Standard: AAMI HE74

HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES

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Scope:

By providing a structured approach to user interface design, this document can help manufacturers develop safe and usable medical devices. This document includes an overview of the human factors engineering (HFE) discipline, a discussion of the benefits of HFE, a review of the HFE process and associated analysis and design techniques, and a discussion of implementation issues and relevant national and international standards and regulations (see annex B). The document also incorporates a listing of applicable government documents and human factors engineering literature citations (see annex E).

For the purposes of this document, the user interface includes all aspects of a device with which users interact when operating the device. Instructions for use and device labeling are an integral part of the user interface. Users are defined as including operators, maintainers, cleaners, and other service personnel as well as other individuals directly affected by the use of the device. Thus, a user may be a caregiver (e.g., anyone who gives a diabetic his/her insulin injection); a patient (e.g., diabetics who administer their own insulin injections); or someone who provides support for either a caregiver or a patient (e.g., a diagnostic ultrasound technician). A caregiver may be a trained clinician or a layperson (e.g., a family member).

NOTE—This definition of user differs from that used in international standards that define a user as the "authority responsible for the use and maintenance of equipment," whereas the operator is defined as the "person handling the equipment."

This document addresses the needs of a diverse group of professionals who handle the planning, funding, management, and performance of research, design, and testing activities related to the safety and usability of medical devices, including:

a) Company, department, project, and product managers;

b) Design and engineering professionals (e.g., human factors engineers, industrial designers, technical writers, information designers, software developers, mechanical engineers, electrical engineers, packaging engineers);

c) Medical researchers and other interested clinicians; and

d) Marketers and other business professionals in the medical device industry.

This document is not intended as a sole source for HFE guidance or as a substitute for human factors expertise. Rather, it is intended to provide readers with a general understanding of how to perform HFE work in an effective way, drawing extensively on related documents (see annex E).

HFE practice varies widely. This variation is partly because of the diversity of its practitioners, who may have backgrounds in fields such as engineering, psychology, or design. Practice differences occur because of the wide variety and complexity of medical devices, which range from simple syringes to complex imaging systems, and which may be used in hospitals, clinics, or the home by various professionals and laypersons.

Thus, it is impossible to prescribe a single set of HFE methods that will be optimal for all design projects. Instead, this document describes an HFE process that requires additional shaping and scaling to suit practitioners' experience and style, as well as project specifications. The document's ultimate goal is to ensure that manufacturers approach user interface design in a rigorous, effective manner.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami he74
Publish Date: 2001-01-01
Page Count: 48
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive

This Standard References

Showing 8 of 8.

45 CFR PT 46
21 CFR PT 50
21 CFR PT 56

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