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 ? • Reference to medical devices N&S • Reference to disposable syringes N&S • Specific N&S for AD syringes for which application ? • Immunization • curative application

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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?

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

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,..)

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 • ………...

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

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

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