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

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).