Diagnostic Equipment – DXA Current State

1. Osteoporosis Assesment (DXA) Industry: Review of Proposed Accessibility StandardsU.S. Access BoardMay 8, 2012Atlanta, GeorgiaGlenn Nygard, Dir. Engineering R&DSkeletal Health Division of Hologic, Inc.

2. Diagnostic Equipment – DXACurrent State • Osteoporosis assessment is done by measuring Bone Mineral Density with Dual-energy X-ray Absorptiometry (DXA) • Other DXA applications include imaging Aortic Calcifications to estimate heart attack and stroke risk as well as Body Composition Analysis to display and quantify lean and fat tissue. • Safety, ergonomic design and easy patient access to the equipment are goals for all DXA equipment manufacturers • No architectural accessibility standards exist for DXA equipment, manufacturers use general requirements for pinch points, material selection, etc.

3. Diagnostic Equipment – DXACurrent State

4. Diagnostic Equipment – DXACurrent State Patient Access to Current Equipment • Table height of 25 - 28” limits patient access to the system • The C-arm may be moved to the table end to make it easier for the patient to get on to the table • When a patient can’t get onto the table a forearm scan may be performed to accommodate a patient in a chair.

5. 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? • Improving patient access to equipment likely involves significant modification including re-design, validation, new manufacturing processes, FDA and international approvals among the expenses. • Re-design expenses and resulting product costs are not known at this time, but are significant and could reduce other technical advances. • If requirements are reassessed, this cost might be reduced.

6. 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 and clearances currently comply, but further assessment of certain proposed requirements in the context of DXA is will be required.

7. Today’s DXA technology has significant mass and volume beneath the patient table for the X-ray and motion sub-systems, limiting the minimum table height. With significant re-design easier patient access may be possible, but this is yet to be proven. Design standards require patient supports to be 4x the patient weight; a patient table rated at 450 lbs must support 1800 lbs. Diagnostic Equipment – DXA additional considerations

8. 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? • As currently drafted, the non-conforming DXA equipment changes would likely involve major structural modifications and substantial time to re-design, validate and manufacture. • Small changes to the table height (2-3 inches of the 23 inch height) can be accomplished in a new product. • A ramp to reduce the table-height for the patient could be built easily, with a manufacturer’s design, or sold as an accessory.

9. 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? Yes. A phased implementation would lessen the impact of redesign, retest, and compliance/registration/regulatory re-filings.

10. 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