Reprocessing Instructions
Reusable Instruments
These reprocessing instructions apply to:
• Reusable surgical instruments supplied by Codman
• Instruments intended for reprocessing in a health care facility setting
These instructions do not apply to single-use devices.
These reprocessing instructions have been validated as being capable of preparing reusable Codman instruments for reuse. It is the responsibility of the reprocessor to ensure that the reprocessing is actually performed using appropriate equipment, materials, and personnel to achieve the desired result.
This normally requires validation and routine monitoring of the process. Any deviation by the reprocessor from these instructions should be evaluated for effectiveness and potential adverse consequences.
WARNINGS
Limitations on
Reprocessing
• Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used.
• Do not exceed 140 °C during reprocessing steps.
• Highly alkaline conditions can damage products with aluminum parts.
• Complex devices, such as those with tubes, hinges, retractable features, mated surfaces, and textured surface finishes, require special attention during cleaning. Manual pre-cleaning of such device features is required before automated cleaning processing.
• Avoid exposure to hypochlorite solutions, as these will promote corrosion.
• Repeated processing has minimal effects on instrument life and function.
• End of useful life is generally determined by wear or damage in surgical use.
• Carefully inspect instruments between uses to verify proper functioning.
• Send damaged instruments to a supplier of authorized repair or refurbishment services.
Under certain classifications of risk, the World Health Organization (WHO), or local regulatory authorities recommend special CJD inactivation processing procedures. Consult WHO and local regulations for further information.
Decontamination
Considerations –
Creutzfeldt-Jakob
Disease (CJD)
Reprocessing Instructions
Care at the
Point of Use
• Clean instruments as soon as possible after use. If cleaning must be delayed, immerse instruments in a compatible detergent solution to prevent drying and encrustation of surgical soil.
• Avoid prolonged exposure to saline to minimize the chance of corrosion.
• Remove excessive soil with a disposable wipe.
Reprocess instruments as soon as is reasonably possible after use.
Containment and
Transportation
Preparation for Cleaning
For instruments that require disassembly for cleaning, perform disassembly as instructed in the instructions for use provided with the instrument.
Integra LifeSciences Production Corporation
11 Cabot Boulevard
Mansfield, MA 02048 USA
LCN 204233-0EN Rev B 09/20 1511214-2
©2020 Integra LifeSciences Corporation. All rights reserved.
A. Manual Cleaning –
ALL INSTRUMENTS
B. Manual Cleaning –
Instruments with cannulations or lumens
(i.e. tubes), or holes
C. Manual Cleaning –
Articulating
Instruments (those with moveable parts)
Automated Cleaning
Cleaning Inspection
Disinfection
Maintenance
Inspection and
Functional Testing
Packaging
Sterilization
Storage
• Clean delicate instruments separately from other instruments.
• Disassemble instruments that are intended to come apart for cleaning.
• Prepare an enzymatic cleaning solution in accordance to the manufacturer’s instructions.
• Soak soiled instruments for 5 minutes.
• Follow the additional steps in Cleaning sections B.
, or C.
, which follow. Select the category that most closely matches the type of instrument.
• Use a soft bristle brush to remove all traces of blood and debris; pay close attention to any hard to reach areas, textured surfaces, or crevices.
• Rinse the instrument thoroughly with warm tap water.
• Ultrasonically clean the instrument for 10 minutes in neutral pH detergent, prepared in accordance with the manufacturer’s instructions.
• Rinse the instrument thoroughly with warm tap water.
• Dry the instrument immediately after final rinse.
• Follow the steps in the section Manual Cleaning – ALL INSTRUMENTS.
• When cleaning, use a tight-fitting, soft, non-metallic cleaning brush or pipe cleaner to scrub the cannula, lumen, or hole. Push in and out, using a twisting motion to remove debris. Use a syringe filled with enzymatic cleaning solution to flush hard to reach internal areas.
• When rinsing, pay particular attention to flush the cannulations, lumens, or holes with warm tap water.
• Dry internal areas with filtered compressed air.
• Follow the steps in the section Manual Cleaning – ALL INSTRUMENTS.
• When cleaning, fully immerse the instrument in the cleaning solution to avoid aerosol generation. Brush with a soft non-metallic bristle brush to remove all traces of blood and debris. Pay close attention to threads, crevices, seams, and any hard to reach areas.
Actuate any moveable mechanisms, such as hinged joints, box locks, or spring-loaded features, to free trapped blood and debris. If the components of the instrument can be retracted, retract or open the part while cleaning the area. For instruments with flexible shafts, flex the instrument under the cleaning solution.
• When rinsing; pay particular attention to internal areas and moveable parts. Actuate moveable parts while rinsing. If the components of the instrument can be retracted, retract or open the part while rinsing the area. For instruments with flexible shafts, flex the instrument under the rinse solution.
• Dry internal areas with filtered compressed air.
• For instrument types with complex design features, such as those described in Manual Cleaning sections B.
and C.
above, it is important to manually clean prior to automated processing to improve the removal of adherent soil. Brush the instrument, actuate mechanisms, agitate and/or irrigate under the surface of the cleaning solution to prevent the creation of aerosols.
• Clean, using the “INSTRUMENTS” cycle in a validated washer disinfector and a pH neutral cleaning agent intended for use in automated cleaning. The cleaning cycle should incorporate enzyme pre-wash, wash, rinse, thermal rinse, and drying steps.
• Load instruments so that hinges are open and cannulations and holes can drain.
• Place heavier instruments on the bottom of containers. Do not place heavy instruments on top of delicate instruments.
• For instruments with concave surfaces, such as curettes, place instrument with the concave surface facing downward to facilitate draining.
• Inspect all instruments before sterilization or storage to ensure the complete removal of soil from surfaces, tubes and holes, moveable parts.
• If areas are difficult to inspect visually, check for blood by immersing or flushing the instrument in a 3% hydrogen peroxide solution. If bubbling is observed, blood is present. Rinse instruments thoroughly after using hydrogen peroxide solution.
• If soil is still present, reclean the instrument.
Codman instruments must be terminally sterilized prior to surgical use. See Sterilization instructions.
Between uses, lubricate moving parts with a water-soluble lubricant in accordance with the manufacturer’s instructions.
A water-soluble lubricant that is considered physiologically safe is recommended for instruments to be steam sterilized.
• Visually inspect the instrument and check for damage and wear.
• Cutting edges should be free of nicks and have a continuous edge.
• Jaws and teeth should align properly.
• Moveable parts should have smooth movement without excessive play.
• Locking mechanisms should fasten securely and close easily.
• Long, thin instruments should be free of bending and distortion.
• If desired, use instrument trays to contain instruments that are provided in sets.
• Double wrap instruments in accordance with local procedures, using standard wrapping techniques such as those described in
ANSI/AAMI ST46-1993.
• Use a validated, properly maintained and calibrated steam sterilizer.
• Effective steam sterilization can be achieved using the following cycles
Cycle Type
Prevacuum
Temperature
132– 134 °C
Exposure Time
4 minutes
Prevacuum 134– 137 °C 3 minutes
Store sterile packaged instruments in a manner that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity.
