has to be performed again according to the “REPROCESSING MANUAL” before patient procedure. ENF-GP2 REPROCESSING MANUAL

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1.5 Reprocessing before the first use

Ch.1

CAUTION • Before immersing the endoscope in reprocessing fluids, confirm that the ETO cap (MB-156) is not attached to the endoscope. If the ETO cap is attached, the reprocessing fluids will be able to penetrate the inside of the endoscope, and it can be damaged. • Store spare accessories in their original packaging to prevent damage. • To prevent damage, do not apply excessive force to the endoscope and accessories during reprocessing. • Vapors from disinfectant solution and alcohol may damage electronic devices such as computers. Properly manage the quality and durability of the devices used in reprocessing rooms and the ventilation performance of the rooms.

1.5

Reprocessing before the first use

New endoscopes, repaired endoscopes, accessories, and the carrying case for endoscopes are not reprocessed prior to shipping from Olympus, regardless of whether those instruments are for new purchase, demo, or loaner purposes. Reprocess all such endoscopes and accessories received from Olympus according to the instructions given in this manual before storage and before using them in a patient procedure.

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1.6 Reprocessing and storage after use

1.6

Ch.1

Reprocessing and storage after use WARNING • Do not reuse detergent solution. • Do not reuse rinse water. • Detergent and disinfectant solution are only effective when used according to the detergent and disinfectant manufacturer’s instructions. Follow the manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time and use life and expiration date required to successful cleaning and achieve disinfection. • If the disinfectant solution is reused, check its efficacy by proper methods, such as using a test strip, according to the disinfectant manufacturer’s recommendations prior to use. • Do not reuse alcohol. • Alcohol is not a sterilant or high-level disinfectant. • To maintain sterility of equipment following sterilization, use sterilization pouches and wraps according to national guidelines. • Store the endoscope and accessories in a proper storage cabinet, following the policies at your institution, applicable national laws and standards, and professional society guidelines and recommended practices. • Improper storage practices, such as not thoroughly drying external and internal surfaces (lumens) prior to storage, will lead to an infection control risk.

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1.7 Reprocessing before patient procedure

Ch.1

1.7

Reprocessing before patient procedure WARNING Improper handling, such as touching a reprocessed endoscope and/or accessories with contaminated gloves, placing a reprocessed device on a contaminated hanger or surface, allowing devices to touch the floor, etc. will recontaminate the device.

NOTE Some national or professional guidelines recommend reprocessing endoscopes prior to their first use of the day, when the certain time passes after disinfecting/sterilizing, or in case the storage time recommended by the national authorities is exceeded. Confirm that the endoscope and accessories have undergone proper reprocessing following their last use and that they have been stored properly. Check the storage period of reprocessed endoscopes, and check for surface contamination (e.g., dust). Check the expiration date marked on all items and check for tears or breaches in the sterile packaging. If there are any doubts or questions concerning whether a device is contaminated, reprocess it again following the instructions given in this manual.

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ENF-GP2 REPROCESSING MANUAL

2.1 ETO cap (MB-156)

Chapter 2

Function and Inspection of the Accessories for Reprocessing

Ch.2

Certain accessories are required for reprocessing the endoscope. This chapter describes the function of these accessories. It also describes how to inspect these accessories before using them to reprocess the endoscope.

2.1

ETO cap (MB-156) ETO cap

Caution Caution is described that the timing of attach to and remove from the endoscope.

Figure 2.1

CAUTION Failing to attach/remove the ETO cap may cause a damage to the endoscope.

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2.1 ETO cap (MB-156)

 Function • When performing gas sterilization (e.g., ethylene oxide gas sterilization, hydrogen peroxide low temperature plasma), the ETO cap must be attached to the venting connector on the control section.

Ch.2

• When performing cleaning and disinfection including ETD, the sterilization cap must be removed from the venting connector on the endoscope connector.

CAUTION If the ETO cap is not attached to the venting connector during the gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism.

Venting connector ETO cap

Figure 2.2

 Inspection Confirm that the ETO cap is free from scratches, flaws, and debris.

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ENF-GP2 REPROCESSING MANUAL

3.1 Compatibility summary

Chapter 3

3.1

Compatible Reprocessing Methods Ch.3

Compatibility summary

The endoscope and accessories are compatible with several methods of reprocessing. For information concerning the applicable reprocessing methods and parameters, refer to Section 3.2, “List of the compatible methods”. Additionally, some reprocessing methods may cause degradation of medical devices that shortens product life. For information concerning degradation of medical devices from reprocessing and its number of times, refer to Section 3.12, “Signs of degradation from reprocessing and its number of times”. Follow the policies at your local institution when choosing which methods to employ.

CAUTION • The methods listed as “compatible” in Table 3.1 are compatible for routine use only when used according to manufacturer’s instructions. Repeated use and reprocessing of endoscopes and accessories lead to gradual wear and tear. Furthermore, reprocessing methods that employ higher temperatures and more caustic/corrosive materials may lead to faster deterioration. In general, sterilization processes are harsher on equipment than disinfection processes. Before each patient procedure, inspect the endoscope and accessories for damage, according to the instructions described in this manual and its companion “OPERATION MANUAL”. • The instructions provided in this manual regarding compatible reprocessing methods are not valid for Olympus devices repaired by a non-Olympus facility. Olympus repairs devices to manufacturer’s specifications using original equipment manufacturer’s (OEM) materials. The use of non-OEM materials to repair an Olympus device may affect the material compatibility and reprocessing efficacy of the device with certain reprocessing chemicals or methods. In the event that your device has been repaired by a non-Olympus facility, contact the repair facility for instructions regarding compatible reprocessing methods.

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3.2 List of the compatible methods

3.2

List of the compatible methods

Reprocessing methods listed in Table 3.1 have been validated with this endoscope and accessories. For details on the chemicals and devices that can be used, refer to Section 3.3 and subsequent sections.

Ch.3

Endoscope

Ultrasonic cleaning*1 Manual cleaning

Alkaline enzymatic detergent

Manual disinfection

Peracetic acid

Drying

Alcohol

Automatic cleaning and disinfection

AER

Neutral enzymatic detergent Glutaraldehyde ETD Double (Peracetic acid) ETD4 (Peracetic acid) ETD4 (Glutaraldehyde) OER-AW*2 (Peracetic acid)*3 WD (alkaline detergent, thermal disinfection)

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ENF-GP2 REPROCESSING MANUAL

ETO cap (MB-156)

Light guide adapter (MAJ-900)

3.2 List of the compatible methods

Sterilization

Hydrogen perioxide*6

V-PRO® maX (Non Lumen cycle, Flexible cycle)

*4*5

STERRAD® NX® with ALLClearTM Technology (Standard cycle, Advanced cycle)

*4*5

STERRAD® NX® (Standard cycle, Advanced cycle)

*4*5

STERRAD® 100NX® with ALLClearTM Technology (Duo cycle)

*5

STERRAD® 100NX® (Duo cycle)

*5

Ch.3

STERRAD® 100S (Long cycle with booster) STERRAD® 100S (Short cycle, Long cycle)

*4*5

Steam (autoclaving) Ethylen oxide gas Low Temperature steam and formaldehyde (LTSF) compatible

not compatible

Table 3.1 *1 The endoscope is only compatible with ultrasonic cleaning as performed in an Olympus-recommended reprocessor, such as OER-AW. When using an AER/WD that is recommended by Olympus other than listed above, contact Olympus. *2 OER-AW is not available in the member states of the EU. *3 ACECIDE disinfectant solution, which is peracetic acid, is execlusively for an Olympus-recommended endoscope reprocessor, such as OERAW(ACECIDE may not be available in some areas). *4 If sterilized alone, use appropriate packaging and sterilize under the appropriate parameters following the policies at your facility. *5 This product can be used to sterilize the endospcope when combined with the endoscope which is compatible with the sterilization shown on the left. *6 The cycles that are not listed in Table 3.1 can not be used for reprocessing.

NOTE The endoscope is compatible with some endoscope reprocessors such as the ETD system distributed by Olympus. Refer to the instruction manual for details on operation. For any other details, contact Olympus.

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3.3 Detergent solution for manual cleaning

3.3

Detergent solution for manual cleaning WARNING • Excessive foaming prevents detergent solution from properly contacting the surfaces of the endoscope and accessories, and may impair effective cleaning.

Ch.3

• Do not reuse detergent solution. Use a neutral (20 – 45°C) or alkaline (20 – 40°C, <pH 10.8) low-foaming enzymatic detergent with no abrasion labeled for use with flexible endoscopes and accessories that has been approved by your national regulatory agency for use in reprocessing flexible endoscopes, accessories, and medical instruments. Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time, use life, expiration date, and rinsing unless otherwise specified by Olympus.The detergents shown in Table 3.2 were used for validation. Trade name

Manufacturer

Alkaline enzymatic

Dr. Weigert

Endozime® AW

Neutral enzymatic

Ruhof

Table 3.2

14

Type

neodisher® Mediclean forte

Detergents used for validation

ENF-GP2 REPROCESSING MANUAL

3.4 Disinfectant solution for manual disinfection

3.4

Disinfectant solution for manual disinfection WARNING • As per Advanced Sterilization Products® Safety Alert, dated January 3, 2005, entitled “Labeling Change to Cidex® OPA Solution Instructions for Use”. – “In rare instances Cidex OPA Solution has been associated with anaphylaxis-like reactions in bladder cancer patients undergoing repeated cystoscopies. Therefore, ASP is contraindicating the use of Cidex OPA Solution for the reprocessing of any urological instruments to be used on patients with a history of bladder cancer.”. • If the disinfectant solution is reused, check its efficacy by proper methods, such as using a test strip, according to the disinfectant manufacturer’s recommendations prior to use. • The endoscope and accessories must be sterilized after using surgical operation. Refer to Section 3.11, “Steam sterilization (autoclaving)”.

Use a peracetic acid or glutaraldehyde disinfectant with the properties shown in Table 3.3 that has been approved by your national regulatory agency for use in reprocessing flexible endoscopes, accessories, and medical instruments. If national or professional guidelines applicable to your institution define “high-level disinfection” and require the use of a high-level disinfectant for flexible endoscopes, accessories, and medical instruments, follow the requirement. Disinfectant

Peracetic acid

Glutaraldehyde

Percentage solution

2 W/V% solution Undiluted solution (dissolving the powdery agent with water) (mixing undiluted solution with activator)

Disinfectant concentration

Peracetic acid approximately 1000 ppm

Glutaraldehyde approximately 2.4%

Operating temperature

Approximately 25°C

Approximately 25°C

Solution shelf life

Within 24 hours

Within 14 days

Table 3.3

Peracetic acid and Glutaraldehyde disinfectant with properties

Unless otherwise specified by Olympus, follow the disinfectant manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time, use life, expiration date and rinsing. If the disinfectant manufacturer does not specify how many times the disinfectant should be rinsed, perform rinsing at least two times. The disinfectants shown in Table 3.4 were used for validation. Trade name Sekusept Cidex®

TM

Aktiv

Activated Dialdehyde Solution

Table 3.4

Type

Manufacturer

Peracetic acid

ECOLAB

Glutaraldehyde

Advanced Sterilization Products

Disinfectants used for validation

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Ch.3