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Inoculating ATS2015 with Bacteria

Worst Case Testing of Sterilization

Simulated-Use Testing Flexible Encoscopes

Simulated-Use Testing Biopsy Forceps

Simulated-Use Testing Laparoscopic Instruments

Simulated-Use Testing Detergents

Package Insert

ATS2015 Mucin/Bone IFU

Instructions for Use

ATS2015 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 ATS2015 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
ATS2015 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.

For microbial killing-efficiency testing, the test microorganism is suspended in ATS2015 to the desired concentration (most commonly 106 viable organisms/device) and inoculated onto the medical device (or appropriate test carrier) for evaluation.

Inoculation of the ATS2015 (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 ATS2015 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
ATS2015 can be made up to contain up to 400ppm hard water to meet FDA requirements for hard water testing.


Cleaning Validation