Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

7.1 Basic Understanding of Diagnostic Imaging Equipment

One challenge to Advisory Committee deliberations about accessibility approaches for these technologies was that Committee members had fundamentally different understandings about what constitutes diagnostic imaging equipment. Members outside the imaging industry generally thought of the machine itself, upon which patients lie or sit and which “takes the picture,” as “diagnostic imaging equipment.” Manufacturers, however, hold a different understanding, founded upon existing FDA definitions (see below). As described in Section 4, in contrast to compact and mobile imaging technologies such as ultrasound and echocardiography machines, the imaging equipment covered by the accessibility standards is part of a system of interacting components, permanently mounted in fixed installations. Manufacturers see imaging equipment systems as an inextricably linked amalgam of the machine with its multiple technological components and accessories that generate the images and the spaces immediately surrounding the machine. These specially designed spaces must perform specific essential functions, such as supporting the equipment’s heavy weight, shielding ionizing radiation or magnetic fields, and providing specialized high power capacity electrical service. The machine that performs the imaging test does not operate in isolation; its immediate surroundings are integral to the performance and safety of diagnostic imaging equipment.

Considering diagnostic imaging equipment in this way, not as the imaging machine alone but as an integrated system with its accessories and installation, is consistent with regulations governing this equipment. As noted in Section 4.3.1, the U.S. Food and Drug Administration (FDA) classifies most diagnostic imaging technologies as Class II medical devices, most of which need FDA clearance (via a “510(k)” notification) prior to being placed on the market. In particular, Section 201(h) of the Federal Food Drug and Cosmetic Act includes accessories^KK with the definition of a medical device.^LL

During Advisory Committee and Imaging Equipment Subcommittee deliberations, considering imaging equipment from this integrated perspective led to recommendations about the development of imaging system “accessibility packages,” renamed “imaging system accessibility configurations” in this report to underscore the understanding of imaging equipment as a fully-integrated system of component parts, including its immediately surrounding space and accessories. Examples of what accessibility configurations might include appear in Section 7.3. First, however, Section 7.2 provides more details about the technological and scientific aspects of diagnostic imaging equipment, introduced in Section 4.3 that might influence efforts to provide access to the imaging machine itself.

Notes

^KK The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

^LL The IEC 60601-1 international standard for medical electrical equipment indicates that medical electrical equipment includes those accessories that are necessary to enable the normal use of the equipment which includes facilitation of its use.