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FAQ's Sterilization

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Q Which technique is recommended: spray, wipe, spray or wipe, discard, wipe.

Q What is the best sterilizer to use for orthodontic instruments, including hinged instruments?

Q We recently heard that there have been some changes in disinfection guidelines for the dental office. Can you send us the guidelines on spray-wipe-spray –vs.- plastic barriers and which areas in the operatory should have what? We are concerned about mirror handles, air/water syringes, suction, etc.

Q After recently introducing the spray-wipe-spray technique in our practice, many of our staff began experiencing allergic reactions from the airborne spray. Although proper precautions and PPE are being used, the staff is complaining about itchy, watery eyes, nose, and mouth irritation. My understanding is that OSHA mandates the spray-wipe-spray technique. My question is, due to the significant problems I am encountering from this technique, is there an alternative for disinfection? I could not locate any other information in the regulatory compliance manual or other OSHA safety manuals.

Q I work in a dental office and recently had a question come up with regard to sterilization. When autoclaving instruments in plastic and paper pouches, which side should be up?

Q I recently consulted with a client who purchased a counter top dishwasher from walmart.com. He said he read it in Christianson's report as being comparable to the instrument washer. I explained that it is not FDA regulated as a medical device and should not be used in a dental office setting for pre-cleaning instruments. How can I provide further information? Has this been addressed with Christianson?

Q What is the source of the peracetic acid/hydrogen peroxide sterilant referenced in the Appendix I in the Oral Healthcare Missions publication. It is the last material listed, but I can't find a source.

Q What are the recommendations on sterilization –vs- single use of endodontic files, rasps, drills, and burs?

Q A graduate of our program recently called and asked about reusing sterilization bags. I commented that the integrity of the bag may be compromised through reuse. Do you have any information to share on this practice?

Continued

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Q Which technique is recommended: spray, wipe, spray or wipe, discard, wipe.

A OSAP is not currently aware of any federal regulations that prohibit the use of the spray-wipe-spray technique. However, individual states, through state legislation or State Board Of Dental Examiners/Licensing Boards, could prohibit the use of disinfecting sprays.

OSAP is not in a position to maintain individual state laws/regulations, therefore, you should contact your State Board directly.

Links to state agencies that may be viewed at:

http://www.dentalwatch.org/org/boards.html

OSAP can provide you with the following general information concerning both techniques.

The Authors of OSAP's From Policy to Practice: OSAP's Guide to the Guidelines. offer the following information:

For pre-cleaning clinical surfaces:

Use a low to intermediate-level disinfectant and the "spray-wipe-spray” technique to clean and disinfect clinical contact surfaces. First clean, then disinfect. Spray the surface to be cleaned with a cleaner or cleaner/disinfectant. Then, wipe vigorously using paper towels. Once cleaned, spray the surface again, this time with a disinfectant. Cover the entire surface, and allow the disinfectant to remain undisturbed on the surface for the contact time indicated on its label. (1)

The authors also offer the following alternative to pre-cleaning clinical surfaces:

Wipe a pre-moistened cleaner-disinfectant towelette over the surface to be cleaned. Check the label to be sure that the wipe is a cleaner (some disinfectant wipes may require a separate cleaner). Carefully follow label instructions. Some wipes may be effective only on a limited surface area (approximately 3 sq. ft.). (1)

After cleaning, disinfect the surface:

Spray the disinfectant over the entire surface, using towels to reduce overspray. Let the surface remain moist for the contact time stated on the disinfectant's label. Wipe the surface dry if it is still wet when ready for patient care. (1)

The authors also offer the following alternative to spraying disinfectants on clinical surfaces:

Saturate the surface using a pre-moistened disinfectant towelette (wipe). Let the surface remain moist for the contact time stated on the disinfectant's label. Wipe the surface dry if it is still wet when ready for patient care. (1)

Resource:

(1) From Policy to Practice: OSAP's Guide to the Guidelines. Copyright 2004 by OSAP.

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Q What is the best sterilizer to use for orthodontic instruments, including hinged instruments?

A Typically, orthodontic practices utilize more than one type of sterilizer due to the variety of instruments and supplies used with orthodontic patients.

Because of the many advantages and disadvantages of each method of sterilization, OSAP is not in a position to recommend any one type of sterilizer. Each orthodontic practice must determine which methods of sterilization best meets the needs of their practice. Although dry heat sterilizers are often recommended, their use may not always be practical due to the prolonged process time required to sterilize instruments.

We can however, provide you with general information concerning the methods of sterilization that should help you determine which ones will meet your needs.

The Centers for Disease Control and Prevention's (CDC) Guidelines for Infection Control in
Dental Healthcare Settings provides the following information for each method of sterilization:

Sterilization Procedures. Heat-tolerant dental instruments usually are sterilized by 1) steam under pressure (autoclaving), 2) dry heat, or 3) unsaturated chemical vapor. All sterilization should be performed by using medical sterilization equipment cleared by FDA. The sterilization times, temperatures, and other operating parameters recommended by the manufacturer of the equipment used, as well as instructions for correct use of containers, wraps, and chemical or biological indicators, should always be followed. (1)

Steam Sterilization. Among sterilization methods, steam sterilization, which is dependable and economical, is the most widely used for wrapped and unwrapped critical and semi-critical items that are not sensitive to heat and moisture. Steam sterilization requires exposure of each item to direct steam contact at a required temperature and pressure for a specified time needed to kill microorganisms. Two basic types of steam sterilizers are the gravity displacement and the high-speed pre-vacuum sterilizer. (1)

The majority of tabletop sterilizers used in a dental practice are gravity displacement sterilizers, although pre-vacuum sterilizers are becoming more widely available. In gravity displacement sterilizers, steam is admitted through steam lines, a steam generator, or self-generation of steam within the chamber. Unsaturated air is forced out of the chamber through a vent in the chamber wall. Trapping of air is a concern when using saturated steam under gravity displacement; errors in packaging items or overloading the sterilizer chamber can result in cool air pockets and items not being sterilized. (1)

Pre-vacuum sterilizers are fitted with a pump to create a vacuum in the chamber and ensure air removal from the sterilizing chamber before the chamber is pressurized with steam. Relative to gravity displacement, this procedure allows faster and more positive steam penetration throughout the entire load. Pre-vacuum sterilizers should be tested periodically for adequate air removal, as recommended by the manufacturer. Air not removed from the chamber will interfere with steam contact. If a sterilizer fails the air removal test, it should not be used until inspected by sterilizer maintenance personnel and it passes the test. Manufacturer's instructions, with specific details regarding operation and user maintenance information, should be followed. (1)

Unsaturated Chemical-Vapor Sterilization. Unsaturated chemical-vapor sterilization involves heating a chemical solution of primarily alcohol with 0.23% formaldehyde in a closed pressurized chamber. Unsaturated chemical vapor sterilization of carbon steel instruments (e.g., dental burs) causes less corrosion than steam sterilization because of the low level of water present during the cycle. Instruments should be dry before sterilizing. State and local authorities should be consulted for hazardous waste disposal requirements for the sterilizing solution. (1)

Dry-Heat Sterilization. Dry heat is used to sterilize materials that might be damaged by moist heat (e.g., burs and certain orthodontic instruments). Although dry heat has the advantages of low operating cost and being non-corrosive, it is a prolonged process and the high temperatures required are not suitable for certain patient-care items and devices. (1)

Dry-heat sterilizers used in dentistry include static-air and forced-air types. (1)

The static-air type is commonly called an oven-type sterilizer. Heating coils in the bottom or sides of the unit cause hot air to rise inside the chamber through natural convection.
The forced-air type is also known as a rapid heat-transfer sterilizer. Heated air is circulated throughout the chamber at a high velocity, permitting more rapid transfer of energy from the air to the instruments, thereby reducing the time needed for sterilization.
Sterilization of Unwrapped Instruments. An unwrapped cycle (sometimes called flash sterilization) is a method for sterilizing unwrapped patient-care items for immediate use. The time required for unwrapped sterilization cycles depends on the type of sterilizer and the type of item (i.e., porous or nonporous) to be sterilized. The unwrapped cycle in tabletop sterilizers is preprogrammed by the manufacturer to a specific time and temperature setting and can include a drying phase at the end to produce a dry instrument with much of the heat dissipated. If the drying phase requirements are unclear, the operation manual or manufacturer of the sterilizer should be consulted. If the unwrapped sterilization cycle in a steam sterilizer does not include a drying phase, or has only a minimal drying phase, items retrieved from the sterilizer will be hot and wet, making aseptic transport to the point of use more difficult. For dry-heat and chemical-vapor sterilizers, a drying phase is not required. (1)

Unwrapped sterilization should be used only under certain conditions: 1) thorough cleaning and drying of instruments precedes the unwrapped sterilization cycle; 2) mechanical monitors are checked and chemical indicators used for each cycle; 3) care is taken to avoid thermal injury to DHCP or patients; and 4) items are transported aseptically to the point of use to maintain sterility. Because all implantable devices should be quarantined after sterilization until the results of biological monitoring are known, unwrapped or flash sterilization of implantable items is not recommended. (1)

Critical instruments sterilized unwrapped should be transferred immediately by using aseptic technique, from the sterilizer to the actual point of use. Critical instruments should not be stored unwrapped. Semi-critical instruments that are sterilized unwrapped on a tray or in a container system should be used immediately or within a short time. When sterile items are open to the air, they will eventually become contaminated. Storage, even temporary, of unwrapped semi-critical instruments is discouraged because it permits exposure to dust, airborne organisms, and other unnecessary contamination before use on a patient (260). A carefully written protocol for minimizing the risk of contaminating unwrapped instruments should be prepared and followed. (1)

The authors of Practical Infection Control In Dentistry also state that orthodontic pliers and cutters require special attention and are best sterilized with dry heat units. The instruments can be placed in an ultrasonic bath containing a rust inhibitor solution before sterilization. The instruments should then be bagged and sterilized immediately after retrieval from the ultrasonic bath. Pliers and cutters should be lubricated with a silicone lubricant once a week. (2)

Surgical milk may also be used to lubricate instruments prior to sterilization. This agent is a concentrated pre-autoclave dip that extends the life of valuable instruments. The non-toxic, odor-free formula inhibits rust and lubricates all hinged instruments. Information on this product may be viewed at:

http://www.youngdental.com/detail.php?urltitle=lorvicsurgicalmilk

Keep in mind that regardless of the method of sterilization used, hinged instruments should be processed open and unlocked.

Because Orthodontics have unique challenges (e.g. orthodontic wires, pliers, cutters, brackets, bands, elastics, orthodontic appliances, etc.) we would like to also refer you to the American Association of Orthodontics for the most current infection control recommendations that address the specific needs of the orthodontic practice.

You may contact The American Association of Orthodontics at:

American Association of Orthodontists
401 North Lindbergh Boulevard
St. Louis, MO 63141-7816
Phone: 314-993-1700
Fax: 314-997-1745

Email address: info@aaortho.org.

Resources:

(1) The Centers for Disease Control and Prevention's (CDC) Guidelines for Infection Control in
Dental Healthcare Settings:

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm

(2) Practical Infection Control In Dentistry, 2nd. edition. By Cottone, Terezhalmy, and Molinari.
Publisher, Williams & Wilkins. Copyright 1996.

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Q We recently heard that there have been some changes in disinfection guidelines for the dental office. Can you send us the guidelines on spray-wipe-spray –vs.- plastic barriers and which areas in the operatory should have what? We are concerned about mirror handles, air/water syringes, suction, etc.

A We believe you are referring to the Centers for Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental Healthcare Settings. The CDC revised and updated the guidelines in December 2003. However, there may also be state/local regulations that OSAP would not be aware of. Therefore, you should also check with your State Board of Dental Examiners/Licensing Board for all applicable infection control requirements in your state.

OSAP would like to refer you directly to the guidelines. In part, they state the following:

Clinical contact surfaces can be directly contaminated from patient materials either by direct spray or spatter generated during dental procedures or by contact with DHCP's gloved hands. These surfaces can subsequently contaminate other instruments, devices, hands, or gloves. Examples of such surfaces include (1):

light handles,
switches,
dental radiograph equipment,
dental chairside computers,
reusable containers of dental materials,
drawer handles,
faucet handles,
countertops,
pens,
telephones, and
doorknobs.
Barrier protection of surfaces and equipment can prevent contamination of clinical contact surfaces, but is particularly effective for those that are difficult to clean. Barriers include clear plastic wrap, bags, sheets, tubing, and plastic-backed paper or other materials impervious to moisture. Because such coverings can become contaminated, they should be removed and discarded between patients, while DHCP are still gloved. After removing the barrier, examine the surface to make sure it did not become soiled inadvertently. The surface needs to be cleaned and disinfected only if contamination is evident. Otherwise, after removing gloves and performing hand hygiene, DHCP should place clean barriers on these surfaces before the next patient. (1)

If barriers are not used, surfaces should be cleaned and disinfected between patients by using an EPA-registered hospital disinfectant with an HIV, HBV claim (i.e., low-level disinfectant) or a tuberculocidal claim (i.e., intermediate-level disinfectant). Intermediate-level disinfectant should be used when the surface is visibly contaminated with blood or OPIM. Also, general cleaning and disinfection are recommended for clinical contact surfaces, dental unit surfaces, and countertops at the end of daily work activities and are required if surfaces have become contaminated since their last cleaning. To facilitate daily cleaning, treatment areas should be kept free of unnecessary equipment and supplies. (1)

Manufacturers of dental devices and equipment should provide information regarding material compatibility with liquid chemical germicides, whether equipment can be safely immersed for cleaning, and how it should be decontaminated if servicing is required. Because of the risks associated with exposure to chemical disinfectants and contaminated surfaces, DHCP who perform environmental cleaning and disinfection should wear gloves and other PPE to prevent occupational exposure to infectious agents and hazardous chemicals. Chemical- and puncture-resistant utility gloves offer more protection than patient examination gloves when using hazardous chemicals. (1)

In addition, most dental practices utilize a combination of barriers and between-patient cleaning and disinfection to maintain operatory asepsis and minimize the potential for cross-contamination.

The use of protective barriers generally eliminates the need for surface disinfection during operatory turn-around. However, surfaces must be cleaned and disinfected anytime the barrier has been compromised as well as at the beginning and end of each clinic day.

Environmental surface disinfectants are supplied as concentrates, premixed solutions, sprays, foams, impregnated wipes, and tablets. Pump-sprays, however, are considered the best vehicle for delivering cleaning/disinfecting agents to contaminated surfaces.

The pump concentrates spray liquid on the surface rather than aerosolizing it, which allows the chemical to penetrate into crevices. In addition, spray bottles eliminate potential inactivation or absorption of the disinfectant by gauze, paper, or sponge applicators. (2) (3) (4)

According to dental infection control expert, Dr. Charles Palenik, disinfection is now called environmental infection control. The emphasis has gone away from the primary use of chemicals to one that uses mostly surface covers. In fact, areas that need attention (disinfection or covering) are now called clinical contact surfaces. (5)

The Authors of OSAP's From Policy to Practice: OSAP's Guide to the Guidelines. Copyright 2004, offer the following information:

For pre-cleaning clinical surfaces:

Use a low to intermediate-level disinfectant and the "spray-wipe-spray” technique to clean and disinfect clinical contact surfaces. First clean, then disinfect. Spray the surface to be cleaned with a cleaner or cleaner/disinfectant. Then, wipe vigorously using paper towels. Once cleaned, spray the surface again, this time with a disinfectant. Cover the entire surface, and allow the disinfectant to remain undisturbed on the surface for the contact time indicated on its label. (6)

The authors also offer the following alternative to pre-cleaning clinical surfaces:

Wipe a pre-moistened cleaner-disinfectant towelette over the surface to be cleaned. Check the label to be sure that the wipe is a cleaner (some disinfectant wipes may require a separate cleaner). Carefully follow label instructions. Some wipes may be effective only on a limited surface area (approximately 3 sq. ft.). (6)

After cleaning, disinfect the surface:

Spray the disinfectant over the entire surface, using towels or reduce overspray. Let the surface remain moist for the contact time stated on the disinfectant's label. Wipe the surface dry if it is still wet when ready for patient care. (6)

The authors also offer the following alternative to spraying disinfectants on clinical surfaces:

Saturate the surface using a pre-moistened disinfectant towelette (wipe). Let the surface remain moist for the contact time stated on the disinfectant's label. Wipe the surface dry if it is still wet when ready for patient care. (6)

Resource:

1) Centers for Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental
Healthcare Settings.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm

2) Infection Control and Management of Hazardous Materials for the Dental Team by
Miller and Palenik. Mosby, 2005.

3) OSAP's Infection Control In Practice: Demystifying Disinfectants, August 2002 and OSAP's
Monthly Focus # 6, 1998

4) Practical Infection Control In Dentistry, 2nd. Ed. By Cottone, Terezhalmy, Molinari. Publisher,
Williams & Wilkins, 1996.

5) Dr. Charles Palenik, MS, PhD. Assistant Director of Infection Control Research and Services.
Indiana University School of Dentistry.

6) From Policy to Practice: OSAP's Guide to the Guidelines. Copyright 2004 by OSAP.

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Q After recently introducing the spray-wipe-spray technique in our practice, many of our staff began experiencing allergic reactions from the airborne spray. Although proper precautions and PPE are being used, the staff is complaining about itchy, watery eyes, nose, and mouth irritation. My understanding is that OSHA mandates the spray-wipe-spray technique. My question is, due to the significant problems I am encountering from this technique, is there an alternative for disinfection? I could not locate any other information in the regulatory compliance manual or other OSHA safety manuals.

A OSAP would like to refer you directly to the Centers for Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental Healthcare Settings (December 2003). The guidelines in part, state:

If barriers are not used, surfaces should be cleaned and disinfected between patients by using an EPA-registered hospital disinfectant with an HIV, HBV claim (i.e., low-level disinfectant) or a tuberculocidal claim (i.e., intermediate-level disinfectant). Intermediate-level disinfectant should be used when the surface is visibly contaminated with blood or OPIM. Also, general cleaning and disinfection are recommended for clinical contact surfaces, dental unit surfaces, and countertops at the end of daily work activities and are required if surfaces have become contaminated since their last cleaning. To facilitate daily cleaning, treatment areas should be kept free of unnecessary equipment and supplies. (1)

The Centers for Disease Control and Prevention's Infection Control Guidelines for Dental Healthcare Facilities provides additional information concerning disinfectants. This report is intended to provide overall guidance for providers to select general classifications of products based on certain infection-control principles. In this report, CDC provides guidance to practitioners regarding appropriate application of EPA- and FDA-registered liquid chemical disinfectants and sterilants in dental health-care settings. CDC's Framework for Disinfectants and Sterilants may be viewed at:

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a2.htm

CDC's Methods for Sterilizing and Disinfecting Patient Care Items and Environmental Surfaces may be viewed at:

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a2.htm

The United States Air Force Dental Investigation Service has an excellent surface disinfecting fact sheet that may be viewed at:

http://www.brooks.af.mil/dis/2QTR05/incontrolfactsheet16.pdf

Intermediate level surfaces disinfectants should be acceptable if they meet certain criteria, such as, being a chemical germicide registered with the EPA as a ‘hospital disinfectant' and labeled for tuberculocidal (i.e., mycobactericidal) activity. In addition, the chemical should have the ability to inactivate HIV and Hepatitis. It should be compatible with equipment, devices, and materials the disinfectant will contact and be suitable for use as a cleaner and a disinfectant.

You may view Appendix A: Regulatory Framework for Disinfectants and Sterilants at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a2.htm
It is important to always follow the disinfectant's label and directions for proper handling, use, PPE, disposal, and other warnings associated with the product. You should also consult the product's Material Safety Data Sheet (MSDS) for further information, including any potential hazards associated with the agent (including any known health risk/hazards).

Appropriate personal protective equipment must be utilized during operatory clean-up procedures. Heavy-duty utility gloves, a mask, protective clothing, and protective eyewear should be worn when cleaning and disinfecting environmental surfaces to protect skin and mucous membranes from chemicals and hazardous or infectious materials.

As an alternative to between-patient disinfection, environmental surfaces may be covered and protected with fluid-resistant barriers. They should be considered as disposable items that are removed, discarded, and replaced between each patient. (1) (2) (3) (4)

It is a personal choice as to whether or not a practice utilizes protective barriers. If a practice chooses not to use barriers, exposed environmental surfaces subject to blood and/or saliva contamination must be cleaned and disinfected between patients.

Most dental practices utilize a combination of barriers and between-patient cleaning and disinfection to maintain operatory asepsis and minimize the potential for cross-contamination.

The use of protective barriers generally eliminates the need for surface disinfection during operatory turn-around. However, surfaces must be cleaned and disinfected anytime the barrier has been compromised as well as at the beginning and end of each clinic day. (1) (2) (3) (4)

Environmental surface disinfectants are supplied as concentrates, premixed solutions, sprays, foams, impregnated wipes, and tablets. Pump-sprays, however, are considered the best vehicle for delivering cleaning/disinfecting agents to contaminated surfaces. (2) (3) (4)

The pump concentrates spray liquid on the surface rather than aerosolizing it, which allows the chemical to penetrate into crevices. In addition, spray bottles eliminate potential inactivation or absorption of the disinfectant by gauze, paper, or sponge applicators. (2) (3) (4)

According to dental infection control expert, Dr. Charles Palenik, disinfection is now called environmental infection control. The emphasis has gone away from the primary use of chemicals to one that uses mostly surface covers. In fact, areas that need attention (disinfection or covering) are now called clinical contact surfaces. (5)

The Authors of OSAP's From Policy to Practice: OSAP's Guide to the Guidelines offer the following information:

For pre-cleaning clinical surfaces:

Use a low to intermediate-level disinfectant and the "spray-wipe-spray” technique to clean and disinfect clinical contact surfaces. First clean, then disinfect. Spray the surface to be cleaned with a cleaner or cleaner/disinfectant. Then, wipe vigorously using paper towels. Once cleaned, spray the surface again, this time with a disinfectant. Cover the entire surface, and allow the disinfectant to remain undisturbed on the surface for the contact time indicated on its label. (6)

The authors also offer the following alternative to pre-cleaning clinical surfaces:

Wipe a pre-moistened cleaner-disinfectant towelette over the surface to be cleaned. Check the label to be sure that the wipe is a cleaner (some disinfectant wipes may require a separate cleaner). Carefully follow label instructions. Some wipes may be effective only on a limited surface area (approximately 3 sq. ft.). (6)

After cleaning, disinfect the surface:

Spray the disinfectant over the entire surface, using towels or reduce overspray. Let the surface remain moist for the contact time stated on the disinfectant's label. Wipe the surface dry if it is still wet when ready for patient care. (6)

The authors also offer the following alternative to spraying disinfectants on clinical surfaces:

Saturate the surface using a pre-moistened disinfectant towelette (wipe). Let the surface remain moist for the contact time stated on the disinfectant's label. Wipe the surface dry if it is still wet when ready for patient care. (6)

United States Air Force Dental Evaluation and Consultation Service provides additional information at:

http://www.airforcemedicine.af.mil/decs/

Resources:

(1) Centers for Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental
Healthcare Settings (December 2003)

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm

(2) Infection Control & Management of Hazardous Materials for the Dental Team. Third Edition.
By Miller and Palenik. Elsevier/Mosby Publishers. Copyright 2005.

(3) OSAP's Infection Control In Practice: Demystifying Disinfectants, August 2002 and OSAP's
Monthly Focus # 6, 1998

(3) Practical Infection Control In Dentistry, 2nd. Ed. By Cottone, Terezhalmy, Molinari. Publisher,
Williams & Wilkins, 1996.

(5) Dr. Charles Palenik, MS, Phd. Assistant Director of Infection Control Research and Services.
Indiana University School of Dentistry.

(6) From Policy to Practice: OSAP's Guide to the Guidelines. Copyright 2004 by OSAP.

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Q I work in a dental office and recently had a question come up with regard to sterilization. When autoclaving instruments in plastic and paper pouches, which side should be up?

A According to the authors of Infection Control & Management of Hazardous Materials for the Dental Team, one should load the sterilizer as instructed by the manufacturer and keep packs, pouches, or cassettes separated from each other so that steam has access to all package surfaces. One should place items on their edges. Some sterilizers come with racks for packages that keep them separated and on their edge. One should not stack packages, pouches, or cassettes flat in layers as stacking impedes steam circulation and air removal in the chamber. (1)

Whenever possible, it is best to place packages on their edges. However, in a steam sterilizer, if paper/poly packages must be placed flat in a single layer, place them paper side down. Placing paper/poly packaging plastic side down may cause condensate to pool inside the pouch resulting in a wet pack.

Resource:

1) Infection Control & Management of Hazardous Materials, 3rd. Edition. By Miller and Palenik.
Elsevier Mosby Publishers. Copyright 2005.

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Q I recently consulted with a client who purchased a counter top dishwasher from walmart.com. He said he read it in Christianson's report as being comparable to the instrument washer. I explained that it is not FDA regulated as a medical device and should not be used in a dental office setting for pre-cleaning instruments. How can I provide further information? Has this been addressed with Christianson?

A First and foremost, any questions or concerns about Christianson's report stating that a Walmart counter top dishwasher is comparable to the instrument washer should be sent directly to him.

OSAP can provide you with the following information:

Home/counter top dishwashers should not be used in the dental practice in place of ultrasonic cleaners and/or thermal washers/disinfectors.

There are automated instrument washers (used to clean only) and thermal disinfectors (cleans and disinfects) that have FDA clearance as medical devices for use in the healthcare setting. These washers look like household washers, however, they operate at much higher temperatures than a dishwasher. The instrument washers/thermal disinfectors may be used in place of the ultrasonic cleaner, however, they are not sterilizers, thus all critical and semi-critical items/instruments must still be sterilized in an autoclave/sterilizer. (1)

It is also important to keep in mind that automated instrument washers/disinfectors are considered medical devices and manufacturers must provide safety and efficacy data to receive FDA clearance to market their product, referred to as a 510(k) or a pre-market clearance. (1)

Washers and washer-disinfectors that are intended for use in processing reusable medical devices are considered devices pursuant to Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). This Act may be found on the FDA website: http://www.fda/gov

In addition, the FDA has a Class II special controls guidance document: Medical washers and medical washer-disinfectors; guidance for the medical device industry and FDA review staff. This document may be found on the FDA website:

http://www.fda.gov/cdrh/ode/guidance/1252.html

Manufacturers did not design household dishwashers for the purpose of cleaning contaminated dental instruments/items and have not sought FDA clearance for their use as a medical device, therefore, they are not to be used for contaminated instruments/items. (1)

Washer/disinfectors and washer/decontaminators that have been cleared for marketing by the Food and Drug Administration (FDA) are a suitable alternative to ultrasonic cleaning. Household dishwashers, however, are not acceptable for healthcare applications. Dishwashers and other household appliances have not been evaluated by the FDA to guarantee adherence to the strict operating parameters that healthcare applications demand. (2)

Additionally, the Centers for Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental Healthcare Facilities (December 2003), in part, states: Removal of debris and contamination is achieved either by scrubbing with a surfactant, detergent, and water, or by an automated process (e.g., ultrasonic cleaner or washer-disinfector) using chemical agents.
If visible debris, whether inorganic or organic matter, is not removed, it will interfere with microbial inactivation and can compromise the disinfection or sterilization process. After cleaning, instruments should be rinsed with water to remove chemical or detergent residue. Splashing should be minimized during cleaning and rinsing. Before final disinfection or sterilization, instruments should be handled as though contaminated. (3)

Considerations in selecting cleaning methods and equipment include 1) efficacy of the method, process, and equipment; 2) compatibility with items to be cleaned; and 3) occupational health and exposure risks. Use of automated cleaning equipment (e.g., ultrasonic cleaner or washer-disinfector) does not require presoaking or scrubbing of instruments and can increase productivity, improve cleaning effectiveness, and decrease worker exposure to blood and body fluids. Thus, using automated equipment can be safer and more efficient than manually cleaning contaminated instruments. (3)

Resources:

1) Infection Control and Management of Hazardous Materials for the Dental Team, 3rd. edition by Miller and Palenik. Mosby Publisher, 2005.

2) OSAP's frequently asked questions: http://www.osap.org/resources/FAQ/index.php?name=4#4

3) The Centers for Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental Healthcare Facilities (December 2003):

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm

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Q What is the source of the peracetic acid/hydrogen peroxide sterilant referenced in the Appendix I in the Oral Healthcare Missions publication. It is the last material listed, but I can't find a source.

A According to the authors of OSAP's Mission Guide, the Peracetic Acid based product in powder form that is listed in the humanitarian guide is Perasafe made by Antec International ( http://www.antechh.com ). It is not FDA cleared as a sterilant nor is it available for sale in the United States. It is approved for use in Europe and has a CE mark. Evidently, the rights to market Perasafe are owned by Dupont Chemical. Antec's distributor in the United States is Biosafety USA Inc., found at http://www.biosafetyusa.com . They do not appear to be pursuing clearance to market or to sell it here. You may however, be able to purchase it in the host country for a humanitarian mission.

As far as the authors are aware, there is no Peracetic Acid powder or concentrate based high-level disinfectant/sterilant product available for sale in the US at this time.

Although Perasafe is not currently for sale in the United States, several articles in J Hosp Infection have evaluated Perasafe against Glutraldehyde and other agents as a high-level disinfectant. Check them out at Pub Med at:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi .

(Once you are directed to Pub Med type in the word: Perasafe in the search window).

General information on Perasafe is also available from the manufacturer's site located at: http://www.antechh.com/perasafegd.html

Also, commercial airlines may not permit you to transport certain hazardous chemicals/agents. Therefore, you should contact the airlines you will travel with for possible restrictions. In order to avoid transporting chemicals you may also want to consider using one of the alternative methods for sterilization listed in the Mission Guide.

There is another alternative that you may be interested in. There is a product called Steris sterilization system. Information about it is provided by Steris in the form of a brochure. The Brochure number is M1868EN. This and other information regarding the system may be viewed at:

http://www.steris.com/resources/lit/literaturesearch.cfm?app=Gas-Liquid-Chemical%20Sterilizers#

As a note: FDA clearance to market, also referred to as a 510(k) is required for all chemical sterilants and high-level disinfectants marketed in the United States. Even though they do list different formulations of peracetic acid, they are not currently available for sale in the United States. The FDA provides a list of chemical sterilants/high-level disinfectants with trade names, manufacturers, and active ingredient that may be viewed at:

http://www.fda.gov/cdrh/ode/germlab.html

One dental infection control expert offers the following suggestion, there is a 7.5% hydrogen peroxide based product, Sporox, (Refer to the FDA's list of cleared liquid sterilants.), that may be safer to handle and dispose of in areas without the resources we have here in the United States.

The United States Air Force's Dental Evaluation and Consultation Service provides the following information concerning Sporox II: Sporox II is a chemical sterilant and high-level disinfectant for heat-sensitive instruments. The product is a pre-mixed, clear, odor-free, 7.5% hydrogen peroxide solution that is tuberculocidal, virucidal, fungicidal, bactericidal, and sporicidal. The manufacturer, Sultan Chemists, claims that Sporox II oxidizes debris quickly and effectively at room temperature, and is safe for soft metal instruments containing brass or copper. At room temperature sterilization is achieved in six hours and high-level disinfection in thirty minutes. The product can be reused for up to 21 days. Test strips are available to determine when the solution needs to be changed, and the company manufactures a sterilizing/disinfecting tray to facilitate product use. Sporox II is priced at $25 per gallon (retail) and $15.00 (government) by and can be purchased by contacting Sultan Chemists at (800) 637-8582, (201) 871-1232, FAX (201) 871-0321, or www.sultanintl.com.

United States Air Force's Dental Evaluation and Consultation Service: http://www.airforcemedicine.af.mil/decs/

An excellent concise guide to high level disinfection under field conditions can be found on the website for the Johns Hopkins Center for Reproductive Health at:

http://www.reproline.jhu.edu/english/4morerh/4ip/IP_manual/12_HLD.pdf

You may also contact the American Dental Association (ADA) and your state/local dental society. They may be able to assist you in contacting society members who do volunteer work. The ADA and dental society should also be able to provide you with contact information for dental volunteer groups, such as the flying doctors. These groups have provided volunteer services from many years and can direct you to additional resources.

The ADA has a great deal of information on their website for health volunteers oversees. To view this information go to:

http://www.ada.org/ada/international/volunteer/directory.asp

Other resources include:

Engender Health: http://www.engenderhealth.org/res/offc/safety/ip-ref/index.html
Health Volunteers Overseas: http://www.hvousa.org

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Q What are the recommendations on sterilization –vs- single use of endodontic files, rasps, drills, and burs?

A OSAP would like to refer you directly to the Center's For Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental Healthcare Settings. In part, the guidelines state the following:

A single-use device, also called a disposable device, is designed to be used on one patient and then discarded, not reprocessed for use on another patient (e.g., cleaned, disinfected, or sterilized). Single-use devices in dentistry are usually not heat-tolerant and cannot be reliably cleaned. Examples include syringe needles, prophylaxis cups and brushes, and plastic orthodontic brackets. Certain items (e.g., prophylaxis angles, saliva ejectors, high-volume evacuator tips, and air/water syringe tips) are commonly available in a disposable form and should be disposed of appropriately after each use. Single-use devices and items (e.g., cotton rolls, gauze, and irrigating syringes) for use during oral surgical procedures should be sterile at the time of use. (1)

Because of the physical construction of certain devices (e.g., burs, endodontic files, and broaches) cleaning can be difficult. In addition, deterioration can occur on the cutting surfaces of some carbide/diamond burs and endodontic files during processing and after repeated processing cycles, leading to potential breakage during patient treatment. These factors, coupled with the knowledge that burs and endodontic instruments exhibit signs of wear during normal use, might make it practical to consider them as single-use devices. (1)

Resource:

1) Center's For Disease Control and Prevention's (CDC) Infection Control Guidelines for Dental
Healthcare Settings.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm

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Q A graduate of our program recently called and asked about reusing sterilization bags. I commented that the integrity of the bag may be compromised through reuse. Do you have any information to share on this practice?

A First and foremost, always consult the directions/instructions for use provided by the manufacturer of the product. Single use disposable items must be disposed after each use. Therefore, sterilization wraps and bags that are not designed for reuse should be disposed of after each use. Reusing single use sterilization wraps/bags/pouches can result in loss of chemical indicator ability, insecure sealing of the package, and an inability of the material to maintain sterility of the contents after processing.

The United States Food and Drug Administration (FDA) regulates sterilization packaging for medical devices intended for use in health care facilities. The term, "medical sterilization packaging systems" used by the FDA refers to sterilization wraps, sterilization packs, sterilization pouches, sterilization containers, sterilization trays, and sterilization cassettes, including related components such as trays, holders or mats, used by health care facilities to package and sterilize medical devices intended for either single use or reuse. (1)

These devices are regulated under 21 CFR §880.6850, Sterilization wrap, which reads:

A sterilization wrap (pack, sterilization wrapper, bag, or accessories) is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. (1)

This draft document may be viewed at:

http://www.fda.gov/cdrh/ode/guidance/1388.html

Resource:

1) FDA: http://www.fda.gov/cdrh/ode/guidance/1388.html

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