scope:

The purpose of this technical information report (TIR) is to provide a relevant source of information, design criteria, and guidelines for the instructional and training materials and processes intended to accompany medical devices used in a non-clinical environment, which for the purpose of this document, is defined as an environment other than a facility where a health professional is continually present whenever a patient is present.

However, much of the information presented in this document can be applied, as well, to the design of instructions and training for the use of medical devices that will be used within clinical environments or in both clinical and nonclinical environments. The information in this document also applies to training and instructions for the use of combination products (e.g., transdermal drug delivery patches), which manufacturers sometimes do not consider to be medical devices.

These guidelines are meant to supplement Annex D of ANSI/AAMI/IEC 62366:2007, ANSI/AAMI HE75:2009, and the numerous references available on the topic of human factor engineering, with a focus on the training and instructional materials that accompany medical devices used outside of clinical environments.

This document will help medical device manufacturers to

a) understand how the design of instructions and training, including the development and validation of labeling and training materials, fits into the user-centered design process;

b) recognize the importance of utilizing a systematic process in the design of these materials;

c) develop an understanding of models of human learning, retention, and transfer of learning and how these models can be applied to the design of training and instructions;

d) recognize the unique advantages and disadvantages of various media available for training and instructions;

e) select appropriate media for training and instructions; and

f) identify specific design guidance applicable to training employing the selected media.

It should be noted that this TIR does not address regulatory requirements that the FDA or other organizations might impose with regard to training and instructions for use for medical devices.