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

[Photo: Picture showing the cover of ANSI/AAMI HE75:2009 Human factors engineering design of 

medical devices document.]

• ANSI/AAMI HE75 – 2009 Human Factors Engineering – Design of Medical Devices

• Chapter 16 –Accessibility Considerations

Background

[Photo: Cover of Americans with Disabilities Act and Architectural Barriers Act Accessibility Guidelines.]

• ADA and ABA 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:

[Photos: Slide contains two photographs, one of the Access Board Executive Director and Board 

Members looking at imaging equipment and the other of a Board Member using a wheelchair preparing 

to transfer onto an exam chair.]

Photos:

[Photos: Slide contains two photographs. One 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. The other photograph is of a wheelchair 

scale.]
Technical Criteria

[Photo: Photograph of a close in view of a hand gripping the support rail along the edge of an exam 

table.]

• Supports - M305

Technical Criteria Across equipment types:

[Photo: Photograph of a close in view of the bore opening of a scanning machine.]

• Communication M306

• Operable Parts M307

Data from Wheeled Mobility Anthropometry Project

[Photo: Picture of a page from Anthropometry of Wheeled Mobility Project Final Report on clear floor 

spaces.]

Example Applications Document

[Photo: Slide contains two pictures. The first is the cover page of the Example Applications of the 

Proposed Medical Diagnostic Equipment Accessibility Standards document. The second is a 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

[Photo: Slide contains two Illustrations. One of a person using a wheelchair executing a parallel transfer 

onto a an exam table and the other of person using a wheelchair executing a perpendicular transfer 

onto a an exam table.]

Transfer Surface Height and Size
Transfer Surface Height 

[Photo: Illustration of an exam table with the transfer surface highlighted showing the 17 inches 

minimum and 19 inches maximum height above the floor.]

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.

Transfer Surface Height 

[Photo: Illustration of an exam chair with the transfer surface highlighted showing the 17 inches 

minimum and 19 inches maximum height above the floor.]

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.

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 

[Photo: Photograph of a bone density scanning machine showing imaging and machinery components 

beneath the examination surface.]

Equipment Design Concerns

Transfer Surface Size 

[Photo: Illustration of an exam table with the transfer surface highlighted showing 30 inches wide 

minimum and 15 inches deep minimum.]

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

deep minimum.

Transfer Surface Size

[Photo: Illustration of an exam chair with the transfer surface highlighted showing 21 inches wide 

minumim and 15 inches deep minimum.]

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

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 

[Photo: Photograph of a close in view of the bore opening of a scanning machine.]

Equipment Design Concerns

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?