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1、Blood Glucose Meter,Working Group Report By The Working Group on Medical Measurements The Seventeenth Forum Meeting October 14-16, 2010,2,Overview,Diabetes Blood glucose monitoring instrument Medical Regulatory Control ISO 15197 Accuracy What could metrology do more？,3,Diabetes Mellitus,Abnormal con
2、centrations of glucose in the blood caused by a relative or absolute deficiency in insulin secretion or by insulin resistance Leading to heart attack, blindness, poor circulation, gangrene, kidney disfunction or death No cure. Monitoring blood glucose is required,4,The 10 leading causes of death by
3、broad income group (2004),5,Leading cause of death ranking tables in Chinese Taipei (20012008),Department of Health, Executive Yuan, Taiwan,6,The Number and Percentage of Diabetes Patients,International Diabetes Institute,2003-2007 Diabetes percentage of people in the world,2003-2007 Number of Globa
4、l Diabetes,Global Diabetes patients, from 194 million in 2003 increased to 246 million people in 2007, estimated in 2025 to 380 million people; The percentage of people, from 5.1% growth in 2003 to 7.3% in 2025 .,The Americas, Europes and Japans diabetes need the glucose monitoring up to 70 % in the
5、 global demand.,2008-2011 Market survey and investment advisory report of blood glucose meter in China,7,Blood Glucose Analyzer,Introduction Multifunction biochemistry test Plasma Sample Displayed, printed and stored in memory Mainly Used by Health Facility Features Excellent Precision and Accuracy
6、Simple, safe operation, autocalibration and autosampling,8,Blood Glucose Meter,Introduction Mainly for layperson to monitor and take action to control the concentration or glucose present in the blood A relatively small drop of blood is placed on a disposable test strip which interfaces with a digit
7、al meter. Inaccuracy 2 times larger than blood glucose analyzer Features Palm of the hand battery powered Volume of blood sample L Test time 3 to 60 sec,9,Global market demand for blood-glucose meter,US$ mn,Diagnostics & Imaging Week,Global blood glucose monitoring device, with 13% growth rate incre
8、ase in 2009. It will reach 9.73 billion U.S. dollars in market size in 2009.,The major manufacturers, including Roche Diagnostics (Roche), Johnson & Johnson (Johnson & Johnson), Bayer Diagnostics (Bayer), Abbott Laboratories (Abbott). They were combined market share of 86%.,20032009 Blood glucose mo
9、nitoring market in the world,2006 Major glucose monitoring vendor market share,2008-2011 Market survey and investment advisory report of blood glucose meter in China,10,FDA Classification of Medical Device,General Controls and Special Controls(510K),General Controls, Special Controls and Premarket A
10、pproval(PMA),GMP (parts of medical devices not needed to inspect),Class I,Class II,Inspection and registration,GMP,Inspection and registration,Class III,GMP,Inspection and registration + Clinical trail reference,Medical Regulatory Control in Chinese Taipei/USA,11,Evaluate the accuracy of blood-gluco
11、se meter,Journal of Biomedical & Laboratory Sciences, 2008,Error Grid analysis,Accu-Check Advantage versus EasyPlus mini/ Bionime Estimated Blood Measured Blood 42 Rightest TM GM300.,A is the district for the measured values with the reference blood glucose values of “20% of the error. B is the dist
12、rict for the error of 20.,Reproducibility analysis of glucose meter,12,ISO 15197 (Metrological Requirement),ISO 15197 (2003)：In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. Scope Measure glucose level in capillary b
13、lood sample self-testing by laypersons for management of diabetes mellitus 4 Design and development 4.3 Traceability Analytical performance evaluation 7.2 Precision evaluation 7.3 System accuracy evaluation 7.4 Minimum acceptable system accuracy,13,4.3 Traceability chain(informative),14,7.2 Accuracy
14、 evaluation,7.2.2 repeatability evaluation Number of instruments: 10 Test in 10 times/instrument Sample: Vein blood Average, Standard deviation, Coefficient of variation 7.2.3 intermediate precision evaluation (precision between reproducibility and repeatability) Number of instruments: 10 Test in 10
15、 days/instrument Average, Standard deviation, Coefficient of variation Same method, test items and location Operator, equipment, calibration, environment and time differ,15,7.3 System accuracy evaluation,Sample: 100 capillary blood Temperature: (23 5) Number of instruments: 2 Standard deviation, Reg
16、ression curve,95% of the result When the blood glucose results below 75 mg / dL, the error should be less than 15 mg / dL When the blood glucose results above 75 mg / dL (inclusive), the error should be less than 20%,16,Factors affecting accuracy,Interferences High levels of certain substances (such
17、 as vitamin C) in blood affects the test result values such as using GDH-PQQ test strips to cause false high glucose result Hematocrit (the amount of red blood cells in the blood). a high hematocrit, test low for blood glucose Traceability of meter Environmental effects (Ambient temperature, Humidit
18、y and altitude) Size and quality of blood sample,17,European directive on In-Vitro Diagnostic Medical Devices (IVDD 98/79/EC), The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference mat
19、erials of a higher order. Blood glucose meter test by NIST SRM 965a glucose in human serum material done by CMS, ITRI in 2008,Investigate the Accuracy of Blood Glucose Meter,SRM 965a,NIST SRM 965a concentration: Level 1 is 34.56 mg/dL， Level 2 is 78.5 mg/dL Level 3 is 122.1 mg/dL， Level 4 is 292.6 m
20、g/dL,FY2008 Investigate 11commercially available blood glucose meters, the result shows that the maximum error value is 80% in 11 pieces of glucose meters。,test,18,Adverse Events,Glucose meters have one of the highest number of Device adverse events reported per year(generally under-reported) in USA
21、 Thousands of Medical Device Reports(MDRs)sent each year 100 deaths associated with glucose meters reported between 1992-2009 in USA 13 deaths caused by non-glucose interference 11 deaths caused by False High result 6 deaths caused by Low result FDA Perspective - Public Health Notification: Potentia
22、lly Fatal Errors with GDH-PQQ Glucose Monitoring Technology by Courtney C. Harper, Ph.D(USA ),19,What could metrology do more？,More samples are tested min. 360 samples 1 More sites used min. at 3 sites 1 Tested over time min. 2 weeks 1 Revising accuracy standard 1 95% (or and = ) ？ of individual glu
23、cose results +12 (or + 15)？mg/dL from the reference glucose values when the blood glucose results below 75 mg / dL and +15% when over 75 mg / dL ,1 CLIA Waiver Studies: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Jan.
24、 30, 2008,Tighter Performance Criteria (test method and MPE),20,Modify Traceability Chain,A Database of High Order Reference Materials and Reference Measurement Procedures by R.i. Weilgosz, BIPM (JCTLM Meeting 2008),21,Establish Commutable Calibrator and Reference Procedure,IVD manufacturers (100),A
25、gents,Medical laboratories (20,000),SI units,Medical laboratories in hospitals (Medical center: 18, Regional hospital: 41, District hospital: 456),Development of CRM Build verification techniques,Provide verification method Assistance of building quality system,Development of verification and tracea
26、bility techniques Clinical medicine (blood glucose, cholesterol, creatinine, urea, uric acid, hormones, etc.),National Standards Laboratory (Primary standard),In-house RM,Traceability,Authentication,People,Thank you,2011 Plan,The Working Group on Medical Measurements The Seventeenth Forum Meeting Oc
27、tober 14-16, 2010,24,Activities of Working Group on Medical Measurements,25,2011 Infrared Ear thermometer Training,Objective: What does the project seek to achieve? Assist member economies to establish or improve control scheme of ear infrared thermometer Share the knowledge on the legislation, stan
28、dards and regulations between different economies and harmonize with each other in metrology or health. Make our participants get to know more about verification, calibration and type approval for Infrared Ear thermometers. Helpful to reduce the trade barrier,26,How does the project meet the priorit
29、ies of your forum and APEC as a whole? Why should APEC undertake this project? In the 2009 APEC Leaders Declaration, Leaders reaffirmed to build up the ability of regional avian influenza and other potential emergency and subemergency disease such as HIV/AIDS and Tuberculosis. Infrared Ear thermomet
30、er has been wildly used to screen patient which is faster, affordable, and easier to use during the outbreak of HIN1 flu and SARS. The accuracy of Infrared Ear Thermometer affects the ability build-up to contain avian influenza. Well control scheme of ear infrared thermometer is needed in member eco
31、nomies,27,Methodology: How do you plan to implement the project?,Clinical application of Infrared Ear thermometer (Clinical Practice ) Infrared Ear thermometer (design, structure compoents and so on) Related Regulations, Standards and Control Measures Hand-on practice share control experience among
32、participant,28,If this proposal builds on the findings or lessons learned from previous projects.,This proposal is built on the previous infrared Ear thermometer survey conducted by APLMF Working Group on Medical Measurements in 2009,29,How you plan to communicate the results or benefits of this pro
33、ject to others,disseminate the knowledge and skills in their economy. And to release and publish the results in the discussion so that all the information will be more available to everyone.,30,Control of IVD Medical Devices from Metrological Perspectives,Purpose Identification of the role of metrol
34、ogy in IVD medical device control and its strategy Key points of Report 1. Administrative control system for IVD medical devices adopted by the health authority and/or metrology 2. Metrological requirements of IVD Medical Device 3. Metrological Infrastructure for IVD Medical Device to assist competent authority and industry 4. Needs of the competent authority and industry Cooperation and coordination between metrology authority and health authority,Thank you,