ANSI/AAMI AT6:2013 – Autologous Transfusion Devices

This standard, ANSI/AAMI AT6:2013, establishes labeling and performance requirements, test methods, and terminology that will help define a reasonable level of safety and efficacy for autologous transfusion devices. Specifically, it includes requirements for sterile, disposable systems and associated electromechanical hardware designed to collect and filter or process, or both, extravasated blood for reinfusion of erythrocytes or filtered whole blood into the patient’s circulation. Aspects of these systems related to collection, anticoagulation (systemic and device), storage, processing and filtration, and reinfusion are within the scope of this standard.

The document outlines the objectives and uses of AAMI standards and recommended practices, emphasizing the advancement of medical instrumentation through safe and effective application of technologies. It details how a voluntary standard recommends information for manufacturers to provide with the product, basic safety and performance criteria, and measurement techniques for conformity assessment. It also discusses recommended practices for the use, care, and processing of medical devices, ensuring safe and effective utilization and maintained performance. The standard is a valuable resource for manufacturers, purchasers, and users, providing a frame of reference for device evaluation and responsible decision-making. It is important to note that all AAMI standards are voluntary and should be applied with professional judgment, considering specific needs and cost-benefit considerations.