# 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 mi nimum 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 mi nimum and maximum

## Knee/Toe Clearance Standard: M303.2.4 “K nee and to e clearance under breast platforms shall be 25 inches (635 mm) Figure M5

• Flat gan try base • Clearance goes to the floor • No provisions fo r 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 ma ximum above the sta nding surface.”

• Derived from ICC A117.1 - 2009 “a ccessible bathing fixtures” • Ma y be inappropriate for mammograph y 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.

• R e - 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 multi year 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.