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Practice Safety/Patient Safety Archived Through 2012
 FAQ - Practice Safety/Patient Safety - Archived Through 2012

 

 

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.

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, orwww.sultanintl.com.

United States Air Force's Dental Evaluation and Consultation Service: https://decs.nhgl.med.navy.mil/DIS61/sec7.htm

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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