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

C. M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair

M303 contains the technical requirements for diagnostic equipment used by patients seated in wheelchairs. In the final rule the Access Board made four significant changes to this section: two significant changes to accommodate the unique challenges of mammography equipment; one significant change to the ramped running slope requirement; and a final significant change to the width and depth of wheelchair spaces.

1. Width and Depth of Wheelchair Spaces

The MDE NPRM proposed to require diagnostic equipment to have a wheelchair space that is at least 36 inches wide (proposed M303.2.2). The MDE NPRM further proposed two alternative depth requirements: 48 inches for wheelchair spaces that are entered from the front or rear, and 60 inches for wheelchair spaces entered from the side (proposed 303.2.3) [sic]. The MDE NPRM preamble also noted that the Access Board was considering adding exceptions in the final rule to the width and depth requirements for wheelchair spaces on raised platforms. NPRM, 77 FR at 6928-6929. The Access Board sought input in questions 31, 32, and 33, regarding the required size of wheelchair spaces on raised platforms, the use of scooters on raised platforms, and the associated costs. Id.

No commenters responded to questions 31 and 33; four commenters responded to question 32. Question 32 asked whether equipment with wheelchair spaces on raised platforms, such as weight scales, can accommodate patients who use scooters, and if they currently cannot, should the width and depth be changed so the equipment is usable by patients who use scooters. One commenter (a disability rights organization) asserted that if diagnostic equipment is accessible for wheelchairs it should also be accessible to scooters and recommended enlarging the space beyond 36 inches. Another disability rights organization opined that most weight scales in healthcare settings are inaccessible to wheelchair users, asserting that even the “accessible” weight scales are only 24 inches wide by 30 inches deep and are too small to accommodate manual wheelchairs and definitely would not accommodate the longer wheelbases of many power wheelchairs and scooters. This commenter recommended taking a “universal design” approach with a requirement of 34 inches wide by 58 inches deep for raised platforms on weight scales. The other two commenters (an academic and state agency concerned with accessibility) agreed that diagnostic equipment with wheelchair spaces on raised platforms should be usable by scooters, but did not provide any suggested dimensions.

The MDE Advisory Committee recommended a minimum platform size of 32 inches clear width and 40 inches clear length (depth). The Committee noted that their proposed recommendation sought to address the unique considerations of weight scales with raised platforms. The Committee stated that this size “accommodates both manual and power wheeled mobility devices including small and mid-size scooters.” MDE Advisory Committee Report, 109, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee relied on the Wheeled Mobility Anthropometry Project findings of wheelbase measurements and the Wheeled Mobility Anthropometry Project’s recommendation of a minimum flat surface of 40 inches in length for platforms to accommodate wheeled mobility devices, including scooters. Id. at 110. The Committee explained that “[t]o have an accurate weight, the entire wheelbase (either 3 or 4 wheels) of a mobility device must rest on and make contact with the platform. The foot pedals, footrests, scooter deck and tip wheels can overhang or extend beyond the platform and still get an accurate weight.” Id.

In order to reconcile the public comments and the MDE Advisory Committee recommendations, the final rule retains the proposed M303.2.2 requirement for minimum width of 36 inches for wheelchair spaces, but provides an exception to permit wheelchair spaces on raised platforms to be a minimum of 32 inches wide. This width restriction assumes that the elbows and hands of persons using mobility devices would overhang the width of the platform and they would still be able to propel themselves. Because the final rule also requires raised platforms over 1½ inches in height to provide edge protection that is a minimum of 2 inches high from the surface of the platform (See M303.2.6 final rule), it was necessary to restrict the height of this edge protection for platforms using the exception of 32 inches wide to 4 inches. This height restriction is to ensure that a clear space is provided above any edge protection to allow the mobility device’s casters and footrests or other components to extend over the edge protection.

For the depth of the wheelchair space, the final rule has retained both alternative depth requirements in proposed M303.2.3: 60 inches for wheelchair spaces entered from the side, and 48 inches for wheelchair spaces entered from the front or rear, discussed below in Section VI.10.c (Section-by-Section Analysis – M303.2.3). However, the Access Board has included an additional requirement for wheelchair spaces that are entered from the front or rear and permit pass-through from one end to the other. This provision requires wheelchair spaces that permit pass-through to have a minimum depth of 40 inches. Less space is required in these circumstances because the wheelchair user does not have to turn around or back out to exit the diagnostic equipment, but can enter and exit continuing on in one direction. Due to the addition of the new requirement, the Board reorganized this provision in the final rule to M303.2.3.1 (front or rear entry depth), M303.2.3.2 (Pass Through Entry), and M303.2.3.3 (side entry depth).

2. Equipment Clearances for Breast Platforms

The MDE NPRM proposed knee and toe clearance requirements for diagnostic equipment used by patients seated in wheelchairs that paralleled the knee and toe clearance requirements from the 2004 ADA and ABA Accessibility Guidelines. NPRM, 77 FR at 6929. The proposed rule included a requirement that 17 inches minimum and 25 inches maximum of the 48-inch wheelchair space depth include knee and toe clearance. The knee and toe clearance would be permitted to be located beneath the diagnostic equipment, such as an optometrist diopter. The proposed rule contained a different requirement for breast platforms on mammography equipment, that of the 48-inch depth minimum of the wheelchair space, the knee and toe clearance under a breast platform would be 25 inches deep (proposed M303.2.4).

Two commenters, one manufacturer and one disability rights organization, commented on the knee and toe clearance under breast platforms. The disability rights organization raised concerns that existing machines do not provide deep enough clearance and that during the examination the breast platform will hit the patient’s knees. The manufacturer also raised concerns with the size of the knee and toe clearance and recommended basing the requirements in relation to the height of the breast platform. Additionally, this commenter raised concerns that mammography equipment must have a stabilizing flange or foot at its base to prevent the equipment from tipping when the gantry is extended. This flange protrudes into the knee and toe clearance. Specifically, this commenter explained that the flange can be designed for optimal accessibility, but is necessary for the safety of the equipment.

The MDE Advisory Committee reviewed this provision and gave multiple recommendations regarding the necessary clearances for breast platforms. The Advisory Committee noted that mammography equipment presents a unique challenge for individuals seated in wheelchairs because the mammography exam requires the patient’s breasts to be placed on top of the breast platform thereby requiring the knees and toes to go deeper beneath the equipment. The MDE Advisory Committee recommended changes to the proposed requirements for knee and toe clearance to create a deeper knee space under breast platforms. The MDE Advisory Committee did not suggest revisions to the proposed knee and toe clearances for diagnostic equipment used by patients seated in wheelchairs, other than for mammography equipment.

The knee and toe clearance requirements were adopted from the 2004 ADA and ABA Accessibility Guidelines and typically will allow a person seated in a wheelchair to pull underneath a work surface or equipment component or permit forward access to a control located above equipment overhanging the knee and toe space. We are persuaded by the MDE Advisory Committee report that mammography equipment presents a unique use and requires different specifications for the knee and toe clearance to ensure that the patient’s breast can rest on top of the platform. The knee and toe clearance underneath mammography equipment must provide sufficient space to allow the patient to get close enough for their breast to be placed on the breast platform in order for the diagnostic procedure to be performed. Thus, the Access Board has reorganized the equipment clearances provision in the final rule into two separate requirements; breast platforms and other equipment. The requirements for breast platforms (M303.2.4.2 in the final rule) account for obstructions in the knee and toe clearance necessary to stabilize the mammography equipment and the location of the patient’s body within the depth of the wheelchair space, such that more of the overall space is allocated to knees and toes. As discussed above, these factors result in an exception to allow equipment components of a low profile to extend into the toe end of the wheelchair space. The requirements for other equipment (M303.2.4.2 in the final rule) are substantively unchanged from the NPRM, and are discussed below in the Section VI.C.10.d (Section-by-Section Analysis – M303.2.4).

a. Knee and Toe Clearance

The proposed rule recommended a knee and toe clearance depth for breast platforms of 25 inches. There were no comments received on this requirement. The MDE Advisory Committee recommended increasing the overall knee and toe space to a minimum 28 inches deep. MDE Advisory Committee Report, 115-116, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee asserted that a minimum of 28 inches in overall knee and toe clearance would accommodate 95 percent of the population. Id.

The Access Board concurs with the MDE Advisory Committee’s conclusion that an increase in the overall knee and toe clearance under breast platforms is warranted. However, the Board is concerned that if the Advisory Committee’s recommendation is adopted without change, it would significantly impact the requirement in the final rule for a 48-inch deep wheelchair space. Because at least 25 inches of the space must accommodate knees and toes, only 23 inches remains to accommodate that portion of the occupied wheelchair not including knees and toes. If the Access Board were to require 28 inches minimum knee and toe clearance, only 20 inches would remain. After reviewing all the evidence before the MDE Advisory Committee, the Access Board has decided to make a number of changes to the requirements for the knee and toe clearances for breast platforms. These new requirements are described in the Section VI.C.10.d (Section-by-Section Analysis – M303.2.4). The requirements are intended to ensure that there is adequate space for a patient seated in a wheelchair to position underneath the equipment and align themselves against the breast platform so that the diagnostic procedures can be performed.

b. Exception for Base Support Allowance and Unobstructed Knee and Toe Space

In the proposed rule, obstructions were not permitted within the knee and toe clearance space. This is consistent with the requirement in the existing accessibility guidelines and standards. One manufacturer commented on this provision, asserting that mammography equipment poses unique challenges and requires separate consideration. The commenter explained that the gantry of a mammography machine includes a base lip which is required for structural and seismic stability, and protrudes into the knee and toe clearance. This commenter recommended revisions to allow for a base lip on mammography equipment.

The MDE Advisory Committee recommended allowing obstructions into the knee and toe clear space, up to a height and depth that still permits the footrests of wheelchairs to pass over it. Specifically, the Committee recommended allowing base supports to be a maximum of 1½ inches high and allowing an additional sloped region above the base support at a depth of 25 inches from the front edge of the breast platform at 1½ inches above the floor, which can extend to a height of 4 inches above the floor at a depth of 28 inches. The MDE Advisory Committee explained its recommendation, noting that:

• The base support is of fundamental importance to mammography equipment and provides structural support, seismic stability, and installation safety. It does obstruct the floor space in front of the gantry and, thus, may limit how close a wheelchair can get to the equipment. To respond to this issue, industry proposed a configuration that would cause minimal obstruction to the floor space in front of the gantry and would allow footrests to ride over it.

To discuss the maximum base support height, the sub-committee looked at anthropomorphic data regarding footrest heights. The footrest height data measures the height from the floor to the top surface of the footrest at its proximal outside corner. To determine the necessary clearance for the footrests, the Committee used the footrest height data and subtracted the thickness of the footrests (~0.5 inch). Allowing a maximum base support height of 1.5 inches will provide room for the structural components necessary for an effective base support design and will also be accessible by around 92% of manual chair users and over 95% of power chair users. MDE Advisory Committee Report, 123-127, 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 need for permitting base components in the knee and toe clear space for mammography equipment. While the Access Board recognizes that this is a deviation from existing accessibility guidelines and standards, the Board believes that mammography equipment presents special challenges due to the diagnostic, structural, and seismic requirements of the diagnostic equipment. In the final rule, the Access Board has created an exception to the height requirement for breast platforms. This exception permits the profile of base components to extend into the wheelchair space at a height of 1½ inches maximum between 17 inches minimum and 25 inches maximum in depth measured from the leading edge of the breast platform. In addition, the Access Board has found that the profile of the base components should increase toward the rear of the clearance space where a patient’s foot and toes will be higher than the heel supporting portion of the footrest. Therefore, the final rule requires that from 25 inches to 28 inches measured from the leading edge of the breast platform, the height of the component above 1½ inches must be beveled at a rate of 2.5:3. This exception preserves a 17-inch minimum of unobstructed floor space measured from the leading edge of the breast platform.

3. Exception to Ramp Running Slope

The MDE NPRM proposed that where there is a change in level at the entry of a wheelchair space that is greater than 1½ inches, the entry shall be ramped and have a running slope not steeper than 1:12 (proposed M303.3). The Access Board explained in the MDE NPRM preamble that this provision is consistent with the 2004 ADA and ABA Accessibility Guidelines’ technical criteria for changes in level. NPRM, 77 FR at 6929. No commenters addressed this provision. The MDE Advisory Committee, during its discussion of wheelchair spaces on weight scales, extensively addressed the permissible slopes of ramps on raised platforms. Specifically, the Committee noted:

• [It] considered the needs of a ramped surface to access the platform on the accessible scale. Because there are different types of scales with different platform heights, the Committee developed a three tiered ramp slope proposal to fit different situations. The Committee reviewed and discussed the provisions on slopes for ramps as they apply to architectural elements in the built environment. The maximum slope for a ramp in the 2010 Standards is a rise of 1 vertical inch for each 12 inches of horizontal distance slope. Under very limited conditions in the built environment, the 2010 Standards allow a steeper ramp for a limited rise. A ramp in the built environment to which this exception applies may use a 1:2 grade slope on a short rise ramp.

Industry experts spoke to the concern for facility space often expressed by healthcare entities. The space constraints affect the desirability of accessible scales since space is often expensive and tight in many medical facilities. Scales that can be wall mounted or portable enhance the flexibility of scales and allow use in tight environments. Currently, these types of accessible scales use the short rise ramp to facilitate easy storage or mounting.

Existing technology for weight cell load allows for a platform profile to go as low as ¾ to 1½ inches. As the height of the platform lowers, the length of the ramp can decrease. The trend in the scale industry is to develop lower weight cell technology. However, industry currently does not know if lower profiles are possible. MDE Advisory Committee Report, 111-112, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The MDE Advisory Committee recommended a three tiered approach for allowable ramp runs on raised platforms: allowing a slope of 1:2 at 0 to 1½ inches, a slope of 1:8 at a height greater than 1½ inches to 2½ inches, and a slope of 1:12 at a height greater than 2½ inches. Id.

The Access Board agrees with the MDE Advisory Committee that additional allowances in the slope of ramp runs of diagnostic equipment used by patients seated in a wheelchair with raised platforms, primarily weight scales, is appropriate. However, for usability and safety reasons, the Access Board has determined that slopes of such ramp runs should not exceed the long standing maximum slope for accessible ramps of 1:8 that is allowable in certain circumstances in the 2004 ADA and ABA Accessibility Guidelines. The Board also notes that the Guidelines only permit changes in level up to ½ inch e.g., thresholds to be steeper than 1:8.

Therefore, the Access Board has decided to add an exception in the final rule to the requirement that ramped entry wheelchair spaces have ramp runs with a running slope no steeper than 1:12 (M303.3.3.1). This exception permits a running slope not steeper than 1:8 for ramp runs with a maximum height of 2½ inches. Consistent with the MDE Advisory Committee recommendations, ramp runs over 2½ inches in height will have to comply with the general requirement of running slopes of not steeper than 1:12.

4. Breast Platform Adjustability

The MDE NPRM proposed to require diagnostic equipment used by patients seated in a wheelchair that have components which are used to examine specific body parts to be capable of examining the body parts of a patient while seated in a wheelchair (proposed M303.4). Additionally, the Access Board proposed specific technical requirements for breast platforms of mammography equipment. The MDE NPRM proposed a height range for breast platforms of 30 inches minimum and 42 inches maximum above the floor (proposed M303.4.1). In the preamble to the MDE NPRM, the Access Board sought input in question 36, on whether the breast platform height range proposed was sufficient to accommodate a patient seated in a wheelchair. NPRM, 77 FR at 6930.

Three commenters responded to this question. One commenter, a medical association, concurred with the proposed provisions. Two other commenters, a disability rights organization and a manufacturer disagreed. The disability rights organization recommended adopting a minimum height range of 24 to 26 inches. The manufacturer indicated that the proposed height range of 30 inches to 42 inches is sufficient, but also noted that several manufacturers lower the breast platform to 25 to 28 inches due to requests for accessibility. This manufacturer also recommended requiring a minimum range of travel for the breast platform instead of a specific minimum and maximum height.

The MDE Advisory Committee recommended changing the breast platform height requirement from a specified height range to a required minimum range bounded by a required high height of 42 inches and a required low height of 26 inches which constitutes the minimum range of travel allowed. MDE Advisory Committee Report, 132, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee Report noted that industry representatives explained that:

• equipment currently manufactured ranges anywhere between 25 and 28 inches for the lowest measurement of the breast platform. There were various reasons cited for each of the positions. Recommendations from accessibility experts who developed mammography protocols for women with disabilities identified a need for a breast platform height of 24 inches. Because this recommendation evolved from technologist experience on equipment with less knee space, disability advocates supported the rationale for 26 inches as the minimum. One member cited the diversity of body types and sizes for persons with disabilities as the rationale for the 26 inches. Another member emphasized the importance of considering patients of short stature in addition to considering patients seated in a wheelchair. Many industry organization members supported the 28-inch minimum. Reasons cited included providing more flexibility for manufacturers and concern that the lower minimum could result in more leg injuries as the technologist lowered the breast platform so close to the lap of the patient using a wheelchair.

The MDE Advisory Committee recommended, by strong majority, a minimum low height of 26 inches and a minimum high height of 42 inches. After review of the comments and the MDE Advisory Committee recommendations, the Access Board has accepted the MDE Advisory Committee’s recommendation of low and high minimum heights. The Access Board believes that this requirement will ensure that the breast platform can be lowered or raised to the proper height for a patient seated in a wheelchair and is also within the range requested from manufacturers for patient accessibility. Therefore, the final rule requires at M303.4.1 that breast platforms have a minimum low height of 26 inches, a minimum high height of 42 inches, and be continually adjustable between the minimum low and high heights.

5. Edge Protection

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 sought public input with question 30 in the MDE NPRM preamble, on whether there is diagnostic equipment with wheelchair spaces on raised platforms that does not provide edge protection.

The Access Board received two comments from disability rights organizations. These commenters recommended requiring edge protection on platforms and one commenter suggested that the edge protection should not encroach into the wheelchair space on the platform and should be designed according to the edge protection requirements from the 2010 ADA Standards.

The Advisory Committee made two recommendations for requiring edge protection on raised platforms; for single ramped entry platforms, the Committee recommended requiring a minimum two-inch high edge protection on the back of the platform opposite the entry ramp and on the two sides of the platform, and for double ramped entry platforms, the Committee recommended a minimum two-inch high edge protection on both sides of the platform. The Advisory Committee explained that edge protection “provides an additional safety feature and guides users of wheeled mobility devices onto the platform.” The edge protection prevents the patient from over-shooting the platform, driving off either side, tipping, or falling. MDE Advisory Committee Report, 112-113, 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 Advisory Committee that edge protection is necessary on raised platforms to provide a mechanism to ensure that wheelchair users do not fall off the platform. Therefore, the final rule requires in M303.2.6 that 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.