36 CFR Part 1195 Proposed Accessibility Standards for Medical Diagnostic Equipment NPRM - Preamble

5. Discussion of Proposed Standards

The proposed standards consist of three chapters. Chapter M1 addresses the application and administration of the proposed standards. Chapter M2 addresses scoping. Chapter M3 contains the technical criteria. The sections in each chapter are discussed below. Although the standards do not impose any mandatory requirements on health care providers or medical device manufacturers, the standards use mandatory language (i.e., shall) because other agencies, referred to as an enforcing authority in the standards, may issue regulations or adopt policies that require health care providers subject to their jurisdiction to acquire accessible medical diagnostic equipment that conforms to the standards. Sections marked as advisory provide guidance on the standards and are not mandatory.

The Access Board is committed to writing standards that are clear, concise, and easy to understand so that persons who use the standards know what is required.

Question 4. Is there language in the proposed standards that is ambiguous or not clear? Comments should identify specific language in the proposed standards that is ambiguous or not clear and, where possible, recommend alternate language that is clear.

Chapter M1 Application and Administration

M101.1 Purpose

The proposed standards contain technical criteria for medical diagnostic equipment that is accessible to and usable by patients with disabilities. The standards provide for independent access to and use of diagnostic equipment by patients with disabilities to the maximum extent possible.

M101.2 Application

As discussed above under Organization of Technical Criteria, the technical criteria are to be applied to medical diagnostic equipment based on the following patient positions that the equipment is designed to support:

• Equipment used by patients in a supine, prone, or side-lying position (see M301);

• Equipment used by patients in a seated position (see M302);

• Equipment used by patients seated in a wheelchair (see M303); and

• Equipment used by patients in a standing position (see M304).

The diagnostic equipment’s labeling, instructions, and promotional material usually identify the patient positions that the equipment is designed to support. Where diagnostic equipment is designed to support more than one patient position, the technical criteria for each patient position supported are to be applied to the equipment. Advisory M101.2 includes examples of diagnostic equipment designed to support more than one patient position and the technical criteria that apply to the equipment.

M101.3 Equivalent Facilitation

The use of alternative designs and technologies that result in substantially equivalent or greater accessibility than specified in the proposed standards is permitted. Generally, alternative designs or technologies that rely on assisted transfer only (e.g., use of a patient lift) are not permitted because they do not provide for independent access to and use of diagnostic equipment by patients with disabilities to the maximum extent possible. However, the standards include technical criteria for clearance in or around the base of the equipment for lift compatibility to allow the use of a patient lift by patients with disabilities for whom independent transfer may not be possible, and the use of alternative designs or technologies for lift compatibility is permitted.

M101.4 Dimensions

The standards are based on adult dimensions and anthropometrics. Dimensions that are not stated as “maximum” or “minimum” are absolute.

M101.5 Dimensional Tolerances

Dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions.

Question 5. What information or resources are available concerning conventional industry tolerances for manufactured equipment such as medical diagnostic equipment?

M102.1 Defined Terms

The following terms are defined in the proposed standards: Enforcing authority, medical diagnostic equipment, operable parts, and transfer surface.

The definition of medical diagnostic equipment is based on Section 510 of the Rehabilitation Act and means equipment used in or in conjunction with medical settings by health care providers for diagnostic purposes. For convenience purposes, the shorter term diagnostic equipment is used in place of medical diagnostic equipment after that term is first used in the standards. Examination tables, examination chairs, weight scales, mammography equipment, and other imaging equipment are examples of diagnostic equipment to which the standards apply.

The definitions of enforcing authority, transfer surface, and operable parts are discussed respectively under M201.1; M301.2 and M302.2; and M307.

Question 6. Should other terms in the proposed standards be defined? Comments should identify specific terms in the proposed standards that should be defined and, where possible, recommend definitions.

M102.2 Undefined Terms

Collegiate dictionaries are used to define terms that are not defined in the proposed standards or in regulations or policies issued by the enforcing authority.

M102.3 Interchangeability

Singular and plural words, terms, and phrases are used interchangeably.

Chapter M2 Scoping

M201.1 Enforcing Authority

The proposed standards do not include scoping requirements that specify the minimum number of types of accessible diagnostic equipment required in different types of health care facilities because Section 510 of the Rehabilitation Act authorizes the Access Board to issue only technical criteria. Other agencies, referred to as an enforcing authority in the standards (see defined terms in M102.1), may adopt the standards as mandatory requirements for entities subject to their jurisdiction. An enforcing authority can be a federal, state, or local government agency that enforces laws prohibiting discrimination on the basis of disability, or regulates health care facilities. As discussed above under Department of Justice Activities Related to Health Care Providers and Medical Equipment, DOJ issued an ANPRM in July 2010 announcing that it was considering amending its regulations implementing Titles II and III of the ADA to specifically require health care providers to acquire accessible medical equipment and that it would consider adopting the standards issued by the Access Board. DOJ also indicated its intention to include in its ADA regulations scoping requirements that specify the minimum number of types of accessible medical equipment required in different types of health care facilities.

Chapter M3 Technical Criteria

Chapter M3 provides technical criteria for accessible diagnostic equipment based on the patient positions that the equipment is designed to support, including equipment used by patients in a supine, prone, or side-lying position (see M301); equipment used by patients in a seated position (see M302); equipment used by patients seated in a wheelchair (see M303); and equipment used by patients in a standing position (see M304). Chapter M3 also provides technical criteria for supports (see M301.3, M302.3, M304.3, and M305); instructions and information communicated to patients though diagnostic equipment (see M306); and operable parts used by patients (see M307). The technical criteria specify measurements in inches and millimeters. The values stated in each system may not be exact equivalents, and each system should be used independently of the other. When discussing the technical criteria below, the measurements are stated in inches only.

Figures showing example applications of the technical criteria to diagnostic equipment are available on the Access Board’s web site at: http://www.access-board.gov/medical-equipment.htm. The figures are provided to help readers understand how the technical criteria apply to diagnostic equipment.

Question 7. Comments are requested on whether the figures can be improved to help readers better understand how the technical criteria apply to diagnostic equipment.

Sources for Technical Criteria

The sources discussed below were used to develop the technical criteria.

2004 ADA and ABA Accessibility Guidelines

The Access Board has developed and updated accessibility guidelines for buildings and facilities for over 30 years. The Access Board’s current guidelines for buildings and facilities were issued in 2004 and are known as the Americans with Disabilities Act and Architectural Barriers Act Accessibility Guidelines (hereinafter referred to as the “2004 ADA and ABA Accessibility Guidelines”). The 2004 ADA and ABA Accessibility Guidelines are codified at 36 CFR part 1191 and are available at: http://www.access-board.gov/ada-aba/final.cfm.

The following technical criteria in the proposed standards are based on the 2004 ADA and ABA Accessibility Guidelines:

• Height of transfer surfaces on diagnostic equipment used by patients in a supine, prone, or side-lying position and diagnostic equipment used by patients in a seated position (see M301.2.1 and M302.2.1);

• Wheelchair spaces, including knee and toe clearance, and change in level at entry to the wheelchair spaces at diagnostic equipment used by patients seated in a wheelchair (see M303.2 and M303.3);

• Structural strength of transfer supports (see M305.2.2); and

• Operable parts (see M307).

The Access Board is also considering additional technical criteria based on the 2004 ADA and ABA Accessibility Guidelines for cross section dimensions and clearances around gripping surfaces on transfer and standing supports, and for reach ranges for operable parts on diagnostic equipment that are used by patients. Questions are included under the applicable sections requesting comments on whether the additional technical criteria under consideration would be appropriate for the equipment features or whether alternative technical criteria would be appropriate.

Wheeled Mobility Anthropometry Project

There have been dramatic changes in mobility devices and the characteristics of people who use these devices. The Access Board and the National Institute on Disability and Rehabilitation Research sponsored a Wheeled Mobility Anthropometry Project to collect measurements of approximately 500 people using a variety of mobility devices, including manual wheelchairs, power wheelchairs, and scooters. The Wheeled Mobility Anthropometry Project was conducted by the Center for Inclusive Design and Environmental Access. The final report on the Wheeled Mobility Anthropometry Project was issued in 2010 and is available at: http://www.udeworld.com/anthropometrics.html.

Data from the Wheeled Mobility Anthropometry Project showed that the seat heights of many mobility devices are above the range specified in the 2004 ADA and ABA Accessibility Guidelines for certain architectural features that involve transfers and that the dimensions for wheelchair spaces, including knee and toe clearance, do not accommodate many people in the sample. Data from the Wheeled Mobility Anthropometry Project also showed that many people in the sample needed a lower operating force to activate certain operable parts. The Wheeled Mobility Anthropometry Project included recommendations for specifications that would accommodate a broader range of people who use mobility devices. The data and recommendations from the Wheeled Mobility Anthropometry Project are discussed in connection with the following technical criteria:

• Height of transfer surfaces on diagnostic equipment used by patients in a supine, prone, or side-lying position and diagnostic equipment used by patients in a seated position (see M301.2.1 and M302.2.1);

• Wheelchair spaces, including knee and toe clearance, at diagnostic equipment used by patients while seated in a wheelchair (see M303.2); and

• Operating force required to activate operable parts used by patients (see M307.4).

The Access Board is considering specifying alternative technical criteria in the final standards based on the Wheeled Mobility Anthropometry Project. Questions are included under the applicable sections requesting comments on the alternative technical criteria.

ANSI/AAMI HE 75

As discussed in the relevant sections below, the Access Board considered the recommended practices regarding accessibility in Chapter 16 of ANSI/AAMI HE 75 in developing the technical criteria. The technical criteria are generally consistent with and supplement the recommended practices in ANSI/AAMI HE 75.

Other Sources

The Access Board used anthropometric data and other standards for the width of transfer surfaces on diagnostic equipment used by patients in a seated position (see M302.2.2), height of breast platforms on mammography equipment used by patients seated in a wheelchair (see M303.4.1), and standing supports in a vertical position for diagnostic equipment used by patients in a standing position (see M305.3.2). The sources are referenced in the relevant sections below.

The Access Board also considered information provided at the July 2010 public meeting that featured panel discussions and presentations by experts and researchers on medical equipment accessibility, health care providers, medical device manufacturers, and other interested parties. The transcript of the meeting is available at: http://www.access-board.gov/medical-equipment.htm. In addition, the Access Board considered public comments relating to medical equipment that were submitted in response to DOJ’s ANPRM on equipment and furniture. The public comments on DOJ’s ANPRM on equipment and furniture are available at http://www.regulations.gov (Docket ID: DOJ-CRT−2010‒0008).

Economic and Technical Impacts

The technical criteria in Chapter 3 address the features that make diagnostic equipment accessible to and usable by patients with disabilities. Comments are requested on the economic and technical impacts of the technical criteria in questions that follow the discussion of the technical criteria. Comments are welcomed from all sources. Manufacturers that currently incorporate accessible features in some of their products or plan to do so in the future are encouraged to comment particularly on Questions 8, 9, and 10. The Access Board will use the information provided in response to the questions to evaluate the economic and technical impacts of the technical criteria.

Question 8. To what extent does diagnostic equipment currently incorporate features that conform to the technical criteria proposed in Chapter M3? If equipment conforms to some but not all of the technical criteria proposed in Chapter M3, the comments should identify which features conform to the technical criteria proposed in Chapter M3.

Question 9. If diagnostic equipment does not currently incorporate features that conform to all the technical criteria proposed in Chapter M3, which technical criteria can be easily incorporated into the design or redesign and manufacture of equipment with little difficulty or expense? Which technical criteria would have the greatest incremental costs on the design or redesign and manufacture of equipment? Comments should include estimates of the incremental costs, where possible.

Question10. How often is diagnostic equipment redesigned? Would incorporating features that conform to the technical criteria proposed in Chapter M3 in the planned redesign of equipment lessen the economic and technical impacts?

Question 11. Are there types of diagnostic equipment that cannot conform to certain technical criteria proposed in Chapter M3 because of the structural or operational characteristics of the equipment?

Comments should identify the specific technical criteria which the equipment cannot conform to and discuss alternative methods for making the equipment accessible to patients with disabilities.

Question 12. Do the technical criteria proposed in Chapter M3 have any positive or negative unintended consequences?

M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position; M302 Diagnostic Equipment Used by Patients in Seated Position

M301 provides technical criteria for diagnostic equipment used by patients in a supine, prone, or sidelying position, and M302 provides technical criteria for diagnostic equipment used by patients in a seated position. The purpose of these sections is to facilitate independent transfer onto and off of diagnostic equipment by patients with disabilities, including those who use mobility devices or aids, and to provide supports for patients with disabilities when positioning their bodies on the equipment. The sections also include provisions for clearance in and around the base of the equipment for lift compatibility to allow the use of a patient lift by patients with disabilities for whom independent transfer may not be possible. Except for the size of the transfer surface (see M301.2.2 and M302.2.2) and certain supports (see M301.3.2 for stirrups, and M302.3.2 for armrests), the technical criteria in these sections are the same and are discussed together below. The technical criteria for transfer surface size and for stirrups and armrests are discussed separately for diagnostic equipment used by patients in a supine, prone, or sidelying position and for diagnostic equipment used by patients in a seated position.

Transfer Surface (M301.2 and M302.2)

The technical criteria in M301.2 and M302.2 address the height and size of the transfer surface, and the transfer sides. The transfer surface is the part of the diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment (see defined terms in M102.1). Depending on the configuration of the equipment, the transfer surface may coincide with the seat area of an examination chair, or occupy only a portion of an examination table or imaging bed platform. The technical criteria do not address the overall width and depth of patient support surfaces because of the diverse shape and size of these surfaces.

Transfer Surface Height (M301.2.1 and M302.2.1)

For many patients who use mobility devices, independent transfer is possible only if the height of the transfer surface is at or near the seat height of their mobility device. The transfer surface height is also critical for patients who use mobility aids such as walkers and canes and may find it difficult to get up onto or down from an examination chair or table or imaging bed platform, and for facilitating assisted transfers.

M301.2.1 and M302.2.1 would require the height of the transfer surface during patient transfer to be 17 inches minimum and 19 inches maximum measured from the floor to the top of the transfer surface. This height range is based on provisions in the 2004 ADA and ABA Accessibility Guidelines for architectural features that involve transfers (e.g., toilet seats, shower seats, dressing benches). Patient support surfaces can be adjusted to heights outside the specified dimensions when not needed for patient transfer such as when performing diagnostic procedures.

Where patient support surfaces are contoured or upholstered for patient comfort or to support patient positioning during diagnostic procedures, the height of the transfer surface measured from the floor may vary across the transfer surface. The highest and lowest points of the transfer surface on such equipment would have to be within the specified dimensions.

Where patient support surfaces are cushioned (e.g., polyurethane on top of cell foam), the upholstery may compress or deflect during use. If the height of the transfer surface is measured from the floor to the rigid platform under the cushion, the top of the upholstery may be outside the specified dimensions. Measuring the height of the transfer surface from the floor to the top of the upholstery under static conditions, without compression or deflection in the transfer surface, would provide a consistent method of measurement given the variety of materials used to cushion patient support surfaces and the differences in how the materials compress or deflect during use.

Question 13. Should the technical criteria specify that the height of the transfer surface from the floor be measured to the top of the upholstery under static conditions, without compression or deflection in the transfer surface? Or should the technical criteria allow for more dynamic conditions and limit the amount of deflection permitted when a specific load is applied to the transfer surface?

Adjustable Height Range Considered

The technical criteria allow the height of transfer surfaces to be either fixed or adjustable within the 17 inches minimum and 19 inches maximum range. Based on the information discussed below, the Access Board is considering requiring in the final standards that the height of transfer surfaces be adjustable from 17 inches minimum to 25 inches maximum during patient transfer. Patient support surfaces can be adjusted outside this range when not needed for patient transfer such as when performing diagnostic procedures.

Many types of diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position currently provide adjustable height patient support surfaces. ANSI/AAMI HE75 recommends that the height of patient support surfaces “should be easy to adjust (ideally, powered) to suit the needs of health care professionals and patients.” ANSI/AAMI HE75 further recommends that the height of patient support surfaces “should be adjustable to a position high enough to accommodate tall health care providers and the range of medical procedures that could occur . . . [and] to a position low enough [19 inches maximum] to allow for the comfort of providers who choose to work in a seated position, to enable patients to keep their feet on the floor while seated, and to accommodate patients who need to transfer laterally between the platform and a chair or wheelchair alongside.” See ANSI/AAMI HE 75, section 16.4.4.

Transfer surfaces that are adjustable to the same heights as the seat heights of mobility devices reduce the effort needed to transfer since patients do not have to lift their body weight to make up the difference between the two surfaces, in one direction or the other. The Wheeled Mobility Anthropometry Project shows the occupied seat heights for people who use mobility devices vary considerably. See Analysis of Seat Heights for Wheeled Mobility Devices at: http://udeworld.com/analysis-of-seat-height-for-wheeled mobility-devices. The seat heights ranged from 16.3 inches to 23.9 inches for manual wheelchair users; 16.2 inches to 28.9 inches for power wheelchair users; and 18.8 inches to 25.3 inches for scooter users. Seat heights for males were typically higher than for females. Thirty (30) percent of male manual wheelchair users and 6 percent of male power wheelchair users had seat heights equal to or less than 19 inches. 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. Thus, transfer surfaces that are adjustable from 17 inches minimum to 25 inches maximum during patient transfer accommodate significantly more patients who use mobility devices.

Ideally, transfer surfaces should be adjustable to any height within the 17 inches minimum and 25 inches maximum range. However, intermediate heights may need to be established within the range because of different methods for providing adjustability (e.g., power, mechanical) or other equipment limitations. The distance between the intermediate heights should be small.

Question 14. Comments are requested on the following questions regarding the adjustable height range (17 inches minimum to 25 inches maximum during patient transfer) that the Access Board is considering requiring in the final standards for transfer surfaces on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position:

1. What types of equipment currently provide patient support surfaces that are height adjustable? If there are several models of the same type of equipment, does at least one model provide patient support surfaces that are height adjustable? What is the range of adjustable heights? If the range of adjustable heights does not include 17 inches to 25 inches, what would be the incremental costs to achieve this range?

2. What types of equipment do not currently provide patient support surfaces that are height adjustable? What would be the incremental costs for the design or redesign and manufacture of the equipment to provide patient support surfaces that are height adjustable within the above range?

3. Are there types of equipment that cannot provide patient support surfaces that are height adjustable within the above range because of the structural or operational characteristics of the equipment? Comments should discuss alternative methods for making the equipment accessible to patients with disabilities.

4. Should intermediate heights be established within the above range? What intermediate heights within the above range would be appropriate to facilitate independent transfer by patients who use mobility devices and aids?

Transfer Surface Size: Equipment Used by Patients in Supine, Prone, or Side-Lying Position (M301.2.2)

As noted earlier, the technical criteria do not address the overall width and depth of patient support surfaces because of the diverse shape and size of these surfaces. ANSI/AAMI HE75 recommends that patient support surfaces “should allow patients to transfer themselves on and off safely and easily and to assume and maintain positions safely and comfortably.” For surfaces on which patients lie down, ANSI/AAMI HE75 recommends that “patients should be able to roll to a side or prone position with minimal need to lift or shift their center of gravity.” ANSI/AAMI HE75 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. See ANSI/AAMI HE 75, section 16.4.7.

On diagnostic equipment used by patients in a supine, prone, or side-lying position, M301.2.2 would require the size of the transfer surface (i.e., part of the diagnostic equipment onto which patients who use mobility devices or aids transfer when moving onto and off of the equipment) to be 30 inches wide minimum and 15 inches deep minimum. The 30 inches minimum width is based on comments submitted by the Disability Rights Education and Defense Fund (DREDF) regarding medical equipment dimensions in response to DOJ’s ANPRM on equipment and furniture. The 30 inches minimum width and 15 inches minimum depth also are generally consistent with the dimensions specified in the 2004 ADA and ABA Accessibility Guidelines for rectangular seats in roll-in showers.

The transfer surface dimensions do not include headrests, footrests, or similar supports for body extremities that do not support the patient’s overall body position. A transfer surface is permitted to be contoured; however, the minimum dimensions would have to fit within the contoured surface and cannot be reduced to accommodate an asymmetrical shape.

As discussed under the technical criteria for transfer sides (see M301.2.3 and M302.2.3), the transfer surface would be located at a corner of the diagnostic equipment (e.g., foot of an examination table) to allow different approaches to the surface and a variety of transfers. The Access Board is considering requiring in the final standards that transfer surfaces be provided at more than one location on diagnostic equipment used by patients in a supine, prone, or side-lying position to accommodate the different ways patients with disabilities may transfer and reposition their bodies from a sitting to a lying position on such equipment.

Question 15. Comments are requested on the following questions regarding the minimum dimensions (30 inches wide and 15 inches deep) proposed for the transfer surface on diagnostic equipment used by patients in a supine, prone, or side-lying position and whether transfer surfaces should be provided at more than one location on such equipment:

a) Do the above dimensions provide sufficient space for patients with disabilities to safely and easily transfer to the equipment?

b) Should the width of the patient support surface be at least as wide as the width of the transfer surface (30 inches minimum) to allow patients with disabilities to reposition their bodies to a lying down position and maintain positions safely and comfortably? What would be the incremental costs for the design or redesign and manufacture of the equipment to make the patient support surface at least as wide as the width of the transfer surface?

c) Would alternative dimensions be appropriate for transfer surfaces? Comments should include information on sources to support alternative dimensions, where possible.

d) Should an adjustable feature (e.g., extendable platform) be permitted to meet the transfer surface dimensions?

e) If transfer surfaces are required to be provided at more than one location on the equipment, where should the transfer surfaces be located?

Transfer Surface Size: Equipment Used by Patients in a Seated Position (M302.2.2)

Seats on diagnostic equipment used by patients in a seated position typically provide back and arm support for patient comfort and stability. The space available for transfer on diagnostic equipment used by patients in a seated position is smaller than the space available on diagnostic equipment used by patients in a supine, prone, or side-lying position.

On diagnostic equipment used by patients in a seated position, M302.2.2 would require the size of the transfer surface to be 21 inches wide minimum and 15 inches deep minimum. The 21 inches minimum width is based on the ideal chair width recommended in Architectural Graphic Standards for auditorium seating. See The American Institute of Architects, Architectural Graphic Standards (10th edition, 2000), page 919. The 15 inches minimum depth is generally consistent with the dimension specified in the 2004 ADA and ABA Accessibility Guidelines for rectangular seats in roll-in showers.

The transfer surface dimensions do not include headrests, footrests, or similar supports for body extremities that do not support the patient’s overall body position. A transfer surface is permitted to be contoured; however, the minimum dimensions would have to fit within the contoured surface and cannot be reduced to accommodate an asymmetrical shape.

Question 16. Comments are requested on the following questions regarding the minimum dimensions (21 inches wide and 15 inches deep) proposed for the transfer surface on diagnostic equipment used by patients in a seated position:

a) Do the above dimensions provide sufficient space for patients with disabilities to safely and easily transfer to the equipment?

b) Would alternative dimensions be appropriate for transfer surfaces? Comments should include information on sources to support alternative dimensions, where possible.

Transfer Sides (M301.2.3 and M302.2.3)

M301.2.3 and M302.2.3 would require the transfer surface to be located so as to provide patients who use mobility devices the option to transfer onto the short side and the long side of the surface, and that each transfer side provide unobstructed access to the transfer surface. These sections would result in the transfer surface being located at a corner of the equipment and the two transfer sides adjoining at the edges of the equipment (e.g., foot of an examination table). Patients who use mobility devices would have the choice to approach parallel to the deep dimension of the transfer surface, parallel to the wide dimension of the transfer surface, or at an angle to the corner of the transfer surface and be able to perform a variety of transfers. Locating the transfer surface at a corner of the equipment and providing unobstructed access to the two transfer sides also would facilitate assisted transfers. Enforcing authorities may specify the clear floor space to be provided adjacent to the transfer sides of equipment in health care facilities.

The transfer sides are permitted to be obstructed temporarily by features such as armrests, side rails, footrests, and stirrups provided they can be repositioned (e.g., folding armrests, removable side rails, retractable footrests and stirrups) to permit transfer. This is consistent with ANSI/AAMI HE 75 which recommends that “side rails, arm rests, leg supports . . . should be positioned, or able to be moved out of the way, so as not to interfere with the ability of users to transfer.” See ANSI/AAMI HE 75, section 16.4.5. Otherwise, no part of the equipment can project beyond the edge of the transfer sides and obstruct access to the transfer surface. This is consistent with ANSI/AAMI HE 75 which recommends that the “base of any patient-support platform should not extend horizontally beyond the edge of the support surface . . . [and] should not impede a patient’s ability to orient a wheelchair next to the support surface.” See ANSI/AAMI HE 75, section 16.4.2.

The Access Board is considering whether the final standards should permit equipment parts to extend horizontally 3 inches maximum beyond the edge of the transfer sides provided they do not extend above the top of the transfer surface. This would allow handholds and other features which may facilitate transfer to be located on the transfer sides. The 2004 ADA and ABA Accessibility Guidelines provide a gap of 3 inches between the edge of a shower seat and the shower compartment entry, and the gap does not appear to interfere with transferring onto and off of the shower seat.

Question 17. Comments are requested on the following questions regarding obstructions on the transfer sides:

a) Should equipment parts be permitted to extend horizontally 3 inches maximum beyond the edge of the transfer sides provided they do not extend above the top of the transfer surface?

b) If equipment parts are not permitted to extend horizontally 3 inches maximum beyond the edge of the transfer sides, would any diagnostic equipment need to be redesigned?

Supports (M301.3, M302.3, and M305.2)

ANSI/AAMI HE 75 recommends that handholds be “integrated into the device . . . [to] increase safety and assist patients in transferring on and off, positioning or repositioning their bodies, and maintaining static position.” See ANSI/AAMI HE 75, section 16.4.6. M301.3, M302.3, and M305.2 provide technical criteria for transfer and positioning supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position. Some supports such as armrests and side rails can be used for transferring and positioning. As discussed under M301.2.3 and M302.2.3, transfer and positioning supports on the transfer sides of transfer surfaces would have to be capable of being repositioned (e.g., folding armrests, removable side rails, retractable footrests and stirrups) to permit transfer.

Transfer Supports (M301.3.1, M302.3.1, and M305.2)

M301.3.1 and M302.3.1 would require transfer supports to be provided for use with the transfer sides. M305.2.1 would require the transfer supports to be located within reach of the transfer surface and not obstruct transfer onto the surface when in position. M305.2.2 would require the transfer supports and their connections to be capable of resisting vertical and horizontal forces of 250 pounds applied to all points of the transfer support. M305.2.3 would require the transfer supports to not rotate within their fittings. These technical criteria are based on provisions in the 2004 ADA and ABA Accessibility Guidelines for grab bars.

Question 18. Comments are requested on the following questions regarding the structural strength of transfer supports:

a) Are transfer supports that can be repositioned (e.g., folding armrests, removable side rails) currently capable of resisting vertical and horizontal forces of 250 pounds applied to all points of the transfer support? If the transfer supports are not currently capable of resisting these forces, what would be the incremental costs for the design or redesign and manufacture of the equipment to provide transfer supports that are capable of resisting these forces?

b) Would alternative technical criteria be appropriate for the structural strength of transfer supports? Comments should include information on sources to support the alternative technical criteria, where possible.

Additional Technical Criteria Considered for Transfer Supports

As discussed below, the Access Board is considering whether additional technical criteria would be appropriate for transfer supports.

Location and Size

Midmark Corporation provided information based on input from accessibility experts regarding side rails on examination tables in comments submitted in response to the DOJ’s ANPRM on equipment and furniture. The side rails are similar in shape to grab bars and are located on each of the long sides of the table. Each side rail can be removed to permit patients to transfer onto and off of the table, and to permit health care personnel to perform diagnostic procedures. The side rails can also be relocated along the table surface (from foot-end to head-end) for patients to position or reposition their bodies, and to maintain static positions. The side rails are 20 inches minimum in length, 6 inches minimum in height above the table surface, and 1 inch measured horizontally from the adjacent edge of the table surface.

The Access Board is considering whether the following technical criteria would be appropriate for the location and size of transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position:

• At least one transfer support would be provided on the side of the transfer surface that is 15 inches deep minimum. The transfer support would be located on the side of the transfer surface that is opposite the transfer side (see M301.2.3 and M302.2.3) similar to the provisions in the 2004 ADA and ABA Accessibility Guidelines for grab bars provided at bathtubs and shower compartments with seats. This would be a minimum requirement. Where possible, it is recommended that supports be provided on each side of the transfer surface that is 15 inches deep minimum for patients to maintain position after they have transferred onto the equipment, and that the supports be repositionable to permit transfer.

• The transfer support would extend horizontally the entire depth of the transfer surface and would be 15 inches minimum in length.

• The gripping surface of the transfer support would be located 1½ inches maximum measured horizontally from the adjacent edge of the transfer surface. This would ensure that the transfer support is within reach and can be effectively used during transfers.

The above technical criteria would likely result in the transfer surface being located at the foot end of examination tables and allow the use of transfer supports similar to the side rails described in the information provided by Midmark Corporation.

Question 19. Comments are requested on the following questions regarding the above technical criteria for the location and size of transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position:

a) Are the above technical criteria for the location and size of transfer supports sufficient to facilitate transfer and maintain position on the equipment?

b) Can transfer supports on different types of equipment meet the above technical criteria for the location and size of the supports?

c) What would be the incremental costs for the design or redesign and manufacture of transfer supports that meet the above criteria?

d) Would alternative technical criteria be appropriate for the location and size of transfer supports? Comments should include information on sources to support the alternative technical criteria, where possible.

e) Should angled or vertical transfer supports be permitted?

Height

The Access Board is considering whether 6 inches minimum and 19 inches maximum above the transfer surface would be an appropriate height for transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position. The minimum height is consistent with the information provided by Midmark Corporation on examination table side rails, and the maximum height is generally consistent with the height of grab bars above shower seats in the 2004 ADA and ABA Accessibility Guidelines.

Question 20. Comments are requested on the following questions regarding the above height range (6 inches minimum and 19 inches maximum above the transfer surface) for transfer supports on diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position:

a) Are transfer supports within the above height range usable by patients with disabilities?

b) Can transfer supports on different types of equipment meet the above height range?

c) Would alternative technical criteria be appropriate for the height of transfer supports? Comments should include information on sources to support the alternative technical criteria, where possible.

Cross Section of Gripping Surfaces

The 2004 ADA and ABA Accessibility Guidelines specify the following dimensions for grab bars to enable individuals with disabilities to firmly grasp the grab bars and support themselves during transfers:

• Grab bars with circular cross sections must have an outside diameter of 1¼ inches minimum and 2 inches maximum.

• Grab bars with non-circular cross sections must have a cross section dimension of 2 inches maximum and a perimeter dimension of 4 inches minimum and 4.8 inches maximum.

The Access Board is considering whether the above cross section dimensions would be appropriate for the gripping surfaces of transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position.

Question 21. Comments are requested on the following questions regarding the above cross section dimensions for the gripping surfaces of transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position:

a) Can the gripping surfaces of transfer supports on different types of equipment meet the above cross section dimensions?

b) Can handholds that meet the above cross section dimensions be integrated into the design of armrests that are cushioned to support arms and elbows?

c) Are there alternative designs for the gripping surfaces of transfer supports that enable patients with disabilities to firmly grasp the supports and support themselves during transfer?

Clearances Around Gripping Surfaces

The 2004 ADA and ABA Accessibility Guidelines specify the following clearances around grab bars to ensure sufficient space for a person to grasp the grab bar: 1½ inches absolute clearance between grab bars and the adjacent wall surfaces; 1½ inches minimum clearance between grab bars and projecting objects below and at the ends of grab bars; and 12 inches minimum clearance between grab bars and projecting objects above grab bars.

The Access Board is considering whether 1½ inches minimum clearance around the gripping surface would be appropriate for transfer supports on diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position.

Question 22. Can transfer supports on different types of equipment provide 1½ inches minimum clearance around the gripping surface?

Stirrups (M301.3.2)

Where stirrups are provided on diagnostic equipment used by patients in a supine, prone, or side-lying position, M301.3.2 would require the stirrups to provide a method of supporting, positioning, and securing the patient’s legs. This is consistent with ANSI/AAMI HE75 which recommends that “[f]or patients with limited leg strength and control, instead of stirrups that support only the foot and require active user leg strength, leg supports that support both the foot and the leg should be used to assist patients in keeping their legs in an appropriate position.” See ANSI/AAMI HE 75, section 16.4.7 (g).

Question 23. Comments are requested on the following questions regarding stirrups:

a) What would be the incremental costs for the design or redesign and manufacture of stirrups that provide a method of supporting, positioning, and securing the patient’s legs?

b) Should diagnostic equipment used by patients in a seated position that provide stirrups such as urodynamics study chairs be required to provide a method of supporting, positioning, and securing the patient’s legs?

Armrests (M302.3.2)

M302.3.2 would require armrests to be provided on diagnostic equipment used by patients in a seated position. This is consistent with ANSI/AAMI HE75 which recommends that “[f]or support surfaces that require the patient to assume a seated position, armrests should be provided to enhance patient comfort, stability, and ease of transfer.” See ANSI/AAMI HE 75, section 16.4.7 (e). Where armrests serve as transfer supports, the armrests would be required to meet the technical criteria in M305.2 for the location and structural strength of transfer supports. Otherwise, there are no technical criteria for armrests.

Head and Back Support (M301.3.3 and M302.3.3)

Where diagnostic equipment used by patients in a supine, prone, or side-lying position, and diagnostic equipment used by patients in a seated position can be adjusted to reclined positions, M301.3.3 and M302.3.3 would require head and back support to be provided throughout the entire range of the incline. This is consistent with ANSI/AAMI HE75 which recommends that the “support surface needs to be adjustable or have adjustable support features (e.g., for the head, neck, back, lumbar region, leg, knee, and foot, as appropriate) to support patients in various postures and body positions in a manner that optimizes their comfort.” See ANSI/AAMI HE 75, section 16.4.7 (h). Although not required by the proposed standards, examination tables that can be adjusted to a sitting position and then reclined to a horizontal position may be easier for patients with disabilities to transfer onto and off of than examination tables that are horizontal only.

Positioning Supports Considered

The Board is considering requiring in the final standards positioning supports such as rails, bars, or panels with handholds to be provided along the sides of diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position that can be adjusted to a reclined position. As noted above, ANSI/AAMI recommends that handholds be “integrated into the device . . . [to] increase safety and assist patients in transferring on and off, positioning or repositioning their bodies, and maintaining static position.” See ANSI/AAMI HE 75, section 16.4.6. Pillows, wedges, and other padding can be used to stabilize and position patients on diagnostic equipment, but are not addressed in the proposed standards because they are not part of the diagnostic equipment.

Question 24. Comments are requested on the following questions regarding positioning supports along the sides of diagnostic equipment used by patients in a supine, prone or side-lying position, and diagnostic equipment used by patients in a seated position that can be adjusted to a reclined position:

a) Should the technical criteria address the configuration of positioning supports (e.g., length, height above the patient support surface, location) to ensure their effectiveness? Or should the technical criteria require that positioning supports be provided within reach and provide flexibility for designing the supports based on the intended use of the equipment?

b) What would be the incremental costs for the design or redesign and manufacture of positioning supports?

c) Are there types of equipment that cannot provide positioning supports along the sides of the equipment because of the structural or operational characteristics of the equipment? Comments should discuss alternative methods to assist patients with disabilities safely position or reposition their bodies, and maintain a static position.

Lift Compatibility (M301.4 and M302.4)

M301.4 and M302.4 would require diagnostic equipment used by patients in a supine, prone, or sidelying position, and diagnostic equipment used by patients in a seated position to be usable with a patient lift for patients with disabilities for whom independent transfer may not be possible. A patient lift may be the only means of providing access to certain equipment that cannot meet the technical criteria for transfer surface height (see M301.2.1 and M302.2.1) because of the structural or operational characteristics of the equipment. For example, full body bone densitometers usually have components that move beneath the length of the patient support surface and may prevent the equipment from meeting the technical criteria for transfer surface height. Requiring the equipment to be usable with a patient lift is critical for ensuring the safety of both patients with disabilities and health care personnel assisting with transfers.

ANSI/AAMI HE 75 recommends that the “base of the device needs to have space underneath or along both sides (if the equipment is narrow) to accommodate the legs of portable mechanical lift equipment so that the patient can be suspended over the support surface before being lowered onto it.” See ANSI/AAMI HE 75, section 16.4.3. Portable floor lifts have legs with wheels that need to fit under or around the base of the diagnostic equipment. Lifts can vary in width along their length, and are usually the widest at the front casters and narrower at the patient sling location. Manufacturers of portable floor lifts usually recommend that the lifts be used with the legs extended in the widest position to maintain stability when lifting and lowering patients.

As discussed below, the technical criteria provide two options for accommodating portable floor lifts consistent with ANSI/AAMI HE75: clearance in the base or clearance around the base. The clearances would be required at the side of the equipment where the portable floor lift is deployed so that the boom of the lift can maneuver far enough over the equipment and safely lower and raise the patient onto and off of the examination surface. The clearances do not restrict the overall size of the equipment base.

Clearance in Base (M301.4.1 and M302.4.1)

Clearance in the base of the equipment allows the legs of a portable floor lift to fit under the base of the equipment. The clearance can be an open area between the supporting posts beneath the equipment, or the equipment can be configured with a wide slot that is recessed into the base enclosure. M301.4.1 and M302.4.1 would require the clearance in the base to be 44 inches wide minimum, 6 inches high minimum measured from the floor, and 36 inches deep minimum measured from the edge of the examination surface. Where the width of the examination surface is less than 36 inches, the clearance depth would be required to extend the full width of the equipment. Equipment components are permitted to be located within 8 inches maximum of the centerline of the clearance width.

Question 25. Comments are requested on the following questions regarding the proposed dimensions for clearance in the base of the equipment to allow the use of portable floor lifts:

a) Are the proposed dimensions for clearance in the base sufficient to accommodate the various portable floor lifts used in health care facilities?

b) Do the proposed dimensions exclude certain types of lifts?

c) Should the clearance in the base be configured differently to allow additional flexibility for the use of portable floor lifts and, if so, how should it be configured?

Clearance Around Base (M301.4.2 and M302.4.2)

Clearance around the base of the equipment allows the legs of a portable floor lift to straddle the base. This option accommodates equipment with solid base enclosures that sit on or close to a floor. M301.4.2 and M302.4.2 would require the base of the equipment to provide a clearance 6 inches high minimum measured from the floor and 36 inches deep minimum measured from the edge of the examination surface. The width of the base permitted within this clearance would be 26 inches wide maximum at the edge of the examination surface and is permitted to increase at a rate of 1 inch in width for each 3 inches in depth. The permitted rate of increase in width can be distributed to each side of the base.

Question 26. Comments are requested on the following questions regarding the proposed dimensions for clearance around the base of the equipment to allow the use of portable floor lifts:

a) Are the proposed dimensions sufficient to accommodate the various portable floor lifts used in health care facilities?

b) Do the proposed dimensions exclude certain types of lifts?

c) Should the clearance around the base be configured differently to allow additional flexibility for the use of portable floor lifts and, if so, how should it be configured?

Overhead Lifts

The technical criteria do not address overhead lifts that are usually mounted on the ceiling and operate on tracks suspended over the diagnostic equipment because the configuration of the equipment does not affect the operation of overhead lifts. Overhead lifts and portable floor lifts are used in health care facilities, and the technical criteria should not be viewed as preferring portable floor lifts. Overhead lifts may be the only option for certain diagnostic equipment because the structural or operational characteristics of the equipment prevent sufficient clearance in or around the base of the equipment for a portable floor lift.

Question 27. If diagnostic equipment is designed for use with overhead lifts, should the equipment be exempted from providing clearance in or around the base for portable floor lifts?

Folding Seats on Equipment Used by Patients Seated in a Wheelchair (M302.4 Exception)

M302.4 includes an exception for diagnostic equipment that is designed for use by patients seated in a wheelchair and provides a folding seat. The exception does not require the equipment to comply with the technical criteria for lift compatibility because patients can use the equipment seated in a wheelchair. However, the folding seat would be required to meet the other technical criteria in M302 for transfer surfaces and supports.

Question 28. Where diagnostic equipment is designed for use by patients seated in a wheelchair and provides a folding seat, should the folding seat be required to comply with the technical criteria in M302 for transfer surfaces and supports?

M303 Diagnostic Equipment Used by Patients Seated in Wheelchair

M303 provides technical criteria for diagnostic equipment used by patients seated in a wheelchair. M303 allows patients who use wheelchairs to position their wheelchairs at equipment typically used in a standing position such as mammography equipment, and also applies to equipment specifically designed for patients seated in a wheelchair such as weight scales and examination chairs.

Wheelchair Spaces (M303.2)

M303.2 would require a wheelchair space to be provided at diagnostic equipment used by patients seated in a wheelchair. M303.2 includes technical criteria for orientation, width, depth, and knee and toe clearance at wheelchair spaces.

M303.2.1 would require wheelchair spaces to be designed so that patients seated in a wheelchair orient in the same direction that patients not seated in a wheelchair orient when using the equipment. For example, if an equipment component used to make images of body parts can be placed at different angles when used by patients who stand and by patients seated in a wheelchair, and patients who stand orient facing the component when it is in place for them, then the wheelchair space would be designed so that patients seated in a wheelchair orient facing the component when it is place for them. If the equipment is designed so that patients not seated in a wheelchair can orient their bodies in various directions when using the equipment, the wheelchair space would be designed so that patients seated in a wheelchair can orient their bodies in the same directions. For example, if patients who stand can orient their bodies facing forwards or sideways in relation to the equipment when in use, the wheelchair space would be designed so that patients seated in a wheelchair can orient their bodies facing forwards or sideways in relation to the equipment when in use (i.e., wheelchair space can be entered from both the front or rear and from the side).

M303.2.2 would require wheelchair spaces to be 36 inches (915 mm) wide minimum. This dimension is based on provisions in the 2004 ADA and ABA Accessibility Guidelines for maneuvering clearance where a clear floor or ground space is confined on all or part of three sides.

M303.2.3 would require wheelchair spaces that can be entered from the front or rear to be 48 inches deep minimum, and wheelchair spaces that can be entered only from the side to be 60 inches deep minimum. These dimensions are based on provisions in the 2004 ADA and ABA Accessibility Guidelines. The Wheeled Mobility Anthropometry Project showed that the 48 inches deep dimension for wheelchair spaces entered from the front or rear does not accommodate many people in the sample, and that increasing the depth of wheelchair spaces entered from the front or rear to 58 inches minimum would accommodate 95 percent of the people in the sample. See Final Report of the Wheeled Mobility Anthropometry Project, pages 86‒88. The Access Board is considering requiring in the final standards wheelchair spaces that can be entered from the front or rear to be 58 inches deep minimum.

Question 29. Comments are requested on the following questions regarding the depth dimension (58 inches minimum) that the Access Board is considering requiring in the final standards for wheelchair spaces that can be entered from the front or rear:

a) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide a wheelchair space that is 58 inches deep minimum?

b) Are there types of equipment that cannot provide a wheelchair space that is 58 inches deep minimum because of the structural or operational characteristics of the equipment?

Diagnostic equipment with wheelchair spaces on raised platforms such as weight scales typically provide low barriers or curbs on the sides of the platform that are not used for entering and exiting the equipment to prevent wheelchairs from slipping off the platform (i.e., edge protection). The Access Board is considering requiring edge protection at wheelchair spaces on raised platforms in the final standards.

Question 30. Is there diagnostic equipment with wheelchair spaces on raised platforms that does not currently provide edge protection? If so, what would be the incremental costs to provide edge protection on such equipment?

Exceptions Considered for Wheelchair Spaces on Raised Platforms

The Access Board is considering adding exceptions in the final standards to the minimum width in M303.2.2 and the minimum depth in M303.2.3 for diagnostic equipment with wheelchair spaces on raised platforms.

The exception to the minimum width in M303.2.2 would apply where ramped surfaces are provided on the opposite sides of the raised platform so that patients using wheelchairs can enter and exit the platform facing the same direction. The exception would permit the width of the wheelchair space between the edge protection to be reduced to 32 inches wide minimum at the platform level. This dimension is based on provisions in the 2004 ADA and ABA Accessibility Guidelines that allow accessible routes, which normally must be 36 inches wide minimum, to be 32 inches wide minimum for short distances such as at door openings. The exception would require a space 36 inches wide minimum to be provided outside the perimeter of the raised platform and above any edge protection so that patients using a manual wheelchair can extend their arms and elbows when they push on the wheel rims to maneuver onto and off of the platforms.

The exception to the minimum depth in M303.2.3 for wheelchair spaces entered from the front or rear would permit a portion of the 48 inch minimum depth of the wheelchair space that accommodates the wheelchair footrests to extend beyond the raised platform and over any edge protection. For example, the wheelchair footrests would be allowed to extend beyond the depth of the raised platform and over any edge protection on wheelchair weight scales used by patients seated in a wheelchair.

If exceptions are permitted to the minimum width and depth of wheelchair spaces on raised platforms, the technical criteria would specify the minimum and maximum height for any edge protection to prevent wheelchairs from slipping off the platform, but also allow the wheelchair footrests to extend over the edge protection where the wheelchair space extends beyond the depth of the platform.

Question 31. Comments are requested on the following questions regarding adding exceptions in the final standards to the minimum width in M303.2.2 and the minimum depth in M303.2.3 for diagnostic equipment with wheelchair spaces on raised platforms:

a) What is the typical distance between the front caster wheels of manual and power wheelchairs and the tips of the toes of the wheelchair user? How much of the 48 inch minimum depth of a wheelchair space that can be entered from the front or rear should be permitted to extend beyond the raised platform and over any edge protection? Comments should include information on sources to support the dimensions, where possible.

b) What should be the maximum height for any edge protection to allow the wheelchair footrests to extend over the edge protection where the wheelchair space extends beyond the depth of the platform? Comments should include information on sources to support the dimensions, where possible.

c) Where the equipment provides supports for patients who stand (e.g., handrails), should the exceptions prohibit the supports from obstructing the 36 inch wide minimum and 48 inch deep minimum space outside the perimeter of the raised platform and above any edge protection?

Scooters have different wheelbases than manual and power wheelchairs. Diagnostic equipment with wheelchair spaces on raised platforms should also be usable by patients who use scooters. Patients who use scooters may have other options for using equipment with wheelchair spaces on raised platforms. For example, a weight scale with a raised platform for wheelchair use may provide a folding seat and supports for patients who can transfer independently from their mobility device to the scale.

Question 32. Comments are requested on the following questions regarding diagnostic equipment with wheelchair spaces on raised platforms and the use of such equipment by patients who use scooters:

a) Is equipment with wheelchair spaces on raised platforms such as wheelchair scales currently usable by patients who use scooters?

b) If the equipment is not currently usable by patients who use scooters, should the width and depth of the raised platform be changed so that the equipment is usable by patients who use scooters? Comments should include information on sources to support the dimensions, where possible.

c) Should folding seats and supports be required on equipment with wheelchair spaces on raised platforms for patients who can transfer independently from their mobility device to the raised platform?

d) If folding seats and supports are provided on equipment with wheelchair spaces on raised platforms, should the raised platform also accommodate scooters?

Question 33. If exceptions are not permitted in the final standards to the minimum width and depth of wheelchair spaces on diagnostic equipment with raised platforms, comments are requested on the following questions:

a) What would be the incremental costs for the design or redesign and manufacture of equipment with raised platforms to provide a wheelchair space that that can be entered from the front or rear and conforms to the dimensions proposed in M303.2.2 and M303.2.3 (i.e., 36 inches wide minimum and 48 inches deep minimum)?

b) What would be the incremental costs for the design or redesign and manufacture of equipment with raised platforms to provide a wheelchair space that can be entered from the front or rear and conforms to the dimensions recommended by the Wheeled Mobility Anthropometry Project (i.e., 36 inches wide minimum and 58 inches deep minimum)?

Knee and Toe Clearance (M303.2.4)

M303.2.4 would require the depth of wheelchair spaces to include knee and toe clearance of 17 inches minimum and 25 inches maximum. Knee and toe clearance under breast platforms would be 25 inches deep. Knee and toe clearance are critical where patients seated in a wheelchair need to position their knees and toes next to or underneath a component of the diagnostic equipment. The component can be deeper than the 25 inches maximum depth required for knee and toe clearance, but a portion of the wheelchair space would be required to include knee and toe clearance of 17 inches minimum and 25 inches maximum under the component.

The dimensions for toe clearance in M303.2.4.1 and knee clearance in M303.2.4.2 are based on the 2004 ADA and ABA Accessibility Guidelines and are shown in the second column of the table below. The Wheeled Mobility Anthropometry Project showed that these dimensions do not accommodate many people in the sample and recommended alternative dimensions that would accommodate 95 percent of the people in the sample. The alternative dimensions recommended by Wheeled Mobility Anthropometry Project are shown in the last column of the table below. See Final Report of the Wheeled Mobility Anthropometry Project, pages 89‒92. The Access Board is considering requiring in the final standards the dimensions for toe clearance and knee clearance recommended by the Wheeled Mobility Anthropometry Project.

Question 34. Comments are requested on the following questions regarding the dimensions for toe clearance and knee clearance recommended by the Wheeled Mobility Anthropometry Project that the Access Board is considering requiring in the final standards:

a) What would be the incremental costs for the design or redesign and manufacture of the equipment to include toe clearance and knee clearance that meets the dimensions recommended by the Wheeled Mobility Anthropometry Project?

b) Are there types of equipment that cannot include toe clearance and knee clearance that meets the dimensions recommended by the Wheeled Mobility Anthropometry Project because of the structural or operational characteristics of the equipment?

M303.2.5 would require wheelchair space surfaces to not slope more than 1:48 in any direction. This is consistent with the 2004 ADA and ABA Accessibility Guidelines.

Changes in Level at Entry to Wheelchair Spaces (M303.3)

M303.3 includes technical criteria for changes in level at the entry to a wheelchair space as may occur at wheelchair weight scales with raised platforms. The technical criteria are consistent with the 2004 ADA and ABA Accessibility Guidelines. Level changes up to ¼ inch high are permitted to be vertical. Level changes between ¼ inch high and ½ inch high would be required to be beveled with a slope not steeper than 1:2. Level changes greater than ½ inch high would be required to be ramped. Ramp runs would be required to have a running slope not steeper than 1:12 and a cross slope not steeper than 1:48. The clear width of ramp runs would be required to be 36 inches minimum. Ramps with drop offs ½ inch or greater would be required to provide edge protection 2 inches high minimum on each side to prevent users from inadvertently travelling off the sides of the ramped surface.

Additional Technical Criteria Considered for Handrails on Ramps

M303.3.3.5 would require handrails to be provided on each side of the ramp when the vertical rise of the ramp exceeds 6 inches. This is consistent with the 2004 ADA and ABA Accessibility Guidelines. The Access Board is considering whether the technical criteria for handrails on ramps in section 505 of the 2004 ADA and ABA Accessibility Guidelines would be appropriate for handrails on diagnostic equipment ramps. These technical criteria are available at http://www.access-board.gov/ada-aba/final.cfm#a505 and address continuity, height, clearance, gripping surface, cross section, surfaces, fittings, and handrail extensions.

Question 35. Comments are requested on the following questions regarding the technical criteria for handrails in section 505 of the 2004 ADA and ABA Accessibility Guidelines:

a) Can handrails on diagnostic equipment ramps meet these technical criteria?

b) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide handrails on diagnostic equipment ramps that conform to these technical criteria?

Components (M303.4)

M303.4 would require the components of diagnostic equipment used to examine specific body parts to be capable of examining the body parts of a patient seated in a wheelchair. The height of the component and any adjustable feature would have to accommodate patients seated in a wheelchair.

For example, an X-ray platform on which a patient places their arm or hand would have to be capable of examining the arm or hand of a patient seated in a wheelchair.

Mammography equipment was the subject of considerable discussion at the public meeting held by the Access Board in July 2010. The discussion highlighted the need for mammography equipment that is accessible to patients seated in a wheelchair. In addition to providing knee and toe clearance at the breast platform (see M303.2.4), the height of the breast platform was identified as critical to ensuring that mammography equipment is accessible to patients seated in a wheelchair. Mammography equipment with adjustable breast platforms is available. M303.4.1 would require the height of the breast platform to be 30 inches (760 mm) high minimum and 42 inches (1065 mm) high maximum above the floor when mammography equipment is used by patients seated in a wheelchair. The Wheeled Mobility Anthropometry Project showed that the seat heights of 96 percent of women using manual wheelchairs and 98 percent of women using power wheelchairs in the sample was between 17 inches and 24 inches above the floor. See Analysis of Seat Heights for Wheeled Mobility Devices at: http://udeworld.com/analysis-of-seat-height-for-wheeled-mobility-devices. Other anthropometric data show the heights of the midpoint of the breast to be 13 inches for the 5th percentile woman and 18 inches for the 95th percentile woman when measured from seat height. See Laura Peebles and Beverley Norris, Adultdata: The Handbook of Adult Anthropometric and Strength Measurements: Data for Design Safety (London, Department of Trade and Industry, 1998), page 71. The proposed height range for the breast platform is based on the above anthropometric data. Breast platforms can be located outside the proposed height range when not used by patients seated in a wheelchair.

Question 36. Comments are requested on the following questions regarding breast platforms:

a) Is the proposed height range for the breast platform (30 inches high minimum and 42 inches high maximum above the floor) sufficient to accommodate patients seated in a wheelchair?

b) Are there other features of the breast platform that the technical criteria should address to ensure accessibility and, if so, how should they be addressed? Comments should include information on sources to support the technical criteria for the features, where possible.

M304 Diagnostic Equipment Used by Patients in Standing Position

M304 provides technical criteria for diagnostic equipment used by patients in a standing position such as a weight scale and X-ray equipment that is used in a standing position for certain diagnostic procedures. M304.2 and M304.3 would require a slip resistant standing surface and standing supports to accommodate patients with mobility disabilities who ambulate, patients who have limited stamina, and patients who have other conditions that affect their ability to maintain the balance needed to position themselves on the equipment or to maintain a standing posture at an equipment component.

The proposed standards do not require diagnostic equipment to support more than one position. Where possible, it is recommended that diagnostic equipment be usable by patients with disabilities in as many positions as possible (i.e., standing position, seated position, and seated in a wheelchair). For example, mammography equipment with adjustable breast plates can be used by patients with disabilities in a standing position where standing supports are provided, in a seated position where a folding or removable seat is provided, and seated in a wheelchair where a wheelchair space is provided. A weight scale with a wheelchair space and ramped entry also can be used by patients with disabilities in a standing position where standing supports are provided and in a seated position where a folding or removable seat is provided.

Question 37. Comments are requested on the following questions regarding whether a folding or removable seat should be required on diagnostic equipment used by patients in a standing position:

a) Should a folding or removable seat be required on weight scale platforms?

b) Should a folding or removable seat be required on other types of diagnostic equipment used by patients in a standing position?

c) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide a folding or removable seat on weight scale platforms or other types of diagnostic equipment used by patients in a standing position?

d) If folding or removable seats are provided on diagnostic equipment used by patients in a standing position, should the equipment be required to meet the technical criteria in M302 regarding transfer surfaces, supports, and lift compatibility for diagnostic equipment used by patients in a seated position?

Standing Supports (M304.3 and M305.3)

M304.3 would require standing supports to be provided on each side of the standing surface on diagnostic equipment used by patients in a standing position. M305.3 would require the standing supports to provide continuous support throughout the use of the diagnostic equipment and to not rotate within their fittings.

M305.3 also provides technical criteria for standing supports in horizontal and vertical positions. Standing supports can be provided in a horizontal position, vertical position, or a combination of horizontal and vertical positions, as long as the minimum length of gripping surface is provided for the support position used on each side of the standing surface. Standing supports that adjust from horizontal to vertical positions and at angles in between, such as a bar that folds up and locks into multiple positions, can be used. These kinds of adjustable supports are not required but would accommodate a broad range of patients with disabilities, particularly where a patient needs to assume multiple body positions for a diagnostic procedure or needs to step up onto a surface and then maintain balance afterwards.

For standing supports in a horizontal position, M305.3.1 would require the gripping surface to be 4 inches long minimum. The top of the gripping surface would be required to be 34 inches minimum and 38 inches maximum above the standing surface. The minimum length of the gripping surface is based on anthropometric data that provides specifications for men and women grasping cylinder grips which are stated as a range from 3.6 inches to 4.5 inches. See Henry Dreyfuss Associates and Alvin R. Tilley, The Measure of Man & Woman: Human Factors in Design, (New York, John Wiley and Sons, 2002), page 43. Where possible, it is recommended that a longer gripping surface or multiple horizontal supports be provided. The minimum and maximum height of the gripping surface above the standing surface is based on the provisions for handrails in the 2004 ADA and ABA Accessibility Guidelines.

For standing supports in a vertical position, M305.3.2 would require the gripping surface to be 18 inches long minimum. The bottom of the support would be required to be 34 inches minimum and 37 inches maximum above the standing surface. The minimum length of the gripping surface is based on provisions for vertical grab bars at accessible bathing fixtures and toilets in ICC A117.1‒2009 Accessible and Usable Buildings and Facilities. The minimum and maximum height of the bottom of the support above the standing surface is based on anthropometric data for the 1th percentile woman (minimum) and the 99th percentile man (maximum). See Henry Dreyfuss Associates and Alvin R. Tilley, The Measure of Man & Woman: Human Factors in Design, (New York, John Wiley and Sons, 2002), pages 13, 14, and 28.

Question 38. Comments are requested on the following questions regarding standing supports for diagnostic equipment used by patients in a standing position:

a) What standing support configurations are currently provided and are they effective for patients with disabilities?

b) Would alternative technical criteria for standing supports be appropriate? Comments should include information on sources to support the alternative technical criteria, where possible.

c) Are angled standing supports effective for patients with disabilities and should technical criteria be provided for angled standing supports? Comments should include information on sources to support the technical criteria for angled standing supports, where possible.

d) Are there industry standards for the structural strength of standing supports?

The 2004 ADA and ABA Accessibility Guidelines specify the following dimensions for grab bars to enable individuals with disabilities to firmly grasp the grab bars and support themselves during transfers:

• Grab bars with circular cross sections must have an outside diameter of 1¼ inches minimum and 2 inches maximum.

• Grab bars with non-circular cross sections must have a cross section dimension of 2 inches maximum and a perimeter dimension of 4 inches minimum and 4.8 inches maximum. The Access Board is considering whether the above cross section dimensions would be appropriate for the gripping surfaces of standing supports on diagnostic equipment used by patients in a standing position.

Question 39. Comments are requested on the following questions regarding the above cross section dimensions for the gripping surfaces of standing supports on diagnostic equipment used by patients in a standing position:

a) Can the gripping surfaces of standing supports on different types of equipment meet the above cross section dimensions?

b) Are there alternative designs for the gripping surfaces of standing supports that enable patients with disabilities to firmly grasp the supports?

The Access Board is also considering whether a 1½ inches minimum clearance around the gripping surface of standing supports would be appropriate to ensure that the surface can be grasped.

Question 40. Can standing supports on different types of equipment provide 1½ inches minimum clearance around the gripping surface without encountering obstructions?

M305 Supports

M305 provides the technical criteria for transfer supports and standing supports. The technical criteria for transfer supports are discussed under M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position and M302 Diagnostic Equipment Used by Patients in Seated Position. The technical criteria for standing supports are discussed under M304 Diagnostic Equipment Used by Patients in Standing Position.

M306 Communication

Where diagnostic equipment communicates instructions or other information to the patient, M306 would require the instructions or other information to be provided in at least two of the following methods: audible, visible, or tactile. For example, magnetic resonance imaging (MRI) and X-ray computed tomography (CT) equipment may instruct the patient to hold their breath for a short period during a scan by means of a flashing light or icon. A flashing light or icon would be sufficient to notify a patient who is deaf to hold their breath, but a voice prompt, sound alert, or tactile vibration would be needed to notify a patient who is blind to hold their breath. For MRI equipment, auditory methods may not be effective due to the noise generated by the equipment and a tactile vibration may be the only effective method to notify a patient who is blind to hold their breath. ANSI/AAMI HE 75 recommends that vibration “be used as a redundant mode for transmitting information such as an attention getting signal.” See ANSI/AAMI HE 75, section 16.3.5.6.

Question 41. Comments are requested on the following questions regarding methods of communication provided by diagnostic equipment:

a) Should diagnostic equipment that communicates instructions or other information to the patient be required to provide the instructions or other information in all three methods of communication (i.e., audible, visible, and tactile)?

b) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide all three methods of communication (i.e., audible, visible, and tactile)?

M307 Operable Parts

M307 provides technical criteria for operable parts used by patients to activate, deactivate, or adjust the diagnostic equipment (see defined terms in M102.1). For example, equipment used for an auditory examination may require the patient to press a button when sounds are heard. M307 does not apply to controls used only by health care personnel or others who are not patients.

M307.2 would require operable parts to be tactilely discernible without activation. Patients who are blind or have low vision have difficulty distinguishing a flat membrane button or similar control unless it is tactilely discernible from the surrounding surface and any adjacent controls. The most common method to ensure that buttons and similar controls are tactilely discernible is to raise part or all of the control surface above the surrounding surface and at a distance from any adjacent controls such that a relief of each individual control can be determined by touch. This also prevents unintended or accidental activation of the operable parts. M307.2 is consistent with recommendations in ANSI/AAMI HE 75 that “features should be operable from controls that are tactilely discernible and that can be explored without being activated.” See ANSI/AAMI HE 75, section 16.3.5.5.

M307.3 would require operable parts such as dials, switches, and levers to be operable with one hand without tight grasping, pinching, or twisting of the wrist. M307.4 would require the force to activate operable parts to not exceed 5 pounds. M307.3 and M307.4 are based on provisions for operable parts in the 2004 ADA and ABA Accessibility Guidelines. M307.3 and M307.4 are also consistent with recommendations in ANSI/AAMI HE 75 that “devices should have at least one mode of use that does not require fine motor control or the performance of simultaneous actions.” ANSI/AAMI HE 75 includes additional recommended practices for accessible controls. See ANSI/AAMI HE 75, section 16.3.3.

The Wheeled Mobility Anthropometry Project recommended that “operable parts that require fine grips preferably should not require exertion of lateral pinch grip forces in excess of 2 pounds force to accommodate the vast majority of … users having at least some grasping capability.” The Wheeled Mobility Anthropometry Project recommended that the 5 pounds maximum force be retained for other types of operable parts. See Final Report of the Wheeled Mobility Anthropometry Project, page 105. The Access Board is considering requiring in the final standards that operable parts used by patients that require fine grips to not exceed 2 pounds maximum operating force.

Question 42. Comments are requested on the following questions regarding the operating force (2 pounds maximum) that the Access Board is considering requiring in the final standards for operable parts used by patients that require fine grips:

a) What would be the incremental costs for the design or redesign and manufacture of the equipment to provide operable parts that meet the above operating force?

b) Are there types of equipment that cannot provide operable parts that meet the above operating force because of the structural or operational characteristics of the equipment?

The 2004 ADA and ABA Accessibility Guidelines require that operable parts be placed within certain reach ranges. For an unobstructed forward reach or side reach, the reach ranges are 48 inches maximum for a high reach and 15 inches minimum for a low reach. ANSI/AAMI HE 75 provides guidance on reach ranges based on provisions in an earlier version of accessibility guidelines for buildings and facilities issued by the Access Board, the 1991 Americans with Disabilities Act Accessibility Guidelines (ADAAG). ANSI/AAMI HE 75 also recommends a remote control as an alternative to a direct reach. See ANSI/AAMI HE 75, section 16.3.2.2. The reach ranges in the 2004 ADA and ABA Accessibility Guidelines provide greater accessibility than the reach ranges in the 1991 ADAAG.

Question 43. Comments are requested on the following questions regarding reach ranges for operable parts on diagnostic equipment that are used by patients:

a) Would the reach ranges in the 2004 ADA and ABA Accessibility Guidelines for an unobstructed forward reach or side reach (48 inches maximum for a high reach and 15 inches minimum for a low reach) be appropriate for operable parts on diagnostic equipment that are used by patients?

b) Would alternative technical criteria be appropriate for reach ranges for operable parts on diagnostic equipment that are used by patients? Comments should include information on sources to support the alternative technical criteria, where possible.