Surgical Instruments Cleaning, Sterilizations and Reuse Guide

2 Pages

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  C  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 •  •  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  Page 1 of 2
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