The Care and Handling of Rigid and Flexible Scopes

Transcription

1 CE ONLINE The Care and Handling of Rigid and Flexible Scopes (An Online Continuing Education Activity) A Continuing Education Activity Sponsored By Grant Funds Provided By

2 Welcome to The Care and Handling of Rigid and Flexible Scopes (An Online Continuing Education Activity) CONTINUING EDUCATION INSTRUCTIONS This educational activity is being offered online and may be completed at any time. Steps for Successful Course Completion To earn continuing education credit, the participant must complete the following steps: 1. Read the overview and objectives to ensure consistency with your own learning needs and objectives. At the end of the activity, you will be assessed on the attainment of each objective. 2. Review the content of the activity, paying particular attention to those areas that reflect the objectives. 3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content. 4. For additional information on an issue or topic, consult the references. 5. To receive credit for this activity complete the evaluation and registration form. 6. A certificate of completion will be available for you to print at the conclusion. Pfiedler Enterprises will maintain a record of your continuing education credits and provide verification, if necessary, for 7 years. Requests for certificates must be submitted in writing by the learner. If you have any questions, please call: CONTACT INFORMATION: 2015 All rights reserved Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado Phone: Fax:

3 OVERVIEW Endoscopes can be diagnostic, limited to only observation of a hollow space or organ, or operative, equipped with channels for irrigation, suction and ability to insert instruments or other accessory items during a surgical procedure. An endoscope may be inserted into the human body by using a natural orifice (anus, cervix, mouth, and urethra) or through a tiny surgical incision. There are three basic types of endoscopes: rigid, semi-rigid, and flexible which is determined by the materials used to make the endoscope. A rigid and semi-rigid endoscope has a stainless steel body and glass rod lenses or fiber optic lenses allows the surgeon visualization of the structure or organ. The construction of a rigid endoscope limits the flexibility of the scope; visualization is allowed by the degree of the lens and not the flexibility of the scope. A flexible endoscope has a flexible, plastic insertion tube with the ability to bend the distal tip. This flexible endoscope allows the physician to access and view more areas of the body than what is available using a rigid endoscope. The rigid endoscope comes in a variety of view angles: 0 degree for forward viewing, 30 and 45 degree for forward oblique views, 70 degree for lateral views and 120 degrees for retrograde views. The flexible endoscope has one lens type, but can be used to view forward, forward oblique, lateral and retrograde by flexing the bending distal tip. OBJECTIVES Upon completion of this continuing education activity, the participant should be able to: 1. Differentiate the surgical uses of flexible and rigid endoscopes. 2. Describe the structural differences between the flexible and rigid endoscope. 3. Discuss the Spaulding Classification System and how to best apply it when determining the sterilization or high-level disinfection method for a flexible and rigid endoscope. 4. List the steps in cleaning a flexible and rigid endoscope. 5. Explain the different sterilization modalities and how to access the manufacturer s sterilization recommendations for flexible and rigid endoscopes. INTENDED AUDIENCE This continuing education activity is intended for perioperative and central service and sterile department (CSSD) personnel who are involved with any aspect of surgical procedures using flexible or rigid endoscopes, or with reprocessing procedures CREDIT/CREDIT INFORMATION State Board Approval for Nurses Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP14944, for 2.0 contact hours. Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes. 3

4 The certificate of course completion issued at the conclusion of this course must be retained in the participant s records for at least four (4) years as proof of attendance. IAHCSMM: The International Association of Healthcare Central Service Materiel Management has approved this educational offering for 2.0 contact hours to participants who successfully complete this program. CBSPD: The Certification Board for Sterile Processing and Distribution (CBSPD) has approved this program for 2.0 contact hours. IACET Pfiedler Enterprises has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET). CEU Statements As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs that qualify under the ANSI/IACET Standard. Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program. RELEASE AND EXPIRATION DATE: This continuing education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in June 2015 and can no longer be used after June 2017 without being updated; therefore, this continuing education activity expires June DISCLAIMER Pfiedler Enterprises does not endorse or promote any commercial product that may be discussed in this activity SUPPORT Funds to support this activity have been provided by Richard Wolf AUTHORS/PLANNING COMMITTEE/REVIEWER Elizabeth Deroian, BA, RN Program Manager/Planning Committee Pfiedler Enterprises Rose Moss, MN, RN, CNOR Nurse Consultant/Author Moss Enterprises Aurora, CO Casa Grande, AZ 4

5 Judith I. Pfister, RN, BSN, MBA Program Manager/Planning Committee Pfiedler Enterprises Julia A. Kneedler, RN, MS, EdD Program Manager/Reviewer Pfiedler Enterprises Aurora, CO Aurora, CO DISCLOSURE OF RELATIONSHIPS WITH COMMERCIAL ENTITIES FOR THOSE IN A POSITION TO CONTROL CONTENT FOR THIS ACTIVITY Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for individuals who control content for an educational activity. Information listed below is provided to the learner, so that a determination can be made if identified external interests or influences pose a potential bias of content, recommendations or conclusions. The intent is full disclosure of those in a position to control content, with a goal of objectivity, balance and scientific rigor in the activity. Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this educational activity. Relevant financial relationships are those in any amount, occurring within the past 12 months that create a conflict of interest. A commercial interest is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. Activity Planning Committee/Authors/Reviewers: Elizabeth Deroian, BA, RN No conflict of interest Rose Moss, RN, MN, CNOR No conflict of interest Judith I. Pfister, MBA, RN Co-owner of company that receives grant funds from commercial entities Julia A. Kneedler, EdD, RN Co-owner of company that receives grant funds from commercial entities 5

6 PRIVACY AND CONFIDENTIALITY POLICY Pfiedler Enterprises is committed to protecting your privacy and following industry best practices and regulations regarding continuing education. The information we collect is never shared for commercial purposes with any other organization. Our privacy and confidentiality policy is covered at our website, and is effective on March 27, To directly access more information on our Privacy and Confidentiality Policy, type the following URL address into your browser: In addition to this privacy statement, this Website is compliant with the guidelines for internet-based continuing education programs. The privacy policy of this website is strictly enforced. CONTACT INFORMATION If site users have any questions or suggestions regarding our privacy policy, please contact us at: Phone: Postal Address: 2101 S. Blackhawk Street, Suite 220 Aurora, Colorado Website URL: 6

7 HISTORY OF ENDOSCOPES The use of endoscopes in surgery has markedly increased during the last century, although the fascination of performing surgery using a telescope dates back to Hippocrates. These early endoscopes used basic glass rods and hot incandescent light to visualize an object. Modern endoscopes use sophisticated prism rod lenses, fiber optics and a cold light source, which provides the surgeon with greater opportunity to perform more advanced surgical procedures than ever before. All surgical disciplines now enjoy the progress made in minimally invasive surgery (MIS) due to the advancements with endoscopes and instruments. Of course, instrument manufacturers were important partners to these pioneering surgeons and manufactured the many inventions, including the automatic insufflator, improved optics, thermo-coagulation devices, and the cold-light source. Today, both rigid and flexible endoscopes are an integral part of the instrument armamentarium used for a variety of surgeries that just a short time ago was only possible as open surgical procedures. These special scopes and their accompanying instruments continue to open new vistas for minimally invasive surgery. CARE OF ENDOSCOPES Rigid and flexible endoscopes are delicate instruments and must be treated with care to ensure they work properly during a procedure. Flexible and rigid endoscopes are constructed differently, but one thing remains the same: rigid and flexible endoscopes require special handling during every step of the reprocessing cycle - surgical use, cleaning, assembly, sterilization, transport and storage - to ensure they are in good working order for the next surgical procedure. It is very costly to repair and replace damaged endoscopes when steps for care, handling and reprocessing are omitted or improperly performed by personnel who handle them. The principles of caring for all endoscopes include: Handle properly to prevent damage. Educate the staff upon orientation and periodically to stay current with best practices. Understand the structure, functionality and surgical use of the endoscope. Utilize the manufacturer s IFU (Instructions for Use) and hospital protocol to properly clean, inspect, assemble, sterilize or HLD (High Level Disinfect) and store the endoscope. Handling and Transporting Endoscopes to CSSD (Central Sterile and Supply Department) Transport is one of the most vulnerable steps in endoscope reprocessing. It is very easy to co-mingle the endoscope with other instruments. Rigid endoscopes are easily damaged when heavy retractors, power equipment or other instruments are placed on top of them, which can result in severely bent or broken rod lenses or light-carrying fiber optics, or crushed operative channels. Flexible endoscopes, or fiberscopes, are easily damaged when they are bent, twisted or crushed between trays or heavy objects. The eyepiece and distal lens of an endoscope are prone to scratches or being shattered when not protected during transport. 7

8 It is very important to separate the endoscope from all other instruments after the procedure and while loading the transport cart with other instruments and instrument trays. An endoscope can be placed into a transport bag to prevent cross-contamination and debris from drying onto the endoscope. Consider placing the endoscope or the transport bag into a container with a lid so that no other instruments or equipment can be placed on top of the endoscope or transport bag during transport. CARE OF RIGID ENDOSCOPES Structure and Uses A rigid endoscope is a non-flexible instrument with a stainless-steel hollow tube that contains optical elements and light carriers for vision and illumination. The four basic parts of a rigid endoscope are (see Figure 1): 1. Distal lens or Objective Lens. Located at the distal end of the endoscope, the objective lens determines the viewing angle forward, oblique, lateral, or retrograde. 2. Shaft of Telescope. The optical element within the endoscope, the shaft is the most expensive and fragile part of the endoscope. There is row of glass lenses and spacers that are precisely aligned within a hollow portion of the endoscope in a row, or train. The fiberoptic light bundle runs parallel to the optical element within the shaft (see Figure 2). 3. Body (Light Post, Valves, or Stopcocks). The light post is at the end of the light bundle and allows the fiber light cable to be attached to the fiberoptic light bundle within the endoscope, transmitting light to the distal portion of the endoscope (see Figure 3). Valves or stopcocks may be a part of the rigid endoscope to assist in directing fluid or gases through the endoscope s channels. 4. Eyepiece. The eyepiece, or ocular lens, allows for direct viewing for the surgeon or for viewing by many by attaching a camera to the eyepiece and projecting the image onto a video monitor. Figure 1 Anatomy of a Rigid Telescope Objective Lens Eyepiece Shaft Light post 8

9 Figure 2 Telescope Shaft is the Optical Element of the Endoscope Figure 3 Light Fibers Fiber optic light fibers Rigid endoscopes are used for both diagnostic and operative procedures. Diagnostic endoscopes are used to view within a cavity or organ, but don t have any channels to pass instruments or devices to perform surgery (see Figure 4). Figure 4 Diagnostic Rigid Endoscopes Lack Channels Operative rigid endoscopes have channels or lumens to allow for irrigation, suctioning, or inserting instruments to perform a variety of surgical procedures, including: cystoscopy, hysteroscopy, operative laparoscopy, ureteroscopy, and bronchoscopy (see Figures 5 and 6). 9

10 Figure 5 Operative Rigid Endoscopes Have Channels Figure 6 Instruments Used with an Operative Rigid Endoscope Handling and Cleaning Rigid Endoscopes Always carry or handle a rigid endoscope by the eyepiece, not the shaft. Grasp the endoscope s ocular lens in the palm of the hand with the light post protruding between the index and second fingers. This prevents the endoscope from being bent from the weight of the eyepiece and minimizes the risk of the endoscope being dropped. Pre-Cleaning the Endoscope in the Patient Care Area The cleaning process should start immediately after the patient s procedure. Use sterile or tap water or, ideally, enzymatic detergent solution and complete the following steps: 1. Flush the channels with solution using a syringe or suction the solution through the channels. 2. Wipe the surfaces with a sponge dampened with water or enzymatic detergent or use an enzymatic detergent sponge. 3. Rinse the surface and suction the channels with tap or sterile water. 4. Secure the endoscope in a transport container with a lid or a transport bag to keep it moist during transport. Check the manufacturer s instructions before applying any enzymatic pre-treat spray to the endoscopes. 10

11 5. Place the secured endoscope within an enclosed transport cart and ensure there are no instruments or equipment lying on top of the endoscope. 6. Transport the secured endoscope to the Central Sterile and Supply Department (CSSD) or designated reprocessing area as soon as possible for terminal reprocessing. Never use sterile saline or saline solution of any kind to clean an endoscope! Saline can damage the metal and epoxy that hold the lenses in place. Disassembly and Cleaning in CSSD Using the manufacturer s instructions, disassemble any removable parts from the endoscope and place both the endoscope and accessories into an enzymatic detergent solution (see Figure 7). Allow the endoscope and parts to soak in the solution for the prescribed time to loosen debris in the channels and on the endoscope s surface. Do not use any abrasive cleaners or metal brushes to clean endoscopes. Never use an ultrasonic machine to clean an endoscope; the process will cause misalignment of the optic lens train or loosen the epoxy on the optical lens or the eyepiece. Figure 7 Disassembly of a Rigid Endoscope Brushing and Flushing the Channels Brush the channels of operative endoscopes with the correct-size brush. The brush needs to have the correct bristle diameter and length to fit the endoscope. The brush s bristles should touch the wall of the channel without folding or bending during cleaning. The correct method to brush the endoscope channels is as follows: 1. Always brush the channels while they are submerged in the enzymatic solution to avoid aerosolization of contaminants. 2. Always advance the brush completely through the channels past the distal end of the endoscope. Swish the brush bristles in the cleaning solution and then pull the brush completely back through the channels. Make sure the brush advances through the channels without kinking or bending. 11

12 3. Use a disposable brush if available. If using a reusable brush, ensure that the brush is routinely cleaned and disinfected. The brush bristles should be intact and not bent or broken and the brush shaft should be straight with no kinks or broken edges. After the channels are brushed and while the endoscope is submerged, flush the channels with the enzymatic detergent solution using a pressure device (syringe or pistol) that will push the enzymatic solution through the channels. Use the manufacturer s recommended pressure settings and number of pulses when using a water pistol or other flush device. Wash the outside of the endoscope with a soft cloth and brush the levers and stopcocks with a soft nylon brush. Do not use a brush to clean the eyepiece and the distal lens! Use only a soft cloth to clean these two lens areas. Rinsing the Endoscope and Channels Thoroughly rinse the scope s surface and channels with tap or, ideally, treated water for the number of flushes and pressure settings of the water pistol or flush device prescribed by the manufacturer. It is very important to rinse the detergent from the channels and endoscope to prevent detergent residue that can aid in the formation of biofilm. Biofilm is very difficult to remove and can impede sterilization or high-level disinfection. Tap water contains particulates that increase the possibility of the formation of biofilm within the channels or instrument surfaces. Tap water can be treated to remove some of the minerals and bacteria commonly found in tap water. This treated water can include water that is demineralized, deionized, or subjected to reverse osmosis. Check with your maintenance department to understand the water treatment process that is used for your decontamination area. Disinfection Prior to Assembly or Clean Storage Manual decontamination removes some bacterial contamination, but not all. For safe handling, your hospital may use a chemical disinfectant to manually or machine-disinfect the endoscope prior to transfer to assembly or clean storage. If your hospital uses a chemical to manually or machine-disinfect the endoscope, consult the manufacturers instructions for both the endoscope and chemical for the best method of use. Be sure to include an additional rinse and dry cycle following chemical disinfection. Always attach a label to the disinfected endoscope to document the pertinent disinfection information before transferring the endoscope for clean storage. An automatic washer-disinfector (AWD) may be used for rigid endoscopes that are heatstable. Endoscopes need to be secured in a special basket to ensure the endoscope s surfaces and channels are safely processed during a cycle in the AWD. Consult the endoscope manufacturer s instructions to ensure your rigid endoscope can be processed with the AWD at your facility. Inspection and Drying Prior to Assembly The endoscope is now ready for inspection prior to assembly into a tray or placement in clean storage if this is the hospital s practice. Ensure the scope is completely free of debris and is dry, especially the channels. Residual water can act as a bacterial breeding ground if left in the endoscope s channels. 12

13 Dry the channels with filtered compressed air or a syringe filled with air and follow with a flush of denatured alcohol. Dry the outside of the endoscope with a soft cloth. A drying cabinet also can be used to dry the endoscope. Use the protocols and prescribed materials from your hospital to perform random or routine quality checks for cleanliness of the endoscope and channels to ensure they are clean and dry. Inspection for Damage and Visual Quality Check the endoscope s exterior surface and objective lens for scratches, dents, burns or other damage before assembly into a tray. Check the endoscope for image clarity by performing the following steps: 1. Hold the endoscope about three inches from a non-glare printed page. 2. Move the endoscope toward the page until it is almost one-quarter inch away from the surface of the page. 3. Verify that the image is clear and sharp, without any distortion. Discoloration or haziness may be due to improper cleaning, rinsing, and moisture within the endoscope, or due to a broken optical lens or misaligned optics. The fiberoptic bundle should be checked for peppering or black dots or shadowy areas on the light post due to broken fibers. Check the fiberoptic bundles by performing the following steps: 1. Connect the endoscope to a portable light source, if available. 2. If a light source is not available, hold the light post toward a bright light to observe the light emitted from the objective lens and direct the objective lens toward a bright light and observe the light post. If black dots cover more than 30% of the light post, the endoscope should be sent in for repair or replacement (see Figure 8). The greater the blackened area, the dimmer the light will be during surgery. Figure 8 Light Post with Broken Fibers See Section on REPAIRS for proper protocol for preparing and shipping endoscopes for repair. 13

14 Packaging for Sterilization A rigid endoscope may be wrapped separately or containerized with other instruments, as prescribed by the manufacturer or by the facility s procedure. Endoscopes added to a tray with other instruments need to be protected so no other instruments are allowed to bump into or rest on top of the endoscope. Consult the manufacturer s instructions for the best packaging options. Details regarding sterilization and high-level disinfection are addressed in a later section of this educational activity. Transport to Clean or Sterile Storage Transport the clean endoscope that has been either disinfected or immediate-use sterilized to clean storage. Secure the clean, dry endoscope in a clean storage area that prevents cross-contamination or damage during storage. Ensure the endoscope has been labeled with the requisite reprocessing information before storage. Sterile packaged endoscopes should be stored in an environment recommended by the Association for the Advancement of Medical Instrumentation (ANSI/ AAMI ST 79:2010/ A2:2011, Section 8.9.2): temperature in storage areas should be approximately 75 F..., at least 4 air exchanges per hour, and relative humidity (to) not exceed 70% (AIA, 2006). 1 CARE OF FLEXIBLE ENDOSCOPES Structure and Uses A flexible endoscope s body is sheathed in a specialized flexible covering rather than the stainless steel used for a rigid endoscope. This flexible covering provides bending capabilities not available with a rigid endoscope. The distal lens offers a more panoramic view compared to a rigid endoscope. There are two types of flexible endoscopes: fiberoptic endoscopes and videoscopes. A fiberoptic endoscope has an eyepiece lens through which the image is viewed by direct vision or by using a camera connected to the eyepiece lens. A videoscope has the camera incorporated into the flexible fiberscope; it is equipped with a video chip positioned at the distal end of the endoscope ( chip on a stick ) to transmit the image directly to the video monitor. There are four main sections of a flexible endoscope (see Figure 9): 1. Control Body. This portion of the scope remains outside the patient and acts as a handle for the surgeon; it also contains the deflecting controls, biopsy port, airwater channels and eyepiece (if it is not a videoscope). 2. Insertion Tube. This is a flexible tube containing channels for the following items: a. operative devices, suction, irrigation and insufflation, b. light bundles that light from the light source to the internal body structure, and c. image bundles that carry the image from the body structure to the eyepiece or attached camera. 14

15 3. Deflection Controls. These are used by the surgeon to steer the lenses in various directions within the internal structure and manipulate the bending section at the distal tip. 4. Light-guide Connector Unit. This section connects to the light source; when using GI scopes, this would also include the suction and insufflation source. Figure 9 Anatomy of a Flexible Endoscope With its panoramic view and wide range of distal tip deflection, the flexible endoscope is useful for a variety of surgical procedures. Flexible endoscopes are used to view the following structures and organs: throat and respiratory structures (nasopharyngoscope, bronchoscope, laryngoscope), stomach and upper small intestine (gastroscope), the large intestine (colonoscope and sigmoid scope), the urinary bladder (cystoscope), the kidneys (nephroscope), the ureters (ureteroscope), and blood vessels and the heart (angioscope). Handling and Cleaning Flexible Endoscopes To correctly handle a flexible endoscope, hold the control body of the flexible endoscope with one hand and the distal tip with the other hand while maintaining a slight bend in the flexible insertion tube. The tip and control body can be secured using one hand but be careful not to severely bend the endoscope. Extreme bending of the flexible insertion tube can compromise the fibers inside the flexible tubing. It is important to protect the distal lens tip, as the lens can be broken if the distal tip is left to dangle and subsequently hit a hard surface during transfer and use. Flexible endoscopes are more complex to clean because of the construction and length of the instrument and there are more reported problems associated with cleaning them. These endoscopes are often cleaned using only a manual cleaning process, which requires an effective set-up and supplies to clean the endoscope according to the manufacturer s instructions. As detailed in the Multisociety Guidelines on Reprocessing Flexible GI Endoscopes (2011), of the reported cases of infection related to GI endoscopes, all of them were directly linked to the failure to follow the manufacturer s instructions related to proper cleaning. This section will detail a manual process, but also will include an automatic process using a machine like an Automatic Endoscopic Reprocessor (AER) or Endoscope Cleaning and Reprocessing (ECR), etc. These machines provide a level of quality that is difficult to replicate using only a manual 15

16 process for cleaning and disinfecting. The machine can deliver consistent process steps as well as measure and print out on the steps taken to reprocess the endoscope; these reports can be used for quality documentation. Pre-Cleaning the Endoscope in the Patient Care Area As with a rigid endoscope, pre-clean the flexible endoscope in the patient care area before transferring to CSSD or designated reprocessing area for terminal reprocessing: 1. Flush the channels with solution using a syringe or use the room suction to suction the solution through the channels (see Figure 10). 2. Wipe the surfaces with a sponge dampened with water or enzymatic detergent or use an enzymatic detergent sponge. 3. Rinse the surface and suction the channels with tap or sterile water. 4. Secure the endoscope in a transport container with a lid or a transport bag to keep it moist during transport. Check the manufacturer s instructions before applying any enzymatic pre-treat spray to the endoscope. 5. Place the secured endoscope within an approved transport cart and ensure there are no instruments or equipment lying on top of the endoscope. 6. Transport to the Central Sterile and Supply Department (CSSD) or designated reprocessing area as soon as possible for terminal reprocessing. Figure 10 Pre-Clean All Endoscopes in the Patient Care Area Never use sterile saline or saline solution of any kind to clean an endoscope! Saline can damage the metal and epoxy that hold the lenses in place. Transport after Procedure to a Terminal Reprocessing Area Flexible endoscopes can be used in various facility patient care areas that are unaccustomed to using and transporting flexible endoscopes. These patient care areas may be using the endoscope during off-hours or weekends (eg, Emergency Department, Respiratory Department, or CCU to list a few). All of these variables present a challenge to ensuring the flexible endoscope is used as intended, pre-cleaned after the procedure and returned in a timely fashion to reprocess. If the flexible endoscope is left unattended for any length of time, it is subject to possible damage and the debris from the procedure may dry and cake onto the inside of the channels. 16

17 Some facilities may recommend leaving the endoscope to soak in an enzymatic detergent solution until it can be transferred back to CSSD for reprocessing. Before implementing this step, ensure that the manufacturer has approved prolonged soaking in any solution. The best process is to pre-clean the endoscope in the procedure area, and if transport is delayed, place the endoscope in a transfer bag to keep it moist. The transfer bag should be secured in a basket or tray, seperated from other articles for transport. Arrange for transfer as soon as possible to avoid any possible damage and debris drying onto the fiberscope s surface or channels. Leakage Testing Leakage testing is the very first step that must be done before proceeding with any cleaning steps (see Figure 11). The leakage test will demonstrate if there is a hole in the covering or inner lining of the flexible endoscope. This test needs to be performed after each use AND before the flexible endoscope is cleaned or submersed. If there is a leak in the flexible covering, fluids can seep into the channels that house the viewing optics, the light fiber optics, and the cables that control the distal tip. If that happens, the endoscope can be further damaged and may require more costly repairs. Each flexible endoscope manufacturer recommends using the manual leakage tester designed for its particular flexible fiberscope. Ensure that you are using the correct equipment and process steps recommended by the manufacturer; there is no universal equipment to leak-test a flexible endoscope! Figure 11 Performing a Manual Leakage Test Steps to perform a manual leakage test are as follows: 1. Ensure that the hose of the leakage tester is attached to the leakage tester and that the hose s locking collar is in good working order. The leakage tester may be a machine or a manually operated device that looks similar to the bulb and gauge of a blood pressure machine. 2. Connect the leakage tester by tightening the locking collar onto the endoscope s connector for leakage test and pressure equalization. This connector is usually located on the side of the control body opposite the control levers. 3. Start the leakage test by either: a) activating the machine to the recommended pressure, or b) closing the knurled screw on the inflating bulb and inflating it to the recommended pressure. 17

18 4. The manufacturer may have you submerge the endoscope in clear water during the inflation step of the leakage test. If so, use only clear water and check the water for any air bubbles; watch if the pressure is falling on the pressure gauge. These are sure signs that the covering is compromised and the endoscope will need to be taken out of service for repair. A later section of this learning activity, REPAIRS, will describe how to prepare the endoscope prior to shipping for repair. 5. If the pressure remains constant and no air bubbles appear, the endoscope s covering is intact. 6. Release the pressure and wait! Release the pressure on the machine or manually unscrew the knurled screw on the inflating bulb. Ensure ALL of the pressure has been released before disconnecting the locking collar from the endoscope s connector. Proceed with disassembly and cleaning. Disassembly and Cleaning in CSSD Even if your facility has an automated machine to process the endoscope, it is recommended that a manual leakage test and a manual cleaning process are performed before using an automated machine. Make sure the gas cap is not connected to the endoscope during cleaning! The gas cap is only for low-temperature sterilization; do not attach it when using any type of liquid with the flexible endoscope. Always start with fresh enzymatic detergent solution and a clean, soft, lint-free cloth. Disassemble any removable parts from the endoscope and place into an enzymatic detergent solution (see Figure 12). Allow the endoscope and any parts to soak in the solution for the prescribed time to loosen any debris on the surface or in the channels. While the endoscope is soaking, use this time to brush the removable parts or wash the light cable. Do not use any abrasive cleaners or metal brushes to clean endoscopes. Flexible endoscopes should never be cleaned using the ultrasonic machine! Figure 12 Soak the Endoscope and Brush the Accessories 18

19 Brushing and Flushing the Channels Next, brush the inside of the endoscope channels and ports. The brush bristles should align to the diameter of the channel and should touch the wall of the channel without folding or bending during cleaning. The proper length ensures the brush will pass completely through the endoscope s channel. The correct method to brush the endoscope channels is as follows: 1. Always brush the channels while they are submerged in the enzymatic solution to avoid any contamination caused by aerosolization. 2. Always advance the brush completely through the channels past the distal end of the endoscope. Swish the brush bristles in the cleaning solution and then reverse the direction of the brush completely back through the channels. Make sure the brush advances through the channels without kinking or bending. 3. Use the proper-sized brush to clean all valves and ports. 4. Use a disposable brush if available. If using a reusable brush, ensure that the brush is routinely cleaned and disinfected. The brush bristles should be intact and not bent or broken, and the brush shaft should be straight with no kinks or broken edges (see Figure 13). Figure 13 Fit the Brush Bristles to the Channel After the channels are brushed and while the endoscope is submerged in the enzymatic detergent solution, flush the channels with a pressure device (syringe or pistol) that will push the enzymatic solution through the channels (see Figure 14). Wash the outside of the endoscope with a soft cloth and brush the levers and stopcocks with a soft nylon brush. Figure 14 Flush the Channels with the Correct Pressure Device 19

20 Do not use a brush to clean the eyepiece and the distal lens! Use only a soft cloth to clean the eyepiece and distal lens. Rinsing the Endoscope and Channels Thoroughly rinse the scope s surface and channels with tap or, ideally, with treated water for the number of flushes prescribed by the manufacturer. It is very important to use the prescribed pressure settings for the pressurized water flush device! Pressure that s too high can cause the channel s lining to tear, resulting in unnecessary repairs. Use the water flush device recommended by the manufacturer and the manufacturer s prescribed pressure and number of pulses for the device. It is very important to rinse all detergent from the channels and endoscope. Detergent residue could impede sterilization or highlevel disinfection and aid in the formation of biofilm. Disinfection Prior to Assembly Decontamination removes some bacterial contamination, but not all. For safe handling, your hospital may use a disinfectant prior to transferring the endoscope to the assembly side of CSSD or transfer to the patient care area for clean storage or further processing. A disinfection cycle can be completed manually, with a machine that only disinfects, or with a machine that cleans and disinfects. When using a manual process, ensure that all of the disinfectant solution has direct contact with all surfaces and channels of the endoscope in order for the chemical to be effective. Follow the manufacturer s instructions for details on disinfection following manual cleaning, whether that is a manual or machine process. The automated machines can be referred to as an AER (Automatic Endoscope Reprocessor) or an ECR (Endoscope Cleaner Reprocessor) and are designed for further cleaning and disinfecting. Some machines will only perform disinfection, some will perform sterilization (STERIS System 1E), and some will do all the steps: leakage testing, cleaning, disinfection and drying (ECR). Perform the following steps before using an automated machine: 1. Ensure that the machine has been approved by the flexible endoscope s manufacturer. 2. Manually perform a leakage test before manual cleaning and manually clean before placing the flexible endoscope into a machine. 3. Ensure that all users understand the capability of the machine; don t use a machine to clean and disinfect when the intent of the machine is only to disinfect. 4. Ensure that the operating steps, chemicals used, and quality tests for the machine are all performed according the machine manufacturer s instructions. Not all endoscopes are validated for all the various types of automatic reprocessing machines (AER, ECR, STERIS System 1E, etc.). Always refer to the endoscope manufacturer s instructions to ensure that the machine is safe to use for the flexible endoscope. 20

21 Drying the Channels Prior to Assembly Dry the channels with a filtered, compressed air device or a syringe. Be sure to stay within the pressure limits set forth by the manufacturer for a compressed air device. Pressure that is too high can tear the interior wall of the channel and cause damage later on. It is recommended to flush the channels with denatured alcohol for optimal drying. Dry the outside of the endoscope with a soft cloth. A drying cabinet also can be used to dry the endoscope (see Figure 15). Hang the flexible endoscope in a vertical position and leave it in the cabinet for the time recommended by the cabinet s manufacturer. Figure 15 Hang a Flexible Endoscope in a Drying Cabinet There are many products available to assist with performing quality checks for the cleaning process of the flexible endoscope s channels. Use your facility s prescribed materials to perform random or routine quality checks of the cleaning process to ensure the channels are completely free of debris and water. These quality checks may be performed before disinfection to ensure the best outcome of disinfection. Inspection for Damage and Visual Quality Use the following steps to inspect the flexible endoscope for damage: 1. Inspect the eyepiece for cloudiness or scratches. 2. Move the handle back and forth while watching the end of the flexible endoscope move to ensure there are no broken cables. 3. Check the connection of the flexible insertion tubing to the control body. There should be no separation at the connection point. 4. The covering on the flexible insertion tube should have no slits, cracks, burns or holes. 5. The distal lens should have no cracks or scratches. Check the endoscope after each use for image clarity as follows: 1. Hold the endoscope about three inches from a non-glare printed page. 2. Move the endoscope toward the page until it is almost one-quarter inch away from the surface of the page. 21

22 3. Verify that the image is clear and sharp, without any distortion. Discoloration or haziness may be due to improper cleaning or rinsing, moisture within the endoscope, a broken optical lens, or misaligned optics. The fiberoptic bundle should be checked for peppering or black dots or shadowy areas on the light post due to broken fibers. Check the fiberoptic bundles by performing any of the following: 1. Illuminate the light bundles with a portable light source and look through the eye piece to ensure there is adequate light (see Figure 16). 2. If no portable light source is available, hold the light post toward a bright light and observe the light emitted from the objective lens. 3. Direct the objective lens toward a bright light and observe the light post. Figure 16 Check the Light Output with a Portable Light Source Less than 30% of the light post should have any visible black dots. The greater the blackened area, the dimmer the light will be when the endoscope is used in surgery. Send the endoscope for repair if any one of these defects is present. See section on REPAIRS for proper protocol before sending endoscopes for repair. Packaging for Sterilization or Storage Flexible endoscopes are considered heat-sensitive endoscopes. Low-temperature gas sterilizers are commonly used to provide terminal sterilization for flexible endoscopes. The flexible endoscope is placed into a suitable sterilization tray with internal sterility assurance indicator(s) and the following is to be completed before wrapping or containerizing: 1. Always, always, always connect the gas cap (aka pressure equalization cap) to the endoscope s connector (the same connector used for the leakage test)! 22

23 The covering of the flexible endoscope cannot withstand the pressure gradient created during sterilization. If the gas cap is not connected before sterilization, the covering on the outside or inside of the channel can split or crack. 2. Ensure that the flexible endoscope s insertion tube is not crimped or severely bent in order to fit into the tray, as this may damage the internal fibers. 3. Ensure that the insertion tube and distal tip are secure in the tray so they do not become crushed or pinched during sterilization or transport. Wrap the tray or container and proceed with low-temperature sterilization. More information regarding low-temperature sterilization is provided in the next section of this learning activity. A flexible endoscope may be placed into clean storage following high-level disinfection. The following steps ensure safe storage for the flexible endoscope: 1. Ensure that the decontamination process that is prescribed pre-storage is completed according to the manufacturer s instructions and the facility s protocol. 2. Complete a disinfection process before storing. 3. Ensure that the endoscope is completely dry before placing in clean storage! Ensure that the steps for drying the flexible fiberscope and channels have been completed. 4. Place a hang tag on the endoscope and list: disinfection process used, date it was last processed, the scope s serial number, and the processor s initials. 5. Ensure that the endoscope is hung in a vertical position and is protected against damage or cross-contamination. 6. Process the flexible endoscope according to the facility s protocol immediately before using for patient care or as detailed in the facility s protocol. STERILIZATION AND HIGH-LEVEL DISINFECTION In 1968, Dr. Earle Spaulding developed a classification system for cleaning and reprocessing instruments and equipment according to the level of infection risk associated with their intended use. He divided the risk level into three categories, all related to body contact: critical (entry or penetration into sterile tissue, cavity or bloodstream), semi-critical (contact with intact non-sterile mucosa or non-intact skin) and noncritical (intact skin). Instruments defined as critical should always be sterilized before use. Instruments considered semi-critical should be at least high-level disinfected (HLD) or, ideally, sterilized. Instruments classified as noncritical should be washed and treated with a lowlevel disinfectant or detergent and water (see Table 1). 23

24 Table 1 Spaulding Classification System Spaulding Classification System Body Contact Level of Risk Disinfection Requirements Entry or penetration into Critical Sterilization sterile tissue, cavity or bloodstream Intact non-sterile mucosa or Semi-critical Sterilization or HLD non-intact skin Intact skin Non-critical Low-level Always check the manufacturer s instructions for material compatibility and sterility efficacy for endoscopes and instruments. Facilities also should refer to the Spaulding Classification when choosing the reprocessing method most appropriate to the risk of infection related to the use of endoscopes and instruments. Use an open tray, rigid container, or tyvek pouch suitable for terminal sterilization, including sterility assurance indicators, to package the instrument. Wrap in a tray using sterilization wrap or containerize into a rigid container (see Figures 17 and 18). Figure 17 Rigid Endoscope Ready for Final Packaging and Sterilization Figure 18 Flexible Endoscope in Sterilization Tray 24

25 The manufacturer validates an endoscope for terminal sterilization based on two criteria: material compatibility (ie, whether or not the material will tolerate the sterilization method) and sterilization efficacy (ie, whether or not the item can be rendered sterile using a particular method). An autoclave, or steam sterilizer, uses high heat under pressure and is the oldest and most reliable sterilization method. However, some endoscopes cannot tolerate the high heat and will need to be processed in a low-temperature alternative. A variety of low-temperature sterilization machines use a gas for the sterilant agent: Ethylene Oxide (EO), Hydrogen Peroxide Gas Plasma or Hydrogen Peroxide Gas Vapor. EO is the oldest and most effective low-temperature gas sterilization method but requires a long aeration time (up to 14 hours), which may delay surgery schedules. Hydrogen peroxide gas is a newer method for low-temperature sterilization. The entire cycle time for hydrogen peroxide sterilization is quick, with a complete sterilization cycle as short as minutes. The machine used for this method quickly converts hydrogen peroxide gas to plasma (STERRAD f ) or to vapor (STERIS V-PRO) and has no residue, doesn t need any aeration time, and doesn t require any special venting or drains. Sterilizers using peracetic acid are considered immediate-use sterilizers. The machine requires a drain, water plumbing and special filters for the water input. A flexible endoscope using this process will be wet when the cycle is done, which requires the endoscope to be used immediately following sterilization. Consult the endoscope manufacturer s instructions to ensure that an endoscope can be sterilized using this method. Endoscopes can be processed with chemicals for high-level disinfection (HLD) or immediate-use sterilization. Common chemicals for either HLD or immediate-use sterilization include ortho-phthalaldehyde (OPA) or glutaraldehyde. Check the following before proceeding with chemical processing: 1. Consult the manufacturer s instructions for recommended chemicals and exposure times to achieve either HLD or sterilization. 2. Consult the Spaulding classification system before processing an endoscope to 25

26 ensure the chosen method aligns with the infection risk level. 3. Review the chemical s label for handling, exposure time, usage, and warnings before proceeding. HLD chemicals should be used in a hooded area to evacuate any fumes from the product. Always check the endoscope manufacturer s instructions before using a disinfectant for HLD or immediate-use sterilization. RIGID AND FLEXIBLE ENDOSCOPIC SUPPORT EQUIPMENT There are several pieces of support equipment that are essential for the performance of rigid and flexible endoscopes, which may include: Light Source. Equipment that produces the light for the scope. Fiberoptic Light Cable. Composed of thousands of glass fibers that are coated with a layer of glass to create a bundle. Camera and Monitors. A camera attached to the eyepiece that can transmit the image onto a monitor that allows the surgeon, as well as the surgical team, to view the body structures without having to look directly into the eyepiece of the endoscope. Video Printer, CD Burner, Memory Stick. Devices that allow the surgeon to videotape, take still pictures or store images for future use, or to add as documentation to the permanent medical record. Fluid Pump or Insufflator. Used to distend the organ or body space for better visualization. Operative instrumentation. Variety of instruments that can aid in surgical procedures (scissors, graspers, electrosurgery desiccators, biopsy forceps, retractors). Cannula/Trocar Sets. Used to create a passage from the outside of the body into a cavity or organ. REPAIRS An endoscope cannot be used if defects are found during inspection. An endoscope should be cleaned and disinfected according to the instructions of the manufacturer and prior to shipping to a repair center. Follow your facility s policies concerning shipment of used equipment for repair and label the shipping container in accordance with the Occupational Safety and Health Administration (OSHA) Occupational exposure to bloodborne pathogens requirements: CFR 29 part 1910:1030, Federal Register (December, 1991). QUALITY REVIEW AND IMPROVEMENTS OF THE PROCESS 26