## 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 **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 o CFR Title 21, MQSA, and clinical organizations explicitly and implicitly define use cases and design requirements o Consensus standards define safety and performance requirements (e.g., mechanical strength, “pinch points”) **Current Accessibility Features** [ Photos: T hree photographs showing typical mammography machines. T he machines are similar looking, one has a patient standing at the machine for an examination. ] Wheelchair accommodations & hand/arm support features are provided **Diagnostic Equipment -**  **Ma mmography**  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: 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 o n 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/To**  **e Clearance Standard: M303.2.4** “Knee and toe clearance under breast platforms shall be 25 inches (635 mm) deep.”  Flat gantry base  Clearance goes to the floor  No provisions for base supports [Illustration: Secondary drawing from Figure M5 of the Example Applications of the Proposed Medical Diagnostic Equipment Accessibility Standards . Drawing shows a woman using a manual wheelchair holding onto the supports of the mammography machine that has been adjusted to a lower height to accommodate a seate d position. ] **Toe Clearance Concerns** Example Base Lip Profile [Photo: The l egs and knee of person using a wheelchair is shown underneath the breast platform of a mammography machine. Alip projecting out from the equipment under the footrests of the wheelchair at the floor level is highlighted.]  Lip often required for structural/seismic stability and installation  Lip profiles can be designed for optimal wheelchair accessibility **Toe Clearance Amendment**  To guarantee wheelchair accessibility and structural stability, add an allowable base lip profile to the toe clearance requirements o 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: M303.2.4.2** 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...” [Illustration: F igure M 6 of the Example Applications of the Proposed Medical Diagnostic Equipment Accessi bility Standards showing the minimum knee and toe clearances required by the proposed Standards. A n outline of a person’s legs and associated portion of a wheelchair are shown in the clearance area.]**Knee Clearance for Mammography**

Dependent on height of breast platform  Clearance for legs necessary at a certain distance below breast platform  Proper knee/torso clearance is dependent on breast platform contour [Photo: Woman using a manual wheelchair pulled up underneath the breast platform and holding onto the supports of a mammography mac hine that has been adjusted to a lower height to accommodate a seated position. T he distance between the breast platform surface and her lap is indicated .] **Knee Clearance Recommendations**  Ensure accessibility and clarify requirements (recommendation): o Restructuring this section to define knee clearance in reference to breast platform height o Clarifying interpretation of this knee clearance definition in relation to 25” knee/toe clearance depth requirement (M303.2.4) **Standing Supports 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” o May be inappropriate for mammography applications [Illustration: Three

- dimensional overview drawing of Figure M5 of the Example Applications of the Proposed Medical Diagnostic Equipment Accessibility Standards showing the features and minimum dimensions required by the proposed Standards. T he two features address ed by the slide are highlighted. ] **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. [Photo: Woman sta nding at the breast platform and holding onto the supports of a mammography machine that has been adjusted to a higher height to accommodate an upright position. T he distance between the floor, supports, and gripping surface are indicated .] **Standing Supp ort Recommendations**   To ensure proper accessibility, recommend:o Defining standing supports in relation to the breast platform o Reassessing length/geometry requirements for standing supports o 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. o Appropriate wheelchair and standing support accommodations should address all accessibility concerns. **Additional considerations D**  **iagnostic 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 wheelcha ir accessibility (e.g., rotated views, diagnostic/interventional modes, arm

- rest interference/pinch points). [Photo: W oman using a manual wheelchair pulled up underneath a breast platform of a mammography machine that has been adjusted to an angled positi oned and lower height to accommodate a seated position.] [Photo: C lose in view of a breast platform with woman using a manual wheelchair pulled up underneath it.] **General Questions and Reponses Diagnostic Equipment**  **- Mammography**  Question 9. If diagnosti c 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 ex pense?  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 multi

-year projects and may be longer for acomplete system redesign.

**Moving F orward**   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 Commi ttee (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.