ATS (Artificial Test Soil) is just a Test Soil
According to AAMI, the FDA, CDC, CEN, Health Canada, CSA, NHS Estates and other regulatory agencies, validation of medical device cleaning, disinfection and sterilization should be done with “test soils” that are modeled on the soils the medical device is likely to be contaminated with during actual clinical use.
*Based on extensive scientific research
*Complies with regulatory requirements
What is ATS?
Formulated and based upon experimental data, Artificial Test Soil (ATS) simulates the "worst case" soil level from patient-used medical devices. ATS is a standardized soil formulation that would be applicable to a wide range of medical device simulated-use testing and cleaning validation.
ATS is composed of protein, carbohydrate, hemoglobin and optionally endotoxins, in proportion to the worst-case levels found in patient-used surgical instruments. FDA and AAMI Guidelines direct medical device manufacturers (MDM's) to use "worst case conditions" in their simulated-use testing. In addition, MDM's are directed to use an organic challenge that embodies the types of soil to which the device will be exposed during clinical use. Guidance documents also recommend "... that the bioburden challenge (organic and microbial) to the cleaning and or disinfection process of the washer and washer disinfectors be determined from clinically used devices.*"
Who Should Consider Using ATS?
ATS can be used as a standardized test soil by:
Medical device manufacturers whose reprocessing protocols need to be developed and validated for users.
Third Party reprocessors of single-use medical devices needing to validate and challenge their reprocessing procedures.
Testing labs and research facilities conducting independent validation testing and research.
Manufacturers of sterile reprocessing equipment when testing equipment such as cleaner/disinfectors and sterilizers.
Manufacturers needing to perform simulated-use evaluations for comparative testing of detergents, disinfectants or sterilants for medical device reprocessing.