RERC-AMI: Home Page for Guidance on AMI Accessibility

Guidance for Designing and Purchasing Accessible Medical Instrumentation

Preface & Executive Summary

This document provides the purpose, scope, and concise summary of this guidance material.

[April 2010 Note: Part of an early version of this guidance was used as a resource for Section 16 (Accessibility Considerations, pp. 230-243) of the new ANSI/AAMI HE 75:2009, Human Factors Engineering - Design of Medical Devices standard (see www.aami.org/publications/AAMINews/Apr2010/he75.html). This document diverges considerably from the AAMI guidance materials, being of larger scope and based more fully on research results of the NIDRR-funded RERC-AMI.]

Introduction

This document provides background information and an overview of the general need for accessible medical devices. The conceptual framework for this guidance is presented, noting that there are multiple strategies for achieving accessibility.

Needs

This document provides descriptions of specific accessibility problems identified with surveys and focus groups of the RERC on Accessible Medical Instrumentation during 2002-2007. Results are presented for a national patient survey, national provider survey, and regional focus groups. The following categories of medical devices are presented: examination tables, medical chairs, weight scales, imaging equipment, monitoring equipment, medication administration equipment, and exercise ergometers.

1. General Guidance

This document provides a compiled list of all the numbered guidance statements for the General Guidance sections below.

Five approaches (or strategies) are preseted for consideration, two of which are very general and three of which are targeted to large classes of products:

General Guidance 1.1: Functional Access Modes. This document provides general guidance on approaches for supporting multiple interface modes of access, with the intent being for the product to provide either direct access or access via support of a user's assistive technology. This guidance targets primarily interfaces with displays and controls. There are 26 guidance statements, about half of which are motivated by the rules and regulations maintained by the US Access Board (in particular Section 508 of the Rehab Act).

General Guidance 1.2: Universal Design. This document provides general guidance on strategies for designing medical equipment interfaces to be accessible and usable for the largest diversity of individuals as possible. There are 29 guidance statements, based largely on principles associated with universal design and inclusive design.

General Guidance 1.3: Telecommunications and Personalized Interfaces. This document provides general guidance on strategies for enhancing accessibility when integrating telecommunications capabilities into home and mobile medical devices, as well as on future possibilities for universal access for certain types of medical products through personalized interfaces and tele-access. There are 8 guidance statements, some of which are based on our assessment of emerging telecommunications, information technology and consumer electronics standards.

General Guidance 1.4: Patient Support Surfaces. This document provides general guidance for health equipment including medical tables, medical chairs, hospital beds,weight scales, x-ray platforms, MRI/CT/PET scan platforms. It is directed towards individuals in the role of healthcare patients or consumers. Where noted this guidance also extracts from the ADAAG regulations maintained by the US Access Board. It is also a pillar for Specific Guidance Sections 2.1 to 2.4 (developed in the next section).

General Guidance 1.5: Accessible Device Controls and Displays, Including Alarm Systems. This document provides general guidance for designing accessible device controls and displays, which are often critical components of medical devices. The guidance provided here is based on the expertise and experience of RERC-AMI staff as well as information from the ANSI/AAMI national standard HE-75: 2009. There are 11 guidance statements for controls, 4 guidance statements for displays, and 7 guidance statements for alarm systems.

2. Specific Guidance for Medical Devices

Specific Guidance is provided for seven product areas where the RERC-AMI team has special expertise and experience, with the first three of these completed by 2008:

Specific Guidance 2.1: Medical Tables. This document provides guidance to promote the design and purchase of medical tables that are accessible for a wide variety of examinations and procedures. [Note that "examination tables" represents a subset of this class, as there are also medical tables that are used for procedural (e.g., dental) and therapeutic (e.g., physical therapy) reasons.]

Specific Guidance 2.2: Medical Chairs. This document provides guidance to promote the design and purchase of chairs that are accessible for a wide variety of examinations and procedures.

Specific Guidance 2.3: Weight Scales. This document provides guidance to promote the design and purchase of scales that will serve users who can stand, wheelchair users, and users who need to sit while being weighed.

Specific Guidance 2.4: Diagnostic Medical Imaging Interfaces. This document provides guidance to promote the design and purchase of products that include x-ray and mamography equipment, and diagnostic medical imaging technologies such as CT and MRI scanners.

Specific Guidance 2.5: Infusion Pumps. This document provides guidance to promote the design and purchase of infusion pumps with accessible interfaces, so that all persons with disabilities have access to the benefits of safe infusion therapies.

Specific Guidance 2.6: Endurance Exercise Machines. This document provides guidance that is applicable to 5 categories of exercise devices: cycle ergometers (bikes), ellipticals, steppers, treadmills and wheelchair cyclers.

Specific Guidance 2.7: Medical Dosing and Dispensing Technologies, including Glucometers.

References and Resources

This document provides a list of the references and resources used for this guidance, about half of which can be accessed via the web.

Also available is a brief summary of reference information related to human performance capabilities, including for physical movements, seeing, and hearing. For a more detailed resource on human capabilities, see the new ANSI/AAMI HE 75:2009, Human Factors Engineering - Design of Medical Devices standard (see www.aami.org/publications/AAMINews/Apr2010/he75.html), in particular Sections 6 (Basic human skills and abilities), 7 (Anthropometry and biomechanics), and 8 (Environmental considerations).

Two types of research tools were developed by the RERC-AMI for measuring accessibility and usability of medical equipment: the Mobile Usability and Accessibility Lab (MUA-Lab) for studies involving human participants with disabilities, and the MedAUDIT (Medical Equipment Device Accessibility and Universal Design Information Tool) classification and accessibility scoring technology.

Note: This document is part of RERC-AMI Project D4.1 (Design Guidelines for Medical Instrumentation).