On January 3, 2022, the US Food and Drug Administration (FDA) sent out a News…
Cold sterilants are chemical solutions used for the purpose of destroying all forms of microbial life including bacterial spores and are used to process heat-sensitive critical and semi-critical dental instruments for reuse. The Food and Drug Administration (FDA) is responsible for regulating all liquid chemical sterilants, requiring all manufacturers of cold sterilant solutions to submit pre-market notification submissions to FDA and to receive clearance before marketing their products.
Glutaraldehyde is approved by the FDA for cold sterilization and/or high-level disinfection of heat-sensitive critical and semi-critical patient care items, and is the most commonly used cold sterile solution in dentistry. Because of glutaraldehyde’s toxic nature and corrosive properties, the U.S. Environmental Protection Agency (EPA) prohibits the use of glutaraldehyde as an environmental surface disinfectant. Additionally, Cal/OSHA regulates glutaraldehyde as a hazardous airborne chemical contaminant. Exposure to glutaraldehyde can cause severe irritation to the skin, mucous membranes, and respiratory system. Its vapors have been associated with cases of occupational asthma, and the FDA requires the all glutaraldehyde labels warn that the product should not be used outside a closed container.
For our OSHA Review Subscribers… Refer to the January/February 2016 issue of OSHA Review in Section VI of your binder for more information on glutaraldehyde use in dentistry
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