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Working group on POCT


       Report
Working group
 Iceland
 Italy
 Norway
 Spain
 Sweden
 Annette Artelt EPBS
Questionnaire from Italy
 Sent in 2007
 Evaluated the answers from from:
   Iceland
   The Netherlands
   Sweden
   Norway...
Questionnaire
 What kind of information is necessary in order
 to move forward on this subject?
 Detailed questionnaire – ...
Questions sent to members before this
meeting
 Policy regarding POCT
 Implementation of ISO standard 22870:2006
 Certifica...
Policies received
 IBMS United Kingdom
 AMLS Ireland
 LabMed Switzerland
 Australia
 Sweden
 Norway
ISO 22870:2006 Point-of-care testing (POCT) --
Requirements for quality and competence

    ISO 22870:2006 gives specific ...
Implementation of ISO 22870
 Work just starting in most countries
Certification of POCT instruments
 IVD Directive
   HMS regulations
   Description of the instrument
   No regulation of t...
Certification of POCT instruments
 UK: Guidance Notes from the Medicines and
 Healthcare products Regulatory Agency
 The D...
Certification of POCT instruments
 Scandinavia: The Scandinavian evaluation of
 laboratory equipment for primary health ca...
Continuing work
 Focus on the quality and the performance of
 the tests
 What kind of tests should be used
 Requirements f...
Common policy
 Question from IFBLS:
   Common policy for IFBLS and EPBS?
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Working Group On Poct

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Presentation outlining the working group's analysis of issues regarding the implementation of POCT directives and the certification of POCT instruments. Work continues to work on issues and develop a common policy.
http://www.epbs.net/bratislava/index.htm

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Working Group On Poct

  1. 1. Working group on POCT Report
  2. 2. Working group Iceland Italy Norway Spain Sweden Annette Artelt EPBS
  3. 3. Questionnaire from Italy Sent in 2007 Evaluated the answers from from: Iceland The Netherlands Sweden Norway Spain
  4. 4. Questionnaire What kind of information is necessary in order to move forward on this subject? Detailed questionnaire – challenges Lack of regulations Diversity within countries
  5. 5. Questions sent to members before this meeting Policy regarding POCT Implementation of ISO standard 22870:2006 Certification of POCT instruments
  6. 6. Policies received IBMS United Kingdom AMLS Ireland LabMed Switzerland Australia Sweden Norway
  7. 7. ISO 22870:2006 Point-of-care testing (POCT) -- Requirements for quality and competence ISO 22870:2006 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of ISO 22870:2006 apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. Patient self-testing in a home or community setting is excluded, but elements of ISO 22870:2006 can be applicable.
  8. 8. Implementation of ISO 22870 Work just starting in most countries
  9. 9. Certification of POCT instruments IVD Directive HMS regulations Description of the instrument No regulation of the sensitivity and specificity of the Analyte
  10. 10. Certification of POCT instruments UK: Guidance Notes from the Medicines and Healthcare products Regulatory Agency The Dutch Healthcare Directorate
  11. 11. Certification of POCT instruments Scandinavia: The Scandinavian evaluation of laboratory equipment for primary health care (SKUP) SKUP gathers information about laboratory instruments intended for use in primary care, as well as organising assessment of such instruments The goal of SKUP is to produce objective and independent information concerning the quality and user-friendliness of laboratory equipment for physicians' offices outside the hospital
  12. 12. Continuing work Focus on the quality and the performance of the tests What kind of tests should be used Requirements for quality of instruments Requirements of competence Questionnaire?
  13. 13. Common policy Question from IFBLS: Common policy for IFBLS and EPBS?

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