# 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 to 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

Note large X- ray source, beam forming 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
• Table heights of 25”, or more may require transfer assistance
• The “C-arm” may be moved to the table-end for transfer.
• A patient who can’t get on the table may get a forearm scan.

# 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 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?
• 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 equipment?
• 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 Equipment - 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 equipment 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 device access for all patients and are thankful for the opportunity to participate in standards development with the United States Access Board.

Thank You