## Osteoporosis Assessment (DXA) Industry: Review of Proposed **Accessibility Standards** U.S. Access Board May 8, 2012 Atlanta, Georgia Glenn Nygard, Dir. Engineering R&D Skeletal Health Division of Hologic, Inc. **Diagnostic Equipment –**  **DXA Current State**   Osteoporosis assessment measures bone mineral density using Dual
- energy X- ray Absorptiometry (DXA) technology.  Manufacturers are committed to give all patients access t o DXA technology; for treating osteoporosis and other conditions.  DXA’s diagnostic quality and the safety of easy, dignified patient scans are part of the ongoing commitment of all device makers.  Other DXA applications include body composition analysis and discovering aortic calcification.  DXA accessibility standards don’t exist today. Standards for structural strength, material choice & known hazards are consistently applied. **Diagnostic Equipment –**  **DXA Current State**  [Photo: Patient being scanned on a DXA machine with an open base where imaging components are seen, staff stands to side .] [Photo: Patient being scanned on a DXA machine with an enclosed base, staff sits at table with computer showing scan to side .] Note large X
- ray source, beam formi ng and motion sub
-systems under the patient on the left. Also, the table must pass X
- rays and must be a single uniform piece. **Diagnostic Equipment –**  **DXA Current State**   Patient Access to Current Equipment o Table heights of 25”, or more may re quire transfer assistance o The “C
-arm” may be moved to the table
-end for transfer. o A patient who can’t get on the table may get a forearm scan. [Photo: Series of images, two showing a patient laying an arm on a DXA machine scanning bed and a third of a forearm scan image .] **Diagnostic Equipment –**  **DXA** Question 2. What other barriers that affect the accessibility and usability of medical diagnostic equipment should be addressed in future updates to the standards?  The DXA exam room can limit patient access. Today, the floor space to accommodate a ramp is not a requirement.**Diagnostic Equipment -**  **DXA**

Question 8 . To what extent does diagnostic equipment currently incorporate features that conform to the technical criteria proposed in Chapter M3?  Some features, such as transfer surface size now comply, additional assessment of proposed table
- height requirements in the context of DXA is needed. **Diagnostic Equipment -**  **DXA** Question 9. If diagnostic equipment does not currently incorporate features t hat 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?  Reducing table height a few inches might be done with little difficulty.  A ramp to reduce table
- height could be sold as an accessory. Which technical criteria would have the greatest incremental costs on the design or redesign and manufacture of equipmen t?  Table height to transfer surface appears to be adjustable & 17” min. Include estimates of the incremental costs, where possible.  The adjustable lifts employed in some systems cost several thousand dollars for the material, alone. **Diagnostic Equip ment**  **- DXA**  Question10. How often is diagnostic equipment redesigned?  DXA equipment system - level design changes are multi
-year projects Would incorporating features that conform to the technical criteria proposed in Chapter M3 in the planned redesign of e quipment lessen the economic and technical impacts?  A planned redesign to meet proposed technical criteria lessens the cost & project risk when compared to an unplanned redesign. **Moving Forward**  DXA manufacturers are committed to providing medical devi ce access for all patients and are thankful for the opportunity to participate in standards development with the United States Access Board. Thank You