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

IV. Significant Changes to the NPRM

This section of the preamble addresses significant changes made from the MDE NPRM to the final rule in response to the comments received, recommendations from the MDE Advisory Committee, and other information that has come to the Access Board’s attention during the rulemaking process. Individual provisions of the rule are discussed in detail under the Section-by-Section Analysis below.

A. Chapter 2: M201 Scoping

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. There was only one significant change to this section, which added a general exception for diagnostic equipment that is unable to meet one or more of the requirements in the final rule.

1. General Exception

The MDE NPRM proposed several limited exceptions to certain provisions addressing the limitations of current technology and design. Through testimony at the public hearings, comments, and MDE Advisory Committee discussions, the manufacturers of imaging equipment consistently raised concerns about inherent barriers to compliance with the proposed MDE Standards due to the location of imaging and mechanical components necessary to achieve the diagnostic aims. Some specific examples include: Dual Energy X-Ray Absorptiometry (DXA) machines, with a mechanism that moves imaging components along a track beneath the patient surface precluding height adjustability for the transfer surface; prone biopsy tables that must be of a sufficient height to permit health care providers access beneath the patient surface to perform procedures, precluding the equipment from meeting the minimum transfer surface height; and mammography machines with low dose radiation detectors that are larger in size than conventional configurations and required to be in locations that partially obstruct clearances for knee and toe space beneath the breast platform. While the MDE NPRM proposed several specific technical exceptions in Chapter 3, the exceptions did not address the manufacturers’ overall concerns regarding imaging equipment. Section 510 of the Rehabilitation Act requires the MDE Standards to provide independent access “to the maximum extent possible.” The Access Board interprets this language as recognizing that, in some situations, current technology may preclude diagnostic equipment from meeting all of the technical requirements in the MDE Standards. Therefore, the Access Board has added a general exception to Chapter 2 allowing compliance to the maximum extent practicable for the rare circumstance where full 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 utilizing this exception is still required to meet all other applicable provisions of the MDE Standards. We anticipate that this exception will be employed on a very limited basis for a few specialized equipment types, primarily imaging equipment. This provision is not intended to exempt a piece of diagnostic equipment from the MDE Standards as a whole. Limitations resulting from existing equipment designs or manufacturing practices that could be altered to meet the requirements are not a basis for invoking this exception; only diagnostically required structural or operational characteristics that cannot be made to comply with the technical requirements without preventing the use of the equipment for its intended diagnostic purpose are covered by this provision.

B. M301 Diagnostic Equipment Used by Patients in a Supine, Prone, or Side-lying Position and M302 Diagnostic Equipment Used by Patients in a Seated Position

In the final rule M301 and M302 provide the technical requirements for diagnostic equipment used in the supine, prone, or side-lying position, and diagnostic equipment used by patients in the seated position. Sections M301 and M302, which ensure that patients can transfer from their mobility devices onto the diagnostic equipment, share many technical requirements. Therefore, the Significant Changes Section addresses the transfer surface and lift compatibility requirements for M301 and M302 together. New exceptions pertaining to weight scales and to the type of equipment that must comply with M301 and the decision to remove the armrest requirements from M302, are also discussed below.

1. Transfer Surface

a. Transfer Surface Adjustability

The MDE NPRM proposed that the same transfer surface height range of 17 inches minimum to 19 inches maximum be applied to both diagnostic equipment used in the supine, prone, or side-lying position and diagnostic equipment used in the seated position (proposed M301.2.1 and M302.2.1, respectively). The Board considered it likely that diagnostic equipment would be adjustable in height to serve practitioners’ needs however, the transfer surface could be fixed within the proposed height range. The Access Board sought public comment in the MDE NPRM preamble on whether the final standards should require the height of the transfer surface to be adjustable from 17 inches minimum to 25 inches maximum. NPRM, 77 FR at 6922-6933, questions 13 and 14. The majority of commenters, including manufacturers and disability advocates, supported both an adjustability requirement and the proposed high transfer height, but disagreed on what should be the low transfer height.

The MDE Advisory Committee recommended a high transfer height of at least 25 inches and recommended that the transfer surface be adjustable in small, virtually continuous increments. MDE Advisory Committee Report, 67-71, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. However, the MDE Advisory Committee did not achieve consensus on what should be the minimum low height. Id.

After considering the public comments and the recommendations from the MDE Advisory Committee, the Access Board has decided to include in the final rule the following requirements for diagnostic equipment used in the supine, prone or side-lying position, and for diagnostic equipment used in the seated position: an adjustable transfer height range with a minimum high and low height; four intermediate transfer heights within the adjustable range; and a specific method to measure the transfer heights. These new requirements are incorporated into the transfer height provision for diagnostic equipment used in the supine, prone, or side-lying position, and for diagnostic equipment used in the seated position, in the final rule (M301.2.1 and M302.2.1, respectively). These provisions have been renamed “Adjustability,” and are discussed in detail below.

(1) Adjustability: Minimum High Transfer Height

In the preamble to the MDE NPRM, the Access Board sought comment in question 14 on whether the final rule should require an adjustable height range of 17 inches to 25 inches; whether equipment currently met this proposed requirement and, if not, what would the cost be to achieve that range; and whether intermediate heights should also be required within the adjustable height range. NPRM, 77 FR at 6923. While 20 commenters responded to question 14, only four commenters explicitly addressed the proposed minimum high height of 25 inches. Of these, two commenters (an accessibility consultant and a state agency concerned with accessibility) concurred with a minimum high height of 25 inches. One commenter, a manufacturer, recommended increasing the minimum high height to 28 inches for all diagnostic equipment except magnetic resonance imaging (MRI) equipment, which has limitations that may prevent it from reaching 28 inches. Another manufacturer gave examples of the height ranges of its beds and stretchers, each of which met the 25-inch minimum high height.

After reviewing the comments and other evidence before it, the MDE Advisory Committee recommended a high transfer height requirement of 25 inches noting that:

• [t]he anthropometric data referenced … in the Wheeled Mobility Anthropometry Project shows seat heights for people who use mobility devices are above 19 inches. For manual wheelchair user’s seats measured up to 23.9 inches; for power wheelchair users up to 28.9 inches; and for scooter users to 25.3 inches. Seat heights for males were typically higher than for females. All the male manual wheelchair users and 92 percent of the male power wheelchair users had seat heights equal to or less than 25 inches. Therefore, transfer surfaces that are adjustable to a 25-inch maximum during patient transfer accommodate most patients who use mobility devices. Since one key factor in ease of transfer is locating the transfer surface near or at the same height as the seat of the wheeled mobility device, moving the minimum high point for adjustability of transfer surfaces, improves access for many. This particularly benefits persons using powered mobility devices and scooters with higher seat heights.

MDE Advisory Committee Report, 69, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The Access Board was persuaded by the arguments of commenters and the MDE Advisory Committee in favor of requiring a minimum high transfer surface height of 25 inches. A 25-inch minimum high height will ensure that the transfer surface can be raised up to the height of the vast majority of wheelchair seat heights, which are 25 inches high or lower. The final rule requires a minimum high transfer surface height of 25 inches for both diagnostic equipment used in the supine, prone or side-lying position (M301.2.1), as well as diagnostic equipment used in the seated position (M302.2.1). Nothing in the rule prohibits a manufacturer from providing a high transfer height above 25 inches as long as transfer is provided within the range specified up to 25 inches. 

(2) Adjustability: Minimum Low Transfer Height

The Access Board received many comments from disability rights organizations, individuals, accessibility consultants, and a health care provider supporting the need for lower height adjustable tables. Specifically, these commenters explained the need for adjustable height tables to facilitate and promote independent or semi-independent transfer. These commenters explained the delay in diagnosis and treatment when patients are unable to transfer from their wheeled mobility device to the examination surface and are inadequately examined while remaining in their wheelchair. These commenters also explained that adjustable tables would enhance both the safety of patients, by reducing the risk of falls and injury incurred from assisted transfer, as well as reducing injury to medical staff and caregivers by lessening the likelihood of back and other lifting injuries. One individual commenter recalled being bruised when she was dragged onto medical equipment that was too high, while another commenter noted that the risk to healthcare workers increases when access to medical diagnostic equipment is not optimized.

In addressing what the low transfer height should be, 12 commenters responded to question 14 specifically addressing the proposed minimum low transfer surface height. Six commenters (an individual, a state agency concerned with accessibility, two accessibility consultants and two disability rights advocates, one whose comment was supported by 50 disability rights organizations) supported requiring a low transfer height of 17 inches. These commenters asserted that the lower height would provide more accessibility, safety for both patients and healthcare providers, and allow more patients to transfer independently or semi-independently. One commenter, a medical association, supported allowing a minimum low height range of 17 to 19 inches recommending as much latitude for manufacturers as possible. The remaining six commenters (manufacturers and a medical association) voiced strong concerns about the cost of complying with a minimum low height of 17 inches, the potential consequences of being unable to raise the equipment up to a height comfortable for practitioners, and whether current technology and designs would allow diagnostic equipment to reach such a low height. Additionally, some of the manufacturers and medical associations voicing support for a minimum low height of 19 inches, indicated that either their equipment currently meets or would be capable of meeting a 19-inch low height requirement.

Like the public commenters, the MDE Advisory Committee was divided on this issue and was unable to reach consensus regarding a minimum low transfer surface height. MDE Advisory Committee Report, 70, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Individual Committee members’ recommendations for a low transfer surface height requirement were split across three options: 17 inches, 18 inches (viewed as compromise to some and a preferred minimum height by others), and 19 inches. Id. at 139-143. The Committee devoted considerable time to examining available evidence, consulting experts, and discussing the merits of the three height options. Id. Additionally, the Examination Tables and Chairs Subcommittee held six meetings, discussed this issue in-depth, and developed a Subcommittee recommendation for the MDE Advisory Committee of 19 inches as the minimum transfer surface height standard, with 17 inches as the “best practice.” Id. The MDE Advisory Committee members heard presentations from several clinicians and manufacturers on the topic of minimum transfer surface height.⁴ Advisory Committee members also considered a presentation from Edward Steinfeld, ArchD on the findings from the Anthropometry of Wheeled Mobility Project, which was conducted at the Center for Inclusive Design and Environmental Access (IDeA) at the State University of New York at Buffalo.⁵ Id.

After careful consideration of the available information, the MDE Advisory Committee was unable to agree upon a recommendation for a transfer surface height, and Committee members were invited to submit minority reports supporting their view of the issue.⁶ The MDE Advisory Committee Report states that “[a] full reading of these Minority Reports is critical to understanding the range of views guiding the various stakeholder organizations that served on the MDE Advisory Committee about the recommendation for the minimum transfer height.” Id. at 143. (The minority reports are available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports).

The minority reports submitted by the disability advocates and academics supported a minimum low height of 17 inches. See Minority Reports from Boston Center for Independent Living Inc., National Network for ADA Centers, and Medical Diagnostic Equipment Advisory Committee,⁷ available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. These minority reports explained the importance of accessible care and of ensuring as many independent transfers as possible. Id. The reports noted that both patients and providers risk injuring themselves during assisted transfer. Id. In their reports, disability advocates and academics asserted that a17-inch low height provides the greatest number of individuals the opportunity to transfer independently. Id. Additionally, the reports pointed to current accessibility standards for toilet seats, shower seats, and tub seats, which require a height of 17 inches minimum and 19 inches maximum. Id. These reports argued that if the MDE Standards moved away from this range, then the Access Board must adopt the lowest end of the range, 17 inches, to provide the most accessibility. Id. Additionally, the National Council on Independent Living asserted that:

• Most manufacturers on the Committee had a 19 to 21-inch surface available currently, with at least one having a product at 18. Their argument has always been that providing the lowest transfer heights would be an extraordinary expense and burden on the business community (their consumer), not based on how it benefitted a patient with a disability. This effort was never supposed to be about the manufacturers or the doctors. It is the charge of this committee to answer questions and come up with recommendations for accessibility, based by some members on engineering and others by experience. NCIL’s 30-plus years of experience as advocates for people with disabilities dictates that we continue to strongly insist that the U.S. Access Board maintain the low accessible height at 17 inches above the floor in order for medical and diagnostic equipment to be accessed by the greatest number of people.

Minority Report from National Council on Independent Living (Sept. 27, 2013), available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports.

The minority reports submitted by manufacturers supported a minimum low height of 19 inches. See Minority Reports from Hologic, Inc., Midmark Corporation, MITA Advisory Committee Members,⁸ and Recommendation of 19-inch Lower Adjustable Height as the Minimum Accessibility Standard (Joint Report),⁹ available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. Similar to the minority reports supporting a minimum low height of 17 inches, these minority reports relied on the existing accessibility standards, such as those for shower seats, tub seats, amusement park rides, toilets, and benches. However, unlike the minority reports from members supporting a minimum 17-inch low height, these reports asserted that because 19 inches is a permissible transfer height under existing accessibility standards, it is similarly acceptable for medical diagnostic equipment. The manufacturers also noted that currently there are not any accessible diagnostic tables on the market that meet a 17-inch low height requirement. The Brewer Company, LLC stated that:

• Brewer has been manufacturing adjustable height examination tables since 2002. These tables were designed specifically for wheelchair accessibility by meeting the 19-inch height referenced in the ADA/ABA Accessibility Guidelines. Brewer is ISO 13485 certified. ISO requires a robust method for recording customer, end user, and clinician feedback. In the 11 years we have been selling adjustable height examination tables we do not have a single complaint on record regarding the accessibility of our 19” low height tables. There have been no requests for a lower table. In addition, market growth of the adjustable height tables with 19 inch low heights provides further evidence that these tables are meeting the accessibility needs of patients requiring independent wheelchair transfer.

Minority Report from The Brewer Company, LLC (Oct. 1, 2013), available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. 
The exam table manufacturers asserted that they would incur costs to comply with a 17-inch low height, but would not incur costs to comply with a 19-inch low height requirement. See Recommendation of 19-inch Lower Adjustable Height as the Minimum Accessibility Standard (Joint Report) (Sept. 27, 2013), available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports (characterizing a table with a 19-inch transfer height as a “baseline 0%” cost increase for “accessible equipment as currently available on the market”).

In their joint minority report, examination table manufacturers asserted, “Based on our analysis, we determined that transfer surface height requirements lower than 19 inches would increase the cost of designing and manufacturing examination tables, reduce the rate of adoption of accessible equipment, and increase the health provider’s cost of purchasing accessible equipment.” Id.

With respect to the cost of compliance for the tables on imaging equipment, some manufacturers noted the inherent difficulty of redesign, the potential cascading impacts of adopting a low height of 17 inches, and the difficulty in that imaging equipment undergoes many years of work before they become commercially available. See Minority Report of GE Healthcare, Phillips Healthcare, Siemens Healthcare, and Hologic, Inc., available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-a-minority-reports. Specifically, the imaging equipment manufacturers asserted that:

• given the integrated nature of the table to the system and its imaging performance, that a change of even a few inches in minimum transfer surface low height constitutes a significant engineering change to the device. Any such change must ensure there are no adverse effects to image quality, system performance, and patient safety. Complete scanner re-testing and re-certification under our formal FDA quality system and design controls are needed to verify overall system performance and safety.

Moreover, the most significant of these design changes can result in cascading alterations to the scanner, potentially leading to unacceptable heating in the case of MR, impacts on image signal/quality, and changes in dose levels to ensure the same, effective, high quality images and increased examination times, that is, additional workflow steps. 
Id.

After carefully considering the totality of comments received and the MDE Advisory Committee materials, the Access Board has concluded that there is insufficient information to designate a single minimum low height requirement at this time. Specifically, there is insufficient data on the extent to which and how many individuals would benefit from a transfer height lower than 19 inches. Due to this lack of sufficient information, coupled with the lack of consensus among the MDE Advisory Committee and the commenters, the Access Board has decided to establish, for five years only, a range for the minimum low height requirement of 17 inches to 19 inches. During the five-year period following issuance of the final rule, any low transfer height between 17 and 19 inches will meet the MDE Standards. The Access Board acknowledges that this is a temporary solution, and has commissioned a study to quantify the portion of the population that would benefit from a low transfer height below 19 inches. A pilot study was completed prior to the publication of this final rule. A sunset provision has been included in the final rule that will repeal this low height range five years after the date of publication in the Federal Register, leaving only the requirements for the high transfer height and the additional transfer positions below the high transfer height. The Access Board intends to amend this portion of the final rule with a subsequent rulemaking to establish a minimum low transfer surface height once the study has been completed and before the sunset provision takes effect.

(3) Adjustability: Transfer Surface Intermediate Heights

In the MDE NPRM there was no requirement for the transfer surface to have intermediate transfer heights. Under the proposed rule, diagnostic equipment would be in compliance if it provided a low transfer height anywhere within the range of 17 inches minimum and 19 inches maximum. In addition to the matter of low transfer height, the Access Board sought public comment in question 14(c) on whether the final rule should require intermediate heights between a minimum low transfer height and a minimum high transfer height. NPRM, 77 FR at 6923. Three commenters responded (two accessibility consultants and a disability rights advocate) and supported the idea of requiring intermediate heights within a minimum low height and minimum high height of the transfer surface. One commenter, an accessibility consultant, recommended intervals of ½ to 1 inch, indicating that ½ inch increments would be more practical to match the varying heights of wheelchairs and mobility devices, which is critical for many patients in performing independent transfers. The MDE Advisory Committee recommended adjustable height in small, virtually continuous increments. To support this recommendation, the MDE Advisory Committee explained:

• that adjustability greatly increases the overall accessibility of equipment for all persons. Adjustable height MDE, such as exam tables, imaging tables and chairs, will make it possible to position the transfer surface near the height of the seat of the mobility device. For some, independent transfers are only possible when there is minimal or no change in vertical height between the seat of the mobility device and the transfer surface. People may prefer or, in some cases, require, transfer to a slightly lower surface moving the transfer surface lower than the seat of the mobility device; then adjusting the transfer surface to above the seat for the return transfer. MDE Advisory Committee Report, 68, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The Access Board has decided to require that the height of the transfer surface be adjustable within the range for the minimum low and high heights in at least four unspecified intermediate heights, but has determined that the intermediate heights should be set a minimum of one inch apart. While the Access Board agrees that continuous adjustment is preferable, requiring such adjustability could preclude the use of certain types of lifting devices such as hydraulic systems that work in increments. The intent is to permit manufacturers flexibility in setting intermediate heights and not prohibitively restrict designs to those of particular manufacturers or equipment.

(4) Adjustability: Method of Measurement

The MDE NPRM proposed that the measurement of the height of the transfer surface for both diagnostic equipment used in the supine, prone, or side-lying position and diagnostic equipment used in the seated position, be taken from the floor to the top of the transfer surface (proposed M301.2.1 and M302.2.1, respectively). The Access Board sought comment in question 13 in the MDE NPRM preamble, on whether the measurement should be taken with the upholstery in static (uncompressed) conditions, or with a certain amount of deflection. NPRM, 77 FR at 6922. The Access Board received eleven comments in response, most of which agreed with measuring the transfer surface in a static condition. A few commenters disagreed: one manufacturer recommended measuring in static conditions, but allowing a ¾ inch bolster in no more than 25 percent of the short side of the transfer surface to be permitted to be outside the height requirement; two commenters (medical association and manufacturer) asserted that the method of measurement should be dependent on the type of diagnostic equipment and left up to the manufacturers; and two commenters (state agency concerned with accessibility and accessibility consultant) recommended that the transfer surface meet the criteria in both dynamic and static conditions. The MDE Advisory Committee concurred with those comments recommending that the measurement be made with the upholstery in a static condition to ensure a consistent point of measurement. The MDE Advisory Committee explained that “[s]ince many transfer surfaces are not perfectly flat, measuring to the highest point in an uncompressed state provides this consistent point of measurement.” MDE Advisory Committee Report, 71, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Access Board agrees with the Advisory Committee’s rationale and the final rule requires that the height be measured from the floor to the top of the uncompressed transfer surface. This method will ensure consistent measurement across all diagnostic equipment. Taking the measurement at the highest point on the transfer surface allows for small bolsters or contours and does not significantly increase the overall height of the transfer for people with disabilities.

b. Transfer Surface Location

The MDE NPRM proposed the same location and transfer sides of the transfer surface for diagnostic equipment used by patients in the supine, prone, or side-lying position (M301) and diagnostic equipment used by patients in the seated position (M302). This transfer surface was located at the end of the diagnostic equipment and provided options to transfer from a mobility device onto one short side and one long side of the transfer surface. (proposed M301.2.3 and M302.2.3, respectively). Numerous commenters objected on the basis that this type of transfer is not always possible for certain types of medical diagnostic equipment; the MDE Advisory Committee agreed with commenter concerns. The Access Board is persuaded by many of the concerns raised by commenters and the MDE Advisory Committee. In the final rule the structure and content of the transfer surface provision has been revised for diagnostic equipment used by patients in the supine, prone, or side-lying positions to provide two types of transfer surfaces; end transfer surfaces and side transfer surfaces. For diagnostic equipment used by patients in the seated position, the Access Board has decided to retain the proposed rule requirements for transfer surface location and transfer sides, but has added an exception to the transfer sides provision in the final rule to address the concerns raised by commenters and the MDE Advisory Committee.

(1) Transfer Surface Location for Diagnostic Equipment Used in the Supine, Prone, or Side-lying Position

Multiple commenters expressed concerns that transfer cannot always occur at the end of the diagnostic equipment as contemplated by the requirements in the proposed rule. One commenter elaborated that stretchers and hospital beds are always entered from one or the other long side of the bed, not the foot end, due to obstructions at the head and foot ends that cannot be removed. Another commenter recommended allowing transfer space at both the center and the end of the transfer surface.

Evidence presented to the MDE Advisory Committee during its deliberations revealed that it is not always possible to transfer from adjoining sides at the end of the diagnostic equipment in the prone, supine, or side-lying position on certain types of equipment such as stretchers and imaging equipment with scanning beds. MDE Advisory Committee Report, 75-82, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. This is because many models of this equipment can be obstructed on the head or foot ends by necessary components such as emergency extraction handles, the gantry design, or integral patient positioning features. Id. For equipment with long patient examination surfaces such as stretchers and the scanning beds of many types of imaging machines, the foot end is not intended as a transfer point; patients transfer onto the surface on either of the long sides, approaching the equipment more towards the center. Id. Additionally, a transfer approach at the foot location may not be practical for many people with disabilities who would have to move themselves or be moved across a significant length of the surface to place their bodies into a position for effective imaging. Id. The MDE Advisory Committee recommended permitting an alternative transfer surface which was rotated in its orientation such that the width paralleled the examination surface’s length and its depth spanned the examination surface’s width, and was located near the center point of the diagnostic equipment surface. Id.

Based on the comments received and the MDE Advisory Committee recommendations, the Access Board has concluded that for diagnostic equipment used by patients in supine, prone, or side-lying positions two transfer surface orientations are possible depending on the intended location from which the transfer is to be made. These orientations are now identified as an end transfer surface and side transfer surface. This necessitated adding the definition of “end transfer surface” and “side transfer surface” to the defined terms (M102.1) in the final rule and resulted in the removal of the proposed M301.2.3 Transfer Sides, as that is now described within the two types of transfer surfaces provided. The end transfer surface accommodates the transfer method conceived of in the proposed rule; where the transfer occurs at one end of the examination surface and allows the patient the option to transfer at the end and on one adjoining side of the examination surface. The side transfer surface responds to the concerns raised by commenters and the MDE Advisory Committee to accommodate diagnostic equipment where transfer occurs within the length of the examination surface and allows patient transfer at the sides of the examination surface. Side transfer surfaces most typically will be imaging equipment, stretchers, hospital beds, and other equipment where the end is obstructed and cannot be used for transfer. Accordingly, the Access Board has reorganized the requirements regarding the transfer surface for M301 into two types based on where the transfer is to occur: “End Transfer” or “Side Transfer.” This revision to provide options for two types of transfer surfaces necessitated adding additional technical criteria addressing transfer surface size (M301.2.3) and transfer supports (M305.2), as well as adding the definition of “end transfer surface” and “side transfer surface” to the defined terms (M102.1) in the final rule. These new requirements are addressed below in the applicable section in the Section-by-Section Analysis.

(2) Transfer Surface Location for Diagnostic Equipment Used in the Seated Position

Commenters also raised concerns with the provisions in the MDE NPRM related to transferring to medical diagnostic equipment used by patients in the seated position. Commenters stated that there is certain diagnostic equipment used by patients in the seated position where transfer at the end of the seat by two adjoining sides is not feasible. Specifically, commenters raised concerns about diagnostic equipment with fixed footrests, such as podiatry and dentistry chairs. Transfer onto these types of diagnostic equipment must be made from either long side, similar to the side transfer surface described above. One commenter explained that fixed footrest chairs are meant to treat patients with their legs extended parallel to the ground. If entered as suggested in the proposed rule the patient would have to enter the chair by positioning themselves onto this fixed footrest section that is at a downward angle and would require the patient to slide up an inclined surface to be properly positioned on the diagnostic equipment.

The MDE Advisory Committee agreed with a majority of the commenters that some examination chairs which have fixed footrests prevent transfer as conceived of in the proposed rule. The Committee noted that:

• the footrests obstruct access to the foot end of the chair. Examples of chairs that fit this category are most dental chairs and podiatry chairs. The current design allows only one long side for transfer, which limits some patient transfers where a patient can use only one side of the body due to paralysis on one side or other such conditions. To address this issue, the recommendation requires chairs with footrest obstructions to allow patient transfers from both [long] sides of the chair. The solution creates the option for either a left or right transfer. MDE Advisory Committee Report, 83, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The Access Board agrees that diagnostic equipment used by patients in the seated position with fixed footrests requires a different transfer approach than those without fixed footrests. Therefore, the Access Board has added an exception to the transfer sides provision (M302.2.4) in the final rule to permit diagnostic equipment with fixed footrests to provide options to transfer from opposing sides of the transfer surface.

The American Dental Association proposed a complete exemption of dental chairs from the MDE Standards, asserting that the Access Board has not provided any evidence that dental offices are inaccessible, citing to the national survey in MDE NPRM “that collected information on the types of medical equipment that are most difficult for individuals with disabilities to access and use. The American Dental Association urge[d] the Access Board to refrain from proposing costly new requirements based on examination chairs that are only ‘moderately difficult’ for disabled patients to use.” The American Dental Association explains that “dental chairs already have many accessibility features built in and manufacturers as well as health care providers have an economic incentive to produce and procure accessible medical diagnostic equipment and therefore, the American Dental Association does not believe that additional regulations are necessary, particularly with respect to dental examination chairs.” Comment of American Dental Association, Notice of Proposed Rulemaking for Medical Diagnostic Equipment, (Apr. 4, 2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0037.

The Access Board does not concur with the comment urging that dental chairs should receive a blanket exemption. The record is replete with evidence that individuals with disabilities do encounter barriers to dental care as a result of inaccessible dental chairs. For example, one commenter, a disability rights organization representing 37,000 members, explained that it asked its members “and others with disabilities about the barriers they encounter when seeking medical care and treatment. The most frequent responses involved access to examination chairs, dentist chairs, scales and mammography and colonoscopy equipment.” Comment of United Spinal Association, Notice of Proposed Rulemaking for Medical Diagnostic Equipment, (June 4, 2012), available at https://www.regulations.gov/document?D=ATBCB-2012-0003-0029. Additionally, at the public hearing on May 8, 2012, a commenter raised concerns about the ability to obtain dental care when unable to transfer onto the dental chair. The public hearing transcript is available at https://www.regulations.gov/docket?D=ATBCB-2012-0003. Accordingly, the Access Board has concluded that dental chairs are appropriately covered by this rule.

c. Transfer Surface Size for Diagnostic Equipment Used by Patients in the Supine, Prone, or Side-lying Position

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). These dimensions were based on the dimensions specified in the 2004 ADA and ABA Accessibility Guidelines for rectangular seats in roll-in showers (36 CFR Part 1191, App. D 610.3.1) and the ANSI/AAMI HE 75 which notes that a standard examination table is 27 inches wide and a bariatric table is approximately 30 to 32 inches wide and recommends wider surfaces to make repositioning easier. ANSI/AAMI HE 75, section 16.4.7, available at http://www.aami.org/he75. The Access Board sought input in question 15 in the MDE NPRM preamble on whether this size transfer surface was sufficient to effectuate transfer. NPRM, 77 FR at 6923-6924. Of the 12 commenters who responded, only two supported the transfer surface size in the proposed rule. Four of the remaining commenters (manufacturers) felt that the transfer surface width should be decreased, while five (disability rights organizations, a medical association, and an individual) believed a larger surface was needed. The last commenter, recommended one size transfer surface for both seated and supine, prone, or side-lying diagnostic equipment. Commenter recommendations for transfer surface width ranged from 24 inches to 36 inches, while no commenters addressed the proposed depth of 15 inches. Those advocating for a larger width were concerned about the ability of the patient to reposition after transfer and about accommodating obese patients. Those commenters supporting a smaller transfer surface raised concerns about the ability to transfer with a large surface preventing the patient from reaching transfer supports on the opposite side of the transfer surface, while still seated in the wheeled mobility device. The commenters were also concerned that making existing tables comply would require entire base redesigns as product stability would have to be re-evaluated with a wider table. Commenters also raised concerns that a larger transfer surface would conflict with bore size limitations on imaging equipment and that it could limit the health care provider’s access to the patient for proper exam. Finally, two commenters, in response to question 15(e), agreed that an adjustable feature such as an extendable platform, should be permitted to meet the transfer surface dimensions so long as it does not move when a load is applied and it is a permanent part of the device.

The MDE Advisory Committee discussions mirrored the comments to the MDE NPRM with recommendations ranging from 24 inches to 36 inches for the width of the transfer surface. The MDE Advisory Committee reviewed evidence about transfer surface size to include: numerous video clips showing various transfers (both assisted and unassisted); industry exhibited tables to show current table and chair widths; and the findings of the Wheeled Mobility Anthropometry Project presented by Dr. Edward Steinfeld of the IDeA Center at the University of Buffalo. MDE Advisory Committee Report, 72-76, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Wheeled Mobility Anthropometry Project provided an analysis of transfer surface dimensions based on data collected from the study. The study is available at http://www.udeworld.com/anthropometrics.html. The data indicated that the minimum width of a table transfer surface could be as narrow as 28 inches and still accommodate 95 percent of the users sampled. Id. Some members of the MDE Advisory Committee noted that there was little gain in usability by increasing the transfer surface width from 28 inches to 30 inches, and that the significant gain in usability came from increasing the surface to 36 inches to accommodate very large or obese patients. MDE Advisory Committee Report, 72-76, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. While the committee members expressed concern about the need to provide accessibility criteria for obese patients, it decided that there is insufficient data to determine specific criteria at this time and recommended accessibility for bariatric patients be addressed in a subsequent rulemaking. Id. The Access Board concurs with the MDE Advisory Committee that while there is a need to address the accessibility needs of obese patients, more research is necessary before requirements can be developed. The MDE Advisory Committee also noted that if the surface is too wide it can become challenging for smaller sized persons to effectuate transfer, and thus by making all accessible equipment 36 inches wide, some patients would be unable to reach across the table to grasp the transfer support on the other side to utilize the support in the transfer process. Id. The MDE Advisory Committee recommended decreasing the required transfer surface width to 28 inches minimum for all diagnostic equipment used by patients in a supine, prone, or side-lying position. Id. at 73.

The MDE Advisory Committee made multiple recommendations for the transfer surface depth of diagnostic equipment used by patients in the supine, prone, or side-lying position. Id. at 74-76. The MDE Advisory Committee differentiated between equipment whose transfer surface was located on the end of the equipment with transfer sides on one short side and one long side of adjoining sides and stretchers and imaging equipment, which the MDE Advisory Committee noted transfer takes place in the center on either of the long sides. Id. For all diagnostic equipment used by patients in a supine, prone, or side-lying position, except imaging equipment, the MDE Advisory Committee recommended increasing the transfer surface depth to 17 inches, explaining that existing equipment already encompasses this dimension. Id. The MDE Advisory Committee included stretchers in this requirement, even though they have a transfer orientation akin to imaging equipment. Id. For imaging equipment, the MDE Advisory Committee recommended a transfer surface size of 28 inches long minimum by 28 inches deep minimum. The MDE Advisory Committee also recommended the addition of an exception for imaging equipment transfer surface size; to allow a decrease in depth to no less than 21 inches where it is technically infeasible to reach the 28 inches minimum. Id. at 75-76. The Committee explained that “all x-ray tables meet the 28-inch table [depth]…because of physical design constraints such as bore size, not all tables used with equipment with bores meet the 28-inch-[deep] criteria, but all meet the 21-inch minimum.” Id.

As discussed above in Section IV.B.1.b (Significant Changes – Transfer Surface Location) the restructure of the transfer surface to include two types of transfer surfaces; end transfer surface and side transfer surface, necessitates new technical requirements for the new side transfer surface. Accordingly, based on the comments received and the recommendations from the MDE Advisory Committee, the final rule establishes different sizes for each of the end and side transfer surfaces. The final rule requires that diagnostic equipment with an end transfer surface be a minimum size of 28 inches wide and 17 inches long. The Access Board has decreased the minimum width of the transfer surface from 30 inches to 28 inches based on the evidence presented to the advisory committee that 28 inches is sufficient to accommodate 95 percent of the users and will ensure that patients are able to utilize the transfer supports on the opposite side of the transfer surface. The Access Board has increased the length of the end transfer surface from 15 inches to 17 inches based on the evidence that diagnostic equipment currently on the market is already built to this dimension. In the final rule, the Access Board does not see a reason to prohibit an adjustable feature, such as a table with extendable sides, from meeting the size requirements of the transfer surface but believes it is unlikely that any diagnostic equipment would contain such a feature.

For diagnostic equipment with side transfer surfaces, the Access Board has decided to require a transfer surface size of 28 inches wide by 28 inches long, minimum. While the MDE Advisory Committee recommended only increasing the transfer surface size for imaging equipment to 28 inches deep by 28 inches wide minimum, the Access Board has concluded that diagnostic equipment used by patients in the supine, prone, or side-lying position with side transfer surfaces involve the same transfer dynamics whether they are imaging equipment, hospital beds, or stretchers and therefore should be subject to the same transfer surface size requirement.

Additionally, the Access Board concurs with the MDE Advisory Committee recommendation to provide an exception for the transfer surface size of imaging equipment in the final rule given the physical limitations affecting surface depth for imaging equipment with bores and the fact that it is unclear when technological advances in bore size may permit larger patient examination surfaces. However, the Access Board has narrowed the application of this exception only to imaging equipment with bores. The Access Board has determined that this exception, as recommended, was intended to account for the space constraints of imaging equipment with bores and wants to ensure the exception stays as narrow as possible. Therefore, in the final rule, the Access Board has provided an exception which permits the imaging bed of imaging equipment with bores’ to be a minimum of 21 inches wide but requires the transfer surface to be the full width of the examination surface. As this exception applies regardless of whether the imaging equipment has an end transfer surface or a side transfer surface, an exception has been added to each requirement (M301.2.3.1 and M301.2.3.2, respectively). Additionally, the Board has added two definitions to the final rule, “imaging equipment with bores” and “imaging bed” to assist with the application of this exception. (M102.1 final rule).

d. Unobstructed Transfer

The MDE NPRM 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 (proposed M301.2.3 and M302.2.3). As explained in the MDE NPRM preamble, the unobstructed access requirement was to ensure that armrests, side rails, stirrups, or other equipment parts attached to the diagnostic equipment did not impede the patient’s ability to transfer. NPRM, 77 FR at 6923. The final rule retains the proposed requirements for unobstructed transfer for diagnostic equipment used in a supine, prone, or side-lying position, as well as diagnostic equipment used in the seated position, and has added a new exception described below.

In the preamble to the MDE NPRM the Access Board noted that it was considering permitting equipment parts to extend a maximum of three inches horizontally beyond the edge of the transfer side. The Access Board explained that “[t]he 2004 ADA and ABA Accessibility Guidelines provide a gap of 3 inches between the edge of the shower seat and the shower compartment entry, and the gap does not appear to interfere with transferring onto and off of the shower seat.” NPRM, 77 FR at 6924. The Access Board sought input from the public in the MDE NPRM preamble question 17, on whether equipment parts should be permitted to extend a maximum of three inches horizontally beyond the edge of the transfer sides, provided that they did not extend above the top of the transfer surface. Id. Six of the eleven commenters who responded to this question supported permitting equipment parts to extend up to three inches horizontally beyond the edge of the transfer surface. However, these commenters were primarily manufacturers who also expressed concerns about the cost of equipment redesign if a provision permitting the three-inch gap was not included in the final standards. The other five commenters, disability rights advocates and an accessibility consultant, did not support allowing equipment parts to extend up to three inches horizontally, unless they were removable. These commenters raised concerns that the equipment parts would impede transfer. Additionally, a manufacturer, responding to question 9 in the MDE NPRM, explained that all beds, stretchers, and cots have side rails that can be moved to allow unobstructed access for transfer.

The MDE Advisory Committee reviewed the comments. The Committee observed that transfer supports provide handholds that facilitate transfers onto and off of the equipment, and that some types of diagnostic equipment have components that create a gap between the transfer surface and the outer edge of the equipment on the side used for transfer. MDE Advisory Committee Report, 78-82, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee reviewed the 2010 ADA Standards for shower compartment seat requirements, which allows a three-inch gap between the edge of a seat and the shower compartment entry, to determine if these gaps presented a problem to individuals attempting to transfer. The MDE Advisory Committee also considered anthropometric data from the Impact of Transfer Setup on the Performance of Independent Transfers study by the VA Pittsburgh Healthcare System in collaboration with the Human Engineering Research Laboratories at the University of Pittsburgh. Id. This study examined the transfer experience with an adjustable height transfer surface. This study is available at http://herl.pitt.edu/ab/. The MDE Advisory Committee explained that “[t]he results showed that 95% of subjects could transfer when the seat and surface are at the same height with a 3.5-inch gap. This data helped inform the recommendation for the exception since the 3-inch criteria is less than that used in the research and should assure effective transfers for most.” MDE Advisory Committee Report, 79, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee recommended allowing a maximum three-inch obstruction protruding from the transfer sides, “placing a limit on the size of the gap between the transfer surface and the outer edge of the equipment on the side used for transfer,” that applies to both the long length (width) and short length (depth) transfer sides. Id. The Committee also recommended special consideration for stretchers, to incorporate the provision of IEC 60601-2-52 to establish a maximum vertical obstruction at no less than one inch below the top of the transfer surface. Id.

Based on the comments received and the MDE Advisory Committee recommendations, the Access Board is persuaded that a gap of up to three inches between the transfer side and the wheeled mobility device will not impede transfer given that accessible diagnostic equipment will be required to be adjustable. In addition, the Access Board is not persuaded that special consideration for stretchers is necessary in order to accommodate the IEC 60601-2-52 prohibition against vertical obstructions within one inch of the top of the patient surface. The final rule would not permit obstruction above the patient surface; consequently, by meeting the IEC requirements manufacturers will meet the MDE Standards.

Accordingly, the final rule includes an exception permitting obstructions of no more than three inches deep beyond the transfer side of the transfer surface provided that such obstructions do not protrude above the top of the transfer surface. A common example of this type of obstruction is articulating side rails on stretchers that move out of the way during transfer, but create a gap between the transfer surface and the mobility device. The exception allowing obstructions of up to three inches is included in each of the new provisions for unobstructed transfer for diagnostic equipment used in the supine, prone, or side-lying position (M301.2.4), and diagnostic equipment used in the seated position (M302.2.5), as Exception 1.

As noted above, the Access Board has retained the original exception from the MDE NPRM, permitting temporary obstructions provided that they can be repositioned out of the way during transfer. In the final rule, the Board moved this provision to Exception 2 to accommodate the new exception discussed above, and added language to specify that this exception may also apply to obstructions that qualify for Exception 1. For example, side rails that create a gap of three inches from the transfer side of the diagnostic equipment to the mobility device when moved out of the way for transfer, but also protrude above the top of the transfer surface when in place as a side rail.

2. Armrests Requirement

In the MDE NPRM, the Access Board required diagnostic equipment used by patients in the seated position to provide armrests (proposed M302.3.2). The only commenter that addressed whether armrests should be required was a manufacturer who requested that beds, cots, and stretchers be excluded from the requirements as they are required to have side rails per IEC 60601-2-52. The MDE Advisory Committee addressed the armrest provision during their discussions of transfer supports and explained that “armrests serve a similar function, and occupy the same physical space as the transfer supports as described in the MDE NPRM. The MDE NPRM requires transfer supports for all chairs, so the additional equipment for armrests for chairs was not only redundant, but could potentially create a physical conflict between the two devices.” MDE Advisory Committee Report, 104, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee recommended that armrests not be required, but if provided they cannot obstruct transfer supports. Additionally, the Committee noted that transfer supports meeting the final requirements, would provide support like that of armrests and enhance patient stability if left in place after a transfer from a mobility device. Id.

After review of the comment and the recommendations of the MDE Advisory Committee, the Access Board is persuaded that requiring armrests as well as transfer supports is redundant and has the potential to cause conflict between the two devices. Therefore, the Access Board has removed the provision requiring armrests from the final rule.

3. Lift Compatibility Exception

The MDE NPRM proposed that diagnostic equipment used by patients in the supine, prone or side-lying position and diagnostic equipment used by patients in the seated position be usable with portable patient lifts. The proposed rule specified base clearance requirements to ensure lift compatibility (M301.4 and M302.4, respectively). The preamble to the MDE NPRM sought comment on whether the final rule should exempt certain diagnostic equipment from these requirements if the equipment was specifically designed to be used with a fixed overhead lift. NPRM, 77 FR at 6927, question 27.

Eleven commenters responded to question 27. Six of the ten commenters (one manufacturer, three medical associations, and two government entities) concurred with the proposed scenario that if equipment was designed for use with overhead lifts then that equipment should be exempted from the proposed base clearance requirements. One commenter, a manufacturer, agreed that equipment designed for use with an overhead lift should be excepted, and also stated that portable floor lifts should be designed to be compatible with exam and procedure tables, not that the tables be redesigned to be compatible with floor lifts. Four of the commenters (three disability rights organizations and an accessibility consultant) were opposed to this exemption and expressed concern that the overhead lift would not be available when needed if the diagnostic equipment was moved to another room or the lift was not functioning. The final commenter, a manufacturer, opposed the exemption unless the overhead lift was included as part of the equipment when sold.

The MDE Advisory Committee reviewed this issue and recommended the use of overhead lifts as an alternative for imaging equipment where portable floor lifts are not feasible. Specifically, the MDE Advisory Committee explained:

• Overhead lifts can provide an alternate means of access instead of clearances around the bases of imaging equipment required for portable lifts. Table structural design and/or room layout may be such that providing the clearances in and around the base may be either technically difficult or impractical. In these cases, a ceiling-mounted lift may be a better method for some types of imaging equipment because the portable lift would need to access the diagnostic imaging table from the side or far end. Some imaging systems already use overhead lifts to assist patients... [Overhead lifts] may offer flexibility over a portable lift because it can transfer the patient from either side placing the patient in the desired imaging orientation, and the ability to move completely out of the way when not needed. MDE Advisory Committee Report, 107, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

After review of the comments received and the recommendations from the MDE Advisory Committee, the Access Board has concluded that fixed overhead lifts may be appropriate and even preferred in certain circumstances. However, the Access Board believes that the determination of the circumstances where an exception is warranted and the types of diagnostic equipment that should be excepted from the portable floor lift requirement is more appropriately left to the enforcing authority. Accordingly, the final rule provides a limited exception to the lift compatibility requirements for fixed overhead lifts in situations where: (1) a fixed overhead lift is provided; (2) the diagnostic equipment is clearly labeled as not compatible with portable floor lifts; and (3) the use of the overhead lift with that diagnostic equipment is specifically permitted by the enforcing authority. The exception applies only if all three conditions are met.

4. Exception from the Requirements of M301 for Certain Examination Chairs that Comply with M302

The Access Board proposed in M101.2 in the MDE NPRM to require diagnostic equipment to meet the standards for each patient position supported, meaning that if diagnostic equipment was designed to support a patient in multiple positions then the equipment would have to meet the technical criteria for each of those positions. The Access Board sought public input in question three in the preamble in the MDE NPRM, on whether organizing the technical criteria functionally by patient position was clear. 77 FR at 6919.

Fifteen commenters responded, with only two disability advocates and one medical association agreeing that the division of the MDE Standards was clear. The manufacturers raised concerns about applying the MDE Standards for multiple patient positions to a single piece of equipment. Multiple commenters recommended that when diagnostic equipment that fits in multiple categories, one category should take precedence. Medical Association and Accessibility Consultants recommended reorganizing the standards by types of facilities or by feature and one manufacturer recommended harmonizing M301 and M302 into one requirement. Additionally, commenters raised concerns about diagnostic chairs which could be reclined into a supine position after transfer; such as podiatry and dental chairs. These commenters argued that requiring the equipment to be designed to accommodate transfer in both positions would not achieve any objective benefit and would impose transfer surface width requirements that would not be appropriate and would be overly burdensome. The MDE Advisory Committee did not make a recommendation on this provision. However, the subcommittee for tables and chairs did explain that while the primary function of examination chairs is to support patients in a seated position, they are also capable of being reclined. The ability to recline is a secondary, rather than a primary purpose. The subcommittee asserted that these types of chairs should be covered by M302.

In response to the comments and Advisory Committee discussions, the Access Board acknowledges that one of the most important features of making diagnostic equipment used by patients in either the supine, prone, or side-lying position or the seated position accessible, is to ensure the patient has the opportunity to transfer independently to the maximum extent possible. The Access Board concurs with the commenters that there are certain examination chairs, such as dentistry and podiatry chairs, where the patient is only intended to transfer while the chair is in a seated position but is then reclined into a supine position while the diagnostic procedure is being performed. The Access Board concurs with commenters that in this limited situation it is unnecessary for the examination chair, which complies with the technical requirements in M302, to also have to comply with the technical requirements in M301. Therefore, in the final rule the Access Board has added an exception to M301.1 which states that examination chairs that comply with M302 and, after the patient transfers into the seat, reclines to facilitate diagnosis, do not have to comply with M301. Additionally, the Board has added a new definition for examination chair in M102.1 in the final rule to assist with the application of this exception. The other commenter concerns regarding the proposed application provision, M101.2, are addressed below in the Section-by-Section Analysis.

5. Exception from the Requirements of M302 for Weight Scales with Integral Seats

The MDE NPRM proposed that diagnostic equipment which could be used by patients in multiple positions must comply with the technical criteria for all positions in which it could be used (proposed M101.2). In the preamble in the MDE NPRM the Access Board proposed an exception to this requirement for folding seats on diagnostic equipment used by patients seated in a wheelchair. The MDE NPRM proposed that this type of diagnostic equipment would have to meet the technical requirements of M302 (diagnostic equipment used by patients in the seated position) and M303 (diagnostic equipment used by patients seated in a wheelchair), with the exception of the lift compatibility requirements in M302.4. NPRM, 77 FR at 6927. The Board explained that because the patients can use the equipment while seated in their wheelchairs, the seat does not have to provide the clearance necessary to be usable with a portable floor lift. Id.

In the MDE NPRM preamble the Access Board sought comment with two questions, 28 and 37. Question 37 asked whether a folding or removable seat should be required on weight scales for use in the standing position. NPRM, 77 FR at 6930. Four commenters responded: three concurred (an accessibility consultant, disability rights organization, and a state agency concerned with accessibility); and one commenter (a manufacturer) agreed it should be an option, but not a requirement. Six commenters responded to question 28, which asked whether a folding seat provided on diagnostic equipment with a wheelchair space should be required to comply with the technical criteria in proposed M302 for transfer surfaces and supports. NPRM, 77 FR at 6927. Five of the commenters (three disability rights organizations, a state agency concerned with accessibility, and an accessibility consultant) asserted that if a seat is provided it should have to comply with the technical provisions for diagnostic equipment used by a patient in the seated position. One of these commenters explained that not all people with disabilities who need to transfer are wheelchair users and some wheelchair users may choose to transfer, even if the device is designed for use in a wheelchair. The remaining commenter, a medical association, noted that it was unaware of any diagnostic equipment with a folding seat, but asserted that if patients can use the equipment in wheelchairs, then they should not be transferred onto the folding seat, and the chair should not have to meet the requirements in proposed M302.

The MDE Advisory Committee discussed weight scales, noting the importance of obtaining a patient’s weight for medical treatment and the difficulty patients in wheelchairs confront with obtaining an accurate weight. See MDE Advisory Committee Report, 66, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. However, the MDE Advisory Committee did not make specific recommendations for requiring a folding seat on diagnostic equipment used in the standing position, nor did it make any specific recommendations for an exception to M302 for seats on weight scales with wheelchair spaces. The Subcommittee on Weight Scales, in explaining its recommendations on size and ramp slope, recognized that “space constraints are of consideration… as medical equipment and adequate space in the acute care or in the medical office setting are often competing. Scales that can be wall mounted or that are portable would facilitate where there are space constraints.” Subcommittee Report – Weight Scales, 7, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report/appendix-b-supporting-documents.

After reviewing the comments and the Subcommittee on Weight Scales Report, the Access Board has determined that weight scales that are designed to be used by patients seated in a wheelchair, but also provides a seat integral to the equipment, present a unique situation which warrants an exception to the general provision of M302.1 in the final rule. The primary purpose of the technical requirements for diagnostic equipment used by patients in the seated position is to facilitate independent transfer from a mobility device onto the diagnostic equipment. Some wheelchair accessible scales also provide a seat for patients who ambulate onto the scale, but due to stability or fatigue issues, may need to sit in order to be weighed. On many of these scales the seat folds down into the wheelchair space to accommodate the ambulatory patient who needs to sit. The MDE Advisory Committee notes that space is already at a premium for weight scales. To require a seat integral to the weight scale to meet the provisions of M302, when it already meets the requirements of M303 would require the weight scale platform to be significantly larger than a weight scale which just provides a wheelchairs space. To accommodate both a wheelchair space and seat permitting transfer from a mobility device, the platform would have to be large enough to accommodate individuals in their mobility devices and also provide enough space to allow for a side or perpendicular transfer from the mobility device onto the seat. Because weight scales with wheelchair spaces and seats are intended to be used by patients remaining in their wheelchairs or ambulating onto the scale, the Access Board has concluded that it is not necessary to require the weight scale to provide the wheelchair space for the patient to use the weight scale in a wheelchair and also provide the space for the patient to wheel onto the weight scale and then transfer onto the seat. Accordingly, the Access Board has excepted integral seats on weight scales that also contain wheelchair spaces meeting all the requirements of M303 from complying with M302. Due to the addition of this exception from all of the M302 requirements, the exception in proposed M302.4, which exempted the folding seat from complying with the lift compatibility requirements, has been removed from the final rule as it is now encompassed under the new exception.

The Access Board acknowledges the comments recommending that accessible diagnostic equipment used in the standing position also provide a seat. However, the Access Board has declined to include such a provision in the final rule because of the potential space impact and because, it will ultimately be up to the enforcing authority to determine what types of diagnostic equipment and how many of each type must be provided in medical settings. However, if diagnostic equipment used in a standing position does provide a seat, but does not provide a wheelchair space, then it would have to comply with the requirements of M302 and M304 in the final rule.

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.

D. M304 Diagnostic Equipment Used by Patients in a Standing Position

M304 provides the technical requirements for diagnostic equipment used by patients in a standing position. There was only one significant change made to the requirement of standing supports on the diagnostic equipment.

1. Standing Supports

The proposed rule included a provision requiring standing supports on each side of the standing surface and compliance with the technical requirements for standing supports in proposed M305.3 (proposed M304.3). Question 38 in the MDE NPRM preamble requested input on the standing support configurations currently provided, their effectiveness for patients with disabilities, whether alternative criteria would be appropriate, whether angled standing supports are effective, and whether there are any industry standards for structural strength requirements. NPRM, 77 FR at 6931.

Two commenters responded to this question. One commenter, a medical association, indicated that standing supports for imaging equipment vary widely based on the type of environment and specific imaging equipment being used. For example, the standing support on a chest x-ray machine and mammography equipment is much different than a support on a fluoroscopic room table that can be moved from a recumbent to standing position. The second commenter, a manufacturer, expressed concerns that the proposed rule was treating supports on breast platforms as standing supports, explaining that this was not the supports’ intended purpose. This commenter argued that these supports are actually arm supports intended to ensure proper patient positioning during the diagnostic exam, and were not intended as an accessibility feature to assist the patient in standing.

The MDE Advisory Committee addressed the issue of standing supports for mammography equipment as well as that of standing supports for wheelchair spaces with raised platforms. For mammography equipment, the MDE Advisory Committee came to a consensus agreeing with the commenter that the “standing supports” on mammography equipment were actually positioning supports and the “primary use of these supports is for positioning of the arms during the imaging process to keep them out of the field of view of the image.” MDE Advisory Committee Report, 135, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee noted that “[i]ndustry representatives posited that if a patient has limitations or balance issues severe enough to need standing assistance, then the healthcare provider should position her in a seated position for safe imaging.” Id. The MDE Advisory Committee recommended removing the requirements for standing supports on mammography equipment and instead adding a requirement for positioning supports. Additionally, the MDE Advisory Committee noted that:

• since the supports mount to the c-arm on many types of mammography equipment, they will move up and down with the breast platform. In these cases, they do not need to be as long as 18 inches to provide sufficient flexibility for patients to reach them. Industry representatives also indicated that there are controls in the area where these positioning supports are located. It is important that the patients’ hands do not accidentally hit these controls when they are holding the positioning supports. For this reason, industry will sometimes intentionally shorten the length of these handholds to less than the 18-inch proposal. Considering these factors, the full Committee agreed that a 12-inch long positioning support would be sufficient if it moved with the movable breast platform. Id.

The MDE Advisory Committee made two recommendations for standing supports on raised platforms with wheelchair spaces: one for single-ramped entry raised platforms, and a second for dual-ramped entry raised platforms. These recommendations would apply when the diagnostic equipment is designed to accommodate both persons seated in wheelchairs and standing persons. For single-ramped entry raised platforms, the MDE Advisory Committee recommended maintaining the requirement for standing supports on both sides of the diagnostic equipment. To address concerns raised by industry representative on the MDE Advisory Committee regarding the space on the platform needed to attach two sets of standing supports which must be outside the minimum clear space required for a wheelchair, the Committee recommended that dual-ramped entry raised platforms require only one standing support on one side of the platform. The MDE Advisory Committee explained that patients may have a stronger side, right or left, and therefore with only one standing support provided, they would need to be able to use their preferred side to hold onto the standing support. With a single entry ramp, supports on both sides are necessary to allow patients to choose to use the right or left side of their body, but on a dual entry ramp the patient can enter or exit on opposing sides to allow them to use their preferred side of their body with only one support. Id.

The Access Board concurs with the commenters and the MDE Advisory Committee that the supports on mammography equipment were intended as positioning supports, not standing supports. However, the Board has determined that an exception is not necessary due to the restructuring of this requirement in the final rule. In the final rule, standing supports are only required on diagnostic equipment used by patients in a standing position that provide a surface on which a patient would stand. This is discussed in greater detail below in Section V.C. (Section-by-Section Analysis – M304.2). Additionally, as discussed below in Section IV.E.1. (Significant Changes – Positioning Supports), the Access Board has elected not to include positioning supports for mammography equipment in the final rule.

With regard to the MDE Advisory Committee recommendations regarding standing supports on diagnostic equipment with raised platforms, the Access Board has decided to include an exception in the final rule for diagnostic equipment with entry and exit that permit pass-through from one end to the other to provide a standing support on only one side of the standing surface, provided that the standing support complies with the requirements in M305.3 for standing supports in a horizontal position. This exception would not just apply to diagnostic equipment on a raised platform designed both for people seated in wheelchairs and in standing positions, it would also apply to equipment designed solely for patients in a standing position and would apply regardless of whether the standing surface is raised on a platform or combined with a wheelchair space. For all other standing surfaces, the Access Board has retained the original requirement of standing supports on two sides of the standing surface from the proposed rule. While the MDE Advisory Committee spoke in terms of raised platforms, the Access Board believes the exception should be permitted where entry and exit permits pass-through from one end to the other, regardless of whether the standing surface is raised. Accordingly, the Access Board has decided to apply this exception to all diagnostic equipment which permits this type of entry and exit in final rule (M304.2.2).

E. M305 Supports

M305 provides the technical requirements for supports on medical diagnostic equipment. There were multiple significant changes made to the transfer supports section, including the addition of new requirements as well as the removal of structural strength requirements from the final rule. Additionally, changes were made to the vertical and horizontal standing supports requirements.

1. Transfer Supports

The MDE NPRM proposed requirements for transfer supports that applied to all transfer surfaces (proposed M305.2). The requirements were the same for transfer surfaces on diagnostic equipment used by patients in the supine, prone, or side-lying position, as well as diagnostic equipment used by patients in the seated position. The proposed standards required transfer supports to be located within reach of the transfer surface and not obstruct transfer, be capable of resisting vertical and horizontal forces of 250 pounds applied to all points, and not rotate in their fittings. The latter two requirements were taken from the 2004 ADA and ABA Accessibility Guidelines for grab bars. 36 CFR Part 1191, App. D. In the preamble to the MDE NPRM, the Access Board posed multiple questions about whether the final rule should include more specific requirements regarding location, length, size, height, and angle for transfer supports; and whether transfer supports should be allowed to rotate in their fittings. The Access Board received 31 comments to these questions and the MDE Advisory Committee made 10 recommendations regarding the transfer support section.

In response to the comments and the recommendations of the MDE Advisory Committee, and in consideration of the changes to the final rule regarding types of transfer surfaces, the Access Board has made multiple changes and additions to the transfer support requirements, located at M305.2. Specifically, the Access Board has added technical specifications to the requirements for location (M305.2.1) and length (M305.2.2) based on the type of transfer support required; has added new technical requirements for height (M305.2.3), cross section (M305.2.4), absence of surface hazards (M305.2.5), gripping surfaces (M305.2.6), and clearance (M305.2.7); and has made changes to the fittings provision (M305.2.8). These new and revised provisions are based on the 2004 ADA and ABA Accessibility Guidelines for grab bars and handrails, 36 CFR Part 1191, App. D. Finally, the Access Board has removed the requirement for structural strength for transfer supports and has decided not to add any positioning support requirements in the final rule. Each requirement is discussed in detail in the Section-by-Section Analysis below.

a. Structural Strength

The MDE NPRM proposed to require transfer supports to be capable of resisting vertical and horizontal forces of 250 pounds at all points (proposed M305.2.2). The Access Board sought input in question 18, on whether current transfer supports are capable of resisting vertical and horizontal forces of 250 pounds at all points. NPRM, 77 FR at 6925. Four commenters (three manufacturers and one accessibility consultant) addressed this requirement: the accessibility consultant concurred with the proposal and the other three commenters opposed this provision. Two of those opposing the 250-pound requirement asserted that very few supports would be able to withstand 250 pounds of force applied to all points in all directions and that the requirements should differ depending on the force vector or live load applied. The remaining opposing commenter supported compliance with the prevailing industry standard IEC 60601 instead of the proposed provision.

The MDE Advisory Committee recommended revising the language proposed in the MDE NPRM to require transfer supports to resist vertical and horizontal forces of 250 pounds at locations determined by the intended use of the equipment. The Committee indicated that “during committee discussions manufacturers stated that industry is required to test the most vulnerable spots on the transfer support. Industry must follow testing parameters found in other standards.” MDE Advisory Committee Report, 103, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

After reviewing the comments received and the recommendations from the MDE Advisory Committee, the Access Board has decided to remove this section in the final rule. The prevailing standard used by industry, IEC 60601 adopted under the ANSI/AAMI ES 60601 series in the U.S., contains provisions that address the structural strength of supports. ANSI/AAMI ES60601-1:2005/(R)2012, available at http://my.aami.org. The IEC 60601 Standard applies to a wide range of medical equipment including much of the diagnostic equipment covered by the MDE Standards and contains allowances for risk assessment not found in accessibility standards, such that support features on diagnostic equipment that will sustain transfers in a safe manner even without a specific provision in the MDE Standards. Id. Accordingly, it is not necessary for the Access Board to address the structural strength of transfer supports in the final rule as it is already covered by industry standards.

b. Positioning Supports

The Access Board noted in the MDE NPRM preamble that it was considering adding positioning supports to the final rule and sought public input with question 24 on whether positioning supports should be required in the final rule. NPRM, 77 FR at 6927. Six commenters responded: two commenters (disability rights organizations) recommended adding positioning supports; two commenters (manufacturers) recommended providing positioning supports within reach of the patient; one commenter (an accessibility consultant) recommended flexibility to allow for design based on use; and the final commenter (a manufacturer) raised concerns about the technical impact for MRI machines. Additionally, as discussed above in Section IV.D.1 (Significant Changes – Standing Supports) and below in Section V.C.17 (Section-by-Section Analysis – M305.2), the MDE Advisory Committee made recommendations to add requirements for positioning supports on mammography equipment and imaging equipment with transfer surfaces having depths greater than 24 inches.

After review of the comments and the MDE Advisory Committee’s recommendations, the Access Board has decided not to require positioning supports in the final rule. Although the Access Board considers positioning supports to be helpful, even necessary in some instances, given the wide range of diagnostic equipment addressed by the final rule, we have insufficient information on which to base a meaningful requirement that could apply to all types of equipment. Additionally, where transfer supports are provided, they can also serve to assist patients to position themselves.

2. Standing Supports

The proposed rule provided technical criteria for vertical and horizontal standing supports. For horizontal standing supports, the Access Board proposed a gripping surface of 4 inches long minimum, the top of which would be required to be located 34 inches minimum and 38 inches maximum above the standing surface (proposed M305.3.1). For vertical standing supports, the Access Board proposed a gripping surface of 18 inches long minimum, the bottom of which would be required to be located 34 inches minimum and 37 inches maximum above the standing surface (proposed M305.3.2). In the preamble to the MDE NPRM the Access Board sought input with question 38 on: a) the current configurations of standing supports, and their effectiveness for persons with disabilities; b) if there were any alternative technical criteria that would be appropriate; c) whether angled supports are effective; and d) whether there are industry standards for the structural strength of standing supports. NPRM, 77 FR at 6931. The Access Board received two comments, one of which addressed standing supports on mammography equipment (discussed above in Section IV.D.1 (Significant Changes – Standing Supports)) and one commenter (medical association) who noted that angled standing supports would be effective and that they are unaware of any industry standards regarding structural strength.

The MDE Advisory Committee reviewed the standing supports provision and while it supported the technical criteria in the proposed rule, the MDE Advisory Committee recommended adding additional criteria for standing supports on raised platforms with wheelchair spaces based on the recommended changes in requirements for standing supports for such diagnostic equipment (discussed above in Section IV.D.1 (Significant Changes – Standing Supports)). The Committee recommended that for single-ramped entry raised platforms with wheelchair spaces, the standing supports located on two sides of the platform have a minimum of 34 inches between supports, be integrated into the platform, and be a minimum of 32 inches in length (at least 80 percent of the platform length) at the platform entry edge. MDE Advisory Committee Report, 136-137, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. For standing supports on dual-ramped entry raised platforms with wheelchair spaces, the MDE Advisory Committee recommended the standing support, required on one side of the platform, be integrated into the platform and stretch the full length of the platform (40-inch minimum). Id.

The Access Board concurs with most of the MDE Advisory Committee’s recommendations; however, although the Committee’s recommendations pertained to diagnostic equipment with wheelchair spaces and standing spaces on raised platforms, the Access Board has decided to apply the recommended criteria to all diagnostic equipment for patients in a standing position that also contains a wheelchair space, regardless of whether the equipment standing surface is raised. In addition, the exception permitting only one standing support is conditioned on that support being positioned horizontally in relation to the standing surface, not vertically. Additionally, the Access Board has adopted the Committee’s recommendation regarding the length of these standing supports necessitating the Access Board to restructure the standing support provision, dividing it into length and height. In the final rule the Access Board permits diagnostic equipment that is required to have standing supports that also provides a wheelchair spaces with one entry to have standing supports with a gripping surface length equal to or greater than 80 percent of the overall length of the platform. For such diagnostic equipment with wheelchair spaces that permit pass-through from one end to the other, the final rule requires the length of the gripping surface of the standing support to be at least equal to the length of the platform.