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

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.