WHO Medical Devices

1. WHO Medical Devices Blood Safety & Clinical Technology Department

2. HTP Cluster Health Technology & Pharmaceuticals Essential Drugs & Medicines Policy (EDM) Vaccines & Biologicals (VAB) Blood Safety & Clinical Technology (BCT)

3. EDM Department Quality Assurance and Safety: Medicines Policy, Access and Rational Use Drug Action Programme Traditional Medicine

4. VAB Department Quality Assurance and Safety: Biological Vaccine Development Vaccine Assessment and Monitoring Access to Technologies Expanded Programme on Immunisation

5. BCT Department Quality and safety of Plasma Derivatives and Related Substances Blood Transfusion Safety Diagnostic imaging and Laboratory Technology Devices and Clinical Technology (DCT)

7. DCT Teams Clinical technology Safe Injection Global Network (SIGN) Medical devices

8. S.I.G.N. Origins Injection overuse and unsafe practices lead to large scale transmission of blood borne pathogens Prevention strategies need to address: Reduction of overuse Achievement of safety Prevention requires a multidisciplinary approach Existence of an informal network, initiated from the field of immunisation

9. S.I.G.N. definition Voluntary association of stakeholders WHO based secretariat & SIGN associates Collaborations: UN organizations, NGOs, Governments, universities, Industry, Professional organizations

10. Medical Devices projects Related to Blood Safety Related to Injection Safety Related to Medical Device Quality and Safety

11. Internal Partners WHO clusters /departments EIP / Organization of health Service delivery SDE / Protection of human environment �.. WHO regions PAHO /AMRO �..

12. Collaboration with PAHO On regional project in the area of medical device Consultation for the development of WHO guidelines on regulation for medical devices Join collaboration with GHTF Benefit from PAHO leadership in organization and coordination of Internet based discussion groups : Med-Devices, Infratech, E.H.T.P,..

13. External partners WHO collaborating centres M.D. regulatory authorities NGOs medical device manufacturers ISO GHTF �..

14. American collaboration FDA Development of a model program for medical devices: An International Guide. MD database : FDA web-site : www.fda.gov/cdrh Collaborating centers : ECRI,�. �..

15. MD Projects related to Blood Safety Haemoglobin colour scale Blood cold chain Blood waste management

16. Haemoglobin colour scale Simple and inexpensive device for the estimation of haemoglobin level design and clinical evaluation done move to commercial partner for production, promotion and distribution

17. Blood cold chain Evaluation of blood cold chain equipment Refrigerators other equipment Implementation of Phase II (3 years)

18. Blood waste management Review of the Literature Guidance document for the disposal of blood waste

19. MD Projects related to Injection Safety Norms and standards for Auto-Disable (AD) syringes Syringes and needle waste management

20. Norms and standards for AD syringes Forum of AD syringe manufacturers proposal for ISO TC 84 Validation of international standard for AD Syringes

21. Syringes and needles waste management Policy for sharp waste Assessment of waste management system Selection of appropriate waste disposal system Regulatory framework adequate resources implementation of waste management system Training and supervision

22. MD Quality & Safety projects Management & maintenance of healthcare equipment Medical waste management Establishing Norms and Standards Harmonization on regulation

23. Management & maintenance of Healthcare Equip. Situation analysis in selected countries Essential Healthcare Technology package Development of management toolkit Improving the process of equipment donations Tools for technical maintenance Specific projects on maintenance Managerial and technical capacity building

24. Medical waste management Joint program with WHO - SDE/PHE to : Develop evidence base and information for policy Prepare guidance material Achieve safety and availability of waste management options Support the development of country plans Aide-Memoire on Safe HCWM

25. Establishing Norms and Standards Liaison Status with ISO technical committees TC 84 : Medical devices for injections TC 210 : Quality management and corresponding general aspect for medical devices Development of an acceptable medical device Nomenclature system UMDNS (ECRI) and/or GMDNS (ISO /CEN) �...

26. Harmonization on regulation (1) Collaboration with GHTF and its study groups SG 1 : M.D. regulatory requirement / pre-market review SG 2 : M.D. vigilance/ post-market surveillance SG 3 : M.D. quality system requirement & guidance Memorandum of Understanding signed with ISO/TC 210 SG 4 : M.D. auditing

27. Harmonization on regulation (2) definition of specific contribution for a better convergence in regulatory practices�.. Possible options : Support to the establishment of an international database on post market surveillance Facilitate the development of an uniform format for an internationally accepted Export Certificate for medical devices Memorandum of Understanding with GHTF � ?

28. Do we have SMART Objectives Specific Measurable Achievable Reasonable Time related

29. Aide-memoire on MD Objective Presentation: Leaflet Introduction Checklist Words of advice Key elements circulation and revision of the draft Med-Devices, GHTF conference,�...