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

V. Section-by-Section Analysis

A. Chapter 1: Application and Administration (Section-by-Section Analysis)

In the final rule Chapter 1 establishes the purpose and the general requirements for the application of the MDE Standards. This chapter received 21 comments and no recommendations from the MDE Advisory Committee. The Access Board made a few editorial changes to some of the provisions, and added one provision M101.3 Existing Diagnostic Equipment, which is discussed below.

M101 General (Section-by-Section Analysis)

This is an introductory section.

M101.1 Purpose (Section-by-Section Analysis)

The MDE NPRM proposed that the purpose of the MDE Standards was to establish technical criteria for diagnostic equipment that is accessible to and usable by patients with disabilities and to provide patients with disabilities independent access to and use of diagnostic equipment to the maximum extent possible. One commenter, a manufacturer, responded to the proposed provision. The commenter asserted that this provision was unclear without a list of applicable disabilities and an explanation on how the maximum extent possible would be determined.

In response to the commenter, the Access Board notes that the term “disability” is defined in the Americans with Disabilities Act (ADA), 42 USC 12102. None of the Standards and Guidelines promulgated by the Access Board include a list of applicable disabilities. Rather, they rely on the definition of disability provided in the ADA. As for determining whether diagnostic equipment provides independent access and egress to the maximum extent possible, that is a decision left to the enforcing authorities that adopt and implement this standard. The Access Board, therefore, declines to implement the commenter’s suggested changes. The Access Board has, however, made two editorial changes to this provision clarifying that “medical diagnostic equipment” is referred to as “diagnostic equipment,” and that these standards are referred to as “MDE Standards” throughout the rule text.

M101.2 Application (Section-by-Section Analysis)

In the NPRM the Access Board proposed that the MDE Standards would be applied to diagnostic equipment based on the patient position the equipment is designed to support. Additionally, this provision stated that where the equipment was designed to support more than one patient position, the MDE Standards for each patient position supported would be applied to the equipment. Fifteen commenters responded to this provision asserting that some diagnostic equipment should not have to comply with more than one patient position requirement. These concerns have resulted in two added exceptions to the final rule. The first is to exempt examination chairs which comply with M302 and can be reclined to facilitate diagnosis after the patient transfers onto the seat from complying with M301. (M301.1, Exception). This exception is discussed above in Section IV.B.4 (Significant Changes – Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302). Additionally, the final rule also exempts weight scales which contain a wheelchair space complying with M303 and that have a seat integral to the equipment from complying with M302 (M302.1, Exception). This exception is discussed above in Section IV.B.5. (Significant Changes – Exception from the Requirements of M302 for Weight Scales with Integral Seats). In the final rule, the application provision was revised due to the addition of the exceptions and a few editorial changes were made for clarity. This provision now requires that sections M301 through M304 of the MDE Standards be applied to diagnostic equipment based on the patient position that the equipment supports during patient transfer and diagnostic use and sections M306 and M307 will be applied to diagnostic equipment that contains communication features or operable parts that are provided for patient use.

M101.3 Existing Diagnostic Equipment (Section-by-Section Analysis)

The MDE NPRM did not address when or how the MDE Standards would be applied to existing medical diagnostic equipment. Commenters raised concerns about the cost of immediate compliance for the more expensive imaging equipment, noting the high cost and the concern that rooms are designed specifically for such equipment. Specifically, at the public hearing on March 14, 2012, two commenters recommended phasing in these requirements for imaging equipment based on when it is replaced. The public hearing transcript is available at https://www.regulations.gov/docket?D=ATBCB-2012-0003.

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. In response to the commenters’ concerns regarding existing equipment, the Access Board has decided to add a new provision which clarifies that the MDE Standards do not address the accessibility of existing diagnostic equipment and that the enforcing authority will determine whether and how diagnostic equipment will be regulated.

M101.4 Equivalent Facilitation (Section-by-Section Analysis)

The MDE NPRM proposed to permit the use of alternative designs or technologies that are substantially equivalent to or provide greater accessibility and usability than strict compliance with provisions in the MDE Standards. One commenter, a manufacturer, requested that the Access Board include examples of acceptable methods for providing equivalent facilitation.

The Access Board is unable to provide examples of acceptable methods of equivalent facilitation, as this section is intended to encompass those design solutions which the Access Board is unaware at the time that this rule is published. Additionally, the final determination of whether a particular design or technology meets this provision will be determined by the enforcing authorities. Therefore, the only change to this provision was to adjust the section number to allow for the addition of the new provision, M101.3 Existing Diagnostic Equipment.

M101.5 Dimensions (Section-by-Section Analysis)

The MDE NPRM proposed that the MDE Standards be based on adult dimensions and anthropometrics. One commenter and the MDE Advisory Committee raised concerns about providing standards for obese patients and pediatric patients. While the Access Board acknowledges that these are additional issues of accessibility, the final rule follows the MDE NPRM framework and provides technical requirements based on adult dimensions and anthropometrics, only. At this point in time the Access Board is focusing on adult dimensions and anthropometrics however, the Access Board may address potential expansions of the MDE Standards to other groups in future rulemakings. The only change to this provision was adjustment of the section number to allow for the addition of the new provision, M101.3 Existing Diagnostic Equipment.

M101.6 Dimensional Tolerances (Section-by-Section Analysis)

The MDE NPRM proposed that dimensions were to be subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions. In the preamble of the MDE NPRM, the Access Board sought public input in question five on available information or resources concerning conventional industry tolerances for medical diagnostic equipment. NPRM, 77 FR at 6920. Six commenters responded to the question. Three commenters (two manufacturers and one medical association) indicated that tolerances vary based on the manufacturer, product design, and manufacturing process and that they are unaware of any industry standard. One commenter, a manufacturer, referenced ASME Y14.5-1994 for dimensional tolerances. Another commenter, a medical association, asserted that tolerances are in operator manuals. The final commenter, a manufacturer, recommended providing tolerances when dimensions are specified and recommended defining a specific tolerance, such as +/- 0.5 inch for linear dimensions.

After considering the comments received, the Access Board has decided to retain the original provision. The Access Board was persuaded by arguments from the commenters that there is not one industry-wide standard that can be applied to all MDE and concurs that the Access Board should not attempt to establish manufacturing tolerances. Where available, tolerances are best addressed by industry standards for the specific materials and methods employed in the manufacturing process. The only change to this provision was to adjust the section number to allow for the addition of a new section, M101.3 Existing Diagnostic Equipment.

M101.7 Units of Measurement (Section-by-Section Analysis)

In the MDE NPRM there was no explanation of the units of measurement used throughout the rule text. In order to avoid confusion and to align this final rule with the other accessibility guidelines and standards promulgated by the Access Board; this provision has been added to explain that the values stated in each system (U.S. customary and metric units) may not be exact equivalents, and each system must be used independently of the other.

M102 Definitions (Section-by-Section Analysis)

This is an introductory section.

M102.1 Defined Terms (Section-by-Section Analysis)

The MDE NPRM proposed definitions for enforcing authority, medical diagnostic equipment, operable parts, and transfer surface. The Access Board sought input in question six in the preamble of the MDE NPRM, on whether there were other terms in the proposed standards that should be defined. NPRM, 77 FR at 6920. Ten commenters responded to this question. One commenter, a medical association, did not offer other terms that should be defined, but stated that there were many instances where the Board used acronyms without a definition. However, this commenter failed to provide any examples. Another commenter, a disability rights organization, suggested modifying the definition of medical diagnostic equipment to clarify that the standard is intended for all medical equipment in which any part of the equipment is used for diagnostic purposes for any amount of time. Another commenter, a manufacturer, recommended changing the term “operable part” to “applied part” and adding a new definition of operable part as “caregiver operated parts,” asserting that this aligns with IEC 60601. Other commenters (manufacturers, medical associations, disability rights organizations, and an individual) suggested the following terms be defined: health care provider, breast platform, patient support surface, transfer supports, positioning supports, prone position, supine position, examination tables, diagnostic purposes, maximum extent possible, landing area, exam table, procedure table, and procedure chair.

After review of the comments, the Access Board declines to add any of the suggested terms to the defined terms section. The definition of medical diagnostic equipment was taken directly from Section 510 of the Rehabilitation Act and thus for consistency has not been altered. 29 U.S.C. 794f. Some of the definitions proposed by commenters are not terms used in the MDE final rule and, therefore, providing the requested definitions would serve no purpose. The definitions for other proposed terms used in the final rule are the same as the ordinarily accepted meanings in the context that applies, and the Access Board does not believe that the reader would be significantly aided in understanding the final rule by adding the requested definitions. However, the Access Board has decided to add six additional terms to this section; end transfer surface, examination chair, imagining [sic] equipment with bores, imagining [sic] bed, side transfer surface, and wheelchair space. As described above in Section IV.B.1.b. (Significant Changes – Transfer Surface Location), the Access Board has added definitions for “end transfer surface” and “side transfer surface” to this provision to describe the two types of transfer surfaces for diagnostic equipment used by patients in the supine, prone, or side-lying position. The “wheelchair space” definition was taken from the 2004 ADA and ABA Accessibility Guidelines and adopted in the MDE final rule to provide consistency across Access Board rulemakings. Examination chair, imagining [sic] equipment with bores, and imagining [sic] bed were added to help clarify application of exceptions added in the final rule. (See M301.1, M301.2.3, and M305.2.2.2). Finally, the Access Board also made a minor editorial change to the title of “operable part” so that all components and parts are referred to in the plural.

M102.2 Undefined Terms (Section-by-Section Analysis)

The MDE NPRM proposed that the meaning of terms not defined in proposed M102.1 or in regulations or policies issued by an enforcing authority, be defined by collegiate dictionaries in the sense that the context implies. There were no comments and no MDE Advisory Committee recommendations on this provision. In the final rule, the Access Board has changed this provision to indicate that the meaning of terms not defined in M102.1 will be given their ordinarily accepted meaning in the context that applies.

M102.3 Interchangeability (Section-by-Section Analysis)

The MDE NPRM proposed that singular and plural words, terms, and phrases are used interchangeably. There were no comments on this requirement and no changes have been made

B. Chapter 2: Scoping (Section-by-Section Analysis)

In the final rule, Chapter 2 establishes that the enforcing authority will determine the number and types of diagnostic equipment to which the MDE Standards will apply. The Access Board did not receive any comments regarding Chapter 2 as written; however, several commenters expressed concern regarding the ability of certain types of diagnostic equipment to comply with the MDE Standards. These concerns, discussed above in Section IV.A.1. (Significant Changes – General Exception), resulted in the addition of the M201.2 General Exception, described below. In addition, the Access Board made one editorial change to M201.1.

M201 General (Section-by-Section Analysis)

This is an introductory section.

M201.1 Enforcing Authority (Section-by-Section Analysis)

The MDE NPRM proposed to explain that the enforcing authority would specify the minimum number of types of accessible diagnostic equipment that would be required to comply with the MDE Standards. There were no public comments regarding this provision. The Access Board has decided to make an editorial change to this section to clarify that the enforcing authority will specify the minimum number and types of accessible diagnostic equipment that will be required to comply with the MDE Standards.

M201.2 General Exception (Section-by-Section Analysis)

The MDE NPRM did not propose a general exception for diagnostic equipment that was not capable of meeting the MDE Standards. As described in Section IV.A.1. (Significant Changes – General Exception), the Access Board received public comments and MDE Advisory Committee recommendations regarding certain types of diagnostic equipment that are unable to meet all of the requirements in the MDE Standards. In response, the Access Board has added a new provision excepting diagnostic equipment from compliance with an applicable requirement in the MDE Standards in the rare circumstance where compliance would alter diagnostically required structural or operational characteristics of the equipment, and would prevent the use of the equipment for its intended diagnostic purpose. Any equipment falling under this exception must comply with the provision(s) in question to the maximum extent practicable, and must fully comply with all other provisions not utilizing this exception.

C. Chapter 3: Technical Requirements (Section-by-Section Analysis)

In the final rule, Chapter 3 establishes the technical requirements for accessible medical diagnostic equipment based on how the diagnostic equipment is used by the patients, including: diagnostic equipment used by patients in a supine prone, or side-lying position (M301); diagnostic equipment used by patients in a seated position (M302); diagnostic equipment used by patients seated in a wheelchair (M303); and diagnostic equipment used by patients in a standing position (M304). Chapter 3 also provides technical criteria for supports (M305), communication (M306), and operable parts (M307). This chapter underwent significant reorganization and changes as described in Section IV.B through IV.E (Significant Changes – M301 through M305). Additionally, the Access Board made editorial changes which are described below in the applicable Section-by-Section Analysis.

M301 Diagnostic Equipment used by Patients in a Supine, Prone, or Side-lying Position (Section-by-Section Analysis)

M301 in the final rule establishes the technical criteria for diagnostic equipment used by patients in a supine, prone, or side-lying position such as, examination tables, imaging tables, hospital beds, and stretchers.

M301.1 General (Section-by-Section Analysis)

The MDE NPRM proposed that all diagnostic equipment used by patients in a supine, prone, or side-lying position must comply with the technical requirements of proposed section M301. As discussed in Section IV.B.4. (Significant Changes – Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302), in response to public comment and recommendations from the MDE Advisory Committee, in the final rule the Access Board has added an exception to this requirement for examination chairs that can be reclined to facilitate diagnosis after the patient transfers. This new exception exempts these diagnostic chairs from compliance with M301’s requirements, as long as the examination chairs comply with the requirements in M302.

M301.2 Transfer Surface (Section-by-Section Analysis)

This is an introductory section.

M301.2.1 Adjustability (Section-by-Section Analysis)

The MDE NPRM proposed a transfer surface height range for diagnostic equipment used by patients in the supine, prone, or side-lying position of 17 inches minimum and 19 inches maximum. The Access Board received multiple comments on this provision and the MDE Advisory Committee provided four recommendations. As discussed in Section IV.B.1.a. (Significant Changes – Transfer Surface Adjustability), in the final rule the Access Board has renamed this provision and now requires the transfer surface height to be adjustable to: (1) a low transfer height of 17 inches minimum and 19 inches maximum; (2) a high transfer height of 25 inches; (3) at least four additional transfer heights located between the low and high transfer heights, separated by one inch minimum increments; and (4) the transfer surface height will be measured from the floor to the top of the uncompressed transfer surface.

M301.2.2 Sunset Provision (Section-by-Section Analysis)

As discussed in Section IV.B.1.a. (Significant Changes – Transfer Surface Adjustability), this is a new provision that was added to the final rule in conjunction with the new requirement of a low height range in M301.2.1. It provides a sunset for the low transfer height provision of five years from the date of publication of this rule in the Federal Register. The Access Board intends to complete the necessary research to determine an appropriate minimum low transfer height prior to the effective date of the sunset, and will update this provision in a subsequent rulemaking.

M301.2.3 Size (Section-by-Section Analysis)

The MDE NPRM proposed a transfer surface size for diagnostic equipment used in the supine, prone, or side-lying position of 30 inches wide and 15 inches deep minimum. (proposed M301.2.2). The Access Board received multiple comments on this provision as well as multiple recommendations from the MDE Advisory Committee. As discussed in Section IV.B.1.c (Significant Changes – Transfer Surface Size), in the final rule the Access Board has revised this provision to account for the two types of transfer surfaces (end and side), requiring end transfer surfaces to be a minimum of 28 inches wide and 17 inches long and side transfer surfaces to be a minimum of 28 inches wide and 28 inches long and has added an exception for transfer surfaces for imagining equipment with bores.

M301.2.4 Unobstructed Transfer (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as they could be repositioned during transfer. Examples of temporary obstructions include folding armrests, removable side rails, retractable footrests, and stirrups. NPRM, 77 FR at 6924. There were no comments received on the proposed provision and the MDE Advisory Committee did not make any recommendations. The final rule retains the requirement for unobstructed transfer, but has reworded the requirement to specify that each transfer surface must provide two unobstructed sides for the patient to transfer.

Additionally, the Access Board sought public input on whether an additional exception to the requirement of unobstructed transfer should be added. NPRM, 77 FR at 6924. Specifically, the Access Board asked whether equipment parts should be permitted to extend a maximum of three inches horizontally beyond the edge of the transfer sides, provided they do not extend above the top of the transfer surface. The Access Board received multiple comments and recommendations from the MDE Advisory Committee on this topic. As discussed above in the Section IV.B.1.d. (Significant Changes – Unobstructed Transfer), the final rule includes a second exception to the unobstructed transfer provision which permits obstructions of no more than three inches to extend beyond the transfer side of the transfer surface, provided that such obstructions do not protrude above the top of the transfer surface.

M301.3 Supports (Section-by-Section Analysis)

This is an introductory section. An editorial change was made to this section as a result of the change in M301.3.2, described below, to replace the word “stirrups” with the term “leg supports.”

M301.3.1 Transfer Supports (Section-by-Section Analysis)

The MDE NPRM proposed to require transfer supports to be provided for use with transfer sides on diagnostic equipment used by patients in the supine, prone, or side-lying position, and that these transfer supports comply with the technical requirements for transfer support in M305.2. There were no public comments and no recommendations by the MDE Advisory Committee on this provision. The only change in the final rule was to update the cross reference to applicable transfer surfaces to accommodate the changes made to transfer surfaces, described above in Section IV.B.1. (Significant Changes – Transfer Surface).

M301.3.2 Leg Supports (Section-by-Section Analysis)

In the MDE NPRM, the Access Board proposed to place the requirements for stirrups on diagnostic equipment used by patients in the supine, prone, or side-lying position in M301. In the final rule the Access Board has decided to move the technical requirements for stirrups to M305, which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that when stirrups are provided on diagnostic equipment used in the supine, prone, or side-lying position leg supports must also be provided and comply with the technical requirements in M305.4. Additionally, in the final rule, the Access Board has made an editorial change in terminology, from stirrups to leg supports, in response to an MDE Advisory Committee recommendation to draw a distinction between stirrups which often only support the feet and leg supports which would support the legs when the patient’s feet are in the stirrups and to provide consistency with the headings of other support provisions which are based on the body part supported.

M301.3.3 Head and Back Support (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed to place the requirements for head and back support for diagnostic equipment used by patients in the supine, prone, or side-lying position in M301. In the final rule, the Access Board has decided to move the technical requirements for head and back support to M305, which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that where diagnostic equipment is used in a reclined position it must provide head and back support that complies with the technical requirements in M305.5.

M301.4 Lift Compatibility (Section-by-Section Analysis)

The MDE NPRM proposed to require that diagnostic equipment used by patients in the supine, prone, or side-lying position be usable with a patient lift and comply with either the proposed clearance in base (proposed M301.4.1) or clearance around base (proposed M301.4.2) technical requirements. One manufacturer commented on this provision, asserting that the proposed requirement was unclear and should clearly state that the diagnostic equipment only has to be compatible with either the clearance around base or the clearance in base provisions. The Access Board considered this comment, but finds that the language is clear as written. This provision clearly states that diagnostic equipment shall comply with clearance in base or clearance around base. In the final rule the Access Board has made an editorial change to clarify the type of lift; namely portable patient lift, and a change to clarify that the clearance provisions only apply when the diagnostic equipment is being used with the portable patient lift.

Additionally, question 27 in the MDE NPRM preamble requested input on whether the final rule should provide an exception from the lift compatibility requirements where the diagnostic equipment is designed for use with overhead lifts. As discussed above in Section IV.B.3. (Significant Changes – Lift Compatibility Exception), the Access Board has decided to add this exception for diagnostic equipment that meets the following three criteria: fixed overhead patient lifts are provided for use with the diagnostic equipment; the use with the fixed overhead patient lift with the diagnostic equipment is permitted by an enforcing authority; and the diagnostic equipment is clearly labeled as not compatible with portable patient lifts.

M301.4.1 Clearance in Base (Section-by-Section Analysis)

The MDE NPRM proposed certain clearance requirements beneath the diagnostic equipment to allow sufficient space for the legs of a portable patient lift to fit underneath the equipment so that the patient could be raised out of their mobility device, moved over to the medical diagnostic equipment, and then be lowered onto the transfer surface. The proposed requirement could be met by providing an open area beneath the equipment, or by configuring the equipment with a wide slot recessed into the base enclosure. NPRM, 77 FR at 6927. The MDE NPRM proposed a clearance in the base of 44 inches wide minimum, 6 inches high minimum measured from the floor, and 36 inches deep minimum measured from the edge of the examination surface. Where the width of the equipment is less than 36 inches wide, the proposed rule required the clearance to extend the full width of the equipment. Id. Additionally, the Access Board proposed to permit equipment components to be located within 8 inches maximum of the centerline of the clearance width. Id. The Access Board sought input in question 25 in the MDE NPRM preamble, on whether the proposed dimensions for the clearance in base requirement is sufficient to allow for the use of portable floor lifts. Id.

Six commenters responded to the question. One commenter, a manufacturer, concurred with the proposed provision. Another commenter, a medical association, explained that portable lifts are a problem in older outpatient facilities due to limited space. Another commenter, a manufacturer, raised concerns about requiring floor based patient lifts with MRI systems, explaining the concern about the significant structural support required in the patient bed which makes the under bed clearance impractical and the concern about requiring non-ferrous materials in the MRI room. This commenter explained a preference for fixed overhead lifts. Three commenters (two manufacturers and one medical association) raised concerns with the six-inch vertical clearance measured from the floor requirement. One manufacturer explained that the proposed six-inch vertical clearance requirement would encompass 100 percent of all portable patient lifts on the market, and that several portable patient lifts only require 2.5 inches clearance, such as those designed to be used with stretchers. This commenter asserted that the proposed six-inch vertical clearance would require redesign of every medical bed and stretcher on the market, and recommended reducing the required clearance. One commenter (medical association) noted that it would be difficult to meet the six-inch clearance from the floor when the table is lowered to 17 inches to allow for transfer. The final commenter explained that a standard that only required either compliance with clearance in the base or clearance around the base, was attainable, but warned that if both were required it would impose significant redesign costs and would increase product costs. This commenter further posited that it would be more cost effective to redesign the lift than the diagnostic equipment. These three commenters also raised concerns that this provision was in conflict with the prevailing standard used by manufacturers for medical beds and stretchers, IEC 60601-2-52, which contains requirements for lift clearance under the equipment.

The MDE Advisory Committee recommended reducing the equipment base clearance for stretchers from 44 inches wide minimum to 39 inches wide minimum. The Committee noted that this was to harmonize the MDE Standards with IEC 60601-2-52, which provides requirements for stretchers and includes lift clearance at the 39-inch width. MDE Advisory Committee Report, 106-107, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The Access Board has reviewed the comments and the recommendations from the MDE Advisory Committee and is persuaded by the arguments in favor of harmonizing the lift clearance requirements with the IEC 60601-2-52. Accordingly, the Access Board has adopted the recommendation from the MDE Advisory Committee, but has decided to apply the reduction in lift clearance width to all medical diagnostic equipment that complies with the clearance in base provision because a lift that deploys effectively under a stretcher should also function properly under other less constrained diagnostic equipment. Secondly, the Access Board has decided to retain the six-inch height clearance requirement but agrees with the commenters that the diagnostic equipment should not have to meet the six-inch height clearance requirement when in position for independent transfer. Therefore, the final rule clarifies that the lift compatibility requirements only apply when the diagnostic equipment is being used with the portable lift, as a lift will only be used when independent transfer is not possible.

M301.4.2 Clearance Around Base (Section-by-Section Analysis)

The MDE NPRM proposed certain requirements to provide clearance around the base of the diagnostic equipment to allow the legs of the portable floor lift to straddle the base of the diagnostic equipment with a solid base that sits on or close to the floor. The proposed rule required a minimum clearance of 6 inches high measured from the floor and 36 inches deep measured from the edge of the examination surface. NPRM, 77 FR at 6927. The width of the base permitted within this clearance would be 26 inches maximum at the edge of the examination surface and was permitted to increase at a rate of 1 inch in width for every 3 inches in depth. Id. In addition, where the width of the examination surface is less than 26 inches, the clearance depth would be the full width of the examination surface. Id. The Access Board sought public input in question 26 in the MDE NPRM, on whether the proposed dimensions for clearance around the base of the equipment was sufficient to allow for the use of portable floor lifts. Id.

Two commenters, both manufacturers, responded to this question. One commenter recommended clarifying that the exam table must be compatible with a patient lift and meet the six-inch clearance, but not when the table is at its lowest level for independent transfer. This manufacturer indicated that its adjustable table does not have a six-inch minimum clearance when at its lowest position, but does meet the standard when the table is raised. The other commenter asserted that the proposed dimensions are not sufficient to accommodate the various portable floor lifts and recommended that the Access Board instead provide technical criteria for the portable patient lift to be usable with diagnostic equipment since it is more cost effective to change the floor lift, than to change the diagnostic equipment. Additionally, this manufacturer reported that all but one of its examination and procedure tables currently meet the clearance around base provision, but opined that if the proposed increase in width of the transfer surface of examination tables and chairs to 30 inches by 15 inches is adopted then it would be required to redesign the examination tables and chairs to have a larger base which would interfere with the ability to meet this clearance around base provision. The MDE Advisory Committee did not address this provision, and thus provided no recommendations on the clearance around the base requirements.

The Access Board has reviewed the comments and has decided to retain the provision from the proposed rule. In the final rule, the Access Board has decided to decrease the size of the transfer surface (See final M301.2.3) and thus the commenter’s concern regarding an increase in base size is not applicable. As described above, M301.4 does not require the 6-inch height clearance to be maintained when the equipment is lowered to the minimum low height for independent transfer as required by M301.2.1, because portable patient lifts will only be used when independent transfer is not possible. Finally, a portable patient lift is not medical diagnostic equipment and, therefore, not within the purview of the Access Board’s regulatory jurisdiction. However, portable patient lifts are integral to ensuring that patients with disabilities who are unable to independently transfer are otherwise able to use the medical diagnostic equipment. Therefore, the Access Board has provided the technical criteria necessary for the portable floor lift to be usable with medical diagnostic equipment.

M302 Diagnostic Equipment used by Patients in a Seated Position (Section-by-Section Analysis)

M302 in the final rule establishes the technical criteria for diagnostic equipment used by patients in a seated position such as examination chairs.

M302.1 General (Section-by-Section Analysis)

The MDE NPRM proposed that all diagnostic equipment used by patients in a seated position must comply with the technical requirements of proposed section M302. As discussed in Section IV.B.5. (Significant Changes – Exception from the Requirements of M302 for Weight Scales with Integral Seats), in response to public comment and evidence presented to the MDE Advisory Committee, in the final rule the Access Board has added an exception to this requirement for weight scales that contain wheelchair spaces and also provide a seat integral to the equipment. This new exception exempts these weight scales from compliance with M302’s requirements for the seat, as long as the wheelchair space complies with the requirements in M303.

M302.2 Transfer Surface (Section-by-Section Analysis)

This is an introductory section.

M302.2.1 Adjustability (Section-by-Section Analysis)

The MDE NPRM proposed a transfer surface height range for diagnostic equipment used by patients in a seated position of 17 inches minimum and 19 inches maximum. The Access Board received multiple comments on this provision and the MDE Advisory Committee provided four recommendations. As discussed in Section IV.B.1.a. (Significant Changes – Transfer Surface Adjustability) in the final rule the Access Board has renamed this provision and now requires the transfer surface to be adjustable to: (1) a low transfer position height at or between 17 inches and 19 inches; (2) a high transfer position of 25 inches; (3) at least four additional transfer positions located between the low and high transfer positions and separated by one inch minimum increments; (4) measured from the floor to the top of the uncompressed transfer surface.

M302.2.2 Sunset Provision (Section-by-Section Analysis)

As discussed in Section IV.B.1.a. (Significant Changes – Transfer Surface Adjustability), this is a new provision added to the final rule in conjunction with the new requirement of a low height range in M302.2.1. It provides a sunset for the low transfer height provision of five years from the date of publication of this rule in the Federal Register. The Access Board intends to complete the necessary research to determine an appropriate minimum low transfer height prior to the effective date of the sunset, and will update this provision in a subsequent rulemaking.

M302.2.3 Size (Section-by-Section Analysis)

The MDE NPRM proposed a transfer surface size for diagnostic equipment used by patients in the seated position of 21 inches wide and 15 inches deep (proposed M302.2.2). The Access Board also solicited comment in question 16 on whether the transfer surface size proposed for seated position diagnostic equipment was sufficient to facilitate independent transfer. NPRM, 77 FR at 6924. Two of the seven commenters who responded supported the proposed requirements. One commenter, a manufacturer, although in agreement with the 21-inch width, stated that the 15 inches deep requirement should be increased to 17 inches, a disability advocate recommended increasing the width to 23 inches, two of the commenters, accessibility consultant and disability advocate, stated that the proposed dimensions were insufficient citing concerns for persons of larger stature or who are obese and may be unable to safely transfer to a surface of that size. One commenter, a manufacturer, recommended harmonizing with the requirements for the seated position with those of the supine, prone, or side-lying position transfer surface size.

The MDE Advisory Committee considered the dimensions for rectangular seats in roll-in showers from the 2010 ADA Standards for Accessible Design and the “ideal” chair width recommended in Architectural Graphic Standards for auditorium seating. MDE Advisory Committee Report, 77, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee also reviewed anthropometric data from a variety of sources. Id. Many Committee members expressed concern about the adequacy of the transfer surface depth. Id. The Committee recommended increasing the minimum depth of the transfer surface from 15 inches to 17 inches, noting that existing equipment already meets or exceeds this dimension. Id. The Committee recommended retaining the 21-inch width requirement, noting that it was sufficient to facilitate independent transfer. Id.

Based on the commenters’ responses and the MDE Advisory Committee recommendations, the Access Board has decided to increase the transfer surface size for equipment used by patients in a seated position to 17 inches deep and retain the 21-inch-wide requirement from the proposed rule.

M302.2.4 Transfer Sides (Section-by-Section Analysis)

In the MDE NPRM, the transfer side provision for diagnostic equipment used by patients in the seated position required transfer surfaces to have the option to transfer from a mobility device onto one short side (depth) and one long side (width) of the surface, and provide unobstructed transfer to the surface. The Access Board received multiple comments and recommendations from the MDE Advisory Committee, which are discussed above in Section IV.B.1.b. (Significant Changes – Transfer Surface Location). In the final rule, the Access Board retained this provision, but made editorial changes to clarify the location of the transfer sides and to relocate the language concerning unobstructed transfer into a new section M302.2.5. The transfer sides are still intended to allow a patient to choose to transfer onto either of two adjoining sides of the transfer surface. Additionally, based on comments and recommendations from the MDE Advisory Committee, the Access Board has decided to add an exception to this provision to accommodate chairs with fixed footrests which prevent transfer onto the adjoining sides. This is discussed in Section IV.B.1.b. (Significant Changes – Transfer Surface Location). As explained above, in order to provide patients with the ability to choose what side of their body they use to transfer, chairs with fixed footrests will provide the ability to transfer from either opposing side of the transfer surface. This allows the patient to choose to transfer from their right or left side and prevents the patient from having to transfer onto a fixed footrest.

M302.2.5 Unobstructed Transfer (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as they could be repositioned during transfer. This requirement is identical to the unobstructed transfer requirement in M301.2.4, and this provision is discussed in the Section V.C.2.d. (Section-by-Section Analysis – M301.2.4). The final rule retains the requirement for unobstructed transfer, but has been reworded to specify that each transfer surface must provide two unobstructed sides for the patient to transfer.

Additionally, as discussed above in the Section IV.B.1.d. (Significant Changes – Unobstructed Transfer), the final rule includes a second exception to the unobstructed transfer provision which permits obstructions of no more than three inches to extend beyond the transfer side of the transfer surface, provided that such obstructions do not protrude above the top of the transfer surface.

M302.3 Supports (Section-by-Section Analysis)

This is an introductory section. An editorial change was made to this section as a result of the change in M302.3.2, described below, to replace the word “stirrups” with the term “leg supports.”

M302.3.1 Transfer Supports (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed that transfer supports must be provided for use with transfer sides on diagnostic equipment used by patients in the seated position, and that these transfer supports must comply with the technical requirements in M305.2 of the proposed rule. There were no comments on this provision and no recommendations by the MDE Advisory Committee. Based on the restructure of the transfer surface provisions, described above in Section IV.B.1.b. (Significant Changes – Transfer Surface Location), and the additional technical criteria added to the transfer supports provisions, discussed above in Section IV.E.1 (Significant Changes – Transfer Supports), the Access Board has made editorial changes to this section. The technical requirements for transfer supports is in M305.2 of the final rule and has been reorganized to mirror the two types of transfer surfaces (end and side) in the final rule for diagnostic equipment used by the patient in the supine, prone, or side-lying position. The transfer surface required for diagnostic equipment used by patients in the seated position is similar to the new end transfer surface and therefore, diagnostic equipment used by patients in the seated position is required to comply with the transfer support provisions for end transfer supports. Additionally, the Access Board has included cross-references to the new transfer support requirements in M305.2.

M302.3.2 Leg Supports (Section-by-Section Analysis)

The MDE NPRM did not propose to require stirrups to provide a method of supporting, positioning, and securing the patient’s legs for diagnostic equipment used by patients in the seated position. However, in response to question 23, on whether diagnostic equipment used by patients in a seated position that provide stirrups should have to provide such support, the Board received six comments. NPRM, 77 FR at 6926. All six commenters concurred that when stirrups are provided for use with diagnostic equipment used by patients in the seated position, a method must be provided for supporting, positioning, and securing the patient’s legs. The MDE Advisory Committee did not address this provision.

The Access Board concurs with the commenters, and the final rule requires that where stirrups are provided on seated diagnostic equipment, leg supports must also be provided and must comply with the technical requirements for leg supports in M305.4. This will ensure that patients with limited leg strength and control will be able to keep their legs in the appropriate position for examination.

M302.3.3 Head and Back Support (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed to place the requirements for head and back support for diagnostic equipment used by patients in the seated position in M302. In the final rule the Access Board has decided to move the technical requirements for head and back support to M305 which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that where diagnostic equipment is used in a reclined position it must provide head and back support that complies with the technical requirements in M305.5.

M302.4 Lift Compatibility (Section-by-Section Analysis)

The MDE NPRM proposed to require that diagnostic equipment used by patients in the seated position be usable with a patient lift and comply with either the proposed clearance in base (proposed M302.4.1) or clearance around base (proposed M302.4.2) technical requirements. This requirement is identical to the lift compatibility requirement for diagnostic equipment used by patients in the supine, prone, or side-lying position, and is discussed in the Section-by Section Analysis for M301.4. In the final rule the Access Board has made an editorial change to clarify the type of lift; namely portable patient lift, reduced the lift clearance to 39 inches and clarified that the clearance provisions only apply when the diagnostic equipment is being used with the portable patient lift. See Section V.C.4. (Section-by-Section Analysis – M301.4.) Additionally, as discussed above in Section IV.B.3. (Significant Changes – Lift Compatibility Exception), the Access Board has added an exception for diagnostic equipment that meets the following three criteria: fixed overhead patient lifts are provided for use with the diagnostic equipment; the use with the fixed overhead patient lift with the diagnostic equipment is permitted by an enforcing authority; and the diagnostic equipment is clearly labeled as not compatible with portable patient lifts.

M303 Diagnostic Equipment Used by Patients in a Wheelchair (Section-by-Section Analysis)

M303 in the final rule establishes the technical requirements for diagnostic equipment used by patients seated in a wheelchair, such as weight scales with wheelchair spaces and mammography equipment.

M303.1 General (Section-by-Section Analysis)

This is an introductory section.

M303.2 Wheelchair spaces (Section-by-Section Analysis)

This is an introductory section.

M303.2.1 Orientation (Section-by-Section Analysis)

The MDE NPRM proposed to require wheelchair spaces to be designed so that a patient in a wheelchair using diagnostic equipment would be oriented in the same direction that other non-wheelchair using patients using the equipment are typically oriented. NPRM, 77 FR at 6927. The Access Board received one comment about this requirement. The commenter, an accessibility consultant, recommended that patient positioning be addressed along with orientation of the wheelchair, noting that there are many cases where it is insufficient to simply position the user facing the same direction as a non-wheelchair user. The commenter asserted that body positioning is key for obtaining accurate results when using diagnostic devices, such as x-ray equipment, and recommends amending the rule text to require wheelchair spaces to be designed so that the patient orients and positions their body in the same position as someone who is not in a wheelchair. There was no recommendation from the MDE Advisory Committee on this requirement. The Access Board has retained the original requirement in the final rule. The Board did not include requirements for patient body positioning because the diagnostic equipment cannot override the position in which an individual is seated in his or her wheelchair. Wheelchairs often are contoured to fit the specific and unique needs of the user and to provide support where it is needed. However, the design of a wheelchair space often influences whether a wheelchair user can orient with respect to diagnostic components. For example, without knee and toe space beneath an optometrist diopter, the patient cannot look into the lens.

M303.2.2 Width (Section-by-Section Analysis)

The MDE NPRM proposed to require that diagnostic equipment used by patients seated in a wheelchair provide a wheelchair space that was at least 36 inches wide. There were no public comments and no MDE Advisory Committee recommendations regarding this requirement. Thus, the final rule retains the 36-inch wheelchair space width requirement. However, the Board added a new exception for wheelchair spaces on raised platforms, as discussed in Section IV.C.1. (Significant Changes – Width and Depth of Wheelchair Spaces), and discussed briefly below.

In the preamble to the MDE NPRM, the Access Board sought input on whether an exception to the width requirement was needed for wheelchair spaces on raised platforms. Multiple commenters responded to this provision and the MDE Advisory Committee recommended reducing the width requirement for wheelchair spaces on raised platforms. The Access Board has added an exception in the final rule that permits wheelchair spaces on raised platforms to be 32 inches wide minimum with edge protection no higher than 4 inches, measured from the platform surface.

M303.2.3 Depth (Section-by-Section Analysis)

The MDE NPRM proposed two wheelchair space depth requirements based on how the wheelchair user enters the space: for spaces entered from the front or rear, 48 inches deep minimum; and for spaces that can only be entered from the side, 60 inches deep minimum. In the preamble in the MDE NPRM, the Access Board noted it was considering increasing the minimum depth for wheelchair spaces entered from the front or rear to 58 inches and sought input in question 29 on whether the Access Board should increase this minimum depth requirement. NPRM, 77 FR at 6928.

The Access Board received eight comments in response to this question. Three commenters (two disability rights organizations and a state agency concerned with accessibility) recommended increasing the depth of front or rear entered spaces to 58 inches. The other five commenters (manufacturers, medical associations and accessibility consultants) recommended retaining the proposed requirement in the MDE NPRM of 48 inches minimum, raising concerns that the size of the rooms in which the diagnostic equipment are located are insufficient to provide additional space. The MDE Advisory Committee did not make recommendations regarding the general requirement for depth for wheelchair spaces, but did make recommendations regarding the depth of wheelchair spaces on raised platforms, which is discussed in above in Section IV.C.1. (Significant Changes – Width and Depth of Wheelchair Spaces).

First, the Access Board clarifies that this provision is not a clear space requirement for wheelchair approach, but is instead the wheelchair space integral to diagnostic equipment for a patient seated in a wheelchair, such as mammography equipment or wheelchair accessible scales. Second, based on the comments received and the absence of recommendations from the MDE Advisory Committee to change the proposed requirement, the Access Board has retained the MDE NPRM’s requirements for a minimum depth of 48 inches for wheelchair spaces entered from the front or rear, and a minimum depth of 60 inches for wheelchair spaces entered from the side. However, the Access Board has reorganized this provision into three separate requirements based on how the wheelchair space is entered, made an editorial change to clarify that front or rear entry is where the wheelchair space entry and exit is provided at only one end, and as discussed in Section IV.C.1. (Significant Changes – Width and Depth of Wheelchair Spaces), added an additional requirement to the depth provision for wheelchair spaces entered from the front or rear to permit a minimum of 40 inches if the wheelchair space provides pass-through from one end to the other.

M303.2.4 Equipment Clearances (Section-by-Section Analysis)

The MDE NPRM proposed knee and toe clearance for diagnostic equipment used by patients seated in wheelchairs to allow for components in the wheelchair space which the patient could approach successfully to use for its intended diagnostic purpose. The proposed requirements for equipment clearances paralleled the knee and toe clearance requirements from the 2004 ADA and ABA Accessibility Guidelines. The proposed rule provided one additional requirement for breast platforms on mammography equipment, proposing the knee and toe clearance under a breast platform to be 25 inches deep (proposed M303.2.4). The MDE NPRM preamble sought input with question 34 on whether the dimensions recommended by the Wheeled Mobility Anthropometry Project should be adopted.¹⁰ Three commenters responded. A manufacturer asserted that adopting a different requirement than what is already required under existing accessibility guidelines and standards would cause confusion and increase costs. A medical association asserted that to the best of their knowledge, imaging equipment already meets the Wheeled Mobility Anthropometry Project recommendations. The final commenter, a state agency concerned with accessibility, recommended adopting the new Wheeled Mobility Anthropometry Project recommendations. The MDE Advisory Committee only provided recommendations pertaining to the knee and toe clearance for mammography equipment.

The Access Board has determined that mammography equipment presents a unique challenge. Mammography equipment contains breast platforms which patients seated in wheelchairs must approach, and successfully maneuver their lower body under the platform enough to allow their chest to be flush with the leading edge of the platform. A separate set of equipment clearance requirements is necessary to address the unique positioning at mammography equipment. Therefore, in the final rule the Access Board has separated out the knee and toe clearance requirements into two provisions; breast platforms and other equipment. Breast platform requirements address the knee and toe clearance requirements for mammography equipment which is usable by patients seated in a wheelchair and is discussed in Section IV.C.2. (Significant Changes – Equipment Clearances for Breast Platforms). All other diagnostic equipment used by patients seated in a wheelchair must comply with the other equipment clearances requirements.

For all other equipment, the Access Board has decided to retain the original requirements in the proposed rule for knee and toe clearance. The Access Board is not persuaded to adopt the Wheeled Mobility Anthropometry Project recommendations for knee and toe clearances at this time. These recommendations represent a significant departure from the 2004 ADA and ABA Accessibility Guidelines. Therefore, the Board has elected in the final rule to retain the proposed provisions in the NPRM for knee and toe clearance for other equipment (M303.2.4.2). Due to the reorganization of the equipment clearances provision in the final rule, the knee and toe clearance requirements for the other equipment section have been renamed depth and height and relocated to M303.2.4.2. In addition, the Access Board has made an editorial change to the toe height requirement to clarify that the measurement is taken from the toe end of the wheelchair space.

M303.2.5 Surfaces (Section-by-Section Analysis)

The MDE NPRM proposed to require diagnostic equipment used by patients seated in a wheelchair to provide a wheelchair space with a surface that does not slope more than 1:48 in any direction. This provision is consistent with the 2004 ADA and ABA Accessibility Guidelines. There were no comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.

M303.2.6 Edge Protection (Section-by-Section Analysis)

The MDE NPRM proposed edge protection on the ramps leading up to the raised platform (proposed M303.3.3.4), but did not require edge protection on the raised platforms themselves. The Access Board received two comments and two recommendations from the MDE Advisory Committee regarding edge protection on raised platforms. As discussed in Section IV.C.5. (Significant Changes – Edge Protection), the final rule requires platforms with wheelchair spaces that are raised more than 1½ inches in height to provide a minimum 2-inch-high edge protection, measured from the surface of the platform, on each side of the platform not providing entry to or exit from the diagnostic equipment.

M303.3 Entry (Section-by-Section Analysis)

This is an introductory section.

M303.3.1 Vertical (Section-by-Section Analysis)

The MDE NPRM proposed that for equipment with a change in level at the entry to the wheelchair space, level changes of up to ¼ inch high are permitted to be vertical. This provision is consistent with the 2004 ADA and ABA Accessibility Guidelines. There were no comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.

M303.3.2 Beveled (Section-by-Section Analysis)

The MDE NPRM proposed that for equipment with a change in level at the entry to the wheelchair space, level changes greater than ¼ inch but not greater than ½ inch would be required to be beveled with a slope not steeper than 1:2. This provision is consistent with the 2004 ADA and ABA Accessibility Guidelines. There were no comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.

M303.3.3 Ramped (Section-by-Section Analysis)

The MDE NPRM proposed that for equipment with a change in level at the entry of a wheelchair space, level changes greater than ½ inch high would be required to be ramped and comply with technical requirements for running slope, cross slope, clear width, edge protection, and handrails. The Access Board received one comment on this provision. The commenter, a medical association, concurred with the requirement for handrails on diagnostic equipment with ramps over six inches in height. The MDE Advisory Committee only reviewed and gave recommendations on the portion of the provision addressing running slope. Therefore, the Access Board has retained the proposed requirements for cross slope, clear width, edge protection, and handrails in the final rule.

Regarding running slope, the MDE NPRM proposed that ramp runs have a running slope not steeper than 1:12. There were no comments on this section; however, as discussed in Section IV.C.3. (Significant Changes – Exception to Ramp Running Slope), the MDE Advisory Committee made a three-tiered recommendation for the allowable running slope. After careful consideration of the Advisory Committee’s recommendations, the Access Board has retained in the final rule the original requirement for running slope, but has added an exception that permits a running slope not steeper than 1:8 for ramp runs with a maximum height of 2½ inches. See Section IV.C.3. (Significant Changes – Exception to Ramp Running Slope) for a full discussion of the rationale for this exception.

M303.4 Components (Section-by-Section Analysis)

The MDE NPRM proposed to require diagnostic equipment used by patients seated in a wheelchair which has components that are used to examine specific body parts, be capable of examining those body parts of the patient while the patient is seated in a wheelchair. For example, an x-ray platform on which a patient places an arm or hand would have to be capable of examining the arm or hand of the patient while seated in a wheelchair. NPRM, 77 FR at 6930. There were no comments on this requirement and it was not addressed by the MDE Advisory Committee. There have been no changes made to this requirement.

M303.4.1 Breast Platform Adjustability (Section-by-Section Analysis)

The MDE NPRM proposed a mammography breast platform height range of 30 inches high minimum and 42 inches high maximum above the floor. The Access Board received three comments on this provision, and the MDE Advisory Committee made several recommendations for changes. As discussed above in the Section IV.C.4. (Significant Changes – Breast Platform Adjustability), the Access Board has revised this provision to require the breast platform to be continually adjustable from a low height of 26 inches to a high height of 42 inches above the floor and made an editorial change to the provision title changing it from height to adjustability.

M304 Diagnostic Equipment Used by Patients in Standing Position (Section-by-Section Analysis)

M304 in the final rule establishes the technical criteria for diagnostic equipment used by patients in a standing position such as a weight scale or x-ray equipment that is used in a standing position for certain diagnostic procedures.

M304.1 General (Section-by-Section Analysis)

This is an introductory section.

M304.2 Standing Surface (Section-by-Section Analysis)

The MDE NPRM proposed to require that the standing surface on which patients stand be slip resistant. In preparing the final rule, the Board has determined that as previously drafted this provision unintentionally placed requirements on the facility floor, as opposed to restricting the requirements to the diagnostic equipment itself. While the Access Board may choose to promulgate requirements for the building under its other rulemaking authority at a later date, this type of requirement is outside the scope of the MDE Standards and therefore M304 in the final rule has been restructured. The requirement for slip resistant and standing supports has been moved under this new requirement applying to standing surfaces. This reorganization ensures that only diagnostic equipment used by patients in a standing position that provides a surface for the patient to stand on must be slip resistant (M304.2.1) and provide standing supports (M304.2.2) in the final rule. Both of these requirements are discussed below.

M304.2.1 Slip Resistant (Section-by-Section Analysis)

The MDE NPRM proposed to require that the standing surface on which patients stand be slip resistant. One manufacturer commented on this requirement, requesting that the rule provide clarification on how to define or measure a standing surface as “slip resistant.” This provision was not addressed by the MDE Advisory Committee. The Access Board has decided to retain the original requirement in the final rule as it is the Board’s understanding that various industries employ different testing methods, there is no universally adopted or specified test for slip resistance, and the assessed level varies according to the measuring method used. Other than the change to clarify that the provision applies only to standing surfaces that are part of the diagnostic equipment, there have been no changes to this provision.

M304.2.2 Standing Supports (Section-by-Section Analysis)

The MDE NPRM proposed requiring standing supports on each side of the standing surface of diagnostic equipment used by patients in the standing position, and compliance with the technical requirements for standing supports in proposed M305.3. The Access Board received multiple comments and two recommendations from the MDE Advisory Committee. As discussed above in the Section IV.D.1. (Significant Changes – Standing Supports) and IV.E.2. (Significant Changes – Standing Supports), the final rule retains the general requirement that standing supports be provided on two sides of the standing surface. In addition, the Access Board has added a new exception for diagnostic equipment with entry and exit that permits pass-through from one end to another to provide one standing support provided it complies with the requirements for standing supports in the horizontal position in M305.3 in the final rule.

M305 Supports (Section-by-Section Analysis)

M305 in the final rule provides the technical requirements for transfer supports, standing supports, leg supports, and head and back supports. Transfer supports are required for diagnostic equipment complying with M301 and M302 and standing supports are required for diagnostic equipment complying with M304. Leg supports and head and back supports apply, where provided, to diagnostic equipment complying with M301 and M302.

M305.1 General (Section-by-Section Analysis)

This is an introductory section.

M305.2 Transfer Supports (Section-by-Section Analysis)

This is an introductory section. As discussed above in Section IV.E.1. (Significant Changes – Transfer Supports), the Access Board strengthened the transfer support requirements and added additional requirements in the final rule to ensure that supports are capable of assisting with independent transfer onto and off of the diagnostic equipment. With the changes to the final rule, the Board sought to harmonize as much as possible, these requirements with the 2004 ADA and ABA Accessibility Guidelines for grab bars. 

M305.2.1 Location (Section-by-Section Analysis)

The MDE NPRM proposed that transfer supports be located within reach of the transfer surface and not obstruct transfer onto or off of the surface when in position (proposed M305.2.1). In the preamble to the MDE NPRM, the Access Board noted it was considering requiring transfer supports to be located no further than 1½ inches from the transfer surface, when measured horizontally, and requiring the transfer support to be located on the side of the transfer surface opposite the transfer side. NPRM, 77 FR at 6925. The Access Board sought public comment with question 19, which asked for input on multiple proposed changes to the transfer support provision, including whether the proposed location of the transfer support, and the requirement that it be located 1½ inches from the transfer surface, would be sufficient to facilitate transfers. Id.

Eight commenters responded to question 19, but only six of the commenters addressed the location of transfer supports. Two commenters, a manufacturer and a state agency concerned with accessibility, concurred with the technical requirements proposed in question 19 for the transfer support location. Another commenter, a disability rights organization, stated that transfer supports should be required on both sides of the equipment. A manufacturer noted that if the proposed transfer surface size of 30 inches wide is adopted, then a transfer support opposite the transfer side would be useless as the patient would be unable to reach the support until nearly fully on the diagnostic equipment. This commenter noted that an adjacent transfer support would be more effective, but would conflict with the provider expectations of bed and stretcher side rails. The final two commenters, a manufacturer and a medical association, raised concerns about requiring any transfer supports on imaging equipment, specifically MRI and CT machines, asserting that the supports may interfere with the image quality.

The MDE Advisory Committee made three separate recommendations for the location of transfer supports: a general requirement, a requirement for stretchers, and a requirement for imaging equipment. For the general provision, the MDE Advisory Committee recommended requiring transfer supports on both sides of the transfer surface that can be removed or repositioned during transfer and are located at a maximum distance of 1½ inches from the transfer surface. The Committee explained that “transfer supports or handholds on adjustable medical equipment facilitate transfers onto a transfer surface by giving the individual something to hold or grab onto while transferring. This recommendation for placement of supports on both sides of the equipment will increase the options during patient transfers.” MDE Advisory Committee Report, 86, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

For stretchers, the MDE Advisory Committee noted that patients enter from either of the long sides, rather than on one long side and one short side, and this change in orientation necessitated a different location for the transfer supports so that the support would be reachable during transfer. The MDE Advisory Committee recommended locating the transfer support “along the long side of the transfer surface on the opposite side of the transfer.” MDE Advisory Committee Report, 87-88, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Additionally, the Committee recommended a horizontal distance from the transfer surface of no more than 3 inches from the edge of the patient support surface, indicating that stretcher transfer supports are part of a rail system that needs to fold and store out of the way and therefore require more space to articulate. Id. at 96.

For imaging equipment, the MDE Advisory Committee recommended requiring transfer supports when the transfer surface was 24 inches deep or less, and requiring positioning supports for transfer surface depths of greater than 24 inches. Id. at 88-89. The Committee recommended requiring one support on the opposite side of the transfer side regardless of whether it was a transfer support or positioning support. The Committee noted that:

• because of the size, diversity, and use of diagnostic imaging tables, this support will carry out different functions on different tables… This two-part recommendation recognizes the different use of the supports based on the table width. The Committee used a 24-inch dividing point for table width to accommodate the dimensions for the maximum reach range. For transfer surface depths on tables less than 24 inches wide, a transfer support must be available on the side opposite the entry of the transfer surface… For transfer surface depths on tables greater than 24 inches wide, a positioning support must be available on the side opposite the entry to the transfer surface. Id.

After review of the public comments and the MDE Advisory Committee recommendations, the Access Board has determined that there is a need for two types of transfer supports, based on the orientation of the transfer surface. As described in Section IV.B.1.b.(Significant Changes – Transfer Surface Location), the Access Board has designated two types of transfer surfaces based on orientation for diagnostic equipment used by patients in the supine, prone, or side-lying position: end and side transfer surfaces, either of which can be employed depending on the configuration and use of the particular equipment. Here, a similar dual approach is warranted for transfer supports. While the MDE Advisory Committee recommended separate requirements based on the type of diagnostic equipment, stretchers and imaging equipment, the Access Board believes that the type of support should be based on where the transfer surface is located on the examination surface. Therefore, the Access Board has separated the location provision into end transfer supports and side transfer supports. End transfer supports cover diagnostic equipment used by patients in the supine, prone, or side-lying position with end transfer surfaces, M301.2.3.1 in the final rule, and all diagnostic equipment with transfer surfaces used by patients in the seated position, M302.2 in the final rule. Side transfer supports cover diagnostic equipment used by patients in the supine, prone, or side-lying position with side transfer surfaces, this includes stretchers and most imaging equipment, M301.2.3.2.

In the final rule the Access Board has decided for end transfer supports to require at least one support located on the long side of the transfer surface, opposite the transfer side. For side transfer supports, the Access Board has decided to require a transfer support which is capable of supporting transfer on each side of the transfer surface. A side transfer surface could contain one transfer support which is capable of being repositioned from one side to the other side depending on which side the patient chooses to transfer or it is acceptable to have two transfer supports, one on each long side, which are both capable of being removed or repositioned on the side the patient chooses to transfer. Additionally, the final rule requires both end and side transfer supports to be located a maximum of 1½ inches measured horizontally from the nearest edge of the transfer surface to the transfer support. In reviewing the MDE Advisory Committee’s recommendations, the Access Board agrees that transfer supports that fold, collapse, or articulate need more space, but disagrees with the MDE Advisory Committee that an allowance for more space should apply only to stretchers and imaging equipment. The Access Board finds that other types of diagnostic equipment, such as hospital beds, also have transfer supports that collapse on either side to allow transfer. Therefore, the Access Board has provided an exception to the general provision which permits supports that fold, collapse, or articulate to be located three inches maximum from the nearest edge of the transfer surface to the transfer support. Additionally, as discussed in Section IV.E.1.b (Significant Changes – Positioning Supports), the Access Board has decided not to include positioning supports in the final rule.

M305.2.2 Length (Section-by-Section Analysis)

In the MDE NPRM there was no requirement for length of the transfer support; however, the MDE NPRM preamble noted that the Access Board was considering requiring the transfer supports to extend the entire depth of the transfer surface and be a minimum of 15 inches in length. NPRM, 77 FR at 6925. The Access Board specifically sought public input with question 19, asking if the proposed length of the transfer supports would be sufficient to facilitate transfer and maintain position on the diagnostic equipment. Id.

Three commenters responded to this issue, two manufacturers and a state agency concerned with accessibility. The state agency concurred with the 15-inch requirement. One commenter did not support a 15-inch length transfer support. This commenter (a manufacturer) stated that a transfer support that is a minimum of 15 inches in length would make it even more difficult to comply with load bearing requirements and recommended that this length requirement be reduced. The second commenter, a manufacturer, recommended revising the proposed provision from requiring the transfer support to extend horizontally the entire depth of the transfer surface, to extend horizontally along the transfer surface to within three inches, to allow for manufacturing tolerances.

The MDE Advisory Committee made three transfer support length recommendations, one for each type of transfer support recommended by the Committee, described above. For the general provision, the MDE Advisory Committee recommended a transfer support with a length of 15 inches minimum, that overlaps the minimum depth of the transfer surface by 80 percent. The Committee explained that the transfer support length provides the gripping surface for the patient to grasp or maintain balance while transferring. MDE Advisory Committee Report, 90, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. For stretchers, the MDE Advisory Committee also recommended 15 inches in length stating that this would provide continuous support for patients and still accommodate the articulation that is necessary for the head and back support on stretchers. Id. For imaging equipment with transfer surfaces less than or equal to 24 inches deep, the Committee recommended requiring a transfer support to extend horizontally along the side of the patient table at the designated transfer location for at least the minimum width of the transfer surface, with a minimum length of 28 inches. For transfer surfaces greater than 24 inches deep, the MDE Advisory Committee recommended requiring a positioning support instead of a transfer support, which extends horizontally along the side of the patient table 12 to 16 inches and is located at a position to accommodate clinical use. Id. at 91-92.

The Access Board agrees with the MDE Advisory Committee that the addition of a requirement for a transfer support length provision is necessary and has adopted many of the MDE Advisory Committee’s recommendations for transfer support length in the final rule. The Board restructured the Committee’s recommendations to fit within the end and side transfer supports discussed above. For end transfer supports the Access Board has adopted the general provision recommended by the MDE Advisory Committee and determined that the required length will be 15 inches minimum. Additionally, the Access Board acknowledges that manufacturers need some flexibility with respect to the location of the support to account for clearances with other equipment components that may articulate or move. Therefore, the final rule requires that the 15-inch minimum length transfer support be positioned along 13½ inches minimum of the depth of the transfer surface.

For side transfer supports the Access Board adopted the MDE Advisory Committee recommendation for imaging equipment, that this support be a minimum of 28 inches long positioned along the width of the transfer surface. In addition, the Board has added two exceptions to the requirements for side transfer supports to address the concerns raised by the MDE Advisory Committee. The first exception addresses articulating patient surfaces, primarily stretchers, where a continuous 28‐inch transfer support may conflict with other supports or railings as the equipment is adjusted. In such cases, the support may be reduced to no less than 15 inches in length. The second exception applies to transfer supports on imaging bed surfaces of more than 24 inches in width, such as large x‐ray tables, where the support is likely to be used in the latter stages of a transfer from a prone or side‐lying position. In these cases, the Access Board finds that permitting the transfer support to be no less than 12 inches long is appropriate. While the exception is based on an Advisory Committee recommendation using the term “positioning support,” this is still transfer support, that can assist with transfer onto the transfer surface and will likely be used to reposition in the later stages of a transfer.

In question 19 part (e) the Access Board sought input on whether angled or vertical transfer supports should be permitted. 77 FR at 6925. Three commenters, a manufacturer, an accessibility consultant, and a disability rights organization, responded and all concurred with the proposal. The MDE Advisory Committee did not specifically address this proposal, however, in its recommendations for the length of transfer supports on imaging equipment, it did recommend that the transfer support should extend horizontally along the side of the patient table. MDE Advisory Committee Report, 90-91, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Access Board considered the public comments and the MDE Advisory Committee’s recommendation, and has decided not to require that transfer supports be horizontal, allowing manufacturers flexibility to contour supports appropriate for the diagnostic purpose of the equipment.

M305.2.3 Height (Section-by-Section Analysis)

In the MDE NPRM there was no specific requirement regarding the height of the transfer support, only that it be “within reach” of the patient (proposed M305.2.1). The Access Board sought input from the public in question 20 of the MDE NPRM preamble, on whether a transfer support height requirement of 6 inches minimum and 19 inches maximum above the transfer surface would be usable by patients with disabilities. NPRM, 77 FR at 6925. Six commenters responded to question 20. Four commenters (two manufacturers, one disability rights organization, and a state agency concerned with accessibility) supported the proposed height range. Three commenters (a manufacturer, a medical association, and a disability rights organization) did not support the proposal. The manufacturer opposing the proposed range raised concerns with its ability to attain a 19-inch height on its diagnostic equipment. The medical association asserted that radiography exam tables are not equipped with transfer bars, and if required should retract fully into the surface of the table and the disability rights organization expressed concern that 19 inches was too high to facilitate safe transfer.

The MDE Advisory Committee supported adding a requirement setting the height of transfer supports within the range described in question 20 in the MDE NPRM preamble, of 6 inches minimum and 19 inches maximum. The MDE Advisory Committee explained that the manufacturers on the Committee determined that this recommendation did not conflict with the IEC 60601-2-52, which provides requirements for side rails to prevent entrapment hazards, and would allow the equipment to be designed to provide accessibility and safety from entrapment hazards. MDE Advisory Committee Report, 94, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Additionally, for transfer surfaces that are greater than 24 inches deep, the MDE Advisory Committee recommended requiring a positioning support instead of a transfer support, with a height of three to six inches above the transfer surface. Id.

The Access Board considered the public comments and the MDE Advisory Committee’s recommendations, and has decided to include a new provision, M305.2.3 in the final rule, that requires the tops of transfer support gripping surfaces to be located 6 inches minimum and 19 inches maximum higher than the top of the associated uncompressed transfer surface during use. This range allows the manufacturer to choose a height between 6 inches and 19 inches to place their transfer supports; it does not require that the transfer supports be 19 inches high. The transfer support is permitted to be horizontal, angled, curved, or a combination of these as long as the top of any point along the gripping surface is located at or between 6 inches and 19 inches. Thus, the commenter’s concern about reaching the 19-inch height is not warranted. Secondly, as discussed above in Section IV.E.1.b (Significant Changes –Positioning Supports), the Access Board has declined to include the MDE Advisory Committee’s recommended positioning supports in the final rule; however, the Access Board does concur with the MDE Advisory Committee that for imaging equipment with transfer surfaces that exceed 24 inches in width, a lower transfer support is warranted. Therefore, in the final rule, the Access Board has provided an exception that permits transfer supports to be located three inches minimum and six inches maximum higher than the tops of the transfer surfaces for imagining beds that are greater than 24 inches wide.

M305.2.4 Cross Section (Section-by-Section Analysis)

The proposed rule did not provide specific requirements for the cross section of transfer supports. However, in the MDE NPRM preamble, the Access Board noted that it was considering adopting the cross sectional dimensions for grab bars from the 2004 ADA and ABA Accessibility Guidelines for transfer supports. NPRM, 77 FR at 6925-6926. Specifically, the Access Board indicated it was considering requiring circular cross sections to have an outside diameter of 1¼ inches minimum and 2 inches maximum, and transfer supports with non-circular cross sections to have a cross section dimension of 2 inches maximum, and a perimeter dimension of 4 inches minimum and 4.8 inches maximum. Id. The Access Board sought input in MDE NPRM preamble question 21, on whether the gripping surfaces of current transfer supports on different types of equipment meet the cross sectional dimensions specified above and whether handholds that meet the above cross section dimensions could be integrated into armrests that are also cushioned to support arms and elbows. Id.

Five commenters responded to question 21. Two commenters (one manufacturer and one accessibility consultant) were opposed to permitting non-rounded cross sections, noting concern that harsh edges or angles may not allow users to comfortably and adequately grasp the support. One commenter (a manufacturer) asserted that because currently there are no standards, existing products would likely not meet the proposed provision. Another commenter (a manufacturer) was concerned that the requirement could preclude the use of cushioned arm pads.

The MDE Advisory Committee expressed confidence “in reliance on the cross section dimensions in the 2010 Standards.” MDE Advisory Committee Report, 99, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee further opined:

• Allowing both noncircular cross sections and circular cross sections gives manufacturers flexibility to employ the best configuration for use of the equipment, hand, grip strength, and power grab functions. While a majority of the Committee members supported a recommendation allowing both noncircular and circular cross sections, some members noted ergonomic considerations support the better functionality of circular cross section gripping surface. Id.

After review of the comments and the MDE Advisory Committee’s recommendations, the Access Board has decided to apply the 2004 ADA and ABA Accessibility Guidelines for grab bar cross sections to transfer supports in the final rule. Accordingly, the final rule includes a new provision, M305.2.4, requiring transfer supports to have one of two cross sections: circular cross sections, with an outside diameter of 1¼ inches minimum and 2 inches maximum; or non‐circular cross sections, a cross section dimension of 2 inches maximum and a perimeter dimension of 4 inches minimum and 4.8 inches maximum.

M305.2.5 Surface Hazards (Section-by-Section Analysis)

The proposed rule did not provide any specific restrictions regarding surface hazards around the transfer supports. No public comments were submitted on this issue, but the MDE Advisory Committee voiced concern about surface hazards stating, “gripping surface configurations must provide an effective and safe surface for patients to hold onto. Sharp edges or abrasive elements may injure and cause the patient to lose their grip during positioning or transfer.” The MDE Advisory Committee recommended that a provision be added to the final rule requiring “gripping surfaces to be free of sharp or abrasive elements and have rounded edges.” The Committee based this recommendation on related provisions in the 2004 ADA and ABA Accessibility Guidelines for handrails and grab bars. MDE Advisory Committee Report, 101, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The Access Board concurs with the MDE Advisory Committee’s recommendation and views the proposed provision as beneficial and consistent with the cross section requirements of M305.2.4, above. Therefore, the Access Board has added a new provision to the final rule, M305.2.5 Surface Hazards, to ensure that transfer supports and surfaces adjacent to transfer supports are free of sharp or abrasive components and have eased edges.

M305.2.6 Gripping Surfaces (Section-by-Section Analysis)

The proposed rule did not provide any specific requirements regarding gripping surfaces on transfer supports. However, in the MDE NPRM preamble the Access Board repeatedly noted that it was considering applying many of the provisions from the 2004 ABA and ADA Accessibility Guidelines for grab bars and handrails to transfer supports. NPRM, 77 FR at 6924-6926. The MDE Advisory Committee explained that:

• [t]ransfer supports may contain elements to provide structural support or prevent patient entrapment. The elements, bars, pickets, spacers, panels, and similar features, connect to the transfer support and may interrupt the gripping surface. At the point of connection, these features impede the ability to grasp completely around the cross section of the gripping surface. MDE Advisory Committee Report, 102, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee recommended requiring the bottom of the transfer support to have no obstructions affecting more than 20 percent of the transfer support’s length. Id.

The Access Board concurs with the recommendation of the MDE Advisory Committee and views the proposed provision as beneficial and consistent with the existing accessibility guidelines. Therefore, the Access Board has added this new provision to the final rule, M305.2.6, which ensures that an adequate surface area for gripping is provided to the patient.

M305.2.7 Clearance (Section-by-Section Analysis)

In the MDE NPRM, the Access Board did not provide any specific requirements for clearances around the transfer support. However, in the preamble to the MDE NPRM the Access Board noted that it was considering applying the 2004 ADA and ABA Accessibility Guidelines for clearance around grab bars to the transfer support provision in the final rule. NPRM, 77 FR at 6926. Specifically, the Access Board sought input from the public in question 22, on whether transfer supports on diagnostic equipment could provide 1½ inches minimum clearance around the gripping surface. Id. Two commenters responded, both manufacturers, and indicated that transfer supports could provide 1½ inches minimum clearance around the transfer support. The MDE Advisory Committee concurred with the commenters and expressed support for the use of the 2010 ADA Standards and International Building Code Requirements (ICC/ANSI A117.1-2009), and recommended adding the requirements to the final rule. MDE Advisory Committee Report, 100, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

Based on public commenter responses and MDE Advisory Committee recommendations, the Access Board has added a new provision to the final rule, M305.2.7, requiring a 1½ inch minimum clearance between the transfer support gripping surface and adjacent surfaces or obstructions.

M305.2.8 Fittings (Section-by-Section Analysis)

The MDE NPRM proposed to require that transfer supports not rotate in their fittings (proposed M305.2.3). Five commenters addressed this provision. Four of the commenters disagreed with this requirement and explained the need for transfer supports to be able to rotate in their fittings. Specifically, one commenter (manufacturer) asserted that the technical criteria from the 2004 ADA and ABA Accessibility Guidelines for grab bars in bathrooms should not be applied to exam tables as they would restrict the ability for the transfer supports to be moved out of the way after transfer. Further, this commenter noted that the requirement conflicts with proposed M302.2.3, which allows for temporary obstructions such as armrests, footrests, and side rails that can be repositioned to allow for transfer. Another commenter (manufacturer) pointed out that bed rails, which are common on hospital beds, require a latched position and an unlatched position, which allows them to rotate in their fittings when not latched. A different manufacturer stated that its seated diagnostic equipment uses armrests as transfer supports, which can be pushed back toward the rear of the equipment to allow entry. An accessibility consultant recommended swing-away or removable armrests for chairs to allow for transfer on either side. The only commenter (accessibility consultant) opposed to allowing transfer supports to rotate in their fittings, expressed concern for the potential for injury if transfer supports rotated unexpectedly during transfer.

The MDE Advisory Committee recommended amending this provision to allow transfer supports to rotate in their fittings, but to require that they not rotate when they are locked into place for transfer. The Committee noted that it is advantageous to allow supports to perform the needed movement, but they should not do so when locked. MDE Advisory Committee Report, 102-103, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The Access Board concurs with the majority of the commenters and the MDE Advisory Committee. As noted in proposed M302.2.3, the Access Board intended to allow manufacturers to provide temporary obstructions such as armrests and bedrails that can be repositioned, or rotate in their fittings, and then be locked into place when needed as a transfer support. Therefore, the Access Board has revised this provision in the final rule to require that transfer supports do not rotate in their fittings when in place for transfer (M305.2.8).

M305.3 Standing Supports (Section-by-Section Analysis)

M305.3 provides the technical requirements for standing supports which are required on diagnostic equipment covered by M304. This provision has been reorganized in the final rule into requirements for length and height, as opposed to vertical and horizontal.

In the MDE NPRM preamble, the Access Board noted that it was considering adopting the cross section dimensions for grab bars from the 2004 ADA and ABA Accessibility Guidelines and applying them to standing supports. The Access Board sought public input in questions 39 and 40 in the MDE NPRM preamble on whether the cross section dimensions for gripping surfaces should be applied to standing supports and whether standing supports can provide a 1½ inch minimum clearance around the gripping surface. Three commenters responded to question 39 (a medical association, accessibility consultant, and a state agency concerned with accessibility). All three concurred with adding cross section dimension requirements to standing supports. Two commenters responded to question 40 (one medical association and a state agency concerned with accessibility), and both concurred that diagnostic equipment could provide a 1½ inch minimum clearance around the gripping surface of standing supports. The MDE Advisory Committee did not address the cross section and clearance proposal for standing supports. Unlike transfer supports, standing supports can be horizontal or vertical and thus there will be variations in the configuration of standing supports dependent on the equipment configuration. Due to this wide variety of allowable standing supports and the significant difference in the nature of how a standing support is used versus a transfer support, the Access Board has decided not to adopt cross section dimensions or require a minimum clearance around the gripping surface for standing supports in the final rule.

Additionally, one commenter (manufacturer) requested that requirements for structural strength be added to the standing support provision. For the same reasons the Access Board has removed the requirement of structural strength for transfer supports (See Section IV.E.1.a. (Significant Changes – Structural Strength) the Access Board declines to adopt such a requirement for standing supports in the final rule.

M305.3.1 Length (Section-by-Section Analysis)

In the MDE NPRM, the Access Board proposed a gripping surface length of four inches minimum for horizontal standing supports. No public comments were submitted on this requirement. The MDE Advisory Committee supported the proposed technical provisions, but recommended adding additional criteria for standing supports on raised platforms with wheelchair spaces. As discussed above in the Section IV.E.2. (Significant Changes – Standing Supports), the final rule requires that horizontal standing supports be positioned horizontally in relation to standing surfaces and retains the proposed requirement of four inches minimum length. The Access Board added a new provision applying to diagnostic equipment containing a wheelchair space that also requires standing supports. This provision, M305.3.1.2 in the final rule, has added two new requirements for this type of equipment. First, for diagnostic equipment containing wheelchair spaces with one entry that also serves as the exit, the length of the gripping surface for horizontal standing supports must be equal to or greater than 80 percent of the overall length of the platform. Second, for diagnostic equipment with wheelchair spaces that permit pass-through from one end to the other, the length of the gripping surface for the horizontal standing support must be at least equal to the length of the platform. In the final rule these requirements are located in M305.3.1.1 Horizontal Position and M305.3.1.2 Diagnostic Equipment Containing a Wheelchair Space.

For vertical standing supports, the MDE NPRM proposed a gripping surface length of 18 inches minimum. There were no public comments submitted on this requirement, and the MDE Advisory Committee supported the proposed technical provisions. In the final rule, the Access Board retained the original requirement for gripping surface length and clarified that the vertical standing supports must be positioned vertically in relation to the standing surface. Both requirements are included in the new M305.3.1.3 Vertical Position provision in the final rule.

M305.3.2 Height (Section-by-Section Analysis)

For horizontal supports, the MDE NPRM proposed a gripping surface height of 34 inches minimum and 38 inches maximum above the standing surface. There were no public comments on this requirement, and the MDE Advisory Committee supported the proposed technical provisions. In the final rule the Access Board retains the original requirement. This requirement has been relocated to M305.3.2.1 in the final rule.

For vertical supports, the MDE NPRM proposed that the bottom end of the support be 34 inches high minimum and 37 inches high maximum above the standing surface. There were no public comments on this requirement, and the MDE Advisory Committee supported the proposed technical provisions. In the final rule the Access Board retains the original requirement, but made a few minor editorial changes to the text. This requirement has been relocated to M305.3.2.2 in the final rule.

M305.3.3 Fittings (Section-by-Section Analysis)

The MDE NPRM proposed to prohibit standing supports from rotating in their fittings. There were no comments on this section and it was not addressed by the MDE Advisory Committee. The Access Board made no changes to this provision.

M305.4 Leg Supports (Section-by-Section Analysis)

As discussed above in Section V.C.3.b (Section-by-Section Analysis – M301.3.2) and Section V.C.7.b (Section-by-Section Analysis – M302.3.2), the technical requirements for leg supports from M301 and M302 have been relocated to M305 Supports. The MDE NPRM proposed that where stirrups are provided, they must provide a method to support, position, and secure the patients legs. Four commenters (medical association, accessibility consultant, disability rights organization, and a state agency) agreed with requiring leg supports when stirrups are provided.

The MDE Advisory Committee agreed that, for procedures that use stirrups and require the leg to be stable, there must be a method to support the patient’s legs. The Committee referenced ANSI/AAMI HE75 which recommends that “[f]or patients with limited leg strength and control, instead of stirrups that support only the foot and require active user leg strength, leg supports that support both the foot and the leg should be used to assist patients in keeping their legs in the appropriate position.” MDE Advisory Committee Report, 105, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee recommended adding additional language to this provision to clarify that “where the equipment provides stirrups, it must also provide an alternate method to support, position, and secure the patients legs (specifically including sufficient support of the patient’s thigh, knee, and calf to stabilize the leg). This method will either supplement or serve as a substitute for the stirrups.” Id.

After reviewing the MDE Advisory Committee recommendations, the Access Board has decided that the proposed provision is sufficient to require the leg support advocated by the MDE Advisory Committee and has therefore not adopted the MDE Advisory Committee recommendation to require an alternate method of leg supports. However, in the final rule the Access Board has made an editorial change in terminology, from stirrups to leg supports, in response to the MDE Advisory Committee recommendation and to provide consistency with the headings of other support provisions that are based on the body part supported.

M305.5 Head and Back Support (Section-by-Section Analysis)

As discussed above in Section V.C.3.c (Section-by-Section Analysis – M301.3.3) and Section V.C.7.c. (Section-by-Section Analysis – M302.3.3), the technical requirements for head and back supports from M301 and M302 have been relocated to M305 Supports. The MDE NPRM proposed to require diagnostic equipment used by patients in the supine, prone, or side-lying position and the seated position that can be adjusted to a reclined position to provide head and back support throughout the entire range of the incline. Three manufacturers commented on this provision. One manufacturer asserted that this requirement was ambiguous and that he had to read it multiple times to understand it; however, this commenter also indicated that the tables it currently manufactures meet the proposed requirement. Another manufacturer noted that existing MRI equipment meets this requirement. The final manufacturer asserted that a reclining backrest necessarily provides head and back support, unless the Access Board intended a different meaning for “support.” The MDE Advisory Committee did not review the proposed requirement for head and back support, and thus provided no recommendations on this requirement.

After review of the comments, the Access Board has decided not to make any changes to this provision in the final rule. All of the commenters on this topic agree that current diagnostic equipment meets the proposed requirement and the Access Board believes that this requirement is clearly articulated. Therefore, the final rule requires that where diagnostic equipment can be adjusted to a reclined position, head and back support must be provided.

M306 Communication (Section-by-Section Analysis)

M306 in the final rule provides the technical criteria for communication from the diagnostic equipment to the patient.

M306.1 General (Section-by-Section Analysis)

The MDE NPRM proposed that, where diagnostic equipment communicates instructions or other information to the patient, the instructions or information must be provided in at least two of the following methods: audible, visible, or tactile (proposed M306.1). The Access Board sought public input in question 41 in the preamble to the MDE NPRM, on whether diagnostic equipment that communicates instructions or other information to the patient should provide information in all three methods of communication, and what the cost to provide all three methods would be. NPRM, 77 FR at 6931. Seven commenters responded. Three commenters (a manufacturer, a medical association, and a state agency concerned with accessibility) concurred with the proposed requirement to provide two methods of communication. Three commenters (two disability rights organizations and one medical association) supported requiring all three modes of communication, and the final commenter (a manufacturer) recommended requiring one mode of communication if the medical provider is present and three modes of communication for home use devices. The MDE Advisory Committee did not address this provision.

The Access Board carefully considered the public comments; however, it has decided to retain the provision from the proposed rule, requiring diagnostic equipment that communicates instructions or other information to the patient to provide the communication in two methods. The commenters were split in their support of two or three methods of communication and the commenters supporting the increase to three methods of communication provided no additional information to warrant the increase. The commenter that recommended different requirements for home-use equipment is not dispositive as this rule does not cover any home use equipment. The Access Board has concluded that providing two means of communication will serve the majority of people and that there was not enough information provided to warrant an increase in this requirement in the final rule.

M307 Operable Parts (Section-by-Section Analysis)

M307 in the final rule provides the technical criteria for operable parts used by patients to activate, deactivate, or adjust the diagnostic equipment. For example, equipment used for an auditory examination may require the patient to press a button when sounds are heard. M307 does not apply to controls used only by health care personnel or others who are not patients. There were no comments received on the proposed provisions, and as discussed below, the provisions from the proposed rule have been retained in the final rule.

The Access Board did receive comments in response to question 43, which sought public input on whether the final rule should include reach range requirements such as those in the 2004 ADA and ABA Accessibility Guidelines for an unobstructed forward reach or side reach for the operable parts provision. Five commenters responded, one commenter (state agency concerned with accessibility) recommended adopting the reach ranges and four commenters (one medical association, one academic, and two disability rights organizations) recommended against adding reach ranges for operable parts to the final rule. One of these commenters (disability rights organization) explained that the 2004 ADA and ABA requirements are not appropriate for application to operable parts of medical diagnostic equipment. The MDE Advisory Committee did not address this provision. Based on the majority of the commenters response, the Access Board has decided not to add reach ranges to the operable parts section at this time.

M307.1 General (Section-by-Section Analysis)

This is an introductory section.

M307.2 Tactilely Discernible (Section-by-Section Analysis)

The MDE NPRM proposed that operable parts intended for patient use be tactilely discernible without activation. Patients who are blind or have low vision have difficulty distinguishing a flat membrane button or similar control unless it is tactilely discernible from the surrounding surface and any adjacent controls. The most common method to ensure that buttons and similar controls are tactilely discernible is to raise part or all of the control surface above the surrounding surface and at a distance from any adjacent controls such that a relief of each individual control can be determined by touch. There were no public comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.

M307.3 Operation (Section-by-Section Analysis)

The MDE NPRM proposed to require operable parts to be operable with one hand and not require tight grasping, pinching, or twisting of the wrist. There were no public comments on this section and it was not addressed by the MDE Advisory Committee. There have been no changes made to this provision.

M307.4 Operating Force (Section-by-Section Analysis)

The MDE NPRM proposed to restrict the force required to activate operable parts to 5 pounds. The Access Board sought public input on this provision in question 42 on whether the operating force should be reduced to 2 pounds. NPRM, 77 FR at 6932. One commenter, a state agency concerned with accessibility, responded and concurred with the suggested reduction. The MDE Advisory Committee did not address this requirement. Although the Access Board initially considered a reduction in the force required to activate operable parts, upon further consideration, the Board found no reason to deviate from the long-established maximum of 5 pounds in the 2004 ADA and ABA Accessibility Guidelines. 36 CFR part 1191, App. D 309.4. Therefore, there have been no changes made to this provision.