INNOVASIS
Surgical Instruments Cleaning, Sterilizations and Reuse Guide
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M Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 Tel +1.801.261.2236 Toll Free (US) (877) 261.2236 Fax +1.801.261.0573 www.innovasis.com
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Surgical Instrument Cleaning, Sterilization and Reuse Device(s): Reusable surgical instruments supplied by Innovasis include fixed assemblies (no moving parts), simple hinged assemblies and instruments with two or more parts that are designed to be taken apart for cleaning and reassembled. More complex instruments may have unique or different cleaning requirements and have separate instructions. Items labeled as Single Use Only are not covered by these instructions. Warning Notice: Instruments are provided non-sterile. Clean and sterilize prior to each use. Disassemble instruments with removable parts prior to cleaning and sterilization. Special attention may be required for small, tight areas and drilled holes; long narrow cannulations and blind holes require particular attention during cleaning. Advice: Devices which cannot be safely cleaned by the following processes are labeled accordingly. Individual procedures accompanying those devices must be followed. In case of damage, the device should be cleaned and sterilized before returning to the manufacturer for repair. Limitations on Reprocessing: Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use as determined by inspection and functional testing (below). Containment and Transportation: Follow hospital protocols when handling contaminated and bio-hazardous materials. Instruments should be cleaned within 30 minutes following use in order to minimize the potential of dried contaminants, staining, or damage. Instruments that have not been properly cleaned and sterilized are considered to be a biohazard and should not be transported. Preparation for Decontamination: Where possible, the devices must be cleaned in a disassembled or opened state. Preparation at the Point of Use: Remove evident soiling by submerging the instrument in ambient cold water (<40°C) or pre-soak solution immediately after use. Do not use hot water (>40°C) or a fixating detergent because the fixation of blood or tissue on the instrument may influence the result of the cleaning and sterilization process. Do not allow blood, tissue or other foreign matter on instruments to dry. After soaking, remove visible surface contamination. Cleaning and disinfecting of instruments with aldehyde-free solvents at higher temperatures is acceptable; however cleaning and decontamination must include the use of neutral cleaners followed by deionized water rinse. Note: Cleaning solutions containing formalin, gluteraldehyde, bleach and/or other alkaline cleaners may damage some instruments; these solutions should NOT be used. Cleaning Process: •
Thoroughly clean instrument: Rinse under running tap water (24-40°C) for at least 90 seconds using a nylon bristled brush until all visible soil has been removed. For instruments with holes or cavities, emphasize cleaning these areas thoroughly. For Box System Inserters or instruments with cannulations, flush the cannulas using a flexible hose for an additional 30 seconds per the picture below.
Flush inserter cannula using a flexible hose placed over the threaded tip as shown •
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Submerge and sonicate instruments (40kHz) in an enzymatic cleaning solution for 10 minutes, or per manufacturer’s instructions. The recommended enzymatic solution is Ruhof Endozime AW Triple Plus with APA at 4mL/L and 28-45°C. Ultra-sonic cleaning is recommended for all instruments. Ultra-sonic cleaning is required for instruments containing moving parts, threads, and/or cavities. Rinse and brush the instruments under running DI water for at least 90 seconds to remove the enzymatic solution. Ensure that that blind holes are repeatedly filled and emptied. Flush cannulations for an additional 30 seconds using a flexible hose as described above.
Manual Drying: Dry the instruments with a lint-free towel. The instruments should not be heated above 140° C. © 2017 Innovasis, Inc.
LG01 Rev F
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Inspection and Functional Testing: • • • • • •
Carefully inspect each device to ensure the instrument is visually clean-i.e., all visible blood and soil has been removed. Check for corrosion, pitting, or discoloration Visually inspect for damage and/or wear. Cutting edges should be free of nicks and present a continuous edge. Check the action of moving parts to ensure smooth operation throughout the intended range of motion. Check instruments with long slender features (particularly rotating instruments) for distortion. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components. Note: If damage or wear is noted, do not use the instrument and notify the appropriate responsible person for return to Innovasis. Note: A calibration recheck of the surgical torque wrenches (LA-T100 & LA-T40) is needed periodically to ensure that they are operating to the prescribed torque specifications. Acceptance Criteria: 90% - 110% of the torque wrench specification (i.e. 36-44 in/lbs for LA-T40 and 90-110 in/lbs for LA-T100). Consigned torque wrenches should be returned to Innovasis for this service at least once every six months.
Packaging: Singly: A standard packaging material may be used. Ensure that the pack is large enough to contain the instrument. In sets: Instruments may be loaded into dedicated instrument trays, or general-purpose sterilization trays. Ensure that cutting edges are protected, and do not exceed 18 kg per tray. Wrap the trays using appropriate method. Sterilization: Sterilize instruments in accordance with specific country/local regulatory requirements. Follow specific instructions per the Instructions for Use provided with the Innovasis system to be sterilized. FDA cleared wraps are recommended for use with the sterilization tray. Remove all packaging materials prior to sterilization. If specific instructions are not available, Innovasis recommends that the instruments be steam sterilized by the hospital using one of the two sets of process parameters below: METHOD Steam Steam
CYCLE Pre-vacuum (Wrapped) Gravity Displacement (Wrapped)
TEMPERATURE 0 0 270 F (132 C ) 0 0 270 F (132 C )
EXPOSURE TIME 20 Minutes 45 Minutes
DRY TIME 60 Minutes 60 Minutes
NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their equipment. Flash sterilization is not recommended on cannulated instruments! Storage: Store sterilized instruments in a dry, clean, and dust-free environment at modest temperatures of 5°C to 40°C. Maintenance: Lubricate hinges, threads, and other moving parts with a commercial water-based surgical grade instrument lubricant (such as surgical instrument milk) to reduce friction and wear. Follow lubricant manufacturer’s instructions. Additional Advice: • • •
When sterilizing multiple instruments in one autoclave cycle, ensure that the sterilizer’s maximum load is not exceeded. It is the duty of the user to ensure that the reprocessing processes are followed, that resources and materials are available to capable personnel, and that hospital protocols and local regulatory requirements are followed. Due diligence and many national laws require that these processes and included resources be validated and maintained properly.
Manufacturer Contact: Contact your local distributor for Innovasis products, or see the contact information at the top of these instructions. The instructions provided above have been validated by the medical device manufacturer as being CAPABLE of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing as actually performed using equipment, materials and personnel in the processing facility achieve the desired result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences.
© 2017 Innovasis, Inc.
LG01 Rev F
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