trophon Companion Cleaning Wipes meet FDA and AAMI1,2 recommended cleaning thresholds for medical devices.
Cleaning is the essential first step in reprocessing ultrasound probes. It is key to the reduction of organic material, microbial load, gel and other soils on the surface of ultrasound probes.
A thoroughly cleaned probe surface is required to ensure effective high level disinfection (HLD).3,4
trophon Companion Wipes have been evaluated using standard methodologies for cleaning efficacy and in accordance with FDA and AAMI guidelines. Probes were contaminated with an artificial test soil, which represented the worst case clinical soil5 likely to be found in an ultrasound examination, then cleaned with a single wipe. Residuals were below 3 μg/cm2 for protein and below 0.1 μg/cm2 for hemoglobin.6 This exceeded the accepted FDA and AAMI cleaning thresholds of 6.4 μg/cm2 (protein) and 2.2 μg/cm2 (hemoglobin).
2. AAMI (TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices)
3. Rutala WA, Weber DJ, HICPAC. Guideline for Disinfection and Sterilization in Healthcare Facilities. USA: Centers for Disease Control; CDC 2008. (https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf)
4. American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI). ST58:2013 Chemical sterilization and high-level disinfection in health care facilities.
5. Alfa MJ, Olson N. Physical and composition characteristics of clinical secretions compared with test soils used for validation of flexible endoscope cleaning. The Journal of Hospital Infection. 2016;93(1):83-8.b.
6. Nanosonics internal testing data.
Note: EPA registration pending in US states: MD & PR