Maintenance

PROPER MAINTENANCE OF INSTRUMENTS

INFORMATION FOR CLEANING, DISINFECTION AND STERILIZATION OF REUSABLE MEDICAL DEVICES: GENERAL PROCEDURES (PDF)

MATERIALS

Most surgical instruments today are made of stainless steel. Stainless steel is an alloy, consisting of various elements that make it extremely resistant to staining and corrosion. Remember, however, that the phrase "stainless steel" really means that these steels "stain less." They are not "stain-free" or "stain-proof."

300 series steel (austenitic) contains no carbon and is considered the most stain-resistant of all steels. However, because it doesn't contain carbon, it can't be hardened. This is good only for containers, speculums, retractors, and handles of instruments.

400 series steel (martensitic) contains a small percentage of carbon, thus it can be hardened. The percentage of carbon content determines the degree of hardness  the more carbon, the higher the attainable hardness. Steels with a lower percentage of carbon are typically used for forceps, needle holders and hemostats. Steels with a higher percentage of carbon are used for scissors and cutting instruments. 400 series steel must be heat-treated to attain the desired degree of hardness. For instance, if a pair of scissors was produced from 400 series steel but not heat-treated properly, its cutting edges would become dull very quickly.

Less carbon content  more stain resistance

More carbon content  less stain resistance

During the manufacturing process, the steel is milled, filed, ground, polished and brushed, all of which disrupt the steel surface. After final finishing, the instrument is exposed to an electro-polishing process to reseal its surface. This process greatly enhances the instrument's surface corrosion resistance.

MANUAL CLEANING

Remove blood, saline, tissue, and other contaminates immediately by rinsing with distilled water (demineralized water).

Clean instruments with a mild soap using a soft bristled toothbrush. Note: Brushing should always be done under distilled water. Do not use metal brushes, steel wool or abrasive powders, which will seriously damage the instruments' surface finish, and make them much more susceptible to corrosion.

Thoroughly rinse instruments with distilled or demineralized water, then dry them before putting them back into their instrument trays for storage. Instruments can be dried using a lint-free cloth or hot air blower.

ULTRASONIC CLEANING AND DRYING

The best method for thorough cleaning of delicate micro-instruments is using an ultrasonic cleaner.

Follow the manufacturer's instructions for proper use of your Ultrasonic cleaner.

Use only "suds" detergents with distilled water (ph 7.0).

Immerse the instruments together in a mesh-type tray, for the time period specified in the Ultrasonic cleaner's instructions. The time period is usually less than 5 minutes. ENSURE THAT instruments DON'T TOUCH while in the tray.

Rinse instruments thoroughly with distilled water. This removes any chemical residue from the surface and prevents instruments from staining.

Dry instruments with a hot air blower rather than hand drying with gauze or towels.

LUBRICATION

If lubricating baths or dips are used, it is absolutely essential that the instruments be totally free of stains and corrosion. Covering corrosion on instruments with a lubricating dip, especially in joints and box locks, seals in the corrosion, and leads to aggressive attacks on the steel during autoclaving. This ultimately results in frozen, or even cracked, joints and box locks.

Always use lubricants that can withstand the high temperatures of autoclaving, such as silicone or Teflon sprays. Never use regular lubricating oils, as they will become gummy when exposed to high temperatures.

PROTECTIVE TIPS

Microsurgical instrument tips can be damaged easily during handling and storage. Always keep a protective cover on delicate tips when the instrument is not in use. Soft silicone tubing with adequate wall thickness and inside diameter will provide good protection for instrument tips. Colour-coded tip guards in various sizes are also available for this purpose.

STERILIZATION

Sterilizing is not cleaning. Instruments must be thoroughly cleaned and rinsed in distilled or demineralized water before sterilization.

Sterilize instruments according to your instructions standards.

Steam autoclaving is the most widely used sterilizing technique due to the minimal time cycle.

See Table 1 below for RECOMMENDED STERILIZER PARAMETERS.

Although flash autoclaving is an accepted sterilization method, it reduces the instrument's lifespan.

ETO sterilization is recommended due to low temperatures and moisture levels during processing. The major limitations with ETO sterilization are the long cycle and aeration time required.

STORAGE

Clean instruments thoroughly before storage.

Store the instruments in a dry place.

Always protect the tips of micro instruments with soft silicone tubing before storage.

Instruments should not touch each other while in storage.

Use trays with silicone mats for storage of micro instruments.

All delicate and costly instruments, such as diamond knives, etc., should be stored separately.

POINTS TO REMEMBER

- Stainless steel "stains less"  it is not "stain-proof."
- Ensure not to let blood, tissue or saline (BSS) dry on instruments.
- NEVER USE SALINE (BSS) FOR RINSING INSTRUMENTS.
- Always use demineralized or distilled water for final rinsing.
- Metal brushes and abrasive powders are a "no-no."
- One ultrasonic cleaning a day will keep the stains away.
- Thoroughly dry instruments with a lint-free cloth or a hot air blower before storage.
- Lubricate joints and box locks after cleaning.
- Use protective covers for delicate tips.
- STERILIZING IS NOT CLEANING.

Prior to first use, medical devices must be cleaned and sterilized.
After each use, it is imperative that medical devices are cleaned immediately.

 

CLEANING AND STERILIZATION PROCEDURES FOR REUSABLE ENDOSCOPIC INSTRUMENTATION

OBSERVE UNIVERSAL PRECAUTIONS DURING CLEANING.

1) During the clinical procedure, keep instruments that are not in use under a damp sterile cloth, or submerge them in a tub of sterile water to prevent debris from hardening.

2) Immediately upon completion of clinical use, immerse instruments in a tub of enzymatic pre-soak solution, for 15 minutes or until the final cleaning has been performed. This procedure will facilitate fast and effective bio-load/bio-burden reduction. N.B. Disassemble instruments and/or open jaws where applicable. WARNING: Do not use bleach or salt solution on endoscopic instruments.

3) With the instrument tips held downward and within the tub solution, flush the shafts internally. Infuse enzymatic solution into the flush/luer port with a 10 cc male syringe. Repeat infusion until solution is clear and free of visible bio-burden.

4) Clean the jaws, links and hinges of the instruments with a small nylon brush. Do not use scouring (metallic) materials. Clean the rest of the instruments with a damp sponge.

5) Re-flush and immerse the instruments in clean, preferably deionized (DI), water.

6) Visually inspect the instruments to confirm cleanliness.

7) Infuse air through the internal shaft to flush out remaining water.

8) Apply medical grade lubricant between all moving parts to ensure functionality of instruments prior to sterilization, i.e. hinge assembly, rotation knobs, etc.

9) Verify instrument functionality, i.e. lever action, knob rotation, ratchet mechanisms, stopcocks, pistons, etc.

10) Proceed with sterilization.

NOTE: Always clean instruments as soon as possible after clinical use. Check for possible damage to instruments throughout the process, and if any is apparent, contact your distributor for repair services.

SEE TABLE 1 FOR RECOMMENDED STERILIZATION PARAMETERS

The sterilizer manufacturer's written instructions for cycle parameters should be followed.  The suggested cycle based on ANSI and AAMI recommended practices consists of:

Method of sterilization

Sterilizer type

Sample configuration

Temperature

Exposure time

Steam

Gravity displacement

Wrapped

132°C to 135°C (270°F to 275°F)

10-25 min.

Steam

Gravity displacement

Wrapped

121°C to 123°C (250°F to 254°F)

15-30 min.

Steam

Gravity displacement

Unwrapped

132°C to 135°C (270°F to 275°F)

10-25 min.

Steam

Gravity displacement

Unwrapped

121°C to 123°C (250°F to 254°F)

15-30 min.

Steam

Pre-vacuum

Wrapped

132°C to 135°C (270°F to 275°F)

3-4 min.

Steam

Pre-vacuum

Unwrapped

132°C to 135°C (270°F to 275°F)

3-4 min.

Steam flash

Pressure Pulse Cycles

Wrapped

132°C to 135°C (270°F to 275°F)

3-4 min.

Steam flash

Pressure Pulse Cycles

Wrapped

121°C to 123°C (250°F to 254°F)

20 min.

Read all information carefully prior to use.

Caution: Federal Law restricts this device for use by or on the order of a physician.

WARNING:

1) Inspect this product thoroughly upon receipt, for shipping damages.

2) Do NOT use any INSTRUMENTS if the product does not perform satisfactorily in a pre-operations test.

3) This information is not designed to be an instructional guide on how to perform any specific operation. Consult medical literature regarding techniques, complications and hazards prior to attempting any surgical techniques.

4) Handle all instrumentation with care to prevent damage and maintain functionality.

5) These products should only be handled by qualified personnel familiar with their operation, assembly and disassembly (when applicable).

6) For ESD (electrosurgical devices), examine prior to each clinical usage for:

a) Loose or damaged monopolar posts
b) Cracks in insulation
c) Loose or damaged electrodes

Note: If any above-described condition exists, do not use device.

Plugs, adapters or electrodes (when applicable) should only be used where they are designed to fit properly. If available, perform a continuity check on the patient return pad and cord by the generator return pad monitoring system. As with any device, immediately discontinue usage if unusual operating characteristics develop, or are observed during the procedure.

GUARANTEE POLICY

Hand-held instruments and trocar products are guaranteed as free of material and workmanship defects for the lifespan of the product.

For more information on cleaning and sterilization procedures, click here.

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