Historical
AAMI TIR50:2014
Post-market surveillance of use error management
The guidelines described in this technical information report (TIR) are not separate from or in opposition to the existing U.S. Food and Drug AdministrationÆs (FDAÆs) and other regulatory bodies' reporting protocols for product failure or adverse events (concerning morbidities or mortalities), which already have standardized protocols. This TIR focuses instead on a process for handling complaints associated with use errors occurring from medical devices, drug delivery systems and combination medical products. These use errors could be from close calls, user dissatisfaction and/or quality complaints as they relate to use error events and therefore would not normally be reported and evaluated. User dissatisfaction is important, as it can be the source of complaints regarding how devices interfere with the normal workflow and require inappropriate levels of attention. This document recognizes the significant efforts during the pre-market phase to evaluate and improve usability. However, products used in the post-market environment can provide the largest usability study data set available. This document seeks to enhance the opportunity to have access to such information.
Content Provider
Association for the Advancement of Medical Instrumentation [aami]
