These Standards (MDE Standards) contain scoping and technical requirements for medical diagnostic equipment (diagnostic equipment) to ensure accessibility to, and usability of the diagnostic equipment by patients with disabilities. The MDE Standards provide for independent access to, and use of, diagnostic equipment by patients with disabilities to the maximum extent possible.
Sections M301 through M304 shall be applied to diagnostic equipment, based on the patient positions that the equipment supports, during patient transfer and diagnostic use. Sections M306 and M307 shall be applied to diagnostic equipment where communication features or operable parts are provided for patient use.
M101.3 Existing Diagnostic Equipment
The MDE Standards do not address the applicability of scoping or technical requirements to existing diagnostic equipment. Enforcing authorities, such as the Department of Justice or the Department of Health and Human Services, have authority over the accessibility of existing equipment and any regulation of that equipment will be effective only to the extent required by such enforcing authorities.
M101.4 Equivalent Facilitation
The use of alternative designs or technologies that result in substantially equivalent or greater accessibility and usability than specified in the MDE Standards is permitted.
The MDE Standards are based on adult dimensions and anthropometrics. Dimensions that are not stated as “maximum” or “minimum” are absolute.
M101.6 Dimensional Tolerances
Dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions.
M101.7 Units of Measurement
Measurements are stated in U.S. customary and metric units. The values stated in each system (U.S. customary and metric units) may not be exact equivalents, and each system shall be used independently of the other.
M102.1 Defined Terms
For the purpose of the MDE Standards, the following terms have the indicated meaning:
- End Transfer Surface
- A transfer surface located at one end of an examination surface that allows patient transfer at the end and one adjoining side of the examination surface.
- Enforcing Authority
- An agency or other governmental entity that adopts the MDE Standards as mandatory requirements for entities subject to its jurisdiction. Enforcing authorities may include, but are not limited to the United States Departments of Justice and Health and Human Services.
- Examination Chair
- Diagnostic equipment with a seat in which a patient typically is positioned with buttocks approximately parallel to the ground and shins approximately perpendicular to the ground. Examination chairs typically have back support and may recline to properly position the patient during examination. Such chairs may also have footrests or stirrups. Examination chairs include, but are not limited to, equipment used for dental, ophthalmic, podiatric, gynecological, urological, and ear, nose, and throat examinations.
- Imaging bed
- A component of diagnostic scanning equipment that accommodates patients in supine, prone, or side-lying positions.
- Imaging equipment with bores
- Diagnostic scanning equipment using magnets, x-rays, or detectors into which a patient and the table on which the patient lies is inserted into the equipment through a cylindrical opening (bore) in order to achieve the positioning accuracy needed during the scan. Such equipment includes, but is not limited to, computerized axial tomography (CT or CAT), positron emission tomography (PET), and nuclear medicine (NM) scanning equipment or a combination thereof.
- Medical Diagnostic Equipment (Diagnostic Equipment)
- Equipment used in, or in conjunction with, medical settings by health care providers for diagnostic purposes.
- Operable Parts
- Components of diagnostic equipment that are used by the patient to activate, deactivate, or adjust the equipment.
- Side Transfer Surface
- A transfer surface located within the length of the examination surface that allows patient transfer on two opposing sides of the examination surface.
- Transfer Surface
- Part of diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment.
- Wheelchair Space
- Space for a single wheelchair and its occupant.
M102.2 Undefined Terms
Terms not defined in M102.1 or in regulations or policies issued by an enforcing authority shall be given their ordinarily accepted meaning in the sense that the context implies.
Words, terms, and phrases used in the singular include the plural and those used in the plural include the singular.