Survey on the Metrological Control for the Medical measurement Instruments

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1 Survey on the Metrological for the Medical measurement Instruments The Working Group on Medical Measurements Singapore November 5-7, 2006 Issued : August 29, 2006 Responded : Six Member Economies, including,,,, Vietnam, and Chinese Taipei ( by October 2, 2006.)

2 Medical Measurement Instruments with OIML Recommendation Q3-A-Responsible Authorities for Metrology control- R 7 Clinical thermometers, mercury-inglass METI & NMIJ/AIST BSMI R 6- Mechanical non-invasive s METI & NMIJ/AIST BSMI R 6-2 Non-invasive automated METI & NMIJ/AIST BSMI R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification R 04 -Pure-tone Audiometers R 4 Clinical electrical thermometers for continuous measurement BSMI R 5 Clinical electrical thermometers METI & NMIJ/AIST BSMI R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical Medical Measurement Instruments with Q3-A-Responsible Authorities for Metrology control-2 METI: Ministry of Economy, Trade and Industry NMIJ: National Metrology Institute of AIST: National Institute of Advanced Industrial Science and Technology : DIRECCIÓN GENERAL DE NORMAS,, (General Bureau of Standards, Economy) : U.S. Food and Drug Administration : Directorate for Standards and Quality BSMI: Bureau of Standards, Metrology, and Inspection

3 Medical Measurement Instruments with Q3-B-Relative Regulations for Metrology control- R 7 Clinical thermometers, mercury-inglass Measurement Law 2 The Weights and Measures, 9,and 0 R 6- Mechanical non-invasive s Measurement Law 3 The Weights and Measures, 9,and R 6-2 Non-invasive automated Measurement Law 3 The Weights and Measures,,and 2 4 R 78 Westergren tubes for measurement of erythrocyte sedimentation rate 5 R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification 6 R 04 -Pure-tone Audiometers Federal Law for Metrology and Normalization R 4 Clinical electrical thermometers for continuous measurement 7 R 5 Clinical electrical thermometers with maximum device Measurement Law 7 The Weights and Measures,,and 3 R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical 8 Medical Measurement Instruments with Q3-B-Relative Regulations for Metrology control-2 :NOM-009-SCFI-993 INSTRUMENTOS DE MEDICIÓN-ESFIGMOMANÓMETROS DE COLUMNA DE MERCURIO, DE ELEMENTO SENSOR ELÁSTICO PARA MEDIR LA PRESIÓN SANGUÍNEA DEL CUERPO HUMANO 2:Section 2 CFR Clinical mercury thermometer 3:Section 2 CFR Noninvasive Blood Pressure Measurement System 4:Section 2 CFR Piston syringe - Recognized standards include many ISO standards 5:Waived from regulation in accordance with P.L The Clinical Laboratory Improvements Amendments 6:Section 2CFR Electrocardiograph - Recognized standards include many ISO standards

4 Medical Measurement Instruments with Q3-B-Relative Regulations for Metrology control-3 7:Section 2 CFR Clinical electronic thermometer - Recognized standards include ASTM standards 8:P.L The Clinical Laboratory Improvements Amendments provides the with responsibility to categorize the complexity and level of regulatory oversite to be applied. Spectophotometers used for certain anlytes has a high complexity 9:Regulations Governing Verification and Inspection of Measuring Instrument 0:Technical Specification for Verification and Inspection of Thermometers :Technical Specification for Verification and Inspection of Non Invasive Automated Sphygmomanometers 2:Verification will be implemented from :Technical Specification for Verification and Inspection of Thermometers( Verification will be implemented from 2008) Medical Measurement Instruments with Q4.-A-Metrology control Procedure-Type Approval or Evaluation/Time Interval- R 7 Clinical thermometers, mercury-inglass /Not Specified (initial only) a R 6- Mechanical non-invasive s /Not Specified (initial only) b R 6-2 Non-invasive automated /Not Specified (initial only) b c R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification c R 04 -Pure-tone Audiometers R 4 Clinical electrical thermometers for continuous measurement c R 5 Clinical electrical thermometers /Not Specified (initial only) c R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical Check with webesite d

5 Medical Measurement Instruments with Q4.-A-Metrology control Procedure-Type Approval or Evaluation/Time Interval-2 a: Exempt form the Premarket procedures b: Subject to Premarket notification application (50K) c: Subject to Premarket notification application (50K) Third party eligible using recognized accredited d: See for a complete explanation and links to the Medical Measurement Instruments with Q4.-B-Metrology control Procedure-Verification/Time Interval R 7 Clinical thermometers, mercury-inglass /Not Specified (initial only) /Not Specified R 6- Mechanical non-invasive s /Not Specified (initial only) / year R 6-2 Non-invasive automated /Not Specified (initial only) ( Verification will be implemented from2009)/ 2 years R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification /2 years R 04 -Pure-tone Audiometers /2 years R 4 Clinical electrical thermometers for continuous measurement R 5 Clinical electrical thermometers /Not Specified (initial only) / year ( Verification will be implemented from2008) /No Specified R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical

6 Medical Measurement Instruments with Q4.2--The level of implementing Pattern Approval or Evaluation R 7 Clinical thermometers, mercuryin-glass R 6- Mechanical non-invasive s R 6-2 Non-invasive automated R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification R 04 -Pure-tone Audiometers R 4 Clinical electrical thermometers for continuous measurement R 5 Clinical electrical thermometers R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical : The CLIA provides "Guidelines for Laboratories" and may be subject to accreditation requirements and proficiency testing. Medical Measurement Instruments with Q4.3--The level of implementing Verification R 7 Clinical thermometers, mercuryin-glass 2,2,3 R 6- Mechanical non-invasive s 2,2,3 R 6-2 Non-invasive automated 2 R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification 2,2,3 R 04 -Pure-tone Audiometers R 4 Clinical electrical thermometers for continuous measurement R 5 Clinical electrical thermometers,2,3 R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical., 2.State/Regional 3.Local/Municipal Accredit Designated Manufactures

7 Medical Measurement Instruments with Q5.-A Other (e.g. health concerned) Responsible Authorities R 7 Clinical thermometers, mercury-inglass Hospital and accredited health facility Requirements R 6- Mechanical non-invasive s Health Dep. Hospital and accredited health facility Requirements R 6-2 Non-invasive automated Hospital and accredited health facility Requirements R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification Hospital and accredited health facility Requirements R 04 -Pure-tone Audiometers Health Dep. & Labor Dep. R 4 Clinical electrical thermometers for continuous measurement R 5 Clinical electrical thermometers R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical : SECRETARÍA DE SALUD, SS, (Health Department, Federal Government) Medical Measurement Instruments with Q5.-B Other (e.g. health concerned) Relatives Regulations R 7 Clinical thermometers, mercuryin-glass R 6- Mechanical non-invasive s R 6-2 Non-invasive automated R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification R 04 -Pure-tone Audiometers R 4 Clinical electrical thermometers for continuous measurement R 5 Clinical electrical thermometers R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical

8 Medical Measurement Instruments with Q5.2 Other Procedure R 7 Clinical thermometers, mercury-in-glass Quality Procedures R 6- Mechanical non-invasive s Quality Procedures R 6-2 Non-invasive automated Quality Procedures R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification Quality Procedures R 04 -Pure-tone Audiometers R 4 Clinical electrical thermometers for continuous measurement R 5 Clinical electrical thermometers with maximum device R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical : Type Approval/Evaluation and Verification Medical Measurement Instruments with Q5.3 The level of Implementation for other R 7 Clinical thermometers, mercuryin-glass R 6- Mechanical non-invasive s R 6-2 Non-invasive automated R 78 Westergren tubes for measurement of erythrocyte sedimentation rate R 90 Electrocardiographs - Metrological characteristics - Methods and equipment for verification R 04 -Pure-tone Audiometers R 4 Clinical electrical thermometers for continuous measurement R 5 Clinical electrical thermometers R 28 Ergometers for foot crank work R 35 Spectrophotometers for medical

9 Medical Measurement Instruments without Q3-A-Responsible Authorities for Metrology control DNG Medical Measurement Instruments without Q3-B-Relative Regulations for Metrology control Federal Law for Metrology and Normalization

10 Medical Measurement Instruments without Q4.-A-Metrology control Procedure-Type Approval or Evaluation/Time Interval Not Required Medical Measurement Instruments without Q4.-B-Metrology control Procedure-Verification Approval or Evaluation/Time Interval / 2 Years / 2 Years / 2 Years / 2 Years / 2 Years

11 Medical Measurement Instruments without Q4.2--The level of implementing Pattern Approval or Evaluation Medical Measurement Instruments without Q4.3--The level of implementing Verification,2,2,2,2., 2.State/Regional 3.Local/Municipal

12 Medical Measurement Instruments without Q5.-A Other (e.g. health concerned) Responsible Authorities : Ministry of Health, Labour and Welfare : Health Department (Subsecretary of Innovation and Quality, CENTEC, COFEPRIS, Programs of Technology Assessment for Health Medical Measurement Instruments without Q5.-B Other (e.g. health concerned) Relatives Regulations Mandatory Std. NOM-208-SSA-2003

13 Q5.2 Other Procedure Medical Measurement Instruments without Medical device market distributions require authorization from the Federal Commission for the Prevention of Sanitary Risks (COFEPRIS- Comision Federal para la Protection) Medical Measurement Instruments without Q5.3 The level of Implementation for other

14 Q6. Kind of medical measurement instruments the WG on Medical Measurements should work medical measurement instruments Comments Clinical thermometers, mercury-in-glass with maximum device, Mechanical non-invasive s, Non-invasive automated, Clinical electrical thermometers for continuous measurement Clinical electrical contact thermometers, Clinical electrical infrared ear-thermometers, Non-invasive automated We expect that such automated portable measuring devices will be widely used in the future. Locally, the metrological control of measuring devices has been focused on industrial applications, neglecting the metrological control of medical devices. Either because of the lack of regulations or limited measuring capabilities to evaluate the conformance of such devices. Traceability of ultrasound measurements to the International System of Units. Are current medical ultrasound measurements traceable to national standards? Do we care? National regulations regarding waster water measurements: NOM 002-SEMARNAT-996, NOM 052-SEMARNAT-2005 This is a low priority subject for the US. Chinese Taipei Automated s, Clinical electrical thermometers Q6.2 Activities on medical measurement instruments APLMF should provide Training Seminar Presentation Others Comments Medical devices are described above mostly used in. The other devices are used in the modern hospitals We expect the WG will continue to organize seminars and present survey results on medical measurements. (Creation of an electronic web site to promote the exchange of technical experiences and scientific developments on metrological issues associated to medical devices) This is a low priority subject to the. Especially, for automated with digital indicator: -How to verify -How to calibrate/ adjust

15 Q6.3 Number of people who would participate in the activities Training Seminar Presentation Others Comments 2 We have no method to verify medical devices. Therefore, we need training our officers both management and inspections. 3 2 We hope to support the activities of WG by preparing speakers for seminars Q6.4 Number of expert(s) contribute as a trainer. Training Seminar Presentation Others Comments 2 We hope to support the activities of WG by preparing speakers for seminars.. Depending on the subject the US will make inquires as to the availability of the trainers. 3

16 Q6.5 Other comments Comments We wish the WG will continue present activities such as organizing seminars and survey on medical measurements.. Survey on the Metrological for the Medical measurement Instruments Conclusion:. According to the responses, basically, only the health authority and metrological authority pay their attention to the medical measurements instruments affairs, though the labour authority may involve in this issue. 2. According to the surveys conducted by this WG during past years, the relative regulations in member economies still quite differ from member economy to economy. Therefore, we encourage member economies make their efforts to harmonize their regulation with OIML and to reduce the technical barrier to trade which is one of the main objects of APLMF. 3. This WG would like to organize training courses in the near future if we could get the support from APLMF and member economies.

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