What is ATS?
The ATS formulation is based upon experimental
data representing the "
worst
case" soil level from patient-used medical devices and therefore represents
a standardized soil formulation that would be applicable to a wide range of
medical device simulated-use testing.
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 represents 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.
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