General Instructions for Use (IFU) – Reusable Surgical Instruments

The following General Instructions for Use (IFU) apply to reusable surgical instruments manufactured and supplied by Ameri Surgical Instruments, Inc.. These guidelines are intended for use by qualified healthcare professionals to support proper handling, cleaning, sterilization, and maintenance of surgical instruments across multiple medical and surgical specialties.

Proper reprocessing is essential to ensure patient safety, maintain instrument performance, and extend product lifespan. Always follow your facility’s validated procedures and applicable local, national, and international regulations.

1. Pre-Use Inspection

• Visual Inspection: Inspect each instrument carefully for visible damage, corrosion, cracks, bends, or surface irregularities.
• Functional Check: Test all movable parts (hinges, locks, jaws, cutting edges) to ensure smooth operation and proper alignment.
• Packaging Integrity: Confirm that sterile packaging (if applicable) is intact and has not been compromised prior to use.

2. Point-of-Use Care

• Immediate Containment: After use, place instruments in a labeled, closed, puncture-resistant container or transport tray.
• Moisture Maintenance: Prevent drying of organic material by covering instruments with a towel moistened with sterile or distilled water, or by using an approved instrument transport gel or foam.
• Prompt Transport: Transport instruments to the designated decontamination area as soon as possible after use.
• Separation: Separate heavy instruments from delicate or precision instruments to reduce the risk of mechanical damage.

3. Decontamination and Cleaning

Initial Rinsing

• Rinse instruments immediately under warm (not hot) running water to remove visible soil.

Enzymatic Cleaning

• Immerse instruments in an approved enzymatic or neutral pH detergent solution according to the detergent manufacturer’s instructions.
• Open, unlock, or disassemble instruments fully to allow solution contact with all surfaces.

Rinsing

• Thoroughly rinse instruments with clean running water or deionized/distilled water to remove detergent residues.
• Flush lumens and internal channels until water runs clear.

Ultrasonic Cleaning (Recommended)

• Use an ultrasonic cleaner with an approved medical-grade detergent.
• Position instruments in an open state and avoid overloading.
• Follow ultrasonic equipment manufacturer’s cycle time and concentration recommendations.

Manual Cleaning

• Manually clean instruments using soft-bristled brushes and non-linting wipes.
• Ensure all joints, serrations, hinges, and recessed areas are thoroughly cleaned.

Optional Disinfection

• If required by facility protocol, instruments may be immersed in an approved disinfectant following cleaning and rinsing.

4. Drying and Inspection

• Dry instruments completely using lint-free cloths or medical-grade compressed air.
• Inspect instruments again for cleanliness, functionality, and visible defects before sterilization.

5. Sterilization

• Follow the sterilizer manufacturer’s Instructions for Use to select an appropriate validated sterilization cycle.
• Steam sterilization (autoclave) is commonly used; ensure parameters such as temperature, exposure time, and drying time meet institutional requirements.
• Package instruments correctly to maintain sterility after processing.

6. Storage and Handling

• Allow instruments to cool naturally after sterilization.
• Store instruments in a clean, dry, and well-ventilated environment.
• Avoid stacking, excessive pressure, or contact with corrosive materials.

7. Important Warnings and Maintenance Notes

• Do Not Use Bleach: Bleach and chlorine-based agents cause corrosion and pitting of stainless steel and will void warranties.
• Lubrication: Use only approved, water-soluble instrument lubricants on joints and moving parts as needed.
• Routine Maintenance: Inspect screw locks, joints, and cutting edges regularly for wear or damage.

Disclaimer

These instructions are provided as general guidance only. Ameri Surgical Instruments, Inc. is not responsible for improper use, reprocessing, sterilization, or handling that deviates from institutional protocols or applicable regulations. Always follow hospital policies, sterilizer manufacturer instructions, and local regulatory requirements.