Mammography Industry: 

Review of Proposed 

Accessibility Standards

U.S. Access Board

May 8, 2012

Atlanta, Georgia

John LaViola, V.P. Engineering

Hologic, Inc. – Breast Health
Diagnostic Equipment – Mammography

Current State

• Appropriate ergonomic design and patient accessibility features are 

goals for all mammography equipment manufacturers

• Per US FDA / EU MDD, manufacturers are required to address 

mammography human factors and usability

• No specific accessibility architectural standards exist for 

mammography equipment, but we have general requirements

• CFR Title 21, MQSA, and clinical organizations explicitly and 

implicitly define use cases and design requirements

• Consensus standards define safety and performance 

requirements (e.g., mechanical strength, “pinch points”)
Current Accessibility Features

Wheelchair accommodations & hand/arm support features are provided
Diagnostic Equipment - Mammography

Question 8: To what extent does diagnostic equipment 

currently incorporate features that conform to the technical 

criteria proposed in Chapter M3?

Some features and clearances currently comply, but 

further assessment of certain proposed requirements in the 

context of mammography applications is required:

• Breast platform

• Knee/Toe clearance

• Standing support definitions
Breast Platform Height Standard: M303.4.1

Question 36. 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?

• Yes, but based on patient accessibility requests, several 

manufacturers lower the breast platform to 25” - 28”

• Recommend reassessing and clarifying height range to be 

an available range of travel instead of a specific minimum 

and maximum
Knee/Toe Clearance Standard: M303.2.4

“Knee and toe clearance 

under breast platforms shall 

be 25 inches (635 mm) 

Figure M5

• Flat gantry base

• Clearance goes to the floor

• No provisions for base supports

be 25 inches (635 mm) 

deep.”
• Lip often required for 

structural/seismic 

stability and installation

Toe Clearance Concerns

Example Base Lip Profile

stability and installation

• Lip profiles can be 

designed for optimal 

wheelchair accessibility
Standing Support Standard: M305.3.2

• “Where the support is vertical, it 

shall be 18” minimum in length 

and the bottom end of the 

support shall be 34” high 

minimum and 37” high 

maximum above the standing 

surface.”

• Derived from ICC A117.1-2009 

“accessible bathing fixtures”

• May be inappropriate for 

mammography applications
Standing Supports for Mammography

• Example: 6” gripping surface at 49” 

above the standing surface for 

patient positioning/immobilization

• For positioning, hand/arm supports 

are placed relative to breast platform

• Structural strength of current 

hand/arm supports comply with 

international safety standards.
Diagnostic Equipment - Mammography

Question 2. What other barriers that affect the accessibility 

and usability of medical diagnostic equipment should be 

addressed in future updates to the standards?

Additional guidance may need to be considered for wheelchair 

accessibility (e.g., rotated views, diagnostic/interventional 

modes, arm-rest interference/pinch points).
Diagnostic Equipment - Mammography

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? 

• As currently drafted, any non-conforming toe (gantry) clearances 

and standing support geometries equipment changes would likely 

involve significant structural modifications.

• Re-design expenses and resulting product costs are TBD and would 

vary from manufacturer to manufacturer. 
Diagnostic Equipment - Mammography

Question10. How often is diagnostic equipment 

redesigned?

Design changes to sub-assemblies are typically multiyear projects and may be longer for a complete system 

redesign.
Moving Forward

• Manufacturers are committed to providing optimal 

accessibility for all patients and welcome the opportunity 

to participate in standards development with the Access 

Board

• On April 20, 2012 at a meeting of the International 

Electro-technical Committee (IEC MT-31*) a spreadsheet 

was distributed to gather input from a broad 

representation of worldwide mammography equipment 

manufacturers regarding areas that may conflict with the 

proposed access requirements in Chapter M3

* IEC MT31 is responsible for development of design and test requirements for the basic 

safety and essential performance of mammographic X-ray equipment.