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

M305.2 Transfer Supports (Section-by-Section Analysis)

This is an introductory section. As discussed above in Section IV.E.1. (Significant Changes – Transfer Supports), the Access Board strengthened the transfer support requirements and added additional requirements in the final rule to ensure that supports are capable of assisting with independent transfer onto and off of the diagnostic equipment. With the changes to the final rule, the Board sought to harmonize as much as possible, these requirements with the 2004 ADA and ABA Accessibility Guidelines for grab bars. 

M305.2.1 Location (Section-by-Section Analysis)

The MDE NPRM proposed that transfer supports be located within reach of the transfer surface and not obstruct transfer onto or off of the surface when in position (proposed M305.2.1). In the preamble to the MDE NPRM, the Access Board noted it was considering requiring transfer supports to be located no further than 1½ inches from the transfer surface, when measured horizontally, and requiring the transfer support to be located on the side of the transfer surface opposite the transfer side. NPRM, 77 FR at 6925. The Access Board sought public comment with question 19, which asked for input on multiple proposed changes to the transfer support provision, including whether the proposed location of the transfer support, and the requirement that it be located 1½ inches from the transfer surface, would be sufficient to facilitate transfers. Id.

Eight commenters responded to question 19, but only six of the commenters addressed the location of transfer supports. Two commenters, a manufacturer and a state agency concerned with accessibility, concurred with the technical requirements proposed in question 19 for the transfer support location. Another commenter, a disability rights organization, stated that transfer supports should be required on both sides of the equipment. A manufacturer noted that if the proposed transfer surface size of 30 inches wide is adopted, then a transfer support opposite the transfer side would be useless as the patient would be unable to reach the support until nearly fully on the diagnostic equipment. This commenter noted that an adjacent transfer support would be more effective, but would conflict with the provider expectations of bed and stretcher side rails. The final two commenters, a manufacturer and a medical association, raised concerns about requiring any transfer supports on imaging equipment, specifically MRI and CT machines, asserting that the supports may interfere with the image quality.

The MDE Advisory Committee made three separate recommendations for the location of transfer supports: a general requirement, a requirement for stretchers, and a requirement for imaging equipment. For the general provision, the MDE Advisory Committee recommended requiring transfer supports on both sides of the transfer surface that can be removed or repositioned during transfer and are located at a maximum distance of 1½ inches from the transfer surface. The Committee explained that “transfer supports or handholds on adjustable medical equipment facilitate transfers onto a transfer surface by giving the individual something to hold or grab onto while transferring. This recommendation for placement of supports on both sides of the equipment will increase the options during patient transfers.” MDE Advisory Committee Report, 86, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

For stretchers, the MDE Advisory Committee noted that patients enter from either of the long sides, rather than on one long side and one short side, and this change in orientation necessitated a different location for the transfer supports so that the support would be reachable during transfer. The MDE Advisory Committee recommended locating the transfer support “along the long side of the transfer surface on the opposite side of the transfer.” MDE Advisory Committee Report, 87-88, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Additionally, the Committee recommended a horizontal distance from the transfer surface of no more than 3 inches from the edge of the patient support surface, indicating that stretcher transfer supports are part of a rail system that needs to fold and store out of the way and therefore require more space to articulate. Id. at 96.

For imaging equipment, the MDE Advisory Committee recommended requiring transfer supports when the transfer surface was 24 inches deep or less, and requiring positioning supports for transfer surface depths of greater than 24 inches. Id. at 88-89. The Committee recommended requiring one support on the opposite side of the transfer side regardless of whether it was a transfer support or positioning support. The Committee noted that:

• because of the size, diversity, and use of diagnostic imaging tables, this support will carry out different functions on different tables… This two-part recommendation recognizes the different use of the supports based on the table width. The Committee used a 24-inch dividing point for table width to accommodate the dimensions for the maximum reach range. For transfer surface depths on tables less than 24 inches wide, a transfer support must be available on the side opposite the entry of the transfer surface… For transfer surface depths on tables greater than 24 inches wide, a positioning support must be available on the side opposite the entry to the transfer surface. Id.

After review of the public comments and the MDE Advisory Committee recommendations, the Access Board has determined that there is a need for two types of transfer supports, based on the orientation of the transfer surface. As described in Section IV.B.1.b.(Significant Changes – Transfer Surface Location), the Access Board has designated two types of transfer surfaces based on orientation for diagnostic equipment used by patients in the supine, prone, or side-lying position: end and side transfer surfaces, either of which can be employed depending on the configuration and use of the particular equipment. Here, a similar dual approach is warranted for transfer supports. While the MDE Advisory Committee recommended separate requirements based on the type of diagnostic equipment, stretchers and imaging equipment, the Access Board believes that the type of support should be based on where the transfer surface is located on the examination surface. Therefore, the Access Board has separated the location provision into end transfer supports and side transfer supports. End transfer supports cover diagnostic equipment used by patients in the supine, prone, or side-lying position with end transfer surfaces, M301.2.3.1 in the final rule, and all diagnostic equipment with transfer surfaces used by patients in the seated position, M302.2 in the final rule. Side transfer supports cover diagnostic equipment used by patients in the supine, prone, or side-lying position with side transfer surfaces, this includes stretchers and most imaging equipment, M301.2.3.2.

In the final rule the Access Board has decided for end transfer supports to require at least one support located on the long side of the transfer surface, opposite the transfer side. For side transfer supports, the Access Board has decided to require a transfer support which is capable of supporting transfer on each side of the transfer surface. A side transfer surface could contain one transfer support which is capable of being repositioned from one side to the other side depending on which side the patient chooses to transfer or it is acceptable to have two transfer supports, one on each long side, which are both capable of being removed or repositioned on the side the patient chooses to transfer. Additionally, the final rule requires both end and side transfer supports to be located a maximum of 1½ inches measured horizontally from the nearest edge of the transfer surface to the transfer support. In reviewing the MDE Advisory Committee’s recommendations, the Access Board agrees that transfer supports that fold, collapse, or articulate need more space, but disagrees with the MDE Advisory Committee that an allowance for more space should apply only to stretchers and imaging equipment. The Access Board finds that other types of diagnostic equipment, such as hospital beds, also have transfer supports that collapse on either side to allow transfer. Therefore, the Access Board has provided an exception to the general provision which permits supports that fold, collapse, or articulate to be located three inches maximum from the nearest edge of the transfer surface to the transfer support. Additionally, as discussed in Section IV.E.1.b (Significant Changes – Positioning Supports), the Access Board has decided not to include positioning supports in the final rule.

M305.2.2 Length (Section-by-Section Analysis)

In the MDE NPRM there was no requirement for length of the transfer support; however, the MDE NPRM preamble noted that the Access Board was considering requiring the transfer supports to extend the entire depth of the transfer surface and be a minimum of 15 inches in length. NPRM, 77 FR at 6925. The Access Board specifically sought public input with question 19, asking if the proposed length of the transfer supports would be sufficient to facilitate transfer and maintain position on the diagnostic equipment. Id.

Three commenters responded to this issue, two manufacturers and a state agency concerned with accessibility. The state agency concurred with the 15-inch requirement. One commenter did not support a 15-inch length transfer support. This commenter (a manufacturer) stated that a transfer support that is a minimum of 15 inches in length would make it even more difficult to comply with load bearing requirements and recommended that this length requirement be reduced. The second commenter, a manufacturer, recommended revising the proposed provision from requiring the transfer support to extend horizontally the entire depth of the transfer surface, to extend horizontally along the transfer surface to within three inches, to allow for manufacturing tolerances.

The MDE Advisory Committee made three transfer support length recommendations, one for each type of transfer support recommended by the Committee, described above. For the general provision, the MDE Advisory Committee recommended a transfer support with a length of 15 inches minimum, that overlaps the minimum depth of the transfer surface by 80 percent. The Committee explained that the transfer support length provides the gripping surface for the patient to grasp or maintain balance while transferring. MDE Advisory Committee Report, 90, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. For stretchers, the MDE Advisory Committee also recommended 15 inches in length stating that this would provide continuous support for patients and still accommodate the articulation that is necessary for the head and back support on stretchers. Id. For imaging equipment with transfer surfaces less than or equal to 24 inches deep, the Committee recommended requiring a transfer support to extend horizontally along the side of the patient table at the designated transfer location for at least the minimum width of the transfer surface, with a minimum length of 28 inches. For transfer surfaces greater than 24 inches deep, the MDE Advisory Committee recommended requiring a positioning support instead of a transfer support, which extends horizontally along the side of the patient table 12 to 16 inches and is located at a position to accommodate clinical use. Id. at 91-92.

The Access Board agrees with the MDE Advisory Committee that the addition of a requirement for a transfer support length provision is necessary and has adopted many of the MDE Advisory Committee’s recommendations for transfer support length in the final rule. The Board restructured the Committee’s recommendations to fit within the end and side transfer supports discussed above. For end transfer supports the Access Board has adopted the general provision recommended by the MDE Advisory Committee and determined that the required length will be 15 inches minimum. Additionally, the Access Board acknowledges that manufacturers need some flexibility with respect to the location of the support to account for clearances with other equipment components that may articulate or move. Therefore, the final rule requires that the 15-inch minimum length transfer support be positioned along 13½ inches minimum of the depth of the transfer surface.

For side transfer supports the Access Board adopted the MDE Advisory Committee recommendation for imaging equipment, that this support be a minimum of 28 inches long positioned along the width of the transfer surface. In addition, the Board has added two exceptions to the requirements for side transfer supports to address the concerns raised by the MDE Advisory Committee. The first exception addresses articulating patient surfaces, primarily stretchers, where a continuous 28‐inch transfer support may conflict with other supports or railings as the equipment is adjusted. In such cases, the support may be reduced to no less than 15 inches in length. The second exception applies to transfer supports on imaging bed surfaces of more than 24 inches in width, such as large x‐ray tables, where the support is likely to be used in the latter stages of a transfer from a prone or side‐lying position. In these cases, the Access Board finds that permitting the transfer support to be no less than 12 inches long is appropriate. While the exception is based on an Advisory Committee recommendation using the term “positioning support,” this is still transfer support, that can assist with transfer onto the transfer surface and will likely be used to reposition in the later stages of a transfer.

In question 19 part (e) the Access Board sought input on whether angled or vertical transfer supports should be permitted. 77 FR at 6925. Three commenters, a manufacturer, an accessibility consultant, and a disability rights organization, responded and all concurred with the proposal. The MDE Advisory Committee did not specifically address this proposal, however, in its recommendations for the length of transfer supports on imaging equipment, it did recommend that the transfer support should extend horizontally along the side of the patient table. MDE Advisory Committee Report, 90-91, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Access Board considered the public comments and the MDE Advisory Committee’s recommendation, and has decided not to require that transfer supports be horizontal, allowing manufacturers flexibility to contour supports appropriate for the diagnostic purpose of the equipment.

M305.2.3 Height (Section-by-Section Analysis)

In the MDE NPRM there was no specific requirement regarding the height of the transfer support, only that it be “within reach” of the patient (proposed M305.2.1). The Access Board sought input from the public in question 20 of the MDE NPRM preamble, on whether a transfer support height requirement of 6 inches minimum and 19 inches maximum above the transfer surface would be usable by patients with disabilities. NPRM, 77 FR at 6925. Six commenters responded to question 20. Four commenters (two manufacturers, one disability rights organization, and a state agency concerned with accessibility) supported the proposed height range. Three commenters (a manufacturer, a medical association, and a disability rights organization) did not support the proposal. The manufacturer opposing the proposed range raised concerns with its ability to attain a 19-inch height on its diagnostic equipment. The medical association asserted that radiography exam tables are not equipped with transfer bars, and if required should retract fully into the surface of the table and the disability rights organization expressed concern that 19 inches was too high to facilitate safe transfer.

The MDE Advisory Committee supported adding a requirement setting the height of transfer supports within the range described in question 20 in the MDE NPRM preamble, of 6 inches minimum and 19 inches maximum. The MDE Advisory Committee explained that the manufacturers on the Committee determined that this recommendation did not conflict with the IEC 60601-2-52, which provides requirements for side rails to prevent entrapment hazards, and would allow the equipment to be designed to provide accessibility and safety from entrapment hazards. MDE Advisory Committee Report, 94, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. Additionally, for transfer surfaces that are greater than 24 inches deep, the MDE Advisory Committee recommended requiring a positioning support instead of a transfer support, with a height of three to six inches above the transfer surface. Id.

The Access Board considered the public comments and the MDE Advisory Committee’s recommendations, and has decided to include a new provision, M305.2.3 in the final rule, that requires the tops of transfer support gripping surfaces to be located 6 inches minimum and 19 inches maximum higher than the top of the associated uncompressed transfer surface during use. This range allows the manufacturer to choose a height between 6 inches and 19 inches to place their transfer supports; it does not require that the transfer supports be 19 inches high. The transfer support is permitted to be horizontal, angled, curved, or a combination of these as long as the top of any point along the gripping surface is located at or between 6 inches and 19 inches. Thus, the commenter’s concern about reaching the 19-inch height is not warranted. Secondly, as discussed above in Section IV.E.1.b (Significant Changes –Positioning Supports), the Access Board has declined to include the MDE Advisory Committee’s recommended positioning supports in the final rule; however, the Access Board does concur with the MDE Advisory Committee that for imaging equipment with transfer surfaces that exceed 24 inches in width, a lower transfer support is warranted. Therefore, in the final rule, the Access Board has provided an exception that permits transfer supports to be located three inches minimum and six inches maximum higher than the tops of the transfer surfaces for imagining beds that are greater than 24 inches wide.

M305.2.4 Cross Section (Section-by-Section Analysis)

The proposed rule did not provide specific requirements for the cross section of transfer supports. However, in the MDE NPRM preamble, the Access Board noted that it was considering adopting the cross sectional dimensions for grab bars from the 2004 ADA and ABA Accessibility Guidelines for transfer supports. NPRM, 77 FR at 6925-6926. Specifically, the Access Board indicated it was considering requiring circular cross sections to have an outside diameter of 1¼ inches minimum and 2 inches maximum, and transfer supports with non-circular cross sections to have a cross section dimension of 2 inches maximum, and a perimeter dimension of 4 inches minimum and 4.8 inches maximum. Id. The Access Board sought input in MDE NPRM preamble question 21, on whether the gripping surfaces of current transfer supports on different types of equipment meet the cross sectional dimensions specified above and whether handholds that meet the above cross section dimensions could be integrated into armrests that are also cushioned to support arms and elbows. Id.

Five commenters responded to question 21. Two commenters (one manufacturer and one accessibility consultant) were opposed to permitting non-rounded cross sections, noting concern that harsh edges or angles may not allow users to comfortably and adequately grasp the support. One commenter (a manufacturer) asserted that because currently there are no standards, existing products would likely not meet the proposed provision. Another commenter (a manufacturer) was concerned that the requirement could preclude the use of cushioned arm pads.

The MDE Advisory Committee expressed confidence “in reliance on the cross section dimensions in the 2010 Standards.” MDE Advisory Committee Report, 99, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee further opined:

• Allowing both noncircular cross sections and circular cross sections gives manufacturers flexibility to employ the best configuration for use of the equipment, hand, grip strength, and power grab functions. While a majority of the Committee members supported a recommendation allowing both noncircular and circular cross sections, some members noted ergonomic considerations support the better functionality of circular cross section gripping surface. Id.

After review of the comments and the MDE Advisory Committee’s recommendations, the Access Board has decided to apply the 2004 ADA and ABA Accessibility Guidelines for grab bar cross sections to transfer supports in the final rule. Accordingly, the final rule includes a new provision, M305.2.4, requiring transfer supports to have one of two cross sections: circular cross sections, with an outside diameter of 1¼ inches minimum and 2 inches maximum; or non‐circular cross sections, a cross section dimension of 2 inches maximum and a perimeter dimension of 4 inches minimum and 4.8 inches maximum.

M305.2.5 Surface Hazards (Section-by-Section Analysis)

The proposed rule did not provide any specific restrictions regarding surface hazards around the transfer supports. No public comments were submitted on this issue, but the MDE Advisory Committee voiced concern about surface hazards stating, “gripping surface configurations must provide an effective and safe surface for patients to hold onto. Sharp edges or abrasive elements may injure and cause the patient to lose their grip during positioning or transfer.” The MDE Advisory Committee recommended that a provision be added to the final rule requiring “gripping surfaces to be free of sharp or abrasive elements and have rounded edges.” The Committee based this recommendation on related provisions in the 2004 ADA and ABA Accessibility Guidelines for handrails and grab bars. MDE Advisory Committee Report, 101, 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 MDE Advisory Committee’s recommendation and views the proposed provision as beneficial and consistent with the cross section requirements of M305.2.4, above. Therefore, the Access Board has added a new provision to the final rule, M305.2.5 Surface Hazards, to ensure that transfer supports and surfaces adjacent to transfer supports are free of sharp or abrasive components and have eased edges.

M305.2.6 Gripping Surfaces (Section-by-Section Analysis)

The proposed rule did not provide any specific requirements regarding gripping surfaces on transfer supports. However, in the MDE NPRM preamble the Access Board repeatedly noted that it was considering applying many of the provisions from the 2004 ABA and ADA Accessibility Guidelines for grab bars and handrails to transfer supports. NPRM, 77 FR at 6924-6926. The MDE Advisory Committee explained that:

• [t]ransfer supports may contain elements to provide structural support or prevent patient entrapment. The elements, bars, pickets, spacers, panels, and similar features, connect to the transfer support and may interrupt the gripping surface. At the point of connection, these features impede the ability to grasp completely around the cross section of the gripping surface. MDE Advisory Committee Report, 102, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee recommended requiring the bottom of the transfer support to have no obstructions affecting more than 20 percent of the transfer support’s length. Id.

The Access Board concurs with the recommendation of the MDE Advisory Committee and views the proposed provision as beneficial and consistent with the existing accessibility guidelines. Therefore, the Access Board has added this new provision to the final rule, M305.2.6, which ensures that an adequate surface area for gripping is provided to the patient.

M305.2.7 Clearance (Section-by-Section Analysis)

In the MDE NPRM, the Access Board did not provide any specific requirements for clearances around the transfer support. However, in the preamble to the MDE NPRM the Access Board noted that it was considering applying the 2004 ADA and ABA Accessibility Guidelines for clearance around grab bars to the transfer support provision in the final rule. NPRM, 77 FR at 6926. Specifically, the Access Board sought input from the public in question 22, on whether transfer supports on diagnostic equipment could provide 1½ inches minimum clearance around the gripping surface. Id. Two commenters responded, both manufacturers, and indicated that transfer supports could provide 1½ inches minimum clearance around the transfer support. The MDE Advisory Committee concurred with the commenters and expressed support for the use of the 2010 ADA Standards and International Building Code Requirements (ICC/ANSI A117.1-2009), and recommended adding the requirements to the final rule. MDE Advisory Committee Report, 100, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

Based on public commenter responses and MDE Advisory Committee recommendations, the Access Board has added a new provision to the final rule, M305.2.7, requiring a 1½ inch minimum clearance between the transfer support gripping surface and adjacent surfaces or obstructions.

M305.2.8 Fittings (Section-by-Section Analysis)

The MDE NPRM proposed to require that transfer supports not rotate in their fittings (proposed M305.2.3). Five commenters addressed this provision. Four of the commenters disagreed with this requirement and explained the need for transfer supports to be able to rotate in their fittings. Specifically, one commenter (manufacturer) asserted that the technical criteria from the 2004 ADA and ABA Accessibility Guidelines for grab bars in bathrooms should not be applied to exam tables as they would restrict the ability for the transfer supports to be moved out of the way after transfer. Further, this commenter noted that the requirement conflicts with proposed M302.2.3, which allows for temporary obstructions such as armrests, footrests, and side rails that can be repositioned to allow for transfer. Another commenter (manufacturer) pointed out that bed rails, which are common on hospital beds, require a latched position and an unlatched position, which allows them to rotate in their fittings when not latched. A different manufacturer stated that its seated diagnostic equipment uses armrests as transfer supports, which can be pushed back toward the rear of the equipment to allow entry. An accessibility consultant recommended swing-away or removable armrests for chairs to allow for transfer on either side. The only commenter (accessibility consultant) opposed to allowing transfer supports to rotate in their fittings, expressed concern for the potential for injury if transfer supports rotated unexpectedly during transfer.

The MDE Advisory Committee recommended amending this provision to allow transfer supports to rotate in their fittings, but to require that they not rotate when they are locked into place for transfer. The Committee noted that it is advantageous to allow supports to perform the needed movement, but they should not do so when locked. MDE Advisory Committee Report, 102-103, 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 majority of the commenters and the MDE Advisory Committee. As noted in proposed M302.2.3, the Access Board intended to allow manufacturers to provide temporary obstructions such as armrests and bedrails that can be repositioned, or rotate in their fittings, and then be locked into place when needed as a transfer support. Therefore, the Access Board has revised this provision in the final rule to require that transfer supports do not rotate in their fittings when in place for transfer (M305.2.8).