Clinical Foundations - Outcome 6

Question 1

One-way movement of reprocessing room

Answer 1

Reprocessing room must have one-way movement of instruments through the reprocessing process, from dirty to sterile.

Question 2

Following these standards will ensure the health and safety of healthcare personnel and patients. Instrument Reprocessing requires multiple steps to achieve sterilization:

Answer 2

Contaminated critical and semi-critical instruments and devices must be taken directly to reprocessing room.

These steps include Precleaning (disassembly, and sorting), cleaning, rinsing, drying, physical inspection, corrosion reduction/lubrication, reassembly packaging, steam sterilization, cooling/drying, storage, and delivery.

Question 3

PPE worn during instrument preparation:

Answer 3

Gown, utility gloves, mask, eye protection

Question 4

PPE worn during packaging:

Answer 4

exam gloves, mask & eye protection

Question 5

PPE worn during sterilization process

Answer 5

clean hands (no gloves), except with loading (wear exam gloves, mask, eye protection)

Question 6

Workflow pattern for reprocessing

Answer 6

Instrument preparation > Packaging > Sterilization Process

Question 7

Classification system for dental devices based on a modified Spaulding classification

Answer 7

Critical Items - used to penetrate soft tissue or bone

Semi-Critical Items - only touch mucous membranes or non-intact skin. Should be sterilized or if it is heat and moisture sensitive, it can be disinfected with high-level disinfection.

Non-Critical Items - contact only intact skin. Must be cleaned or disinfected if contaminated. These can also be covered with a barrier.

Every dental device will be classified by the dental assistant using these categories and then reprocessed accordingly. Handpieces are considered a critical item

Question 8

Instrument Reprocessing Area

Answer 8

Every dental office must have a designated reprocessing area that includes sections for cleaning, packaging, sterilization, and storage of sterile devices

Question 9

Instrument Reprocessing Area Requirements

Answer 9

-Ideally, these sections should be separated by walls or partitions to direct the flow from one to the other and minimize spray and splatter generated during reprocessing.

-The instrument reprocessing area should be centrally located with easy access from patient care areas.

-It must have a one-way workflow that proceeds from a contaminated or ‘dirty’ zone to a cleaned zone, to a sterile zone, and finally into the storage zone.

-It must have ventilation.

-Hand hygiene stations must be available.

-The surfaces, such as countertops and floors must be easily cleaned.

Question 10

Detailed Instrument Reprocessing Steps

Answer 10

1. Transport: Contaminated instruments must be transported to the reprocessing area in a manner that minimizes the risk of exposure to contaminants.
2. Cleaning: Before any sterilization or disinfection procedure, cleaning is an essential step to reduce the number of microorganisms present and remove blood, saliva, and other materials that may insulate microorganisms from the sterilizing agent. This can be done by manually scrubbing, or with an instrument washer or an ultrasonic cleaner.

-Rinsing: The instruments must be rinsed if manual cleaning or ultrasonic cleaning is performed.
-Drying: Instruments must be thoroughly dried to ensure proper sterilization in an autoclave if manual or ultrasonic is used.
-Inspection: After cleaning and drying, the instruments must be physically inspected to ensure all debris has been removed.
-Corrosion reduction/lubrication: To maintain proper function some instruments must be lubricated regularly.
*hinged instruments must be lubricated to maintain proper function (i.e., milk bath).
*handpieces are lubricated according to manufacturer’s instructions

3. Packaging: Packaging is used to deliver instruments to the patient in a sterile condition. It will also prevent instruments from cross-contamination during storage, or when they are transported from one area to another.
4. Sterilization: There are several processes to ensure that microorganisms from a patient procedure are not carried to the other patients or to dental personnel. The most efficient are sterilization processes that kill all forms of life on an instrument.
5. Storage: Instrument sterility must be maintained until the sterilized packs, pouches, or cassettes are opened for use at the chairside. Instruments must be labeled with the sterilizer number, load number of that sterilizer, and sterilization date. Instruments must be stored in a clean, dry location in a manner that prevents contamination or damage.
6. Delivery: Instrument sterility must be maintained until the sterilized packs, pouches, or cassettes are opened for use at the chairside. Reprocessed dental instruments or devices must be inspected for integrity upon opening the instrument or device pack or cassette at the point of use. The results of the internal chemical indicator must be validated prior to the use of dental instruments or devices
7. Quality assurance: To ensure instrument sterility, a program of monitoring using biological and chemical indicators is used in reprocessing. A quality assurance program also includes training, record keeping, and maintenance.

Question 11

Pre-cleaning and Cleaning Dental Devices

Answer 11

Pre-cleaning and cleaning is the removal of visible soil, organic and inorganic contamination from a device or surface, using either the physical action of scrubbing with a surfactant or detergent and water or an energy-based process (e.g., ultrasonic cleaners or thermal washers) with appropriate chemical cleaning agents. The action of sterilization cannot occur unless cleaning has occurred .

Question 12

Basic Principles of Pre-Cleaning & Cleaning

Answer 12

The manufacturer’s directions for the cleaning and decontamination of dental instruments or devices must be followed with special attention paid to the working end of instruments on which dental material can become fixed.

Decontamination begins at the point of use with gross debridement done in the clinic operatory on handpieces and instruments which have visible debris.

Contaminated critical and semi-critical dental instruments and devices must be taken directly to the area designated for receiving contaminated devices and if required, initial disassembly completed.

If dental instruments and devices cannot be cleaned immediately after use, the instruments or devices must be kept moist in a transport container using a holding solution or spray specifically intended for this use. This can also be a damp towel or cloth over the instruments to keep debris from drying on.

Long-handled brushes will be used when handling or manually cleaning contaminated instruments and devices.

Reusable dental instruments must be cleaned with an instrument detergent or enzymatic product that is used according to the manufacturer’s instructions.

Automated cleaning equipment (e.g., ultrasonic cleaners, instrument washers) must be operated and maintained according to manufacturer’s instructions.

Devices requiring hand cleaning by manufacturer’s directions (i.e., Ultrasonic scaler tip/ hub must be brushed beneath the surface of the cleaning solution using a long-handled brush to prevent spreading of contaminated aerosols.

Cleaning accessories (e.g., long-handled brushes) must be disposable or thoroughly cleaned and high-level disinfected or sterilized between uses.

After cleaning (if manual cleaning or ultrasonic was used) the instruments must be thoroughly dried on lint-free towels

Question 13

Pre-Cleaning of Instruments - in operatory

Answer 13

-Pre-cleaning is done in the operatory to remove visible debris. This can be done with a disinfectant wipe or a wet gauze 2X2. An example of this would be to use a disinfectant wipe or gauze to remove dental materials residue from the slow-speed handpiece after a hygiene appointment for example

Question 14

Cleaning Methods

Answer 14

Instruments must be cleaned prior to disinfection or sterilization. Three ways are available: washer/disinfectors, ultrasonic cleaning or manual cleaning,

Question 15

Automated Washer

Answer 15

Washer/disinfectors operate very much like household dishwashers. However, they must be approved for dental use. The advantage of these is their capacity to hold more instruments and to complete a dry cycle. This is a preferable method of cleaning the instruments. Critical and semi-
critical medical devices shall be cleaned using an automated process whenever possible

Question 16

Ultrasonic Cleaning

Answer 16

Ultrasonic energy initiates a process known as cavitation. It is a very efficient cleaning process that is far superior to any other currently in use. It is safer than manual cleaning because there is less handling of instruments decreasing possibilities of cuts and finger nicks and also the spatter of debris generated by brushing. Make sure all items are completely immersed. It is important to note that this is a cleaning method to remove debris from instruments and does not sterilize or disinfect instruments. Thorough rinsing is necessary to remove the loosened soil and detergent

Question 17

Manual Cleaning of instruments

Answer 17

Manual Cleaning of instruments

Question 18

Instrument packaging

Answer 18

The packaging is used to deliver instruments to the patient in a sterile condition. It will also prevent instruments from cross contamination during storage, or when they are transported from one area to another. Before an instrument is packaged, they must be cleaned, rinsed, dried, and inspected

Question 19

Before Packaging

Answer 19

Decontaminated and cleaned critical instruments and devices must be inspected and assembled into sets or trays designed to maintain sterility during storage, before being wrapped and packaged.

Clean dry instruments and devices will be inspected for cleanliness (free of debris: i.e. Bioform and dental materials from prior use), and instrument integrity (free of damage: i.e., broken working ends, deep scratches on working ends).

Re-clean by manual scrubbing any debris still remaining after inspection

Remove from circulation any damaged instruments and replace

Equipment/devices requiring lubrication must be lubricated prior to sterilization.

Hinged instruments must be immersed in a rust inhibitor prior to sterilization and packaged open and unlocked.

Handpieces must be lubricated prior to sterilization.

Question 20

Packaging

Answer 20

The purpose of instrument „packaging‟ is to ensure that sterility is maintained when instruments are stored between uses

Each instrument pack or cassette must have an external Class 1 process indicator applied to, or visible from, the exterior of the package.

Each instrument pack must have an internal chemical indicator Class 5 or 6 multi-parameter indicator.

Packages will be labeled with the sterilizer number, load number of that sterilizer, and sterilization date that they were reprocessed.

Question 21

Selection of a wrapper

Answer 21

It must permit easy penetration by steam under pressure, and at the same time allow for the elimination of residual air.

During storage after sterilization, it must act as an effective and reliable filter against microorganisms and dust in the environment.

It must be robust enough to withstand the sterilization process and handling during storage.

It must be easily closed or sealed.

It must be consistent in quality, economical and readily available

Transparency and water repellency are both highly desirable characteristics.

Question 22

Types of Wrappers typically used in Dental Office

Answer 22

Flat Wraps:
Advantages-Used for items that are too large to fit in any paper bags or are too heavy and may tear paper bags, such as cassettes.
Disadvantages-Time consuming when packaging. Wrapping technique is required to maintain package sterility.

Plastic/Paper Pouches:
Advantages-Transparent (can see instruments) and self-sealing.
Disadvantages-The paper can puncture easily when moist. Ensure bags have run through a complete dry cycle of the sterilizer.

Wrapped perforated cassettes:
Advantages-Easily penetrated by steam. Must be covered with a paper/cloth wrapper for contents to remain sterile.
Disadvantages-Expensive for the initial purchase

Question 23

IMPORTANT Information about wrappers

Answer 23

All wrappers must be carefully checked for holes or other defects prior to use, after sterilization and again before the contents are removed for use.

Staples, paper clips, pins, and masking tape are never used to close packages for sterilization because they can create holes or leaks through which microbes and dust can penetrate.

Use the appropriate size of the package for the number of instruments to be processed. Do not pack instruments too tightly.

Ensure instruments are completely dry before removing them from the sterilizer. (3M, Sterilization Pack Loading Canada)

Question 24

Demonstrate the process for using and maintaining steam sterilizers.

Answer 24

Sterilization is a complex process requiring specialized equipment. It is essential to provide ongoing training and regular monitoring for use and quality assurance.

To ensure instruments are safe for re-use on patients, correct cleaning, packaging, and sterilization methods must always be followed The goal is to break the chain of infection in order to prevent disease transmission between patients, the dental team, and the public.

Steam sterilizers require daily, weekly, often monthly maintenance. Prior to using any type of steam sterilizer, ensure to follow manufacture instructions for its use and maintenance. Always refer to the manufacture’s instructions for safe use and maintenance.

Question 25

Storage of Dental Instruments

Answer 25

A package and its contents should remain sterile until some event causes the item(s) to become contaminated. This is considered “event-related” packaging.

The shelf life of a packaged sterile item depends on:

The quality of the wrapping material

Storage conditions

Conditions during transport

The amount of handling

Question 26

Storage Guidelines

Answer 26

• Do not store sterile supplies or patient care items under the sink (or any location where they may become wet), on the floor, windowsills, or any area other than designated shelving/cabinets.

Do not store sterile items with items not intended for clinical use such as office or cleaning supplies.

The clean storage area must be limited to “clean” reprocessing activities only and all other activities are prohibited.

Critical instruments must be wrapped or placed in containers (eg. cassettes or organizing trays) designed o maintain sterility during storage.

Some sterile items and dental supplies in clean, dry, and dust/lint-free areas with limited access such as in covered or closed cabinets.

Where ever possible, instrument packages will be placed on their sides in drawers or containers designated for storing sterile items.

Avoid stacking instrument packages on top of each other, as it increases the risk of pouches puncturing or tearing.

Keep like items together: sterile with sterile and clean with clean.

Packages will be placed so that it allows for a first-in-first out rotation of instrument stock.

Do not handle sterile packages unnecessarily to avoid contamination.

Question 27

Delivery of Dental Instruments

Answer 27

Sterile dental instruments or devices must be maintained and delivered as sterile until the point of use. The point of use is just before using them in a dental procedure in the operatory.

• When assistants obtain reprocessed dental instruments or devices for patient use, they must inspect the package for integrity prior to opening the instrument or device pack or cassette at the point of use.
• Once the package is open, the results of the internal chemical indicator must be assessed prior to the use of the dental instruments or devices for patient care.
• In the event that a package is compromised, the instruments and devices will be re-cleaned, re-packaged, and sterilized again.

Question 28

Quality insurance in dental reprocessing

Answer 28

It is critical to ensure that sterilization has taken place before using any dental devices in patient-treatment. The process of monitoring and testing of reprocessing procedures and equipment along with documentation is called quality assurance. It is often the responsibility of the dental assistant to perform the monitoring or testing and maintaining the documentation for audit purposes.

Question 29

3 Forms of monitoring to ensure condition of sterility

Answer 29

Mechanical
Chemical
Biological Indicators

Question 30

Mechanical Monitoring

Answer 30

Data is displayed on the sterilizer as each cycle progresses and is recorded for each load completed either by physical printout or electronic record and by observing the gauges or displays on the sterilizer. Each step is recorded in detail such as start time, load number, temperature, the pressure of every sterilization cycle. Physical aspects allow for easier recall of instrument packages in the event of an equipment malfunction. Any cycles that fail to reach “complete” will require all instrument packages in this load to be reprocessed

Question 31

Chemical Monitoring

Answer 31

Chemical Indicators are devices that respond with a chemical or physical change when exposed to the sterilization cycle. One or more “class” of chemical indicators will be included in every package that is sterilized. A “pass” indicates that certain conditions were achieved at the location of the chemical indicator and is safe to use in patient care. A “fail” indicates that conditions to achieve sterilization were not achieved for this package. This package should not be used until it has been successfully reprocessed. Appropriate class/classes of chemical indicators must be used for the intended end purpose of the instrument package.

Each instrument pack or cassette must have an external Class 1 process indicator applied to, or visible from, the exterior of the package, and an internal chemical indicator that is a Class 5 or 6 multi-parameter indicator. Indicators must be used inside the material and/or instrument packs whenever implantable devices are used.

Question 32

Classes of Chemical Monitoring - Class 1

Answer 32

Class 1 - a chemical indicator indicates a package has gone through a sterilization process. Indicates the minimal length of time to achieve the endpoint. Respond to heat only and are used to identify packs yet to be processed. Demonstrate the rapid and even penetration of steam.

Question 33

Classes of Chemical Monitoring - Class 4

Answer 33

Class 4:

Chemical indicator are multi-parameter indicators, such as heat and pressure or heat and steam or combination of temperature and time of exposure.

Question 33

Classes of Chemical Monitoring - Class 5

Answer 33

Class 5:

Chemical indicator responds to parameter indicators, such as heat, pressure, and steam or by time, temperature and saturated steam.

Question 33

Classes of Chemical Monitoring - Class 3

Answer 33

Class 3:

Chemical indicator responds to a single parameter, pressure, or steam heat. The test is labeled accordingly and responds to specific parameters during the sterilization.

Question 33

Classes of Chemical Monitoring - Class 2

Answer 33

Class 2:

Process indicators demonstrate the rapid and even penetration of steam and by implication the adequacy of air removal. Used in specific tests such as the Bowie Dick test for the pre-vacuum type of sterilizers (example of pre-vacuum sterilizers: Bravo or Lisa)

Question 34

Classes of Chemical Monitoring - Class 6

Answer 34

Emulating indicators are cycle verification indicators that are designed to react to all critical variables for specified sterilization cycles. This condition is likely to occur when there is: incorrect packaging, incorrect load, air/steam mixtures, an incorrect cycle for load contents. (3MTM Attest TM Products Sterile U Network)

Question 35

Failure in Sterilization Processes

Answer 35

In the event of a failure in the sterilization process (failure of the sterilizer, failure of chemical indicators or the failure of the biological indicator) there must be a process in place to investigate the cause of the event, document actions taken, and recall sterilization loads if necessary.

Was there a sterilizer malfunction that could account for the failure to achieve the endpoint?

Has there been a change(s) in the product and/or sterile barrier system?

If either mechanical indicators, external or internal chemical indicators indicate inadequate processing, items in the load must not be used until after investigation, the problem is corrected and the load is successfully reprocessed
Has the loading density increased or decreased within the sterile barrier system?

Has the sterilization processing container/configuration changed (e.g., the number of packages has increased or decreased, or the configuration was not the same as that used during validation?

Was sterilizer calibration and/or routine maintenance conducted appropriately?

Was the correct sterilizer process chosen for the product sterilized?

Was the chemical indicator handled under the manufacturer’s recommended practices?

Have there been changes in the utilities supplied to the sterilizer that could materially affect cycle execution (pressure, flow rate, non-condensable gases in the steam supply, etc.?

Did that instrument pack, in fact, actually go through a sterilizer cycle?

If either mechanical indicators, external or internal chemical indicators indicate inadequate processing, items in the load must not be used until after investigation, the problem is corrected and the load is successfully reprocessed

Question 36

Biological Monitoring

Answer 36

Biological monitoring is achieved with the use of biological indicators which consist of spores on a carrier or an incubation medium. It must be conducted daily in the first full load of each sterilizer and incubated for a specific amount of time with each type of cycle used (i.e., wrapped and unwrapped cycles if both are used), the results are recorded in a monitoring logbook (

At the beginning of the workday, the challenge pack is assembled and placed in the area of the sterilizer considered least favorable to sterilization (cold point). Meanwhile, an unexposed biological indicator from the same lot is used to verify the viability of the test indicator itself. The control indicator vial should yield positive results for bacterial growth as it had not been exposed to sterilizing. The anticipated results of the sterilized BI testing shall be negative (spores are not detected)

Important note: While waiting for the BI test results, all instruments must be quarantined until results are negative (a negative culture)

The results of biological monitoring must be recorded and retained as long as necessary for medical-legal purposes. Always follow manufactures instructions for proper use of biological monitoring equipment . If showing positive results (bacterial growth) all instruments must be recalled.

Question 37

Most common reasons for a positive Biological indicator are..

Answer 37

-overloading
-failure to provide adequate package separation
-incorrect or excessive packing material

Question 38

Demonstrate the maintenance of the reprocessing area.

Answer 38

The manufacturer’s instructions of the dental units and dental equipment must be followed for daily and weekly maintenance. If a dental clinic is equipped with closed water systems or other special water delivery systems are utilized regular maintenance should be established.

Automated cleaning equipment (e.g., ultrasonic cleaners, thermal washers) must be operated and maintained according to manufacturer’s instructions and this must be documented.

Question 39

The sterilization process does what? What are the guidelines for critical & semi-critical devices?

Answer 39

The sterilization process destroys all microbial forms including bacterial spores. If a device has been sterilized, it indicates that all life forms have been destroyed. The guidelines in many health or government agencies state that critical or semi-critical devices that come into contact with a patient’s bodily fluids must be heat-sterilized

Question 40

Most common form of heat sterilization?

Answer 40

The most common form of heat sterilization is steam sterilization, however other forms of sterilization are available such as chemical vapor sterilization or dry heat sterilization. Alberta guidelines do not contain these options and instead state that “heat-tolerant dental instruments are sterilized in the dental office using steam under pressure (autoclaving)”

Question 41

What is Flash sterilization?

Answer 41

“Flash” sterilization, is referred to as reprocessing loose instruments, not in wraps, packages, or cassettes. It is not done routinely. Flash sterilization must not be used for implantable devices. Scheduling of procedures and lack of instrumentation are not valid reasons for routine flash sterilization of instruments

Question 42

Restricted/impracticle sterilizing techniques

Answer 42

Liquid chemical sterilant must not be used to sterilize critical instruments. These sporicidal chemicals (e.g., glutaraldehyde, peracetic acid, and hydrogen peroxide) are highly toxic and their effectiveness cannot be verified with biological indicators

Glass bead sterilizers” must not be used to sterilize critical or semi-critical instruments (e.g., endodontic files), as their effectiveness is inconsistent for sterilization between patients. Boiling, ultraviolet light, ovens designed for food preparation, and microwave ovens must not be used for the instrument or device sterilization.

Low-temperature sterilization using ethylene oxide gas (ETO) is used extensively in larger health-care facilities, such as hospitals. Heat- and moisture-sensitive patient-care items may be sterilized with ETO without damaging effects. The extended sterilization times (typically, 10 to 48 hours), as well as the hazardous vapors produced, make this method impractical for private-practice dental care settings. As well, handpieces cannot be effectively sterilized using ETO due to the decreased penetration of ETO gas through small lumens. Other types of low-temperature sterilization methods (e.g., hydrogen peroxide gas plasma) exist; however, these methods are not yet practical for dental offices

Question 43

Summary of methods of sterilization

Answer 43

Steam
-Flash sterilization
-Unsaturated Chemical Vapor

Dry Heat
-Static air (dry heat oven)
-Forced air (rapid heat transfer)

Ethylene Oxide Sterilization

Liquid Chemical Sterilant