scope:

This document provides guidance to medical device manufacturers from a human factors perspective on the aspects of product design; design of processing instructions for use (IFU); education and training design; and development, verification, and validation of the device processing process to meet the needs of personnel working in a health care facility processing environment. Limitations and challenges on human factors imposed by processing environments have a direct impact on the effectiveness of product designs, processing IFU, and the processing procedure. The processing lifecycle of the device is considered to be from the point-of-use at the end of a patient procedure to delivery to the point-of-use prior to the next patient procedure.

Inclusions

This technical information report (TIR) addresses processing as a design element; product design; processing procedures; the development of the IFU; education, training, and competency assessment; and validation from a human factors engineering perspective.

Exclusions

This TIR does not address processing requirements for devices (see ANSI/AAMI ST79); requirements for the manufacturer on what information should be provided to the user (see ANSI/AAMI ST81 and AAMI TIR12); or the processing of single-use devices.