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

AD syringe market: The situation today 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 Immunization –Limited market –well defined users –existing specifications –WHO/UNICEF policy for use of AD syringes in Immunization

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.

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

ISO Standards ISO 9001 and 9002 –General application for products and services ISO and –Medical device industry with or without design control requirement ISO –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

Conclusion

Our Objective is now to... S peed up the I ntroduction of G ood N orms & Standards ……………... for AD Syringes