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FDA Public Hearing on Clinical Accuracy Requirements for Point of Care Blood Glucose Meters

Industry Perspective: Tighter Performance Criteria forBlood Glucose Meters

March 16, 2010

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

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• AdvaMed is the world’s largest association AdvaMed is the world’s largest association representing manufacturers of medical devices, representing manufacturers of medical devices, diagnostic products, and medical information systems.diagnostic products, and medical information systems.

• AdvaMed member companies produce the medical AdvaMed member companies produce the medical devices, diagnostic products and health information devices, diagnostic products and health information systems that are transforming health care through systems that are transforming health care through earlier disease detection, less invasive procedures, earlier disease detection, less invasive procedures, and more effective treatments.and more effective treatments.

AdvaMed Description

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• Industry commitment to designing and manufacturing Industry commitment to designing and manufacturing meters that meet the needs of individuals with meters that meet the needs of individuals with diabetesdiabetes

• Major goal: Improve meter accuracyMajor goal: Improve meter accuracy

• Key strategies include:Key strategies include:

– Reduce use errorReduce use error

– Reduce the impact of interferentsReduce the impact of interferents

Improve overall quality of testing

for patients

Objectives

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• Recognizes importance of usability improvements by Recognizes importance of usability improvements by industryindustry

– 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 Sets minimum threshold for acceptable device performanceperformance

Background- ISO 15197

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• Strides in improving performance since approval of ISO Strides in improving performance since approval of ISO 15197 (15197 (Requirements for blood-glucose monitoring Requirements for blood-glucose monitoring systems for self-measurement in managing diabetes systems for self-measurement in managing diabetes mellitus)mellitus)

• Integration of ergonomic/human factor aspects and Integration of ergonomic/human factor aspects and overall usability engineering in device designoverall usability engineering in device design

– Array of technological advancesArray of technological advances

– These usability improvements will depend on the These usability improvements will depend on the individual system—no single blood glucose individual system—no single blood glucose monitoring system will meet the needs of all patientsmonitoring system will meet the needs of all patients

Major Advances ThroughUsability Improvements

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• Faster test timesFaster test times• Smaller blood samples for decreased discomfortSmaller blood samples for decreased discomfort

– issue of discomfort highlighted at FDA Oct. 2001 issue of discomfort highlighted at FDA Oct. 2001 Panel; recommendation re. AST labeling instructions Panel; recommendation re. AST labeling instructions to support patient compliance despite limitationsto support patient compliance despite limitations

• Overall increased robustness (e.g., cleaning solutions Overall increased robustness (e.g., cleaning solutions and hardware testing-drop, shock, and vibration)and hardware testing-drop, shock, and vibration)

• Enhanced meter displays (e.g., larger readouts, Enhanced meter displays (e.g., larger readouts, backlighting, and universal symbols)backlighting, and universal symbols)

• Ergonomic design (e.g. smaller meters for more Ergonomic design (e.g. smaller meters for more discreet testing)discreet testing)

• Non-changeable unit of measure by userNon-changeable unit of measure by user• No coding, calibration, or timingNo coding, calibration, or timing

A Glimpse of UsabilityImprovements

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• Wider temperature rangeWider temperature range• Improved reagent stability for longer use life and Improved reagent stability for longer use life and

decreased susceptibility to exposuredecreased susceptibility to exposure• Biosensor in addition to photometric technologyBiosensor in addition to photometric technology• Plasma-referenced resultsPlasma-referenced results• Integrated meter and lancing deviceIntegrated meter and lancing device• Improved voice simulators for visually impairedImproved voice simulators for visually impaired• Flagging test results (e.g., meal markers)Flagging test results (e.g., meal markers)• Innovative software to organize meter dataInnovative software to organize meter data• No individual test strip or lancet handling to reduce use No individual test strip or lancet handling to reduce use

errors and increase ease of useerrors and increase ease of use

A Glimpse of UsabilityImprovements

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• Enhanced user feedback (e.g., beeps, vibrations, and Enhanced user feedback (e.g., beeps, vibrations, and reminders for testing)reminders for testing)

• Underfill detectionUnderfill detection• Error messages for degraded test strips and Error messages for degraded test strips and

temperature extremestemperature extremes• Clarity of error messagesClarity of error messages• Mitigation of use risk-lockouts (e.g., changing of units Mitigation of use risk-lockouts (e.g., changing of units

and delta checks)and delta checks)

A Glimpse of UsabilityImprovements

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• Most of these usability improvements are beyond the Most of these usability improvements are beyond the current standard—not required under ISO 15197current standard—not required under ISO 15197

• Beyond usability improvementsBeyond usability improvements, other significant , other significant improvements include less susceptibility to interferents improvements include less susceptibility to interferents (e.g. hematocrit, oxygen)(e.g. hematocrit, oxygen)

• All of these advances are part of industry efforts to All of these advances are part of industry efforts to support technology innovations that improve health support technology innovations that improve health care and lead to better outcomes.care and lead to better outcomes.

Beyond UsabilityImprovements

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• Clinical studies show home BGMs meeting the current Clinical studies show home BGMs meeting the current accuracy standard for self-testing (ISO 15197) were accuracy standard for self-testing (ISO 15197) were associated with improved glycemic control and positive associated with improved glycemic control and positive clinical outcomes (e.g. DCCT)clinical outcomes (e.g. DCCT)

• Current standard produces clinically acceptable resultsCurrent standard produces clinically acceptable results—According to Consensus Error Grid analysis (EGA), —According to Consensus Error Grid analysis (EGA), 95% of results in range A (no effect on clinical action) 95% of results in range A (no effect on clinical action) and remainder in range B (altered clinical action with and remainder in range B (altered clinical action with little/no effect on clinical outcome)little/no effect on clinical outcome)

• Strongly suggest consideration of EGA as important Strongly suggest consideration of EGA as important tool for objective assessment of BGMs for self-testingtool for objective assessment of BGMs for self-testing

• Impact of criteria changes on current meters should be Impact of criteria changes on current meters should be considered (e.g. increased test time, usability, cost) considered (e.g. increased test time, usability, cost)

BGMs and Role in DiabetesCare

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• The current accuracy criteria in ISO standard is specific The current accuracy criteria in ISO standard is specific to self-monitoring/home use—not professional useto self-monitoring/home use—not professional use

• Industry fully support efforts to develop increased Industry fully support efforts to develop increased accuracy requirements for BGMs used in hospitals and accuracy requirements for BGMs used in hospitals and long-term facilities [CLSI POCT(12): long-term facilities [CLSI POCT(12): Point-of-Care Point-of-Care Blood Glucose Testing in Acute and Chronic Care Blood Glucose Testing in Acute and Chronic Care Facilities]Facilities]– Both FDA and industry are engaged in this effort.Both FDA and industry are engaged in this effort.– The potential consequences of an inaccurate The potential consequences of an inaccurate

glucose result in these particular settings (e.g. glucose result in these particular settings (e.g. immediate treatment decisions, increased immediate treatment decisions, increased susceptibility of hospitalized patient) merit guideline susceptibility of hospitalized patient) merit guideline development for meters used in those settings.development for meters used in those settings.

– Standard for home use was not intended for tight Standard for home use was not intended for tight glycemic control (TGC) in hospital—we fully support glycemic control (TGC) in hospital—we fully support efforts to address in POCT(12)efforts to address in POCT(12)

Guidelines for BGMs forHospital Use

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• Recent advances made by industry contributing to Recent advances made by industry contributing to overall device performanceoverall device performance

• As part of that commitment along with other revisions to As part of that commitment along with other revisions to the home use standard, industry strongly supportsthe home use standard, industry strongly supports– revising accuracy standard for revising accuracy standard for >>95% of individual 95% of individual

glucose results to: glucose results to: ++15 mg/dL from the reference 15 mg/dL from the reference glucose values and glucose values and ++15% (ISO 15197, Section 7)15% (ISO 15197, Section 7)

• Also consensus recognition that the standard for Also consensus recognition that the standard for hospitals is CLSI POCT(12), not ISO 15197 hospitals is CLSI POCT(12), not ISO 15197

• Also discussion of interfering factors and how to best Also discussion of interfering factors and how to best deal with in ISO 15197deal with in ISO 15197

• Industry supports all these effortsIndustry supports all these efforts

Support for Evolution of BGMsfor Home Use

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• Near completion of updated CLSI POCT(12), which will Near completion of updated CLSI POCT(12), which will set out latest guidelines for BGMs in hospital setting, set out latest guidelines for BGMs in hospital setting, including considerations of overall accuracy and TGCincluding considerations of overall accuracy and TGC

• ISO 15197 could be adopted into FDA guidance to ISO 15197 could be adopted into FDA guidance to support enforcement for use in self-testing onlysupport enforcement for use in self-testing only

• In the end, usability and analytical performance should In the end, usability and analytical performance should be carefully weighed to support meters that meet be carefully weighed to support meters that meet individual patients’ needsindividual patients’ needs

• We look forward to ongoing work with FDA and the We look forward to ongoing work with FDA and the global standards community in systemic review of ISO global standards community in systemic review of ISO 15197 as well as the completion of POCT(12) to 15197 as well as the completion of POCT(12) to support BGM innovation and the needs of userssupport BGM innovation and the needs of users

Other Considerations

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