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FAQ's Sterilization

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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?

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?

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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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