Steve Brotman, MD, JD Senior Vice President, Payment and Health Care Delivery Policy, AdvaMed

1. FDA Public Hearing on Clinical Accuracy Requirements for Point of Care Blood Glucose MetersIndustry Perspective: Tighter Performance Criteria forBlood Glucose Meters Steve Brotman, MD, JD Senior Vice President, Payment and Health Care Delivery Policy, AdvaMed March 16, 2010

2. AdvaMed Description • AdvaMed is the world’s largest association representing manufacturers of medical devices, diagnostic products, and medical information systems. • AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments.

3. Objectives • Industry commitment to designing and manufacturing meters that meet the needs of individuals with diabetes • Major goal: Improve meter accuracy • Key strategies include: • Reduce use error • Reduce the impact of interferents Improve overall quality of testing for patients

4. Background- ISO 15197 • Recognizes importance of usability improvements by industry • Weighs performance criteria goals against the capabilities of existing self-monitoring devices • Protect against performance requirements that cause manufacturers to focus design improvements on analytical performance at the expense of other important attributes (i.e. greater convenience, greater compliance) • Sets minimum threshold for acceptable device performance

5. Major Advances ThroughUsability Improvements • Strides in improving performance since approval of ISO 15197 (Requirements for blood-glucose monitoring systems for self-measurement in managing diabetes mellitus) • Integration of ergonomic/human factor aspects and overall usability engineering in device design • Array of technological advances • These usability improvements will depend on the individual system—no single blood glucose monitoring system will meet the needs of all patients

6. A Glimpse of UsabilityImprovements • Faster test times • Smaller blood samples for decreased discomfort • issue of discomfort highlighted at FDA Oct. 2001 Panel; recommendation re. AST labeling instructions to support patient compliance despite limitations • Overall increased robustness (e.g., cleaning solutions and hardware testing-drop, shock, and vibration) • Enhanced meter displays (e.g., larger readouts, backlighting, and universal symbols) • Ergonomic design (e.g. smaller meters for more discreet testing) • Non-changeable unit of measure by user • No coding, calibration, or timing

7. A Glimpse of UsabilityImprovements • Wider temperature range • Improved reagent stability for longer use life and decreased susceptibility to exposure • Biosensor in addition to photometric technology • Plasma-referenced results • Integrated meter and lancing device • Improved voice simulators for visually impaired • Flagging test results (e.g., meal markers) • Innovative software to organize meter data • No individual test strip or lancet handling to reduce use errors and increase ease of use

8. A Glimpse of UsabilityImprovements • Enhanced user feedback (e.g., beeps, vibrations, and reminders for testing) • Underfill detection • Error messages for degraded test strips and temperature extremes • Clarity of error messages • Mitigation of use risk-lockouts (e.g., changing of units and delta checks)

9. Beyond UsabilityImprovements • Most of these usability improvements are beyond the current standard—not required under ISO 15197 • Beyond usability improvements, other significant improvements include less susceptibility to interferents (e.g. hematocrit, oxygen) • All of these advances are part of industry efforts to support technology innovations that improve health care and lead to better outcomes.

10. BGMs and Role in DiabetesCare • Clinical studies show home BGMs meeting the current accuracy standard for self-testing (ISO 15197) were associated with improved glycemic control and positive clinical outcomes (e.g. DCCT) • Current standard produces clinically acceptable results—According to Consensus Error Grid analysis (EGA), 95% of results in range A (no effect on clinical action) and remainder in range B (altered clinical action with little/no effect on clinical outcome) • Strongly suggest consideration of EGA as important tool for objective assessment of BGMs for self-testing • Impact of criteria changes on current meters should be considered (e.g. increased test time, usability, cost)

11. Guidelines for BGMs forHospital Use • The current accuracy criteria in ISO standard is specific to self-monitoring/home use—not professional use • Industry fully support efforts to develop increased accuracy requirements for BGMs used in hospitals and long-term facilities [CLSI POCT(12): Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities] • Both FDA and industry are engaged in this effort. • The potential consequences of an inaccurate glucose result in these particular settings (e.g. immediate treatment decisions, increased susceptibility of hospitalized patient) merit guideline development for meters used in those settings. • Standard for home use was not intended for tight glycemic control (TGC) in hospital—we fully support efforts to address in POCT(12)

12. Support for Evolution of BGMsfor Home Use • Recent advances made by industry contributing to overall device performance • As part of that commitment along with other revisions to the home use standard, industry strongly supports • revising accuracy standard for >95% of individual glucose results to: +15 mg/dL from the reference glucose values and +15% (ISO 15197, Section 7) • Also consensus recognition that the standard for hospitals is CLSI POCT(12), not ISO 15197 • Also discussion of interfering factors and how to best deal with in ISO 15197 • Industry supports all these efforts

13. Other Considerations • Near completion of updated CLSI POCT(12), which will set out latest guidelines for BGMs in hospital setting, including considerations of overall accuracy and TGC • ISO 15197 could be adopted into FDA guidance to support enforcement for use in self-testing only • In the end, usability and analytical performance should be carefully weighed to support meters that meet individual patients’ needs • We look forward to ongoing work with FDA and the global standards community in systemic review of ISO 15197 as well as the completion of POCT(12) to support BGM innovation and the needs of users