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

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?