Architectural and Transportation Barriers Compliance Board

Standards for Accessible Medical Diagnostic Equipment

Background

  • Section 4203 of Patient Protection and Affordable Care Act
    • (Public Law 111-148, 124 Stat. L. 119)
  • Added Section 510 to the Rehabilitation Act of 1973 on March 23, 2010
  • Title:  “ESTABLISHMENT OF STANDARDS FOR ACCESSIBLE MEDICAL DIAGNOSTIC EQUIPMENT”

Background

  • ANSI/AAMI HE75 – 2009 Human Factors Engineering – Design of Medical Devices
    • Chapter 16 – Accessibility Considerations
 Picture showing the cover of ANSI/AAMI HE75:2009 Human factors engineering design of medical devices document.

Background

  • ADA and ABA Accessibility Guidelines
Cover of Americans with Disabilities Act and Architectural Barriers Act Accessibility Guidelines.

Organization

  • Preamble
  • Text of the Proposed Rule
  • Example Applications

Organization

  • Chapter M1:  Application and Administration
  • Chapter M2:  Scoping
  • Chapter M3:  Technical Criteria

Technical Criteria Equipment used by patients:

  • in a supine, prone, or side-lying position – M301
  • in a seated position – M302
  • seated in a wheelchair – M303
  • in a standing position – M304

Photos:

 Photograph of the Access Board Executive Director and Board Members looking at imaging equipment. Photograph of a Board Member using a wheelchair preparing to transfer onto an exam chair.

Photos:

 Photograph shows a woman using a wheelchair positioned underneath optometry equipment.  The chair typically used for eye examinations has been removed to permit the woman to position at the equipment. Photograph of a wheelchair scale.

Technical Criteria

  • Supports – M305
 Photograph of a close in view of a hand gripping the support rail along the edge of an exam table.

Technical Criteria Across equipment types:

  • Communication  M306
  • Operable Parts  M307
 Photograph of a close in view of the bore opening of a scanning machine.

Data from Wheeled Mobility Anthropometry Project

 Picture of a page from Anthropometry of Wheeled Mobility Project Final Report on clear floor spaces.

Example Applications Document

 Cover page of the Example Applications of the Proposed Medical Diagnostic Equipment Accessibility Standards document. Sample page from the Example Applications of the Proposed Medical Diagnostic Equipment Accessibility Standards document.

Steps

  • Comment Period
  • Public Hearing
  • Advisory Committee

Responses to NPRM

  • 46 questions were posed in the preamble
  • 51 commenters
  • Range of comments

Initial Review

  • Nature of responses to questions
  • Issues affecting multiple interest

Recommended Issues

Issues Areas

  • Transfer surface height and size
  • Permitted obstructions to the transfer surface
  • Transfer support location and configuration
  • Depth of wheelchair spaces

Recommended Issues

Transfer Surface Height and Size

Illustration of a person using a wheelchair executing a parallel transfer onto an exam table. Illustration of person using a wheelchair executing a perpendicular transfer onto an exam table.

Transfer Surface Height

M301.2.1 Height.  The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm) maximum measured from the floor to the top of the transfer surface.

 Illustration of an exam table with the transfer surface highlighted showing the 17 inches minimum and 19 inches maximum height above the floor.

Transfer Surface Height

M302.2.1 Height.  The height of the transfer surface during patient transfer shall be 17 inches (430 mm) minimum and 19 inches (485 mm) maximum measured from the floor to the top of the transfer surface.

Illustration of an exam chair with the transfer surface highlighted showing the 17 inches minimum and 19 inches maximum height above the floor.

Transfer Surface Height

NPRM Question 14

  • Adjustability - 17 inches min. and 25 inches max. range
  • Minimum Height

Transfer Surface Height

Patients

  • Height is a major concern
  • Range of users accommodated

Transfer Surface Height

Manufacturers

  • Seat profile
  • Components beneath transfer surface
  • Span between the lowest transfer height and optimal caregiver height
  • Cost and redesign

Transfer Surface Height

Equipment Design Concerns

Photograph of a bone density scanning machine showing imaging and machinery components beneath the examination surface.

Transfer Surface Size

M301.2.2 Size.  The transfer surface shall be 30 inches (760 mm) wide minimum and 15 inches (381mm) deep minimum.

Illustration of an exam table with the transfer surface highlighted showing 30 inches wide minimum and 15 inches deep minimum.

Transfer Surface Size

M302.2.2 Size.  The transfer surface shall be 21 inches (610 mm) wide minimum and 15 inches (381 mm) deep minimum.

Illustration of an exam chair with the transfer surface highlighted showing 21 inches wide minumim and 15 inches deep minimum.

Transfer Surface Size

NPRM Questions 15 and 16

  • Sufficiency of proposed requirement
  • Minimum width
  • Alternative dimensions

Transfer Surface Size

Patients

  • Space for transfer
  • Repositioning after transfers
  • Range of body sizes – large and obese
  • Ergonomics

Transfer Surface Size

Manufacturers

  • Use of supports
  • Corner shape on transfer sides
  • Relationship to base design
  • Equipment proportions
  • Redesign and costs
  • Impact on exam room layouts

Transfer Surface Size

Equipment Design Concerns

Photograph of a close in view of the bore opening of a scanning machine.

Transfer Surface Size

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

  • Width: increase to 35 to 36 inches
  • decrease to 25 to 28 inches
  • Same requirement for Equipment Used by Patients in Seated Position

Transfer Surface Size

M302 Diagnostic Equipment Used by Patients in in Seated Position

  • Alternate dimensions – 17 inches min. depth
  • Relationship to size requirement
  • for M301

Questions?