Towards ISO Standards for AD syringes: Update from WHO Gerald Verollet World Health Organization 3rd SIGN Meeting - New Delhi
The Good AD Syringe definition:The World’s Perspective • Manufactured according to international standards • Used only once • Safe and easy to dispose
Curative Major market Multiple user profiles Absence of norms and standards Absence of evidence regarding prevention effectiveness Immunization Limited market well defined users existing specifications WHO/UNICEF policy for use of AD syringes in Immunization AD syringe market: The situation today
From the last SIGN meeting Specific International Standard for AD syringes was recommended
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.
Principle Consensus Industry-wide Voluntary Actors Manufacturers users National standard bodies Specialists WHO ? Development of International Standards
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
WHO relations with ISO • Category A liaison status with TC 84 • Official relation with ISO
Stages of the development of International Standards • Proposal: Presentation of the proposal to the ISO /TC 84 “NEW WORK ITEM PROPOSAL” • Preparatory • Committee • Enquiry • Approval • Publication
World Health Organization • Contact with ISO for the proposal • Contribution to field evaluation of AD syringes • Independent review of field evaluation results • development of guideline for regulation on MD • Aide-memoire on medical device • Co-ordination of post-market surveillance • Arbitration on export certification • Ethical assurance • Contacts with Ministries of Health
AD Syringes Manufacturers • Assurance that syringes meet / exceed standards • Concept and design • Manufacturing • Packaging and labelling • Technical collaboration to improve standards and safety • International Association of Safe Injection Technologies (IASIT) • PULL or PUSH > Proactive Approach ?
Recognition and use of international standards • Production of good standards is not enough • Recognition of standards is needed
National Regulatory Authorities • Responsibility to ensure syringes safety and effectiveness • Periodic review of policies and regulations • selection of control authorities
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
Our Objective is now to... • Speed up the • Introduction of • Good • Norms & Standards • ……………... for AD Syringes