Preface

This guidance is intended to help people with disabilities fully access medical products and services, both as healthcare patients and providers. Guidance for accommodating the variation inherent in any human population in the design of medical equipment is provided. The goal is to make medical devices as accommodating of human diversity as possible in order to improve the accessibility, usability, performance, and safety of medical instrumentation for all users. For most medical devices, the effective use of human factors practices will be synergistic with enhancing accessibility as long as product designers recognize and include individuals with disabilities as intended users in all stages of the usability evaluation process. There are many ways to design products to be accessible, as reflected by the structure of this document.

Executive Summary

This guidance serves as a resource for medical instrumentation consumers, designers, and procurers. Various general strategies and specific accessibility considerations are presented for making medical devices accessible to users with disabilities, both as healthcare patients and providers. General information related to the overall need for accessible medical instrumentation is presented, as well as specific accessibility problems identified by RERC-AMI surveys and focus groups for examination tables, medical chairs, weight scales, imaging equipment, monitoring equipment, medication administration equipment, and exercise ergometers. Section 1: General Guidance provides different strategies for overall approaches for making medical devices accessible to users with disabilities. Section 1 is based largly on existing guidance that can be applied to medical devices. Section 2: Specific Guidance provides specific design guidelines for making different product classes accessible. Section 2 is based on RERC-AMI evaluations of different products with respect to accessibility. Reference information is also provided for human performance characteristics related to physical movements, hearing, and seeing. Specific resources that were referenced in this guidance are provided.

Update, April 2010: 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 (www.aami.org/publications/AAMINews/Apr2010/he75.html) national standard. However, by 2007 there was significant divergence between the RERC-AMI's information and the HE 75:2009 standard, both due to the natural process of compromise within the AAMI Human Factors committee, and new research results by the RERC-AMI. Some of this information, made available as part of the NIDRR-funded RERC-AMI, is available for use by parties interested in implementing the