36 CFR Part 1195 Standards for Accessible Medical Diagnostic Equipment - Preamble

I. Executive Summary

A. Purpose and Legal Authority

The Access Board is an independent federal agency established by Section 502 of the Rehabilitation Act (29 U.S.C. 792). The Access Board is responsible for developing accessibility guidelines and standards under various laws to ensure that individuals with disabilities have access to and use of buildings and facilities, transportation vehicles, and information and communication technology. Pursuant to these laws, other federal agencies have adopted the Access Board’s guidelines and standards as mandatory requirements for entities subject to their jurisdiction.

On March 23, 2010, Section 4203 of the Patient Protection and Affordable Care Act (ACA) amended Title V of the Rehabilitation Act, which established the rights and protections for individuals with disabilities, by adding Section 510. Pub. L. 111-148, 124 Stat. 570). Section 510 of the Rehabilitation Act charges the Access Board, in consultation with the Commissioner of the Food and Drug Administration, with issuing standards that set forth the minimum technical criteria to ensure that medical diagnostic equipment (diagnostic equipment) used in (or in conjunction with) “physician’s offices, clinics, emergency rooms, hospitals, and other medical settings, is accessible to, and usable by, individuals with accessibility needs, and shall allow independent entry to, use of, and exit from the equipment by such individuals to the maximum extent possible.” 29 U.S.C. 794f.

The statute gives examples of diagnostic equipment, including “examination tables, examination chairs (including chairs used for eye examinations or procedures, and dental examinations or procedures), weight scales, mammography equipment, x-ray machines, and other radiological equipment commonly used for diagnostic purposes by health professionals.” 29 U.S.C. 794f. This list is not considered exhaustive, but is illustrative of types of medical diagnostic equipment.

Section 510 of the Rehabilitation Act instructs the Access Board to promulgate technical standards regarding accessibility of medical diagnostic equipment, but does not give the Access Board authority to enforce these standards. Compliance with the MDE Standards becomes mandatory only when an enforcing authority adopts the MDE Standards as mandatory for entities subject to its jurisdiction. Additionally, the enforcing agencies will determine the application and scope of these standards, such as who must comply and the extent to which medical diagnostic equipment used by covered entities must comply with these MDE Standards. As discussed below, the U.S. Department of Justice (DOJ) may adopt the MDE Standards as mandatory requirements for health care providers pursuant to its authority under Titles II and III of the Americans with Disabilities Act. Other federal agencies may adopt the standards as mandatory requirements for health care providers pursuant to their authority under Section 504 of the Rehabilitation Act.

Private parties, including individuals with disabilities, have also entered into settlement agreements with health care providers to enforce the ADA and Section 504 of the Rehabilitation Act.

The Commissioner of the Food and Drug Administration designated the Director of the Center for Devices and Radiological Health (FDA-CDRH) to consult with the Access Board on the development of the MDE Standards. The Access Board has worked throughout the process with the FDA-CDRH in developing these Standards.

B. Summary of Major Provisions and Organization of Technical Criteria

The Access Board has divided the MDE Standards into separate technical criteria based on how the diagnostic equipment is used by the patient: (1) supine, prone, or side lying position (M301); (2) seated position (M302); (3) while seated in a wheelchair (M303); and (4) standing position (M304). For each category the Access Board has provided technical criteria to allow independent access to and ensure the diagnostic equipment was usable by patients with disabilities to the maximum extent possible. The technical requirements for diagnostic equipment used by patients in the supine, prone, or side-lying position and diagnostic equipment used by patients in the seated position focus on ensuring the patient can transfer from a mobility device onto the diagnostic equipment. The other two categories, M303 and M304, focus on the necessary technical requirements to allow the patient to use the diagnostic equipment while seated in their wheeled mobility device, or while standing, respectively.

The MDE Standards also include technical criteria for supports (M305), for instructions or other information communicated to patients through the equipment (M306), and for operable parts used by patients (M307).

C. Costs and Benefits

The MDE Standards are advisory and are not binding until adopted by an enforcing authority. The Access Board’s mandate was to establish only the minimum technical criteria, however enforcing authorities may establish scoping requirements in the future. As such, the final rule does not directly impose any obligations on health care providers or medical device manufacturers. Only when another federal agency, through separate rulemaking, adopts the MDE Standards (in whole or in part) as mandatory for entities under its jurisdiction, will compliance be required. At this point, the Access Board does not know whether enforcing authorities will adopt the MDE Standards, nor (if they do) to what extent health care practices or particular types of medical diagnostic equipment will be required to comply with the Standards’ technical requirements. For this reason, the Board cannot estimate the incremental monetary or quantitative impacts of the final rule.

Nevertheless, the Board is able to characterize qualitatively some of the potential impacts of these Standards. If enforcing agencies adopt the MDE Standards as mandatory for entities regulated under their jurisdiction, the Standards could affect health care providers, medical device manufacturers, and individuals with disabilities. Once health care providers and facilities are required to acquire accessible medical equipment, they could incur compliance costs, to the extent that their equipment is not already accessible. Medical device manufacturers would then decide whether to incur incremental costs to meet the demand for accessible equipment, and some or many manufacturers may have an economic incentive to produce accessible equipment. Finally, given the many barriers to health care that patients with mobility and communication disabilities encounter due to inaccessible medical diagnostic equipment, individuals with disabilities will benefit from access to and use of diagnostic equipment meeting the MDE Standards. Consequently, they may be able to receive health care comparable to that received by their non-disabled counterparts.

In addition, the Standards could yield some immediate benefits, even before any adoption by implementing agencies in formal rulemaking. First, the technical specifications for accessible MDE incorporated in the Standards will benefit enforcing agencies that are considering similar accessibility requirements for entities under their jurisdiction. Although enforcing agencies have full authority over whether to adopt the Access Board’s final rule (in whole or in part), the technical specifications in the MDE Standards reflect the input from a diverse set of stakeholders and provide solid groundwork for any future rulemaking pertaining to the accessibility of medical diagnostic equipment. Second, the Standards will serve as a best-practice document for the medical device industry and for health care providers and facilities. While the MDE Standards are non-binding, health care providers can use this final rule as guidance on how to provide equitable access to medical diagnostic equipment for people with mobility and communication disabilities. Manufacturers can also use the MDE Standards as they target their research and development efforts at producing diagnostic equipment that can be used by a larger segment of population – one that includes more people with disability and older adults.

The Board thus concludes that the potential benefits of the MDE Standards justify its potential costs; that the MDE Standards will impose the least burden on society, consistent with achieving the regulatory objectives; and that the regulatory approach selected will maximize net benefits.