| FAQ - Sterilization - Archived Through 2012
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?
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:
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)
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):