Instructions for Use
ATS can be used to quantitatively measure residual components of
protein, hemoglobin, and carbohydrate (and optionally endotoxin) after various treatments of medical
devices (e.g., cleaning protocols and disinfection and sterilization
protocols). Microorganisms can be added to ATS if viable counts are needed.
Both bacteria and viruses can be inoculated and the viability of the
organism will not be detrimentally affected by the soil composition.
Surface Testing
ATS can be inoculated in a defined amount and allowed to dry overnight. This
provides a defined inoculum and test under worst-case conditions.
Lumen Testing
The soil is flushed through the lumen channel or the device is
immersed into the soil. Excess soil is allowed to drain away. The device may
be dried for up to 2 hours prior to testing. This provides a reproducible
soil level that mimics levels of soil remaining on medical devices within
routine in-hospital reprocessing (dry) times.
Inoculation:
For microbial killing-efficiency testing, the test microorganism is
suspended in ATS to the desired concentration (most commonly 10
6
viable organisms/device) and inoculated onto the medical device (or
appropriate test carrier) for evaluation.
Inoculation of the ATS (with or without microorganisms) onto a test medical
device followed by up to 24 hours of drying to provide a "worst-case"
challenge. Following the guidelines outlined in AAMI TIR#12, the ATS would
act as the inorganic/organic challenge for this protocol. After air drying
on the test carrier, the soil may also be fixed using 2.5% glutaraldehyde to
provide a greater challenge for washing/ detergent testing. This mimics what
might occur in actual patient-use when devices are not adequately cleaned
and are high-level disinfected using glutaraldehyde solutions.
Hard Water
ATS can be made up to contain up to 400ppm hard water to
meet FDA requirements for hard water testing.
Applications
Cleaning validation
-
Apply to medical device (If bioburden is to be
included, suspend the test organism is ATS to desired concentration).
Allow to dry at room temperature for 30-60 minutes.
-
Post-cleaning, collect a suitable sample from the
medical device.
-
Use sterile RO or DI water for sample
collection.
-
Assess residual soil parameters (e.g. Protein,
hemoglobin, LPS, carbohydrates) or perform viable cell count using
accepted protocols.
Disinfectant/Sterilant:
- Resuspend test organism in ATS to desired
concentration.
- Apply to medical device or test
carrier. Allow to dry at room temperature for 30-60 minutes.
- Perform cleaning and/or disinfection/sterilization.
(Suitable time exposure)
- Post-cleaning, collect a suitable sample from the
medical device.
- Use sterile reverse osmosis water for sample
collection.
- Assess residual soil parameters (e.g. protein,
hemoglobin, LPS, carbohydrate) or perform viable cell count using accepted
protocols.
