Reprocessing And Sterilization Guide

A cleaning and sterilization process that meets ADA and CDC guidelines is vital to an effective infection control program. All local regulatory requirements must be followed. Use of a complete system that encompasses and fulfills all critical cleaning and sterilizing elements minimizes risk to patients and staff.

Terminology:

Reprocessing: A validated process used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use.

Cleaning: Physically removing all visible soil and organic contamination, either by scrubbing with a surfactant or detergent and water, or by processing through an ultrasonic or instrument washer. Clean does not mean the instruments are sterile.

Disinfecting: A cleaning process that destroys pathogens and other microorganisms. Disinfecting should be an intermediate level disinfection using a product with an EPA-registered claim for activity against hepatitis B. Disinfecting is not a substitute for sterilization as it does not kill all microorganisms on an instrument.

Sterilizing: A process that, when performed properly, kills all microorganisms – bacteria, fungi, viruses and highly resistant bacterial endospores on instrument surfaces.

Storage: Holding sterilized items in a controlled environment until disbursed for patient use.

Staff Safety:

Instruments used on patients should be considered contaminated and hazardous to office staff responsible for reprocessing. Protective safety gear should be used to ensure staff protection. Staff responsible for reprocessing should wear non-puncture gloves, protective eye shields and clothing protection (gown).

Equipment Maintenance and Verification:

All cleaning and sterilizing equipment must be properly maintained according to the manufacturer’s instructions. Sterilization failures can and do occur. Without proper monitoring, these failures may be overlooked, resulting in serious consequences to patients, and potentially, to staff. Common reasons for sterilization failure include:

• Unit malfunction
• Improper cleaning of instruments
• Overloading the sterilization unit
• Improper packaging
• Improper timing and temperature
• Incorrect maintenance of sterilizer

Monitoring and Verification:

Sterilizing units should be monitored by the operator several times a week to ensure the unit is operating properly. Thermometers, timers, pressure levels, and other indicators should be visually monitored to ensure the unit is operating within parameters. In addition to physically monitoring, chemical and biological monitoring should be used according to industry standards. Chemical indicators should be placed inside each instrument pack, if the packaging does not have an external indicator to verify sterilization was completed. Chemical indicators should not be the sole source of verification as the chemicals/dyes used can present false readings of complete sterilization. Biological (spore) monitoring should be performed weekly. Spore testing is the only process that meets all sterilization verification parameters.

Cleaning/Sterilizing Process:

Cleaning instruments provides an opportunity to examine, replace or remove damaged instruments, as well as prepare the instruments for sterilization. Instruments should be properly staged through each cycle to ensure proper sterilization can be completed. The following basic considerations should be observed:

1. As appropriate, instruments must be disassembled, opened or unclamped for reprocessing.
2. Instruments should be cleaned or placed in a soaking solution immediately after use to keep solid debris from hardening on the device surface.
3. All cleaning solutions/detergents must be pH neutral. Avoid cleaning agents containing the following:
   1. Phenols – petroleum based or petroleum derivative types of products
   2. Iodophors (Iodine complex) – or similar types of products
   3. Tartaric acid, bleach, peroxide, other teeth whitening or tartar removal agents or byproducts, or other strong oxidizing agents
   4. Alkaline (> pH 9) or acidic (< pH 5) based products
   5. Esters — acid-based products (chemical names often ending in ‘oate’)
   6. Ketones — checmical names often ending in ‘anone’ or “one’
   7. Temperatures above 193°C/380°F –which are possible along the sides and bottom of steam sterilizing units
4. Manufacturer’s recommendations for solution/detergent concentration, soak time and water temperature must be observed.
5. Powder-based cleaners must be dissolved completely before instruments are immersed.
6. Filtered or distilled water should be used for all processes to eliminate the possibility of corrosion, staining or bacterial contamination from chemicals and pathogens found in most water systems.
7. Like metals should be processed together. Rusting instruments can cross contaminate other instruments during reprocessing and should be removed from use.

Cleaning Process:

1. Hand Cleaning:
   1. Due to safety issues, hand cleaning should be performed only if no other options are available.
   2. Personal protective equipment should be used (gloves, gown, eye protection).
   3. Contaminated instruments should be moved to the cleaning area immediately after patient use.
   4. A soft bristle brush or cloth should be used to remove contamination. Never use abrasive scrubbing pads, wire bristle brushes or steel wool.
   5. Minimize the risk of puncture injury by cleaning only one instrument at a time, keeping it low in the sink to minimize splatter.
   6. Use pH neutral cleaners – follow all manufacturer instructions.
   7. All cleaning solutions must be thoroughly rinsed from the instruments for a minimum of 20 seconds under clean, running water – preferably filtered or distilled.
   8. Inspect all instruments to ensure that all contaminants have been removed, paying critical attention to hinges, joints, cavities, bore holes and serrations. Failure to remove all contamination may result in a failure in sterilization.
   9. Visually inspect the instruments for any damage, corrosion, or other issues that may result in them being unsuitable for patient use. Remove these instruments from use.
   10. Allow instruments to dry in a clean, uncontaminated area.
   11. Hand cleaning is not a substitute for sterilization.
2. Ultrasonic Cleaning:
   1. Ultrasonic units must be inspected and tested according to the unit manufacturer’s recommended schedule to ensure they function properly.
   2. Contaminated instruments should be moved to the cleaning area immediately after patient use.
   3. Personal protective equipment should be used (gloves, gown, eye protection).
   4. Use pH neutral cleaners – follow all manufacturer instructions.
   5. Do not use household cleaners as they may cause pitting, corrosion, rust and other damage to instruments. There is also the risk of damaging the ultrasonic by using these types of cleaner.
   6. Follow the unit manufacturer’s recommendations for loading – avoid overloading. Overloading the ultrasonic can result in improper cleaning.
   7. Use cassettes or baskets as recommended by the unit manufacturer to ensure the instruments are not touching or overlapping.
   8. Do not lay instruments on the bottom of the ultrasonic, as this can interfere with cleaning and cause damage to the instruments or the ultrasonic unit.
   9. Follow the unit manufacturer’s instructions for cycle time based on the immersion method you are using.
   10. Once the ultrasonic is activated, the lid or cover should be kept on to reduce the release of spatter or aerosol into the area.
   11. All cleaning solutions must be thoroughly rinsed for a minimum of 20 seconds under clean, running water – preferably filtered or distilled.
   12. Inspect all instruments to ensure that all contaminants have been removed, paying critical attention to hinges, joints, cavities, bore holes and serrations. Failure to remove all contamination may result in a failure in sterilization.
   13. Visually inspect the instruments for any damage, corrosion, or other issues that may result in them being unsuitable for patient use. Remove these instruments from use.
   14. Allow instruments to dry in a clean, uncontaminated area.
   15. Ultrasonic processing is not a substitute for sterilization.
3. Automated Washer Unit:
   1. Automated washing units must be inspected and tested according to the unit manufacturer’s recommended schedule to ensure they function properly.
   2. Contaminated instruments should be moved to the cleaning area immediately after patient use.
   3. Personal protective equipment should be used (gloves, gown, eye protection).
   4. Use pH neutral cleaners – follow all manufacturer instructions.
   5. Do not use household cleaners as they may cause pitting, corrosion, rust and other damage to instruments.
   6. Follow the manufacturer’s recommendations for loading – avoid overloading the unit. Overloading the washer can result in improper cleaning.
   7. Ensure water flow is adequate for the method of instrument packaging used in the unit.
   8. Inspect all instruments to ensure that all contaminants have been removed, paying critical attention to hinges, joints, cavities, bore holes and serrations. Failure to remove all contamination may result in a failure in sterilization.
   9. Visually inspect the instruments for any damage, corrosion, or other issues that may result in them being unsuitable for patient use. Remove these instruments from use.
   10. Allow instruments to dry in a clean, uncontaminated area if the washer does not have a cycle for drying the instruments. Commercial or home level washers are not suitable for cleaning medical instruments.
   11. Automated washer processing is not a substitute for sterilization. Some automatic washers can be used as a disinfector.

Prior to Final Sterilization:

1. Inspect all instruments for proper operation and function.
2. Oil hinges and joints using oils designated by local regulations. Test all hinges and joints (as needed) to ensure smooth operations.
3. Ensure all hinged, jointed or clamped instruments are sterilized in the open or loose position.

Sterilizing Process:

1. Only FDA-approved dry or steam heat sterilizers should be used.
2. Monitor the sterilizer’s mechanics (thermometer, timers, pressure levels, etc.) to ensure proper functioning.
3. Spore test heat sterilizers on a weekly basis.
4. Follow the manufacturer’s maintenance instructions to ensure proper functioning.
5. Follow the manufacturer’s instructions for cycle time and temperature, loading and monitoring.
6. Make sure packaging materials are compatible with the sterilizer being used. Improper packaging can cause sterilization to fail. Unless otherwise noted, packaging is single use only.
7. Items must be arranged to allow for free circulation of the sterilizing agent.
8. If the packaging does not have an indicator to verify sterilization was completed, place a chemical indicator inside each instrument pack.
9. Instrument packs must be allowed to dry completely in the sterilizing unit before handling to reduce contamination to the instruments. Instruments must remain in packages until use.
10. Use filtered or distilled water. Follow the unit manufacturer’s instructions for types and amounts of water.