Mammography Industry: Review of Proposed Accessibility Standards U.S. Access Board May 8, 2012 Atlanta, Georgia

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 Wheelchair accommodations and standing support features are provided in all systems 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 (e.g., radiation shielding, breast compression, imaging geometries, patient support features) Consensus standards define safety and performance requirements (e.g., mechanical strength, “pinch points”)

Current Accessibility Features

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

Breast Platform Height Standard: M 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 AND TOE CLEARANCE

Knee/Toe Clearance Standard: M Flat gantry base Clearance goes to the floor No provisions for base supports “Knee and toe clearance under breast platforms shall be 25 inches (635 mm) deep.” Figure M5

Example Base Lip Profile Lip often required for structural/seismic stability and installation Lip profiles can be designed for optimal wheelchair accessibility Toe Clearance Concerns

Toe Clearance Amendment To guarantee wheelchair accessibility and structural stability, add an allowable base lip profile to the toe clearance requirements Standard for profile of base lip should be developed from anthropometric data on wheelchair footrest positioning To improve accessibility and minimize technical constraint, clearance should be specified as 25” minimum

Knee Clearance Standard: M Standard references knee clearance relative to the floor “Knee clearance shall be provided at a depth of 11” minimum and 25” maximum at 9” above the floor and at a depth of 8” minimum at 27” above the floor…”

Knee Clearance for Mammography Clearance for legs necessary at a certain distance below breast platform Proper knee/torso clearance is dependent on breast platform contour Dependent on height of breast platform

Knee Clearance Recommendations Ensure accessibility and clarify requirements (recommendation): Restructuring this section to define knee clearance in reference to breast platform height Clarifying interpretation of this knee clearance definition in relation to 25” knee/toe clearance depth requirement (M )

STANDING SUPPORTS

Standing Support Standard: M “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 A “accessible bathing fixtures” May be inappropriate for mammography applications

Standing Supports for Mammography 6” is ample for gripping surface 49” above standing surface 34”-37” would be too low Standing supports referenced from breast platform Defines arm position relative to breast position Structural strength of supports guaranteed by IEC and IEC safety standards.

Standing Support Recommendations To ensure proper accessibility, recommend: Defining standing supports in relation to the breast platform Reassessing length/geometry requirements for standing supports Considering a specification on how far away from the chest wall the standing supports should be located

REMOVABLE SEAT COMPATIBILITY

Removable Seat Considerations Question 37 b) Should a folding or removable seat be required on other types of diagnostic equipment used by patients in a standing position? Mammography equipment accessibility should be achieved without the requirement for use of a folding or removable seat. Appropriate wheelchair and standing support accommodations should address all accessibility concerns.

ADDITIONAL CONSIDERATIONS

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., views other than CC, diagnostic/interventional modes, arm-rest interference/pinch points).

GENERAL QUESTIONS AND REPONSES

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, the non-conforming toe (gantry) clearances and standing support geometries equipment changes would likely involve significant structural modifications and substantial manufacturer re-design/test expense. Re-design expenses and resulting product costs are TBD and would vary from manufacturer to manufacturer. However, if these requirements are reassessed as described in the preceding slides, this cost could be minimized with no compromises to patient accessibility.

Diagnostic Equipment - Mammography Question10. How often is diagnostic equipment redesigned? Typically, mammography equipment design cycles are 5 to 10 years. Would incorporating features that conform to the technical criteria proposed in Chapter M3 in the planned redesign of equipment lessen the economic and technical impacts? Yes. A phased implementation timeline would lessen the impact of redesign, retest, and compliance/registration/regulatory re-filings.

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.