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Reprocessing Instructions LoneStar™ Retractors Model 1100 Series Aluminum Retractors • Model 2200 Series Stainless Steel Retractors INTRODUCTION This document is intended to provide detailed instructions for effectively processing reusable LoneStar™ Retractors, both aluminum and stainless steel. All reusable instruments should be thoroughly cleaned and sterilized to prepare them for use. Reusable instruments must be inspected each time they are processed to determine when the end of serviceable life has been reached and can no longer be safely used. Instruments which can be disassembled should be disassembled for cleaning to ensure maximum contact between surfaces and cleaning tools and solutions. (See specific instructions for each instrument) CooperSurgical, Inc. has validated the processes provided in these instructions to be capable of effective instrument processing. Equipment, operators, cleaning agents and procedures all contribute to the efficacy of processing. Healthcare facilities should ensure that selected processing steps are safe and effective within their systems. Alternative methods of processing these instruments outside the instructions described in this document may be suitable for reprocessing; however, these have not been evaluated by CooperSurgical, Inc. Operators and healthcare facilities which choose to perform processes outside the instructions described in this document must validate these processes before use. In the event that national or regional government requirements conflict with the recommendations provided here, these shall override the recommendations of CooperSurgical, Inc., but must be validated before use. WARNINGS AND PRECAUTIONS Some accessories used with the LoneStar Retractors (e.g. stays) are single use materials. Single use accessories used with the reusable instruments should be discarded after use. CooperSurgical, Inc. cannot guarantee that the single use accessories will perform safely and effectively if they are reprocessed and reused after the initial use. Reusable instruments must be rinsed thoroughly after use and after cleaning to ensure removal of gross soil and residual cleaners and solvents. Gross soil is damaging to instrument surfaces and inhibits thorough cleaning and subsequent sterilization. Residual cleaners and solvents can impede further processing, may affect the surface finish of the instrument over time, and may lead to adverse tissue reactions.
1. CLEANING There are two methods for cleaning that have been validated by CooperSurgical, Inc. Any healthcare facility should be able to perform the manual cleaning process. For those facilities that use automated washer-disinfectors, an automated method has also been validated. Personnel are cautioned to use personal protective apparel due to the unknown and potentially hazardous nature of biological fluids and soils present. Specific detergents or cleaning solutions vary in requirements for concentrations and temperatures required for optimal cleaning performance. Use temperatures in this document as guidance, to be superseded by the detergent/cleaner manufacturer’s directions for use. Any processes outside of the recommendations in this document must be validated before use. The quality of water used to prepare solutions and rinse reusable instruments can affect the efficacy of the process and the instrument reuse life. CooperSurgical, Inc. recommends the use of freshly prepared purified water or sterile water for dilutions of solution and rinsing of instruments. Non-purified water can add mineral deposits and recontaminate instruments with microorganisms. Mineral deposits can impede sterilization and affect the condition of the instrument, resulting in staining, corrosion, and/or other damage. Equipment and Materials Required for Manual Cleaning • • • • •
Personal protective apparel/equipment as recommended by cleaning solution supplier Cleaning bath, sink, or other vessel large enough to accommodate full immersion of instruments Freshly prepared cleaning solution intended for manual cleaning (use enzymatic, neutral, or alkaline detergents) Soft-bristled brushes and sponges Clean, low-lint or lint-free cloth
Equipment and Materials Required for Automated Cleaning • • • •
Personal protective apparel/equipment as recommended by cleaning solution supplier Legally marketed (FDA-cleared and/or CE-marked) medical device washer or washer-disinfector Cleaning solution intended for automated cleaning (use enzymatic, neutral, or alkaline detergents) Racks and accessories to hold and support instruments during processing
POINT OF USE During and immediately after the clinical procedure, instruments should be treated to reduce and remove gross soil materials. Instruments should be wiped with low-lint or lint-free absorptive materials, such as low-lint or lint-free wipes to remove solid tissues
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and the majority of bodily fluids. Immediately after use, all disposable single-use accessories should be removed and discarded into appropriate biohazardous waste containers. Instruments should be placed into a transport container that will protect them from damage during transport and should be kept moist. TRANSPORT TO PROCESSING AREA Transport the instruments to the processing area as soon as practical. Minimize holding time before removing organic debris. Ensure that lighter instruments are not mixed with heavier instruments to avoid damage to the instruments due to mechanical abrasion. Seal or enclose the transport container to prevent fluid loss and the potential for cross-contamination of other areas. PREPARATION •
Disassemble all jointed LoneStar Retractors by removing the threaded screw shafts at each joint.
•
Remove all single use accessories and discard in an appropriate waste container designed for biohazardous materials if this has not been performed at point of use. - Remove all LoneStar stays that have not been removed at point of use and discard in an appropriate biohazardous waste container.
•
There are no reusable accessories for the LoneStar Retractors; only the frame and joint screws are to be retained.
CLEANING Cleaning should take place as soon after use as practical. Soils should not be allowed to dry onto the instrument surfaces. The manual process and the automated process were validated independently and are considered equivalently effective when performed according to the instructions in this document. Do not use metal-bristled brushes on the instruments. MANUAL CLEANING PROCESSES 1.
After disassembling all components of the frame and joint screws and discarding all single-use accessories, place the instrument components into a clean sink or cleaning container.
2.
Use a neutral or alkaline enzymatic detergent specifically designed for manual cleaning of medical instruments. Prepare a fresh solution of detergent at the detergent manufacturer’s recommended concentration using water at the detergent manufacturer’s recommended temperature.
3.
Ensure that the instruments are fully immersed in the prepared solution. Soak the instrument for a minimum of two (2) minutes at room temperature (68-77°F/20-25°C) or longer if indicated on the detergent manufacturer’s instructions for use. Use the detergent manufacturer’s recommended temperature if it is different from room temperature.
4.
After soaking the instruments, remove them from the detergent solution and rinse them under cool (50-68°F/10-20°C) running tap water for a minimum of one (1) minute to reduce the biological tissues present and remove detergent residuals.
5.
Prepare a fresh solution of neutral or alkaline detergent specifically designed for manual cleaning of medical instruments. Prepare the solution at the detergent manufacturer’s recommended concentration and temperature using purified or sterile water.
6.
Ensure that the instruments are fully immersed in the prepared solution. Using a soft-bristled brush, thoroughly clean all surfaces of the instruments, paying particular attention to the slots in the frame(s), the threads on the hinge joints, and the surfaces of the hinge joints.
7.
Remove the instruments from the detergent solution and rinse thoroughly under running purified or sterile water for one (1) minute or until visible signs of detergent are removed, whichever is longer.
8.
Examine the instrument for signs of residual soil. If there are any signs of residual soil on the instrument, repeat the cleaning process.
9.
Reassemble the instrument, ensuring that the serial number on all frame sections match.
10. Dry the instrument with a low-lint or lint-free towel or wipe. AUTOMATED CLEANING PROCESS 1.
Ensure that all gross soil has been wiped or rinsed from the surfaces of the instruments. All LoneStar Retractors may be processed together in an automated washer or washer-disinfector.
2.
Use only a legally marketed (FDA-cleared and/or CE-marked) medical device washer or medical device washer-disinfector. Industrial use and household use dishwashers are not acceptable for the cleaning of medical devices.
3.
Place the instruments loosely within a rack designed for the medical washer or medical washer-disinfector, using a holddown screen if indicated by the washer/washer-disinfector manufacturer.
4. Load the rack with the instruments into the washer/washer-disinfector and close the door.
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5. Select a cycle intended for instruments that has the following parameters at a minimum: PARAMETER
TOLERANCE
Detergent Pre-wash rinse
Neutral or Alkaline medical device detergent Minimum of one Minimum of 00:15 (mm:ss) Cold tap water or better quality Minimum of one repetition Minimum of 02:00 (mm:ss) Warm tap or purified water (minimum of 140°F/60°C) Minimum concentration per detergent manufacturer’s IFU Minimum of one Minimum of 00:15 (mm:ss) Warm tap or purified water (minimum of 110°F/43.3°C) Minimum of one Minimum of 01:00 (mm:ss) Purified water (minimum of 180°F/82.2°C) Minimum of default cycle setting
Wash
Post-wash rinse
Thermal rinse*
Drying**
* Only heat-based medical device washer-disinfectors will include a thermal rinse. Medical device washers that do not include a thermal disinfection phase should be set to have a minimum of a 01:00 (mm:ss) rinse following the post-wash rinse using purified water. ** Drying time will be variable dependent on the size and composition of the load, altitude, environmental conditions, and air temperature and source characteristics.
NOTE: automated wash processes that include additional phases or longer phase durations are anticipated to deliver equivalent or better cleaning efficacy as the minimal validated parameters. Additional phases and longer phase durations may be added if they are within the healthcare facility’s normal procedures. 6.
Start the cycle and allow it to run through conclusion.
7.
Medical washer-disinfector default cycles often use high heat during the final stages of the processing cycle. Use caution and heat-protective gloves when opening and removing the wash rack at the end of the cycle.
8.
Examine the instruments for signs of residual soil. If there are any signs of residual soil on the instrument, repeat the cleaning process.
9.
If the instruments are not thoroughly dry following the automated process, dry the instruments with low-lint or lint-free towels or wipes.
2. INSPECTION All instruments must be inspected for signs of damage, wear or residual soil each time they are reprocessed. If residual soil is observed during inspection, the cleaning process must be repeated for the instrument. Remaining soils can impede effective sterilization by shielding remaining microorganisms and can lead to tissue reactions in subsequent patients. SURFACE FINISH Inspect the surface of the instrument. The surface should be smooth. Some staining and discoloration may occur depending on the exact formulation of the detergents used and the water quality. Staining will not impact performance of the retractors as long as there are no signs of corrosion or surface pitting. HINGE JOINTS Pay particular attention to the hinge joint region and the threaded surfaces of any models that include joints. Ensure that there are no signs of corrosion in the joint and that the threads do not appear gouged, frayed, worn, or pitted. Pay particular attention to the threaded joint surfaces and observe for trapped soil material. ASSEMBLY Re-assemble the frame components of the instrument with the threaded screw shafts. Pay attention to the feel of the screw in the joint. The rotation should be smooth. Jerking or locking of the shaft before it is fully engaged may be a sign of damage to the thread surface or the presence of corrosion or retained material between the mated surfaces. Unscrew the shaft if it feels like it is catching on the surface and closely inspect the condition of the surfaces using low magnification and a good light source. Retained organic residue must be removed to ensure adequate sterilization. Corrosion may impede proper function of the retractor during surgical procedures. If signs of residual soil are present, repeat the cleaning process. If signs of corrosion are present, contact a service department (internal or external) for potential repair.
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3. WRAPPING Prior to terminal sterilization, the instruments must be packaged to preserve sterility after processing during storage. Legally marketed sterilization packaging (e.g. CSR wrap) that is compatible with and labeled for use with the chosen sterilization method should be used. CooperSurgical, Inc. has not evaluated the sterilization efficacy of the processes recommended in this document using containment systems (e.g. procedure/case trays, cassettes, rigid reusable sterilization containers); therefore, users who choose to use a containment system in the sterilization of these instruments should verify that the process is effective under these conditions. Containment systems can impede the ingress and egress of sterilant (moist heat, gaseous sterilant chemicals). CooperSurgical, Inc. recommends individually wrapping the instruments prior to sterilization. The instruments should be wrapped using one of the common closure techniques, using properly sized material and secured with tape or adhesive designed and labeled for use with the sterilization process chosen. Instruments should be labeled with identifying information and sterilization date to facilitate selection for use after processing.
4. STERILIZATION - MOIST HEAT (STEAM) Individually packaged instruments using legally marketed sterile barriers with labeling consistent with the following parameters may be sterilized prior to use and between subsequent uses. Legally marketed (FDA-cleared and/or CE-marked) moist heat (steam) sterilizers should be used. The following parameters have been validated for use with the instruments within the scope of this document: STERILIZATION PROCESS
EXPOSURE EXPOSURE TEMPERATURE TIME
DRY TIME
Gravity Displacement
250°F/121°C
30 minutes
30 minutes
Pre-vacuum
270°F/132°C
4 minutes
30 minutes
Pre-vacuum
273°F/134°C
3 minutes
30 minutes
5. STORAGE Individually packaged instruments should be cooled to a safe handling temperature following moist heat sterilization prior to final storage. Individually packaged instruments should be transported to a clean, temperature and humidity controlled sterile supply storage area. If instrument packaging is compromised during storage (becomes wet, torn, or seals are open), the instrument must be reprocessed through cleaning, inspection, and sterilization prior to use. Do not stack instruments or allow other product or instruments to be stacked on top of them. Protection from dust and moisture is recommended. Ensure that traceability and identity is maintained throughout storage and up to subsequent use.
6. VALIDATION OF PROCESSES CooperSurgical, Inc. performed validations for the cleaning of the instruments. The following detergents were used in the validations demonstrating efficacy: Klenzyme®, Manu-Klenz™, ENZOL®, Neutrad®, Prolystica® Ultra-Concentrate Neutral Detergent and Prolystica® Ultra-Concentrate Alkaline Detergent CooperSurgical, Inc. does not endorse the use of the identified products in lieu of other similar products designed for use with medical devices; however, this information may provide a basis for comparing the formulations to select an appropriate alternate in facilities or locations where these detergents are not readily available. The parameters listed in the automated cleaning section as the minimum parameters for automated cleaning are identical to the parameters used in the validation, with the exception of the dry time. Post-cleaning dry time was eliminated for the cleaning process validation to facilitate detection of soil residuals, if present, in order to reduce the potential for a false negative result.
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