RHINO-LARYNGO VIDEOSCOPE 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 ... 7

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 and Chemical Agents ... 11 3.1

Compatibility summary ... 11 Microbiological efficacy ... 12 Material durability ... 12 List of compatible methods validated in terms of microbiological efficacy and material durability ... 13 List of compatible methods validated in terms of material durability ... 14

3.2

Water (for reprocessing) ... 15

3.3

Detergent solution ... 15

3.4

Disinfectant solution ... 16

3.5

Rinse water ... 16

3.6

Ethylene oxide gas sterilization ... 17

Chapter 4 Reprocessing Workflow for Endoscopes and Accessories ... 19 4.1

Summary of reprocessing workflow ... 19

4.2

Workflow for manually cleaning and disinfecting endoscopes and accessories... 20

4.3

Workflow for cleaning and disinfecting endoscopes using an AER/WD ... 21

4.4

Workflow for manually cleaning and sterilizing endoscopes and accessories... 22

ENF-V4, ENF-VH2 REPROCESSING MANUAL

i

Contents

Chapter 5 Reprocessing the Endoscope ... 23 5.1

Summary of reprocessing the endoscope ... 23

5.2

Preparing the equipment for reprocessing ... 24 Equipment needed ... 24

5.3

Precleaning the endoscope ... 26 Equipment needed ... 26 Preparation ... 27 Wipe the insertion section ... 27 Detach the endoscope from the video system center ... 28 Detach the endoscope from the light source ... 28

5.4

Leakage testing of the endoscope ... 29 Equipment needed ... 29 Perform the leakage test ... 30

5.5

Manually cleaning the endoscope ... 39 Equipment needed ... 39 Clean the external surfaces ... 40 Immerse the endoscope in detergent solution ... 44 Remove detergent solution from the endoscope ... 44 Dry the external surfaces ... 45

5.6

Manually disinfecting the endoscope ... 45 Equipment needed ... 45 Preparation ... 45 Immerse the endoscope in disinfectant solution ... 46 Remove the endoscope from disinfectant solution ... 46

5.7

Rinsing the endoscope following disinfection ... 47 Equipment needed ... 47 Rinse the endoscope ... 48

5.8

Sterilizing the endoscope ... 49 Equipment needed ... 49 Ethylene oxide gas sterilization of the endoscope ... 49 STERRAD® 100S/NX®/100NX® sterilization of the endoscope ... 51 V-PRO® maX sterilization of the endoscope ... 53

5.9

Presoaking the endoscope ... 54 Equipment needed ... 55 Presoak the endoscope ... 55

ii

ENF-V4, ENF-VH2 REPROCESSING MANUAL

Contents

Chapter 6 Reprocessing Endoscopes Using an Automated Endoscope Reprocessor/Washer-Disinfector... 57 6.1

Reprocessing endoscopes using an automated endoscope reprocessor/washer-disinfector... 57

Chapter 7 Storage and Disposal ... 61 7.1

Precautions of storage and disposal ... 61

7.2

Storing the disinfected endoscope and accessories ... 62

7.3

Storing the sterilized endoscope and accessories ... 63

7.4

Disposal ... 64

ENF-V4, ENF-VH2 REPROCESSING MANUAL

iii

Contents

iv

ENF-V4, ENF-VH2 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.

 Terms used in this manual AER/WD: AER and WD are abbreviations for Automated Endoscope Reprocessor and Washer-Disinfector, which are used for reprocessing the endoscopes and accessories.

Disinfection: Some countries classify the disinfection level and define “high-level disinfection”, and other countries do not. The term “disinfection” is used, including meaning “high-level disinfection”, in this manual. For disinfectant solution, follow the instructions as described in Section 3.4, “Disinfectant solution”.

ENF-V4, ENF-VH2 REPROCESSING MANUAL

1

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 hospital • 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 cleaning, disinfection, and sterilization, 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-V4, ENF-VH2 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 contact them. • The endoscope reprocessor, video system center, 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/WD) 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 residual detergent solution may cause adverse reactions in patients. Therefore, rinse all external surfaces of the endoscope thoroughly with water to remove residual disinfectant solution following disinfection and residual 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.

ENF-V4, ENF-VH2 REPROCESSING MANUAL

3

1.4 Precautions

Ch.1

WARNING • 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 the 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. • 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 • 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.

4

ENF-V4, ENF-VH2 REPROCESSING MANUAL

1.4 Precautions

Ch.1

WARNING • 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. • Only Olympus-recommended or Olympus-endorsed AERs/WDs have been validated by Olympus. When using an AER/WD that is not recommended by Olympus, the manufacturer of the AER/WD is responsible for validating compatibility of the AER/WD with each Olympus endoscope and accessory. • Before using an AER/WD, 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/WD to reprocess the endoscope, contact the manufacturer of the AER/WD 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, 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.

ENF-V4, ENF-VH2 REPROCESSING MANUAL

5

1.4 Precautions

Ch.1

WARNING • 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.

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.

6

ENF-V4, ENF-VH2 REPROCESSING MANUAL

1.5 Reprocessing before the first use

1.5

Ch.1

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.

1.6

Reprocessing and storage after use WARNING • Do not reuse detergent solution. • Do not reuse rinse water. • Disinfectant solution is only effective when used according to the disinfectant manufacturer’s instructions. Follow the manufacturer’s instructions regarding activation (if required), concentration, temperature, contact time, use life, and expiration date required to 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. • 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.

ENF-V4, ENF-VH2 REPROCESSING MANUAL

7

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. 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.

8

ENF-V4, ENF-VH2 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

Figure 2.1

ENF-V4, ENF-VH2 REPROCESSING MANUAL

9

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 light guide connector.

Ch.2

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.

10

ENF-V4, ENF-VH2 REPROCESSING MANUAL

3.1 Compatibility summary

Chapter 3

Compatible Reprocessing Methods and Chemical Agents Ch.3

3.1

Compatibility summary

The endoscope and accessories are compatible with several methods of reprocessing. However, not all reprocessing methods are compatible with all endoscopes and all accessories. Reprocessing with incompatible methods can cause equipment damage even if the number of reprocessing cycles is small. For appropriate reprocessing methods, see Table 3.1 and 3.2. Follow the policies at your local institution when choosing which methods listed in Table 3.1 and 3.2 to employ.

CAUTION • The methods listed as “compatible” in Table 3.1 and 3.2 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 reprocessing methods and chemical agents 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 and chemical agents.

ENF-V4, ENF-VH2 REPROCESSING MANUAL

11

3.1 Compatibility summary

Olympus provides information regarding validated methods in terms of the following two criteria.  Microbiological efficacy  Material durability

Ch.3

 Microbiological efficacy If it is stated that a method is “validated” in terms of microbiological efficacy, it means that instruments have been reprocessed successfully using the standardized method described in this manual.

 Material durability If it is stated that a method is “validated” in terms of material durability, it means that the method can be adopted as a repetitive reprocessing procedure. Just because the material durability is confirmed, it does not mean that a certain degree of microbiological effectiveness is guaranteed.

12

ENF-V4, ENF-VH2 REPROCESSING MANUAL

3.1 Compatibility summary

 List of compatible methods validated in terms of microbiological efficacy and material durability For sterilization

Steam sterilization (autoclaving) Ethylene oxide gas sterilization (gas mixture: 20% ethylene oxide gas/80% CO2, for countries other than the USA)

Ch.3

Ethylene oxide gas sterilization (100% ethylene oxide gas) For disinfection

ACECIDE disinfectant solution*1 2 – 3.5% glutaraldehyde

For cleaning

Detergent solution Ultrasonic cleaning

Endoscope *2 ETO cap (MB-156)

compatible

not compatible

Table 3.1 *1 ACECIDE disinfectant solution is exclusively for an Olympus-recommended endoscope reprocessor, such as OER-A and OER-AW (ACECIDE may not be available in some areas). *2 The endoscope is only compatible with ultrasonic cleaning as performed in an Olympus-recommended endoscope reprocessor, such as OER-A and OER-AW (OER-A and OER-AW may not be available in some areas). When using an AER/WD that is recommended by Olympus other than listed above, contact Olympus.

NOTE The endoscope is compatible with some endoscope reprocessors such as the ETD*1 system distributed by Olympus. Refer to the instruction manual for details on operation. For any other details, contact Olympus. *1

This product may not be available in some areas.

ENF-V4, ENF-VH2 REPROCESSING MANUAL

13

3.1 Compatibility summary

 List of compatible methods validated in terms of material durability Low temperature steam and formaldehyde sterilization*1 V-PRO® maX (Flexible cycle, Non Lumen cycle)*2

Ch.3

STERRAD® 100S (Long cycle, Short cycle)*3 STERRAD® NX® (Advanced cycle, Standard cycle)*3, *4 STERRAD® 100NX® (Duo cycle)*3, *4 Endoscope *5 ETO cap (MB-156) *5

compatible

not compatible

Table 3.2 *1 This method may not be available in some areas. *2 Olympus products have been validated by STERIS Corporation for the microbiological efficacy. As for the sterilizer, contact STERIS Corporation. Also, refer to the “V-PRO® maX” instruction manual. *3 Olympus products have been validated by ASP (Advanced Sterilization Products) for the microbiological efficacy. As for the sterilizer, contact ASP. Also, refer to the “STERRAD® 100S/NX®/100NX®” instruction manual. *4 Olympus products can be processed with or without ALLClear Technology. For further details, contact ASP. *5 For further details, contact Olympus.

 STERRAD® 100S/NX®/100NX® CAUTION Sterilization by STERRAD® 100S/NX®/100NX® system may deteriorate the adhesive of the insertion section. Depending on the circumstances, replacement of the insertion section may be required. Before use, confirm that the endoscope is free from any damage or other irregularities. For further details, contact Olympus.

14

ENF-V4, ENF-VH2 REPROCESSING MANUAL

3.2 Water (for reprocessing)

 V-PRO® maX CAUTION Sterilization by V-PRO® maX system may deteriorate the adhesive of the insertion section. Depending on the circumstances, replacement of the insertion section may be required. Before use, confirm that the endoscope is free from any damage or other irregularities. For further details, contact Olympus.

3.2

Water (for reprocessing)

Water is used for leakage testing and manual cleaning of the endoscope and accessories. For these purposes, use either fresh, potable water or water that has been processed (e.g., filtered, deionized, or purified) to improve its chemical and/or microbiological quality. Consult with your hospital’s infection control committee. When rinsing the endoscope and accessories following disinfection, use the water as described in Section 3.5, “Rinse water”.

3.3

Detergent solution WARNING • Excessive foaming prevents detergent solution from properly contacting the surfaces of the endoscope, and may impair effective cleaning. • Do not reuse detergent solution.

Use a medical-grade, low-foaming, neutral pH detergent that may or may not contain enzymes. Follow the instructions provided by the detergent manufacturer regarding concentration, temperature, contact time, and expiration date. Contact Olympus for the names of specific brands of detergent solution that have been tested for compatibility with endoscopes and accessories.

ENF-V4, ENF-VH2 REPROCESSING MANUAL

15

Ch.3