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What Norms and Standards for Auto-Disable (AD) Syringes ?

What Norms and Standards for Auto-Disable (AD) Syringes ?. Gerald Verollet World Health Organization. Preliminary questions. What are AD syringes Introducing curative AD syringes Appropriate use of AD syringes Forum of AD syringe Manufacturers. Do we need N&S for AD syringes ?.

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What Norms and Standards for Auto-Disable (AD) Syringes ?

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  1. What Norms and Standards for Auto-Disable (AD) Syringes ? Gerald Verollet World Health Organization

  2. Preliminary questions • What are AD syringes • Introducing curative AD syringes • Appropriate use of AD syringes • Forum of AD syringe Manufacturers

  3. Do we need N&S for AD syringes ? • Reference to medical devices N&S • Reference to disposable syringes N&S • Specific N&S for AD syringes for which application ? • Immunization • curative application

  4. Addressing Safety Needs in the Immunization AD Syringe market • Limited market • Well defined users • Existing specifications • WHO/UNICEF policy for use of AD syringes in immunization

  5. Addressing Safety Needs in the Curative AD Syringe Market • Major market • Multiple user profiles • Absence of norms and standards • Absence of evidence regarding prevention effectiveness

  6. Existing options • Nothing specific for AD syringes except WHO spec. for EPI • Manufacturers consensus on AD syringe specifications • International standards

  7. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Pre-market Post-market On-market

  8. Life Cycle of a Medical Device Conception and Design Manufacture Packaging Labelling Advertising Sale Use Disposal Norms and Standards

  9. Standard: Definition • Documented agreements • For consistent use as: • Rules • Guidelines • Definitions of characteristics • To ensure that materials, products, processes, and services are fit for their purpose.

  10. Importance of Norms and Standards • Norms and standards guarantee effectiveness • Norms and standards ensure quality • Definition of quality • Control of quality • Norms and standards provide safety ………. • N&S create a market

  11. Norms and Standards Providers • National standardization • National standard body : e.g., AFNOR • Regional standardization • Regional standard organization : e.g., European Norm (CEN) • International standardization • forum of national standard bodies > ISO

  12. Principle Consensus Industry-wide Voluntary Actors Manufacturers Users National standard bodies Specialists WHO ? Development of International Standards

  13. ISO Standards for Quality and Environment • ISO 9000 • Quality management • ISO 14000 • Environmental management • Systematic approach reduces cost of waste generated

  14. ISO Standards • ISO 9001 and 9002 • General application for products and services • ISO 13485 and 13488 • Medical device industry with or without design control requirement • ISO 7886-1 • Sterile hypodermic syringes for single use • part 1: Syringes for manual use • ISO ???? • AD Syringes

  15. AD Syringes Manufacturers • Assurance that syringes meet / exceed standards • Concept and design • Manufacturing • Packaging and labelling • Technical collaboration to improve standards and safety

  16. Users of AD Syringes • Users should be qualified and trained • Growing consumer demand for safe injections • Awareness regarding risks associated with reuse

  17. Principle Information Authority Harmonization Actors National regulatory authorities Global Harmonization Task Force (GHTF) WHO ? Implementation of International Standards

  18. National Regulatory Authorities • Responsibility to ensure syringes safety and effectiveness • Periodic review of policies and regulations • Export / manufacturer’s certificate

  19. Control Authorities • Manufacturer’s declarations • Private testing laboratories • E.g., “Notified body” for CE mark products • E.g., TUV in Germany • Each country could have its own • Auditing

  20. Global Harmonization Task Forcehttp://www.ghtf.org • Forum for: • National regulatory authorities • Industry representatives • Objectives: • Convergence of national regulations • Promotion of technological innovation • Facilitation of international trade

  21. Global Harmonization Task ForceStudy Groups 1- Regulatory requirements / pre-market review 2- Medical device vigilance / post-market surveillance 3- Quality system requirements and guidance • Collaboration with ISO 4- Auditing

  22. World Health Organization • Co-ordination of post-market surveillance • Arbitration on export certification • Ethical assurance • Independent review of field evaluation results • Contacts with Ministries of Health

  23. Actors of the Quality System • Norms and standards providers • Global Harmonization Task Force (GHTF) • National regulatory authorities • AD syringes manufacturers • Users • WHO • Control authorities

  24. Communication Between the Actors AD syringes manufacturers Nal Reg A Users ISO GHTF WHO

  25. Communication Between the Actors AD Syringe Manufacturers Nal Reg A Users ISO GHTF WHO

  26. Questions for the AudienceWhat N&S for AD syringes ? • What definition for an AD syringe ? • How can we collaborate on a global quality and safety policy for AD and other syringes ? • Do we need a specific ISO standard for AD syringes?

  27. The Good AD Syringe definition:The World’s Perspective • Manufactured according to international standards • Used only once • Safe and easy to dispose

  28. Questions for the AudienceWhat N&S for AD syringes ? • What definition for an AD syringe ? • How can we collaborate on a global quality and safety policy for AD and other syringes ? • Do we need a specific ISO standard for AD syringes?

  29. Forum for AD Syringes Manufacturers • Consensus on waste management • Training strategy for user • Co-ordination of AD syringes field evaluation • Exchange of information • One voice for negotiation with ISO, GHTF, and WHO • Relation with the Healthcare Industry Manufacturer Associations (EUCOMED, ADVAMED,..)

  30. Questions for the AudienceWhat N&S for AD syringes ? • What definition for an AD syringe ? • How can we collaborate on a global quality and safety policy for AD and other syringes ? • Do we need a specific ISO standard for AD syringes?

  31. Answer:Yes, A specific International standard for AD syringes is recommended • First step : Preparation of a proposal prepared by the forum of AD syringe manufacturers • second step : Presentation of the proposal to the ISO /TC 84 • ………...

  32. Is it a SIGN Objective... • Specific • International • Guarantee on • Norms & Standards • ……………... for AD Syringes

  33. AD Syringe Market,a Healthcare challenge • Reduction of unsafe infection • Reduction of contamination with waste • Healthcare industry leading the safe and clean products campaign • >>> Safe injection / No waste

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