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

(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.