Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

Executive Summary

Provisions of Section 4203 of the Patient Protection and Affordable Care Act (ACA) require the Architectural and Transportation Barriers Compliance Board (U.S. Access Board), in consultation with the Food and Drug Administration (FDA), to issue accessibility standards for medical diagnostic equipment (MDE) to accommodate adults with disabilities. To maximize their health and wellbeing, persons with disabilities require access to the same range of MDE as individuals without disabilities, including examination tables, examination chairs, weight scales, mammography equipment, and diagnostic imaging equipment. Importantly, the Americans with Disabilities Act and Section 504 of the Rehabilitation Act require health care practitioners and delivery systems to provide persons with disabilities full and equal access to their health care services and facilities. However, neither law specifies accessibility standards for MDE.

To meet the ACA Section 4203 mandate, the U.S. Access Board issued a Notice of Proposed Rulemaking in the Federal Register (February 9, 2012) proposing MDE accessibility standards for adults with disabilities. At its January 11, 2012 meeting, the Access Board voted to establish an advisory committee to make recommendations to the Board on issues raised by comments on and questions about the proposed MDE standards. After soliciting nominations for committee membership, the U.S. Access Board empanelled the Medical Diagnostic Equipment Accessibility Standards Advisory Committee (the MDE Advisory Committee), comprised of individuals from 24 organizations representing a range of stakeholders and ex officio members from the FDA, Department of Justice, and the Department of Veterans Affairs.

The MDE Advisory Committee met from September 2012 through May 2013. Much of the Committee work occurred within five Subcommittees that addressed major categories of MDE: Examination Tables and Chairs; Stretchers; Diagnostic Imaging Equipment; Mammography Equipment; and Weight Scales. In June 2013, Advisory Committee members agreed upon 54 recommendations for the MDE standards presented in the following table. In all instances except one, MDE Advisory Committee members reached consensus on their recommendations. However, Committee members failed to agree upon the recommended lowest or minimum height for adjustable-height transfer surfaces.

MDE Advisory Committee Recommendations

Summary Table

5.1 Transfer Surface Height

5.1.1 Transfer Surface Height Adjustability. The transfer surface should have an adjustable height in small virtually continuous increments.

5.1.2 Transfer Surface High Height. The transfer surface should have an adjustable height range with an upper height measuring at least 25 inches.

5.1.3 Transfer Surface Low Height. No agreement on final low height

5.1.4 Transfer Surface Height Measurement. The transfer surface height should be measured from the floor to the highest point on the seat in an uncompressed state, inclusive of bolsters.

5.2 Transfer Surface Size for Equipment Used by Patients in Supine, Prone, or Side-Lying Position.

5.2.1 Transfer Surface Size

5.2.1.1 Transfer Surface Width. The transfer surface should be 28 inches wide minimum for equipment used by patients in a supine, side-lying, or prone position.

5.2.1.2 Transfer Surface Depth. The transfer surface should be 17 inches deep minimum for all equipment used by patients in a supine, side-lying, or prone position with the exception of imaging equipment.

5.2.1.3 Transfer Surface Size for Stretchers. The transfer surface should be 28 inches wide minimum and 17 inches deep minimum located on both long sides of stretchers.

5.2.1.4 Transfer Surface Size for Imaging Equipment. The transfer surface should be 28 inches wide minimum and 21 inches deep minimum. The transfer surface should be located such that the long dimension of 28 inches is located parallel to the patient scanning/imaging side of the table. The specific location is to be designated by the manufacturer so as to carry out the functions for the diagnostic procedure. The width of the patient scanning/imaging table (side to side) at the designated transfer location should be 28 inches minimum or the maximum extent technically feasible, but in all cases no less than 21 inches.

5.2.2 Transfer Surface Size for Equipment Used by Patients in Seated Position.

5.2.2.1 Transfer Surface Width. The transfer surface should be 21 inches wide minimum for examination chairs and other equipment used by patients in a seated position.

5.2.2.2 Transfer Surface Depth. The transfer surface should be 17 inches deep minimum for equipment used by patients in a seated position.

5.2.3 Transfer Surface Measurement. The transfer surface should be measured from the center-point of each side of the transfer surface.

5.3 Transfer Sides.

5.3.1 Permitted Obstructions to Transfer Sides for Equipment Used by Patients in a Supine, Prone, Side-Lying or Seated Position. A 3-inch maximum obstruction is permitted at transfer sides.

5.3.2 Transfer Sides for Equipment Used by Patients in a Supine, Prone, or Side-Lying Position.

5.3.2.1 Transfer Sides for Stretchers. The transfer surface shall be located to provide the ability to transfer from a mobility device onto both long sides of the surface.

5.3.2.2 Transfer Sides for Imaging Equipment. The transfer surface should be provided on at least one long side of the table.

5.3.3 Transfer Sides for Equipment Used by Patients in Seated Position.

5.3.3.1 Transfer Sides for Exam Chairs with Fixed Footrests. The 17 inch minimum depth and 21 inch minimum width should be located on both sides of examination chairs with a fixed footrest to allow for a left or right transfer.

5.4 Transfer Supports.

5.4.1 Transfer Support Location for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. Transfer supports should be required on both sides of the transfer surface and be movable or removable so they can be out of the way during transfer.

5.4.1.1 Transfer Support Location for Stretchers. The transfer surface for stretchers should be oriented along the long side of the surface.

5.4.1.2 Transfer and Positioning Support Location for Imaging Equipment. Transfer supports should be provided for imaging equipment with transfer surfaces with depths of less than or equal to 24 inches. Positioning supports should be provided for imaging equipment with transfer surfaces with depths greater than 24 inches. The transfer supports or positioning supports should be located opposite the transfer side.

5.4.2 Transfer Support Length for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The transfer support should be a minimum length of 15 inches positioned so that the transfer support overlaps the minimum depth of the transfer surface by 80%.

5.4.2.1 Transfer Support Length for Stretchers. Transfer supports on stretchers should be a minimum of 15 inches long.

5.4.2.2 Transfer and Positioning Support Length for Imaging Equipment with Transfer Surfaces. Transfer supports for imaging equipment should be 28 inches minimum in length and positioning supports shall be 12 to 16 inches minimum in length.

5.4.3 Transfer Support Height for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. Transfer supports should be positioned 6 inches minimum and 19 inches maximum above the transfer surface.

5.4.3.1 Positioning Support Height for Imaging Equipment. Positioning supports should be positioned 3 to 6 inches above the transfer surface.

5.4.4 Transfer Support Distance From Transfer Surface for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The transfer support should be located a maximum distance of 1½ inches from the transfer surface.

5.4.4.1 Transfer Support Distance from Transfer Surface for Stretchers. Transfer supports should be located along the long side of the transfer surface on the opposite side of the transfer. The horizontal distance from the transfer surface should be no more than 3 inches from the edge of the patient support surface.

5.4.4.2 Transfer Support Distance from Transfer Surface for Imaging Equipment. Supports (transfer or positioning) should be located 1 ½ inches maximum from the transfer surface. The distance may extend up to 3 inches where the support must fold, collapse, come off, or articulate.

5.4.5 Transfer Support Position for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The transfer gripping surface should be located within the minimum and maximum heights.

5.4.5.1 Transfer and Positioning Support Position for Imaging Equipment. The transfer or positioning support should be oriented horizontally on imaging equipment with transfer surfaces.

5.4.6 Transfer Support Gripping Surface Cross Section for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The gripping surface cross section should comply with the provisions for gripping surface cross section configurations contained in the 2010 Standards.

5.4.7 Transfer Support Gripping Surface Clearance for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. There should be a 1½ inches minimum clearance around the gripping of transfer supports as proposed by the Access Board.

5.4.8 Transfer Support Gripping Surface Hazard for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The gripping surfaces of the transfer support must be free of sharp or abrasive elements and have rounded edges.

5.4.9 Interruptions Along Transfer Support Gripping for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The bottom of the transfer support shall have no obstruction affecting more than 20% of its length.

5.4.10 Transfer Support Fittings for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The transfer supports shall not rotate when locked in place for patient transfer or use.

5.4.11 Transfer Support Structural Strength for Equipment Used in a Supine, Prone, Side-Lying, or Seated Position. The transfer supports and connections must contain the strength to resist vertical and horizontal forces of 250 pounds at locations determined by the intended use of the equipment.

5.5 Armrest Recommendations

5.5.1 Armrest Provision for Equipment Used by Patient in Seated Position. Armrests are not required but if provided cannot obstruct transfer supports.

5.6 Stirrups.

5.6.1 Stirrups for Equipment Used by Patient in Supine, Prone, or Side-Lying Position. Where the equipment provides stirrups, it must also provide an alternate method to support, position, and secure the patient’s legs (specifically including sufficient support of the patient’s thigh, knee, and calf to stabilize the leg). This method will either supplement or serve as a substitute for the stirrups.

5.7 Lift Compatibility.

5.7.1 Lift Compatibility Clearance in Base for Equipment Used by Patient in Supine, Prone, or Side-Lying Position.

5.7.1.1 Lift Compatibility Clearance in Base for Stretchers. The base of the equipment must provide a clearance of 39 inches wide minimum.

5.7.1.2 Lift Compatibility Clearance in Base for Imaging Equipment. An overhead lift may be used as an alternative option in lieu of the provisions for clearances in and around the equipment base where portable lifts are not feasible.

5.8 Wheelchair Spaces for Diagnostic Equipment Used by Patients Seated in a Wheelchair.

5.8.1 Wheelchair Spaces on Raised Platforms.

5.8.1.1 Clear Platform Size. The platform should be a minimum clear width of 32-inches and a minimum clear length of 40-inches.

5.8.1.2 Entry to Wheelchair Spaces on Raised Platforms.

5.8.1.2.1 Ramped Entry Slope. Raised platforms should have a ramp with slopes that do not exceed the following:

Rise 0 to 1 ½ inches – 1:2 Slope
Rise >1 ½ to 2 ½ inches – 1:8 Slope
Rise >2 ½ inches – 1:12 Slope

5.8.1.2.2 Single Ramped Entry – Edge Protection on the Platform and Platform Sides. A 2 inch high edge protection must be provided on the back of the platform, opposite the entry ramp and a minimum 2 inch high edge protection on the sides of the platform.

5.8.1.2.3 Double Ramped Entry – Edge Protection on the Platform Sides. A minimum 2 inch high edge protection must be provided on both sides of the platform for double ramped entry platforms.

5.8.1.2.4 Edge Protection on Platforms 1½ inches or less in Height. Edge protection is not required on platforms 1 ½ inches or less in height.

5.8.2 Knee and Toe Clearance Under Breast Platform. The overall knee and toe space should be increased to a minimum of 28 inches deep, from the initially proposed 25 inch absolute dimension; increasing the knee clearance directly underneath the breast platform to a minimum of 18 inches; and assuring unobstructed floor space in front of the base support at a minimum of 17 inches.

5.8.2.1 Height of Breast Platform At Time of Measurement. All knee and toe clearances should be measured when the top of the breast platform is set at 34 inches above the floor.

5.8.2.2 Knee Clearance Depth at 27” Above the Ground. The knee clearance should be increased at 27 inches above the ground to 18 inches minimum.

5.8.2.3 Overall Knee and Toe Clearance. The overall knee and toe space should be increased to a minimum of 28 inches.

5.8.2.4 Unobstructed Floor Space. The unobstructed floor space in front of the base support should be a minimum of 17 inches deep.

5.8.2.5 Toe Height. The toe height should be 18 inches minimum, measured above the ground when the top of the breast platform is 34 inches above the ground.

5.8.2.6 Clearance Depth at Toe Height Above the Ground. The toe clearance depth should be 22 inches minimum at toe height.

5.8.2.7 Base Support Allowance. Base support is permitted to obstruct the clear floor space if it fits within the allowed base support volume. Base supports can be a maximum of 1½ inches high. An additional sloped region above the base support is permitted at a depth of 25 inches from the front edge of the breast platform at 1½ inches above the floor, and can extend to a height of 4 inches above the floor at a depth of 28 inches from the front edge of the breast platform.

5.8.2.7.1 Mammography Chair Footrest. Mammography chairs must meet the requirements for equipment used for patient in a seated position with the additional requirement that any footrests must accommodate and ride over the base support.

5.8.3 Breast Platform

5.8.3.1 Breast Platform Height. The height of the top of the breast platform should be decreased to 26 inches above the floor. The upper height range for the breast platform was not controversial and remained as proposed. The final version of the criteria must clarify that the specified height range is a minimum range of travel.

5.9 Standing Support for Equipment Used by Patients in a Standing Position.

5.9.1 Standing Supports In Reference To Mammography Equipment. The requirement for standing supports should be removed for mammography equipment. To be useful, positioning supports must be shaped for grasping, positioned within reach range of all users, and be 12 inches long minimum when located on the moving C-arm or 18 inches long minimum when in a fixed location.

5.9.2 Standing Supports on Ramped Entry Raised Platforms with Wheelchair Spaces.

5.9.2.1 Standing Supports on Single Ramped Entry Raised Platforms with Wheelchair Spaces. Standing supports should be located on both sides of platforms, a minimum of 34 inches between supports, integrated into the platform, and 32 inches minimum length (at least 80% of the platform length) at the platform entry edge for a single ramp entry raised platform.

5.9.2.2 Standing Supports on Dual Ramped Entry Raised Platforms with Wheelchair Spaces. Standing supports should be located on one side of the platform, integrated into the platform and stretching the full length of the platform (40 inch minimum) for dual ramped entry raised platforms.