Exemptions Project Update Diabetes Technology 豁免项目更新糖尿病技术.pptVIP

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Exemptions Project Update Diabetes Technology 豁免项目更新糖尿病技术.ppt

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* * * * * * * FDA Public Hearing on Clinical Accuracy Requirements for Point of Care Blood Glucose MetersIndustry Perspective: Tighter Performance Criteria forBlood Glucose Meters March 16, 2010 Steve Brotman, MD, JD Senior Vice President, Payment and Health Care Delivery Policy, AdvaMed 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. AdvaMed Description 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 Objectives 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 Background- ISO 15197 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 Major Advances ThroughUsability Improvements Faster test times Smaller blood samples for decreased discomfort issue of discomfort highlighted at