New Requirements for Medical Diagnostic Equipment

New regulations have been issued for medical diagnostic equipment. Are your customers aware, and compliant?

This summer, new regulations were issued that will require some evaluation of – and possible investment in – medical diagnostic equipment for healthcare providers.

On July 26, the 34th anniversary of the Americans with Disabilities Act (ADA), Attorney General Merrick B. Garland signed a final rule under Title II of the ADA to improve access to medical diagnostic equipment (MDE) for people with disabilities. The rule was published on August 9, 2024 and adopts the MDE Standards that the Access Board issued in January 2017.

Previously, on May 1, 2024, the Department of Health and Human Services published a Final Rule under Section 504 of the Rehabilitation Act that, among other things, adopts the Access Board’s 2017 MDE Standards for health care providers who receive federal financial assistance.

The reasoning behind the regulations is to ensure that any person with a disability can receive medical treatment as conveniently, safely, and comfortably as any other patient within a healthcare setting.

Congress charged the Access Board with developing and maintaining minimum technical criteria. The Access Board is an independent federal agency 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.

The DOJ and the HHS have adopted the Access Board’s guidelines and standards as mandatory requirements for entities subject to their jurisdiction and will be handling the implementation and enforcement of the requirements.

Bobby Stinnette, Accessibility Specialist, and Wendy Marshall, Attorney Advisor, on behalf of the Access Board, shared insights on why these regulations were implemented and what they mean for providers.

Reasons behind the regulations

All people, regardless of physical ability, should be able to receive medical services, the Access Board said. “Our rulemaking and the most recent Department of Justice (DOJ) and Department of Health and Human Services (HHS) rulemakings adopting the Medical Diagnostic Equipment (MDE) Standards describe the importance of accessible medical diagnostic equipment and provide firsthand accounts of instances where individuals with disabilities were unable to receive healthcare or received substandard care due to a lack of accessible exam tables, weight scales, radiological or other diagnostic equipment,” the Board said. “People with disabilities are frequently unable to receive prostate exams, mammograms, skin biopsies, or gynecological exams, or received incomplete physical exams because they could not transfer to an exam table.”

Congress charged the Access Board with developing and maintaining minimum technical criteria to ensure that “medical diagnostic equipment used in or in conjunction with physician’s offices, dental offices, clinics, emergency rooms, hospitals, and other medical settings, is accessible to, and usable by, individuals with accessibility needs[] … and … allow[s] independent entry to, use of, and exit from equipment by such individuals to the maximum extent possible” 29 U.S.C. § 794f.

The MDE Standards address independent access to, and use of, MDE by people with disabilities to the maximum extent possible and set forth the minimum technical criteria to ensure that medical 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.”

MDE covered includes 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. This list is not considered exhaustive but is illustrative of types of medical diagnostic equipment, the Access Board noted.

The MDE Standards address diagnostic equipment by the position in which it is used by the patient. The four types are: supine, prone, or side-lying position; seated position; seated in a wheelchair; or standing position. The MDE Standards also provide technical requirements for supports, communication, and operable parts.

For MDE that is intended for the patient to transfer onto, such as equipment used in the supine, prone or side lying position or used in the seated position, the MDE Standards require the transfer surfaces to be height adjustable from a high height of 25 inches to a low height of 17 – 19 inches. There must be four intermediate heights between the high and low, with a minimum separation of one inch. (Note: The Access Board issued a final rule, effective September 23, 2024, setting the low transfer height to 17 inches, however, this change has not yet been adopted by the enforcement agencies.)

Scoping requirements

According to a Department of Justice notice on the Federal Register, the scoping requirements for the final rule state that where public entities’ services, programs, and activities use MDE, at least 10% of the total number of units, but no fewer than 1 unit, of each type of equipment in use must meet the MDE Standards.

However, in rehabilitation facilities that specialize in treating conditions that affect mobility, outpatient physical therapy facilities, and other services, programs, or activities that specialize in treating conditions that affect mobility, at least 20%, but no fewer than 1 unit, of each type of equipment in use must meet the MDE Standards, the DOJ said.

“The rule allows public entities to use designs, products, or technologies as alternatives to those prescribed by the MDE Standards, as long as the alternatives provide substantially equivalent or greater accessibility and usability than the MDE Standards require,” the notice in the Federal Register states. “Facilities with multiple departments, clinics, or specialties must disperse their accessible MDE proportionately. The rule also requires public entities that use examination tables or weight scales to acquire at least one accessible unit of each such category of equipment within two years after this final rule is published.”

Additional resources

For additional resources or questions, the Access Board provides free technical assistance on its accessibility guidelines and standards through its helpline at 1-202-272-0080, extension 3, from 10:00 a.m. to 5:00 p.m. (ET) weekdays. For technical assistance specifically on the accessibility of medical diagnostic equipment, email mde@access-board.gov.

The Access Board has a webinar “Medical Diagnostic Equipment Final rule” that provides detailed information on the MDE final rule.

Also, DOJ final rule is available for review on the Federal Register’s website at www.federalregister.gov.

A fact sheet that provides information about the final rule is available on ada.gov.

The HHS final rule under Section 504 of the Rehabilitation Act may be viewed or downloaded at: www.federalregistar.gov A fact sheet on the rule is available here: Fact Sheet.

Key dates

The following are dates that Repertoire readers should be aware of:

Access Board:

DOJ final rule on Accessibility of Medical Diagnostic Equipment Used by State and Local Governments

All MDE that state and local government entities purchase, lease, or otherwise acquire after October 8, 2024, must comply with the MDE Standards until the entities have met the amount of accessible MDE specified in the rule.

By August 9, 2026, state and local government entities that use examination tables and weight scales must have at least one examination table and one weight scale that meets the MDE Standards.

HHS final rule under Section 504 of the Rehabilitation Act.

All MDE that recipients purchase, lease, or otherwise acquire after July 8, 2024, must meet the MDE Standards until they have the required amount of MDE specified in the rule.

By July 8, 2026, at least one examination table and one weight scale that meets the MDE Standards must be acquired for any facility in which such MDE is used.

Key points

The MDE Standards published by the Access Board in 2017, have recently been adopted as enforceable by DOJ and HHS.

There must be four intermediate heights between the high and low, with a minimum separation of one inch.
The Access Board issued a final rule, effective September 23, 2024, setting the low transfer height to 17 inches; however, this change has not yet been adopted by the enforcement agencies.
On August 9, 2024, the DOJ issued a final rule on the accessibility of medical diagnostic equipment (MDE) under Title II of the Americans with Disabilities Act (ADA), applicable to state or local government entities that offer services, programs, or activities through use of MDE. 28 CFR Part 35, 89 FR 65180.
On May 1, 2024, HHS adopted the Access Board’s technical standards for MDE as part of its recent final rule under Section 504 of the Rehabilitation Act prohibiting discrimination against individuals with disabilities by federally funded health care providers. 45 CFR 84, 89 FR 40066.
DOJ and HHS have adopted the low-transfer surface height of 17 – 19 inches.
DOJ and HHS have indicated, in the preambles accompanying their final rules, that they will consider issuing supplemental rulemakings under title II and Section 504 proposing to adopt the Access Board’s 17-inch low transfer height standard.