Purpose To provide adequate disinfection for reusable semi-critical equipment other than scopes. Processing of scopes is covered in 01.05.04. Audience Policy Guidelines for High- Level All those in the UTMB Health System who clean, disinfect, sterilize or store patient care instruments and other healthcare items. Reusable semi-critical equipment will be processed as described below and stored in a manner to prevent re-contamination. Equipment must always be cleaned per manufacturer s instructions for use (MFG IFU) prior to high-level disinfection. Transportation of contaminated equipment will be in impermeable containers labeled biohazard. 1. For those departments that perform high-level disinfection with chemicals, the area for reprocessing should be separated from the area where items are stored. If only two sinks other than the handwashing sink are available, one should be designated clean and the other dirty. 2. Cidex ortho-phthalaldehyde (OPA) is used for high level disinfection. OPA does not irritate the eyes and nasal passages, does not require exposure monitoring, has a barely perceptible odor and requires no activation. It will stain proteins grey and must be thoroughly rinsed to prevent discoloration of the patient s skin and inflammation of mucous membranes. 3. Cidex OPA solution should be stored in its original sealed container at controlled room temperature 15-30 C (59-86 F) in a well-ventilated, low traffic area. The expiration date of the Cidex OPA solution is found on the original container as received from the manufacturer. Once opened the unused portion of the solution may be stored in the original container for up to 75 days until used. Calculate 75 days from when the original container was opened and record this date on the bottle. Verify that the expiration date on the original container is longer than 75 days. 4. Reprocessing should be performed away from patient care areas, and the area should be well-ventilated. The area must have sufficient air changes to prevent build up of vapor. Healthcare workers who process instruments in Cidex OPA must wear PPE including face shield, fluid-resistant gown and gloves. If latex gloves are used, don 2 pair of gloves. A single pair of gloves may be used if made from 100% synthetic copolymer, nitrate rubber or butyl rubber. 5. The bucket and tray systems used for OPA disinfection must be made from polypropylene, acrylonitrile-butadiene-styrene, polyethylene, glass-filled polypropylene and/or polycarbonate plastics. Prior to placement of instruments into the disinfectant solution, they must be thoroughly cleaned with a suitable detergent by brushing the surfaces to remove all blood, body fluids, tissue and any other foreign matter. Hinged instruments must be opened to permit thorough removal of all organic material. Lumens in instruments must be thoroughly brushed and irrigated until clean. 6. The soaking bucket or tray containing OPA solution must be labeled with name of Page 1 of 12
Processing Ultrasound Probes with Trophon EPR the solution, date of first use, and date of expiration. The instruments must be fully immersed, hinged instruments opened, instrument lumens filled with disinfectant and the cover closed. High-level disinfection requires 12 minutes for OPA. 7. Checking the MEC of the OPA solution must be monitored with a chemical test strip and results documented each time the solution is used. 8. The temperature of OPA solution must be checked and documented each time the solution is used. Minimum temperature required is 20ºC or 68ºF. The sole purpose of the Trophon EPR is to high level disinfect validated ultrasound probes (see section B2.1) according to the specified processes outlined in this manual. It is not intended for any other use. Do NOT use this device for any application other than its expressed purpose. The Trophon EPR together with the Sonex-HL is a high-level instrument grade disinfectant system. The Trophon EPR is NOT intended to reprocess single use devices The Trophon EPR is NOT intended to pre-clean ultrasound probes The cable management system is an accessory designed for use with the Trophon EPR (see section A4.2) Chemical Indicator use is required with every disinfection cycle. More information can be found in the Chemical Indicator Instructions for use, provided with the Chemical Indicator. The Trophon Printer, Trophon Connect, Trophon Wall Mount and the Trophon Cart are accessories designed for use with the Trophon EPR; contact your customer service representative or visit the Nanoionics website for additional information. Refer to Part D for information on the Trophon Print At the beginning of the cycle, the Trophon EPR creates an aerosol of concentrated hydrogen peroxide. This is quickly and evenly distributed over the surface of the probe, including very small crevices. This process provides thorough, high level disinfection of the shaft and the handle of the probe. The device breaks down the hydrogen peroxide into small amounts of water and oxygen and safely vents them into the external environment Pre-cleaning and transportation of probe from procedure room 1. Perform hand hygiene and don clean gloves. 2. Remove 2 appropriate MFG recommended wipes from container and place on clean counter. 3. Place 2 paper towels side-by-side on clean counter. 4. After procedure, remove condom from probe and discard condom in regular trash in exam room. 5. Use one wipe to remove excess ultrasound gel from probe. Use a cotton tipped applicator to remove any particles from grooves in the probe. Place probe on clean paper towels on counter. 6. Use second wipe and start with probe end and follow through to end of power cord. Inspect probe to ensure all residual ultrasound gel has been removed. Repeat step if necessary. 7. Place probe on clean paper towel. 8. Remove gloves and perform hand hygiene. 9. Don clean glove. 10. Transport clean trans-vaginal probe to Trophon room in a covered impermeable container labeled biohazard. High-level disinfection I. Load disinfectant cartridge Page 2 of 12
II. III. 1. Perform hand hygiene and don clean gloves and safety glasses. 2. Always check expiration date on the cartridge before use. If the cartridge has expired, contact EHS for disposal (ext 21781. Do not attempt to open or load a damaged cartridge or a distorted cartridge. Do not manually pierce the cartridge. 3. For a list of probes that may be disinfected in the Trophon EPR, refer to the following: Nanosonics website @ www.nanosonics.us. Note: only validated probes may be placed in the Trophon EPR. 4. Visually inspect probe to ensure probe is free of all organic material and is dry BEFORE proceeding with the high-level disinfection process. If probe still contains organic material, repeat step 5 under cleaning. 5. Load cartridge 6. Cartridge door will automatically open when cartridge needs replacing. Do NOT force cartridge door open as this may damage and render the device nonfunctional. 7. Screen message: CARTRIDGE EMPTY. REPLACE CARTRIDGE NOW is displayed. 8. Press the button under OK to open the cartridge door. 9. Do not insert empty cartridges into the device. Remove gloves and safety glasses and perform hand hygiene. Note: refer to IFU enclosed with Trophon Sonex-HL for detailed instructions on installation and/or replacement of Trophon Sonex-HL cartridges. Note: cartridges will last for approximately one month from date of installation, depending on usage and whether the device has been switched off. 10. If the Trophon device is in Sleep Mode, press the restart button. The screen should display message WAKING UP FROM SLEEP. 11. When the device is ready, screen message will be LOAD PROBE AND INDICATOR. 12. Open the chamber door and load the probe, ensuring the probe is straight and not touching the walls or the bottom. The tip of the probe must be above the embossed line. 13. Refer to diagram in user s manual for loading the probe Load the probe wearing gloves, follow diagram in user s manual Load the Chemical indicator 14. See diagram in users manual. PPE required: gloves 15. A Chemical Indicator must be used for each disinfection cycle and can only be used once. Place the chemical indicator in the holder on the floor of the device chamber, red side up. (Note: verify expiration on indicator prior to use. 16. Follow the diagram for loading the chemical indicator in the MFG: IFU IV Process 1. Closing the Chamber Door If the door is not properly closed, screen message will be displayed CLOSE CHAMBER DOOR. 2. The next Screen message will be: IS THE PROBE CLEAN AND DRY? Respond YES if the probe has been cleaned and dried. 3. Once the device is ready, screen message: PRESS START TO BEGIN Press the START button to initiate the cycle. Screen message will be DISINFECTIONG. Remove gloves and perform hand hygiene.. High Level cycle will take 7 minutes to complete 4. When the cycle has been successfully completed, the device will sound an audible alarm. Screen message: CYCLE COMPLETE REMOVE AND WIPE PROBE. Perform hand hygiene and don clean gloves NOTE: If the probe is not removed within 1 minute of the cycle being complete, the warm-up time will increase for the subsequent cycle. IV. Check chemical indicator1. 1. Remove the used Chemical Indicator from the device and verify the chemical indicator color change from red to orange or lighter to validate successful high-level disinfection before discarding. Follow diagram in the user s manual Page 3 of 12
2. If the chemical indicator passes (refer to Chemical Indicator Insert), remove probe and wipe the probe with a lint-free cloth. Visually inspect the probe and ensure any peroxide residue is removed. Cove the probe with a peel pack. 3. Document the results of the chemical indicator and other required information on the log after each use. 4. Transport probe to probe rack for storage or store probe in probe rack located next to the Trophon EPR. Remove gloves and perform hand hygiene 5. Required information Printer labels: 2 labels will print after each cycle. Items a-c will automatically print on the labels. Items d-g must be recorded manually on the labels. Place one label on the Trophon Log Sheet and the other on the peel pack palced over the probe. a. Date and time of cleaning b. Cycle number c. Trophon LCD Status (pass or fail) d. Chemical indictor status (pass or fail) e. Operator s initials f. Probe # g. MRN of patient probe was used on 6. If chemical indicator fails, refer to section B2.7.2 in MFG IFU. 7. Incomplete or failed cycle: refer to MFG IFU section B5. Document corrective action next to notes section on printed label below patient s medical record number. 8. Routine Care and maintenance: refer to MFG IFU Section B6 9. Maintenance issues: contact CES and 76143 and notify supervisor. V. Remove disinfectant cartridge 1. Perform hand hygiene. Don clean gloves and safety glasses. 2. The device will automatically prompt to run a purge cycle if the cartridge has expired. 3. Screen message will say REPLACE THE CARTRIDGE AND CLOSE CARTRIDGE DOOR 4. Cartridge door opens automatically. Do not use excessive force to open. 5. Lift cartridge out by touching the areas exposed while the bottle is in the holder and avid touching pierced areas. 6. Empty used cartridge should be disposed of in nearest waste receptacle. TEE- High-level disinfection by immersion is the accepted method of infection control for Echocardiog transesophageal transducers. Philips recommends that a protective transducer cover be raphy Lab used during studies. This procedure covers cleaning and disinfecting the various parts of the transducer. Different solutions may be used on different parts. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions. Before performing this procedure, read Warnings and Cautions, Transducer Care and Operator Safety, and Warnings and Cautions for TEE Transducer Care. Cleaning and Disinfecting TEE Transducers 1. Disconnect the transducer from the system, and remove any accessories attached to or covering the transducer. 2. Clean the transducer distal tip and flexible shaft using any of the following: enzymatic cleaner, mild soap solution, or an approved wipe. Follow the manufacturer's instructions for use. Do not use iodine-based soaps. 3. Use water to gently rinse the distal tip and flexible shaft thoroughly. Do not rinse or Page 4 of 12
Other equipment not specified Off-Site Transportatio n of Sterile Items immerse the handle, steering mechanism, cable, or connector. 4. Choose a high-level disinfection solution compatible with your transducer. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions. Follow the label instructions for preparation and solution strength. If a pre-mixed solution is used, be sure to observe the solution expiration date. 5. Disinfect the distal tip and flexible shaft by placing them into the appropriate disinfectant as shown in the illustration. Follow the instructions on the disinfectant label for the duration of transducer immersion. Do not immerse transducers longer than the minimum time needed for your level of disinfection 6. Remove the distal tip and flexible shaft from the disinfectant and thoroughly rinse with water according to the instructions from the disinfectant manufacturer. 7. Check the transducer for any residual organic material. If any is present, remove it and disinfect the transducer again. 8. Gently dry the distal tip and flexible shaft with a sterile cloth or pad, or allow it to air dry. 9. Lightly wipe only the steering mechanism and handle with a pad moistened with rubbing alcohol (70% isopropyl alcohol), or use approved cleaners as directed on the handle and steering mechanism. 10. Use a soft cloth lightly dampened in a mild soap or detergent solution to clean the cable, the strain reliefs, and the connector. A soft-bristled brush can be used to clean only the metal surfaces of the connector. 11. Choose the disinfection solution compatible with your cable and connector. For a list of compatible disinfectants, see Choosing Disinfectants and Cleaning Solutions. Follow the label instructions for preparation and solution strength. If a pre-mixed solution is used, be sure to observe the solution expiration date. 12. Wipe or spray the cable, strain relief, and connector with the disinfectant, following disinfectant label instructions for wipe durations, solution strengths, and duration of disinfectant contact with the cable. Ensure that the solution strength and duration of contact are appropriate for the intended clinical use of the device. Ensure that the disinfectant solution does not enter the device. 13. Hang the transducer on a wall-mounted rack, and let it air dry. 14. Examine the transducer for damage, such as cracks, splitting, fluid leaks, or sharp edges or projections. If damage is evident, discontinue use of the transducer and contact your Philips representative Always follow MFG IFU. Minimum PPE when cleaning and disinfecting equipment: gloves. Perform hand hygiene and don new gloves when moving from dirty to clean part of process. Item must be clean prior to soaking in OPA. Rinse with filtered water, dry and store in accordance with MFG IFU and department protocol. Off-site transportation from SPD on the UTMB campus to the hospital/clinics will be carried out using closed containers, and closed containers will be used for items being returned to SPD. Page 5 of 12
References 1. Rutala WA, Weber DJ. Selection and Use of Disinfectants in Healthcare, In Mayhall, CG, Ed. Hospital Epidemiology & Infection Control. Fourth Edition, Lippincott Williams and Wilkins, 2012. 2. Association for the Advancement of Medical Instrumentation. Quality Control 2010:10:97-136. 3. Young M. Quality control of table-top steam sterilizers. Managing Infection Control 2007; 82-97. Page 6 of 12
QUALITY CONTROL PROCEDURE FOR CIDEX OPA TEST STRIPS Processing Steps: STORAGE AND USE OF OPA TEST STRIPS CIDEX OPA TEST STRIPS must be discarded 90 days after the bottle is opened or on the expiration date of the bottle, whichever comes first. The test strip bottle must not be left open for more than 30 minutes. Keep the bottle tightly closed after removing the test strip. Do not refrigerate or freeze the bottle of test strips Protect the strips from heat, light and moisture PREPARATION OF CONTROL SOLUTIONS Use full strength CIDEX OPA Solution as a positive control. To prepare a negative control, dilute 1 part CIDEX OPA Solution with 1 part of water. TESTING PROCEDURE Submerge 3 test strips in each freshly prepared solution for 1 second each. Remove. The 3 strips dipped in full strength positive control solution should exhibit a complete purple color on the indicating pad at 90 seconds. The 3 strips dipped in the diluted negative control solution should either remain completely blue or exhibit an incomplete color change to purple at 90 seconds. Refer to the color chart on the test strip bottle for interpretation of results. TESTING FREQUENCY The testing of positive and negative controls should be performed on each newly opened bottle of CIDEX OPA Solution Test Strips. Testing of freshly prepared positive and negative controls should be performed when test strips are improperly stored or handled. UNSATISFACTORY QC TEST PERFORMANCE If the results obtained from using positive and negative controls indicate the test strip is not functioning properly, discard strips. DO NOT USE STRIPS. Chec k () Comments/follow-up Surveyor s Name: Surveyed HCW s Initials: Survey Date: Surveyed Area: Page 7 of 12
CIDEX OPA TEST STRIPS QUALITY CONTROL LOG Location/Department: Purpose: Document performing quality control of the Cidex OPA Quality Control strips when a new bottle of strips is opened. Definitions: a Expiration date is printed on the label by the manufacturer b Discard date is calculated by adding 90 days to the open date of the strips c Quality control means both positive and negative controls are performed each time a new bottle of QC strips is opened. Procedure to Prepare the Positive & Negative Controls: POSITIVE Control - use full strength, activated Cidex OPA (30 ml); NEGATIVE Control is one part activated Cidex OPA (15 ml) and one part water (15 ml). Timing is critical. Insert 3 strips into each of the two control solutions for (1) second. Remove excess solution by standing up the strips. Read results in exactly ninety (90) seconds. Controls Results: To PASS on the positive controls, the dipped QC strip(s) must turn purple; if any blue appears on indicating pad apart from the top line, the solution did not pass ( FAILS ); to PASS on the negative controls, the strip color is blue or blue/purple. *Corrective Action Key: use the following key to denote action if either control did not pass: D: Cidex OPA Solution Test Strips discarded today because test failed; D1: Cidex OPA Solution Test Strips discarded today because bottle was left open; D2: Cidex OPA Solution Test Strips discarded today because bottle was not dated when opened. Test Date Year Cidex OPA Solution Lot# and Manufacturer a Expiration Date Cidex OPA Strips Lot# and Manufacturer a Expiration Date Cidex OPA Strips: Date Opened and Calculated b Discard Date c Positive Quality Controls All 3 results:(pass/fail) Pass = only purple color c Negative Quality Controls All 3 results:(pass/fail) Pass = Blue or blue/purple Print Employee Name performing Quality Controls *Corrective Action Key (use reverse side for comments) Page 8 of 12
PROTOCOL FOR HIGH-LEVEL DISINFECTION CIDEX OPA Chec Processing Steps: k () CIDEX OPA CONTAINER Label with chemical name (if not official Cidex container). Cover fluid at all times. MSDS sheets for Cidex OPA should be easily accessible. Label container with expiration date and initial each time the chemical is changed. Cidex OPA must be discarded at 14 days even if the OPA Test Strips indicate that there is a minimally effective concentration (MEC) in the Cidex OPA solution. TEST STRIPS Date bottle of test strips when opened (expiration at 90 days or the expiration date on the bottle of test strips, whichever comes first). Cidex OPA working solution must be tested EACH TIME when medical instruments are reprocessed. Dip test strip into solution for 1 second. Do not shake strip after removal. Remove excess solution from the pad by standing the strip upright on a paper towel. Read the results of the chemical reaction 90 seconds after the test strip has been removed from the solution. The entire indicating pad must be completely purple to pass the test indicating an effective concentration of the solution. Compare this color reaction to the color chart on the side of the test strip bottle. If any blue appears on the indicating pad apart from the top line, this is a failure, verifying the solution is below the MEC and should be discarded. Document the results of the test strip. If the color of the test strip matches the fail panel on the color chart: Check the test strips expiration date. If the test strips are out of date, discard and retest with new strips. If test strips are in-date, discard solution, rinse out container, and refill with fresh solution. Retest new solution and document test results. Cidex OPA working solution temperature must be checked each time medical instruments are reprocessed. SOAKING IN CIDEX OPA Cidex OPA is a high-level disinfectant. Do not soak instruments in Cidex OPA prior to steam or plasma gas sterilization Do not soak single-use disposables. They must be discarded after use All instruments that cut or biopsy must be sterilized (do not soak in Cidex OPA). Instruments that are soaked in Cidex OPA must be pre-washed in enzymatic solution prior to high-level disinfection. ALL particulate matter must be removed (brushes and enzyme cleaners are available for this process) Instruments must be TOTALLY SUBMERGED in the solution. All lumens must be filled and air pockets eliminated. Instruments must soak for 12 MINUTES using a timer at a minimum of 68ºF or 20ºC. After removal of instruments from the Cidex OPA solution, they must be Comments/follow-up Page 9 of 12
rinsed in 2 gallons of *filtered tap water. The devices must be submerged for at least one minute. All lumens must be irrigated with at least 100 ml of water. After the initial rinse, the water must be used for no other purpose and discarded. This rinse process will be repeated with 2 gallons of fresh *filtered tap water 2 more times for a total of three (3) rinses. * 0.2µ filter Surveyor s Name: Surveyed HCW s Initials: Survey Date: Surveyed Area: Page 10 of 12
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QUALITY CONTROL PROCEDURE FOR 3M COMPLY RAPICIDE MONITORS PREPARATION OF CONTROL SOLUTIONS To prepare positive and negative control solutions for testing, obtain a container of Rapicide High-Level Disinfect and Sterilant solution. Verify that the solution has not met or exceeded the labeled expiration date. For the positive control, the full strength solution should be used. To prepare a negative control, dilute one part of full strength Rapicide High-Level Disinfectant and Sterilant solution with one part of room temperature water. Label each control solution appropriately. TESTING PROCEDURE Following the directions for use, dip three indicator strips in each of the above freshly prepared solutions. The three strips dipped in the full strength positive control solution should exhibit a complete red color on the indicator pad when read at 75 seconds. The three strips dipped in the diluted negative control should either remain completely yellow or exhibit an incomplete color change to red when read at 75 seconds. Refer to the visual standard on the test strip bottle for interpretation of the results. This visual is also displayed below. Chart here?: TESTING FREQUENCY It is recommended that the testing of positive and negative controls be performed on each newly opened test strip bottle of Rapicide Glutaraldehyde Indicator test strips. After this initial testing, it is recommended that testing of freshly prepared positive and negative controls be performed on a regular basis as established by your own quality control procedures and program. This testing program will serve to minimize errors between different users, use of outdated materials or product that has been improperly stored or handled. UNSATISFACTORY QC TEST PERFORMANCE If the results obtained from using the positive and negative controls indicate the test strip is not functioning properly, discard the remaining strips. DO NOT USE. For customer support, contact Medivators at 1-800-444-4729. Page 12 of 12
QUALITY CONTROL PROCEDURE NOTE: Single use disposables must not be reprocessed. Instruments that cut or biopsy must be sterilized. DEPARTMENT OF HEALTHCARE EPIDEMIOLOGY Page 13 of 12