Diagnostic devices processed in healthcare facilities need appropriately approved processing instructions to reduce the risk of cross-contamination or spread of disease between patients or healthcare professionals. Manufacturers have a responsibility to validate processing instructions to ensure that the device is safe for its intended use or reuse when properly followed in the clinical setting.
Cleaning, disinfection and sterilization validations must demonstrate that the process is effective in raising soil components to the predetermined levels specified in AAMI TIR30 (AAMI ST98: draft) and ISO 15883-5. Disinfection verifications are usually done to support high-level disinfection criteria for such devices; however, depending on the intended use of the device criticality classification or the support equipment used with these devices, medium-level or low-level disinfection procedures may be appropriate. Disinfection verifications are typically required for devices that cannot be sterilized using high temperatures (eg steam sterilization, dry heat) and are not compatible with ethylene oxide.
EUROLABperforms verifications in accordance with AAMI TIR30, AAMI TIR12, AAMI ST91 and FDA guidance documents. Since this is a growing area of reprocessing EUROLABis constantly working with US FDA regulators and manufacturers to ensure the most up-to-date guidance and best practices are used.
EUROLABspecializes in scope processing work for both scope and automated endoscope reprocessing (AER) equipment. Automated processes are preferred to reduce human factors in device processing to provide a more consistent cleaning and disinfection process.
Applicable Standards
For Scope Cleaning Validations, the devices are contaminated with a clinically relevant test soil and allowed to dry. The manufacturer's recommended cleaning procedure is used to handle the devices and then removed for residual markers. Sample extracts are analyzed for selected organic markers (ie protein, hemoglobin, TOC) to determine the effectiveness of the cleaning procedure.
For disinfection validation, the following levels are appropriately selected depending on the criticality of the devices and use in the clinical setting. Scopes are mainly processed through high-level disinfection, but equipment that supports the use of the scope can be treated through medium or low-level disinfection.
High-level disinfection: This test targets Mycobacterium spp.
Intermediate level disinfection: This test demonstrates a 6-day reduction of four common plant organisms (i.e., Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli) and Mycobacterium spp.
Low-level disinfection: This test requires a 6-day reduction of four common plant organisms (Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus).
EUROLAB, with its highly expert team and internationally accredited laboratories, Scope Transaction Verification Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
